Minutesof286thmeetingofRegistration Board - 14jan2019 PDF

MINUTES OF 286th MEETING OF REGISTRATION BOARD
HELD ON 14th to 16th NOVEMBER, 2018
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Item Detail of Item Pages

No.
I. Confirmation of Minutes: 03
a. Minutes of 285th meeting of Registration Board
II. Letter of Dr. Amanullah Khan (Director DTL, Balochistan Quetta) 04 – 06
regarding approval of panel for inspections
III. Availability/Shortage of Life Saving Drugs 07 – 15
IV. Division of Pharmaceutical Evaluation & Registration. 16 – 749
 Pharmaceutical Evaluation Cell (PEC) … …. . (16-552)
 Registration-I ………. …………. ………….. (553-596)
 Registration-II ………… ……….. …….. ….. (597-637)
 Registration-III ………… ………… ……….. (638-660)
 Registration-IV . ………… ……… ………… (661-663)
 Registration-V …………. …………. ………. (664-685)
 RRR Section …………… …………. ……….. (686-746)
 Export Facilitation Desk……… ……… ……. (747-749)
V. Division of Biological Evaluation & Research 750 – 803

VI. QA & LT Division 804 – 830
VII. Additional Agenda 831 – 1011
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4
Islamabad.
Minutes for 286th Meeting of Registration Board , DRAP (14 – 16th November, 2018) |1
286th meeting of Registration Board was held on 14–16th November, 2018 in the
committee room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting
was chaired by Dr. Obaidullah, Director, Pharmaceutical Evaluation & Registration Division,
DRAP. The meeting started with recitation of the Holy Verses. The meeting was attended by
following:-
1. Dr. Rafeeq Alam Khan Member
Meritorious Professor/Chairman, Faculty of Pharmacy,
Univeristy of Karachi. (Pharmacologist)
2. Maj.Gen. Dr. Tahir Mukhtar Sayed. Member
Director General Medicine, Pak Army, Rawalpindi. (Physician)
3. Prof.Dr.Ghulam Sarwar. Member
Dean,Faculty of Pharmacy, Jinnah University for Women, Karachi
(Expert in Drug Manufacturing)
4. Dr.Aslam Shah, Senior Manager, Member
Indus Hospital, Karachi (Expert in Hospital Pharmacy)
5. Dr.Qurban Ali, ex-Director General, Member
National Veterinary Laboratory (Expert in Veterinary Medicine)
6. Dr. Amanullah Khan, Member
Director, Drugs Testing Laboratory, Quetta
Government of Balochistan/ Provincial Member
7. Dr. Shafiq ur Rehman, Member
Director, Drugs Testing Laboratory, Lahore
Government of Punjab/ Provincial Member
8. Syed Adnan Rizvi, Member
Director, Drugs Testing Laboratory, Karachi
Government of Sindh/ Provincial Member
9. Dr. Muhammad Khalid Jawed, Member
Director, Drugs Testing Laboratory, Peshawar
Government of Khyber Pakhtunkhwa/ Provincial Member
10. Mr. Muhammad Aslam, Member
Assistant Draftsman-II, Ministry of Law & Justice, Islamabad
11. Dr. Noor-us-Saba, Member
Director, Biological Evaluation & Research Division, DRAP
12. Dr. Hafsa Karam Ellahi, Additional Director, Member
Representative of QA&LT Division, DRAP
13. Mr. Abdullah, Member
Additional Director (PE&R), DRAP.
14. Dr.Muhammad Akram, Represntative of Animal Husbandry Co-opted
Commissioner, M/o National Food Security & Research. Member
Dr. Muhammad Akram, Reprentative of Animal Husbandry Commissioner attended

the meeting on 16th November, 2018 only.
Mr. Zaheeruddin M.Babar (Dy.Director-Reg.I), Mr. Muhammad Amin (Dy.Director-
Reg.II/IV), Mst.Tehreem Sara (Dy.Director-RRR) and Mr. Asif Jalil (Incharge PEC), assisted
by respective Assistant Directors presented the agenda of PE&R Division. Director, BE&R
was assisted by respective Assistant Directors, presented the agenda of Biological Evaluation
& Research Division. Dr.Hafsa Karam Ellahi (Additional Director) & Mr. Abdul Sattar
Suhrani (Dy./Add:Director) presented the agenda of QA & LT Division.
Mr. Farooq Bukhari, Mr. Hamid Raza, Mr. Arshad Mehmood & Mr. Iftikhar (PPMA),
Dr.Sadia Moazam & Dr. Aftab Ahmed Khan, (Pharma Bureau) and Mr. M.Asad Malik
(PCDA) attended the meeting as observers.
Item No.I: Confirmation of Minutes of 285th Meeting of Registration Board.
285th meeting of Registration Board was held on 3rd to 4th October, 2018. The draft minutes
were circulated among the members of meeting on 1st November, 2018 with the request to
forward their comments (if any) within 04 to 05 days. None of the members have disagreed
the draft minutes. Fair minutes duly approved and signed by Chairman Registration Board
have been circulated to all memebers and concerned divisions for implementation.
Dr. Amanullah Khan, Director DTL, Govt. of Balochistan has written a letter via email
addressed to the Secretary, Registration Board regarding approval of panel for inspection by
Registration for local drug manufacturers and imported abroad drug manufacturers. The
above letter is not concerned with 285th meeting of Registration Board. The said letter has
been placed in instant meeting of Registration Board as an agenda item for its consideration.
Decision: Registration Board confirmed the minutes of 285th meeting of

Registration Board.
Item No. II: Letter of Dr.Amanullah Khan (Director DTL, Balochistan Quetta)
regarding approval of panel for inspections
Subject: Approval of PANEL for INSPECTIONS by the Registration Board for local
drug Manufacturer (s) and Imported Abroad drug Manufacturer(s) .
Dear Sir,
Reference to the subject, It is observed with serious concerned ,that panel for inspection(s) in
some cases are constituted without the approval of the registration board which is violation of
rule 24(4) of the Drugs (L.R & A.) Rules 1976.
Chapter III
REGISRATION OF DRUGS
The Drugs (L.R & A) Rules, 1976 Rules 24 (4) are reproduced here and read as;
“The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of
the Board the premises of a manufacturer of drugs and to submit its report to the Board”.
In this context it is submitted that being a responsible members of the registration board it
becomes necessary to abide the Drug Rules in its true letter and spirit.
In some cases I personally feel that the rules are over looked and in the process the panel(s) is
constituted without the approval of the board.
As a member of the registration board I do expect that in future the registration board which
is the only authorize body shall constitute the panel for inspection(s) for the approval of drug
molecule(s) for the local manufacturer within country and imported drug molecule(s) abroad
or as the case may be.
The collective wisdom of the entire registration board is required for the smooth and effective
working of the board in the national interest.
Furthermore it is also proposed that all those panel(s) for inspection cases which are
constituted without the approval of the registration board may be brought back to the
registration board for one time retrospective approval to avoid any legal complication from
any concerned quarters
Regards
Dr Amanullah khan
Director DTL, Balochistan Quetta.
Discussion: The Board was apprised that as per Rule 24 (10) of Drugs (L,R &A) Rules,
1976 Registration Board in 262nd meeting dated 20-21st October, 2016 authorized its
Chairman for deciding various matter including constitution of panel of inspectors for
product specific and GMP inspections. Such panel include member of Registration Board,
Central Licensing Board, Policy Board, officers of DRAP and provincial Drugs Control
Administration. Moreover, panels for abroad inspections are also approved by Secretary, M/o
NHSR&Co. It is pertinent to mention that August member who has dissented was also part of
262nd Registration Board meeting.
Dr Amanullah Khan, Director DTL, Quetta submitted his note of dissent, which he has also
forwarded via e-mail with the request to incorporate in main minutes. It reads as under:
“I feel its violation of rule 24 (4) of the Drugs (L.R & A.) Rules 1976 to constitute
panel(s) of experts for inspection without the approval of the August Registration
Board.
Mr Chairman Registration Board has informed that in 262 –M, already powers has
been delegated to the Chairman to constitute panel of experts for inspection it might
be true but I strongly disagree with such centralized indefinite power of delegation .
The delegation of power may not be demanded by the chairman RB because in the
mind of every member there arises a question of favouritism or compulsion. In some
cases such as in a very minor case or in an urgency in specific case one time power
may be delegated to the Chairman RB but it should not be for the indefinite period.”
The Board was apprised that delegation of power is covered under the Drugs (Licensing,
Registering & Advertising) Rules, 1976 and since then such delegation of powers are
entrusted to Chairman Registration Board for disposal of day to business of the Board. The
under mentioned rule position was read by Secretary Registration Board during meeting:
"The Registration Board may authorize Chairperson, or any of its member for
performance of specific functions of Board including the disposal of day to day
business of Board through the Secretary of the Registration Board."
The Board was further apprised that it has delegated its various powers to its Chairman as per
above rule in its 262nd meeting held on 20-21st October, 2016. Since then, Chairman is
performing such functions as per rules and procedures / SOPs as approved by Registration
Board. August member who has dissented was also part of that meeting.
Furthermore, Registration Board in 277th meeting dated 27–29th December, 2017
again discussed matter for constitution of panel for verification of stability data and decided
as under.
"Registration Board deliberated that inorder to ensure earliest availability of generic version
of new drug formulation, it is important to adopt a swift and robust process for verification of
stability data. In this regard, panel are being constituted by Registration Board. However, at
times availability of members of panels delay the on-premises verification of stability data.
Therefore, Board decided to authorize its Chairman for constitution of panel for verification
of stability data".
Performance of various functions by Chairman, Registration Board is done mostly
through Post Registration Variation Committee (PRVC) as per SOPs approved by the Board.
Same was also informed to Registration Board in 277th meeting dated 27–29th December,
2017 as follows:
Case No.01: Constitution of Post Registration Variation Committee (PRVC).

Registration Board has authorized Chairman for performance various functions. Such
cases are processed on file by concerned registration section for decision. It has been decided
that in order to increase the efficiency of work and to increase the output of the Division, a
Committee under the title ‘Post Registration Variation Committee’ (PRVC) has been
constituted with following composition:
i. Director (PE&R)/Chairman Registration Board.
ii. Additional Director (PE&R)/Secretary Registration Board.
iii. Deputy Director (concerned section) and/ or Assistant Director (concerned
section).
2. The Committee shall work with following TORs:-
a) This committee shall be authorized to process all such cases for which Chairman
Registration Board or any other functionary of PE&R Division has been authorized by
the Registration Board. All such miscellaneous cases received in the concerned
sections shall be considered by this committee for evaluation and decision making in
the light of prevailing SOPs and relevant rules position.
b) The committee shall meet preferably twice a week and presence of Chairman and at
least two members is mandatory to process cases of respective sections.
c) To make recommendations for improving the procedure/process of Post Registration
Variation cases for consideration of competent authority/forum.
d) All cases of post registration variations that are received in each section during this
time shall be presented by each section before the committee with complete working
on the case as per SOP approved by Registration Board.
e) All the sections of PE&R Division shall prepare minutes of their relevant cases and
communicate the decisions of the committee immediately.
Decision: Registration Board endorsed the procedure adopted for consideration of post-
registration variations and grant of export registrations
During preparation of draft minutes, two other members namely Dr. Ghulam Sarwar & Syed
Adnan Rizvi (Director DTL Karachi) also sent an e-mail wherein they endorsed the above
note of dissent of Dr. Amanullah Khan; However, no such dissent was shown by the above
two members during meeting.
Decision: Registration Board noticed that the powers delegated to Chairman

Registration Board in 262nd meeting for panel constitution and other
functions are in accordance with the provisions of Drugs (Licensing,
Registering and Advertising) Rules 1976 and therefore legal status of this
practice cannot be questioned. It was also observed that such powers of
the Board are not for an unlimited period, rather powers have been
delegated for a period of three years only.
Furthermore, job of power delegation is entrusted and related to the ex-

officio position and designation of Chairman Registration Board and it is
not person specific. Chairs of the Board are being changed according to
Government decisions and this has happened in recent past; hence these
powers are not specific to a single personality.
Moreover, performance and functions of the Board executed through its

secretariat is a robust indicator that shows that Registration process,
dossier evaluation, post registration variation approvals, panel
constitution and subsequent inspections resulted in prompt availability of
many life saving medicines including new drug entities. Panel members
forward their recommendations to Registration Board as per approved
format and the Board takes final decision about a drug product after
deliberation on findings / recommendations of inspection panel.
Keeping in view the rule position explained above and performance

shown by Registration Board, it was decided that power delegation under
Rule 24 (10) of Drugs (Licensing, Registering and Advertising) Rules 1976
be continued till the tenure of present Board gets completed.
Item No. III Availability/Shortage of Life Saving Drugs.
A committee to ensure availability of life saving drugs is working on directions of the

CEO, DRAP. Five meetings of the committee have been conducted so far to resolve the
complaints from different quarters regarding non-availability of different life saving drugs for
public and many of the products have been ensured to be available in market by efforts of the
committee.
The committee discussed and decided followings items in its 5th meeting held on 14th
September, 2018 and for which support of Registration Board is needed to ensure free
availability of Life Saving Drugs by implementing the recommendations of committee as
decided or any other action as the Board deems fit.
A. Shortage of Following Drugs as reported by Sheikh Zayed Hospital, R.Y. Khan:-

 Letter dated: 12.06.2018 from CDC, Punjab to relevant firms to ensure availability.
 Letter dated: 11.08.2018 from SZH R.Y. Khan to relevant firms to ensure availability.
 Letter dated: 31.08.2018 from Section Officer (Purchase-I), Specialized Healthcare &
Medical Education Department, Government of Punjab to relevant firms to ensure
availability.
S. No. Item
1. Inj. Pheniramine Maleate
2. Tab. Acetazolamide 250mg
3. Inj. Adernaline
4. Inj. Atropine
5. Tab. Phenobarbitone
6. Inj. Verapamil
7. Inj. Digoxin 0.5mg / 2ml
Note:-
CDC, Punjab reported vide letter dated 04.09.2018 that they are also problems of
black marketing (specially in case of Calcium Gluconate Injection) and lack of cooperation of
M/s. Ethical Laboratories regarding fulfilling the shortage of AZM Tablet.
2. CDC, Punjab further reported that despite working of two and half months, there was
only improvement of fulfilling of shortage of single drug i.e. Benzyl Penicillin Injection.
While all others drugs remained short and further reported that same issue has been addressed
by Specialized Healthcare & Medical Education Department, Punjab. CDC, Punjab requested
to take necessary action in this regard.
PROCEEDING OF THE MEETING:-

The Secretary committee apprised the committee’s members that the matter for non-
availability of these generic medicines were already taken up and discussed in 4th meeting of
committee on availability of life saving drugs. There are following reasons for non-
availability of these generic medicines.
S. No. Item Reason of Non-Availability
1. Inj. Pheniramine Maleate M/s. Sanofi Aventis replied that Avil Inj. (Pheniramine) is not
available due to some challenges.
2. Tab. Acetazolamide 250mg M/s. Ethical Labs. replied that AZM Tab. (Acetazolamide) is not
being manufactured due to low price.
M/s. Remington Pharmaceuticals replied that we are not
manufacturing our product Setacar Tablets (Acetazolamide) with
registration # 016666, as its production cost is not economically
viable and it was discontinued in January, 2009
3. Inj. Adernaline M/s. Venus Pharma, M/s. Elite Pharma, M/s. PDH and M/s. Bajwa
Pharma replied that Adernaline Inj. is not commercially viable.
4. Inj. Atropine M/s. Venus Pharma, M/s. Elite Pharma, M/s. PDH and M/s. Bajwa
Pharma replied that Atropine Inj. is not commercially viable.
5. Tab. Phenobarbitone M/s. Ferozsons replied that 194-KG quota is not sufficient for supply
whole year and demanded 600-KG quota.
6. Inj. Verapamil M/s. Abbott replied that Isoptin Inj. (Verapamil) is not available
from last five years due to low price.
M/s. Searle IV Solutions replied that Calan Inj. (Verapamil) is on
stability studies and more over also showed concerns our low price.
7. Inj. Digoxin 0.5mg / 2ml M/s. GSK replied that Lanoxin Inj. (Digoxin) is now available in
market.
DECISION:-
The matter of non-availability is being referred to Registration Board along with reply of the
firm and reasons for non-availability of above mentioned generic medicines for taking further
necessary action by the Registration Board as already recommended in 4th meeting of
committee that the matter may be placed before Registration Board as agenda item for the
issuance of show cause notice for non-compliance to the condition of registration or any other
action which the Registration Board may deem appropriate.
B. Shortage of Drugs as reported by CDC, Punjab vide letter dated 08.09.2018:-

CDC, Punjab informed that following critically needed drugs remained short in the
month of August, 2018 in the market of the Punjab.
S. No. Item No. of Districts where Reason of Non-Availability
non-availability of
medicine is reported
1. Amphotericin B 23
2. Clobazam 19 M/s. Sanofi Aventis replied that Frisium 10mg Tab.
(Clobazam) is available in market.
3. Acetazolmide 15 M/s. Ethical Labs. replied that AZM Tab.
(Acetazolamide) is not being manufactured due to
low price.
M/s. Remington Pharmaceuticals replied that we are
not manufacturing our product Setacar Tablets
(Acetazolamide) with registration # 016666, as its
production cost is not economically viable and it was
discontinued in January, 2009
4. Quinine 15
5. Ergotamine 14 M/s. GSK showed concerns on quota allocation of
combination Ergotamine.
(Migril etc)
6. Phenobarbitone 12 M/s. Ferozsons replied that 194-KG quota is not
sufficient for supply whole year and demanded 600-
KG quota.
7. Atropine 08 M/s. Venus Pharma, M/s. Elite Pharma, M/s. PDH
and M/s. Bajwa Pharma replied that Atropine Inj. is
not commercially viable.
8. Verapamil 07 M/s. Abbott replied that Isoptin Inj. (Verapamil) is
not available from last five years due to low price.
M/s. Searle IV Solutions replied that Calan Inj.
(Verapamil) is on stability studies and more over
also showed concerns our low price.
9. Nifedipine 07 M/s. Sanofi Aventis replied that Adalat LA 30 Tab.
and Adalat LA 60 Tab. (Nifedipine) are available in
market now. Previously, there were some issues in
import.
10. Hydrochlorthiazide 05
11. Thyroxin 04 M/s. GSK replied that thyroxine tablets freely
available in market.
12. Alprazolam 03 M/s. Pfizer replied that xanax is available in market.
Minutes for 286 Meeting of Registration Board , DRAP (14 – 16th November, 2018)
th
|8
13. Digoxin 02 M/s. GSK replied that Lanoxin Inj. (Digoxin) is now
available in market.
14. Chlorpheneramine 02
Maleate
15. Methylergometrine 01 M/s. Shaigan replied that they are not manufacturing
(Methergin) Ergomine Injection (Methylergometrine) due to
pricing hardship.

The Secretary committee apprised the committee’s members that the matter for non-
availability of these generic medicines were already taken up and discussed in 4th meeting of
committee on availability of life saving drugs. There are following reasons for non-
availability of these generic medicines.
DECISION:-
The matter of non-availability is being referred to Registration Board along with reply
of the firm and reasons for non-availability of above mentioned generic medicines for taking
further necessary action by the Registration Board as already recommended in 4 th meeting of
C. Shortage of Drugs as reported by CDC, Punjab vide letter dated 10.08.2018

CDC, Punjab informed that following critically needed drugs remained short in the
month of July, 2018 in the market of the Punjab.
S. Item No. of Districts where non- Reason of Non-
No. availability of medicine is Availability
reported
a. Acetazolamide 22 Same as mentioned in
agenda item no. I & II.
b. Clobazam 19 -do-
c. Quinine 18 -do-
d. Ergotamine combination (Migril etc) 16 -do-
e. Phenobarbitone 14 -do-
f. Methylergotamine (Methergin) 14 -do-
g. Atropine 11 -do-
h. Hydrochlorthiazide 10 -do-
i. Nifedipine 08 -do-
j. Verapamil 04 -do-
k. Digoxin 04 -do-
l. Chlorpheneramine Maleate 02 -do-
m. Thyroxin 02 -do-
n. Alprazolam 02 -do-
Note:-
A letter has been sent to Secretary (DRB), DRAP, Islamabad for the provision of the
registered brands of above mentioned Generic Medicines which remained short in the month
of July, 2018 as reported by CDC, Punjab so that proper surveys may be conducted to ensure
availability.
DECISION:-
D. Non-Availability of Vaccines (MMR/Hepatitis-A) as reported by Shifa International

Hospitals Ltd, Islamabad vide letter dated 20.08.2018
S. No. Item Short Since Reason of Non-Availability

1. MMR or MMR-V March, 2018 M/s. GSK replied that cannot supply till 2019 due
to globally constrain in supply due to unexpected
issues during one of the complex manufacturing
processes.
M/s. Sanofi Aventis replied that the production of
MMR vaccine has been discontinued globally and
will be no more available in future.
2. Hepatitis-A Sept, 2015 M/s. Sindh Medical Store replied that vaccine will
be available within couple of month.
DECISION:-
E. Non-Availability of Rabies Vaccines
Sr. Brand Name Registration Holder Reason of Non-Availability/ Reply
No. From the Registration Holder
1. Verorab M/s. Sanofi-aventis Pakistan Vaccines by Sanofi Pasteur are
Limited, Karachi. manufactured globally at a single source
to fulfill the requirements of whole world
and supplies of Rabies Vaccine are
constrained due to increase in global
demand.
2. Lyssavac-N M/s. Hakimsons (impex) (Private) Discontinued in 2016.
Ltd. Karachi.
3. Indirab M/s. Hospital Services & Sales, Our Principal is not in a position to
Karachi. supply Indirab as there are restrictions by
Indian Government for exports due to
great scandal of Chinese Vaccines
withdrawal.
4. Rabi Gene M/s. Gene-Tech Laboratories, Our parent company M/s. Institute
Vaccine Karachi. Butantan has excused the production of
vaccine with the excuse of reforms.
5. Rabies M/s. National Institute of Health, Non-Availability is due to late
Vaccine Park Road, Islamabad. Registration of changed Source by
Registration Board.
F. Discontinuation of Supply of Humatrope 5mg (15IU) Injections

M/s. Eli Lilly Pakistan (Pvt) Ltd, Karachi has applied for discontinuation of supply of
Humatrope.
Sr. No. Item 282nd DRB Decision
1. Humatrope 5mg (15IU) Injections Registration Board referred the application to the
Reg. No. 041179 committee on availability of life saving drugs
Minutes for 286th Meeting of Registration Board , DRAP (14 – 16th November, 2018) | 10
The Secretary committee apprised the committee members that following list of
Registered alternative brands of “Humatrope” is shared by Biological Drugs Division:-
Sr.# Reg. No. Brand Name & Composition Importer
1. 088708 Omnitrope Solution for Injection M/s. Novartis Pharma (Pakistan)
Each mL contains:- Limited, Karachi
Somatropin…………3.3mg
2. 088709 Omnitrope Solution for Injection -do-
Each mL contains:-
Somatropin…………6.7mg
3. 039824 Eutropin Injection 4IU M/s. Hoffmann Human Health
Each vial contains:- Pakistan Ltd., Lahore
Recombinant Human Growth Hormone 4IU.
4. 014989 Saizen Injection 10 I.U. M/s. Hilton Pharma, Karachi
Each vial contains:-
Somatropin (V-Hgh) 10 I.U.
5. 014990 Saizen Injection 4 I.U. -do-
Somatropin (V-Hgh) 4 I.U.
6. 018289 Eutropin Injection M/s. Majeed Sons, Rawalpindi
Human Growth Hormone Recombinant
Somatropin 40 I.U.
7. 028494 HHT Freeze Dried Powder for Injection M/s. Seignior Pharma, Karachi
Somatropin 4 I.U.
8. 041173 Norditropin Nordilet 5mg/1.5ml Solution for M/s. Novins International (Pvt)
Injection Ltd., Karachi
Each mL Solution contains:-
Somatropin………3.3mg
9. 041174 Norditropin Nordilet 10mg/1.5ml Solution for -do-
Injection
Each mL Solution contains:-
Somatropin………6.7mg
10. 047639 Humatrope 6mg Cartridge Kit Injection M/s. Eli Lilly Pakistan (Pvt) Ltd,
Cartridge Kit contains:- Karachi
One Humatrope Cartridge contains 6mg
Somatropin (Rdna Origin)
One Prefilled Diluent Syringe containing 3ml
Diluting Solution (Growth Hormone) (For Human
Use)
11. 047640 Humatrope 12mg Cartridge Kit Injection M/s. Eli Lilly Pakistan (Pvt) Ltd,
Cartridge Kit contains:- Karachi
Use)
12. 047641 Humatrope 24mg Cartridge Kit Injection -do-
Cartridge Kit contains:-
Use)
DECISION:-
The application is referred back to Registration Board for being the ultimate authority
to decide the application of M/s. Eli Lilly Pakistan (Pvt) Ltd, Karachi. As Eli Lilly brands are
established, it may not e deregistered.
G. Discontinuation of Production of Unipeg-V (Peginterferon Alfa 2S) 1800mcg
Injection (Reg. No. 079525)
M/s. Getz Pharma, Karachi has applied for discontinuation of supply of Unipeg-V
(Peginterferon Alfa 2S) 1800mcg Injection (Reg. No. 079525).
S. No. Item 282nd DRB Decision
1. Unipeg-V (Peginterferon Alfa 2S) 1800mcg Registration Board referred the application to
Injection (Reg. No. 079525) the committee on availability of life saving
drugs

The Secretary committee apprised the committee members that following list of
Registered alternative brands of “Unipeg-V” is shared by Biological Drugs Division:-
Sr. No. Reg. No. Brand Name & Composition Importer
1. 077535 Pegaron Injection M/s. Nexter Pharma, Karachi
Each prefilled syringe contains:-
Pagalated Interferon 2a 180mcg/ml (Antiviral
agent)
2. 059281 Pegaferon 180ug Injection each Ampoule of M/s. Nexter Pharma, Karachi
1mL contains:-
Pegylated Interferon Alfa 2a (40 Kd Peg)
………………180ug
3. 052296 Pegdan Injection M/s. Danas International (Pvt)
Each vial contains:- Ltd., Islamabad
Pegylated Recombinant Human Interferon
Alfa 2a…………180mcg
4. 052297 Pegdan Injection -do-
Each pre-filled syruinge contains:-
Pegylated Recombinant Human Interferon
Alfa 2a…………180mcg
5. 079524 Unipeg-PFS M/s. Getz Pharma (Pvt) Ltd.,
Each pre-filled syringe contains:- Karachi
Peginterferon Alfa 2a……..180mcg
Pegdan injection
DECISION:-
The application is referred back to Registration Board for being the ultimate authority
to decide the application of M/s. Getz Pharma (Pvt) Ltd., Karachi on its own merits.
H. Priority consideration of formulations due to shortage in market.

DRAP has received references from following various Professionals requesting attention
to shortage of several critical drugs mentioned hereafter:
i. Dr. Bashir Hanif (President Pakistan Society of International Cardiology).
ii. Dr. Iqtidar A. Khan (Professor, Department of Pediatrics & Child Health & Interim
Chairman, Division of Women & Child Health, The Agha Khan University,
Karachi)
iii. S.M. Wasim Jafri MD (Chair & Associate Dean, (Department of Continuing
Professional Education, The Agha Khan University, Karachi).
a. Polystyrene Sodium Sulfonate Resin-Powder Sachet & Jar:

This is a cat ion-exchange resin administered orally used to reduce high levels of
potassium in the blood (Hyperkalemia). Sodium polystyrene Sulfonate removes
potassium by exchanging sodium ions for potassium ions in the intestine. The
majority of this cat ion exchange seems to take place in the large intestine where
potassium ions are excreted in greater amounts. Non availability of this resin seriously
poses challenges to manage critically ill hyperkalemia patients.
b. Phenytoin Sodium Capsules 100mg and Suspension 125mg per 5ml -120ml
Phenytoin Sodium capsules and suspension is used to prevent and control seizures
(also called an anticonvulsant or antiepileptic drug to treat Grand mal and
psychomotor epilepsy). Phenytoin sodium exerts an anti –epileptic action without
causing general depression of the CNS. The drug is believed to stabilize rather than
elevate the seizures threshold and to limit the spread of seizure activity.
c. Potassium Chloride 10% Liquid:
Potassium is vital in the human body, and potassium chloride by mouth is the
common means to treat low blood potassium. Potassium chloride 10% Liquid is an
electrolyte replenisher used to treat low levels of potassium in the blood;
hypokalemia.
Potassium Chloride used to treat or prevent low level of potassium in the blood. A
normal level of potassium in the blood is important. Potassium helps your cells,
kidneys, heart, muscles and nerves work properly. Some conditions that can lower
your body’s potassium level include severe prolonged diarrhea and vomiting,
hormone problems such as hyperaldosteronism, or treatment with diuretics thus
requiring potassium supplementation.
In the light of above discussion DRAP has been requested to expedite on priority
basis the registration and availability of above cited drugs. Accordingly following
applications have been found in available record and are presented here for
consideration of Regoistration Board.
Decision: Registration Board discussed the matter in length and decided to process
above molecules on priority to ensure free availability of these drugs. The
Board further advised to get views of PPMA and Pharma Bureau on such
matter of availability of drugs and send a consolidated report for
consideration of Registration Board.
Accordingly following applications were considered by the Board and decided accordingly:
1. Name and address of manufacturer / "M/s PharmEvo Private Limited. Plot # A-29, North
Applicant Western Industrial Zone, Port Qasim, Karachi"
Brand Name+Dosage Form+Strength Epilep 125mg/5ml Suspension
Composition "Each 5ml of The Oral Suspension Contains:
Phenytoin…125mg"
Diary No. Date of R& I & fee Dy.No.24562 dated 16-7-2018 Rs.20,000/- 16-7-2018
Pharmacological Group Anti-epileptic
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price 120ml;As per PRC
Approval status of product in Approved by USFDA
Reference Regulatory Authorities.
Me-too status Dilantin of M/s Pfizer
GMP status Last GMP inspection report dated 23-02-2018
concluding as under:
“Based on the areas inspected, the people met and
documents reviewed, and considering the findings of
the inspection M/s Pharm Evo Pvt. Ltd. Karachi was
considered to be operating at acceptable level of
compliance with GMP standards as today.”
Remarks of the Evaluator2
Decision: Approved.
Brand Name+Dosage Form+Strength Kay Gone 10gm Sachet
Composition "Each Sachet Contains:
Sodium Polystyrene Sulfonate…10gm"
Pharmacological Group Ion-exchange resin
Type of Form Form-5
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price As per PRC
Approval status of product in Approved by USFDA as 454gm per bottle
Me-too status -
Remarks of the Evaluator2 Evidence of Me-too status required.
Decision: Deferred for evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number, brand name and
name of firm or else application on Form 5-D along with submission of differential
fee and stability study data as per the requirements of 278th meeting of
Registration Board.
Brand Name+Dosage Form+Strength Epilep 100mg Capsule
Composition "Each capsule contains:
Phenytoin Sodium…100mg"
Type of Form Form-5
Me-too status PHENTON-S CAPSULES 100MG of M/s MEHRAN
TRADERS KARACHI (Reg.#015775)
Decision: Approved with innovator’s specification.
Brand Name+Dosage Form+Strength K-Plus 10% Oral Solution
Composition "Each 5ml Solution for Oral Administration Contains:
Potassium Chloride…500mg"
Pharmacological Group Electrolyte
Type of Form Form-5
Approval status of product in
Me-too status
the inspection M/s PharmEvo (Pvt.) Ltd. Karachi was
Remarks of the Evaluator2 Firm has submitted revised form 5 with following
composition:
“K-Plus syrup 1gm/5ml
Each 5 ml syrup contains:
Potassium Chloride …. 1gm”.
Following me too reference has been verified against
revised formulation:
Potassium chloride syrup of M/s Specific Karachi
(Reg.#003198)
Firm has submitted reference of Kay-CEE –L Syrup
approved by MHRA of UK against revised composition
which is of different strength i.e. 0.3727gm per 5ml.
Decision: Deferred for evidence of approval of applied formulation in reference
regulatory authorities / agencies which were adopted by the Registration Board in
its 275th meeting.
Item No. IV Division of Pharmaceutical Evaluation &Registration
Pharmaceutical Evaluation Cell
S.No. Detail
Case No. 01 Registration applications for local manufacturing of (Human) drugs
a. New cases
b. Deferred cases
Case No. 02 Registration applications of newly granted DML or New section
(Human)
a. New DML
b. New/Additional section(s)
c. Deferred cases
Case No. 03 Registration applications for local manufacturing of (veterinary) drugs
a. New Cases
b. Deferred Cases
Case No. 04 Registration applications of newly granted DML or New section
(Veterinary)
a. New DML /section
Case No. 05 Registration applications of categories to be considered on priority
a. Export Facilitation
b. Local manufacturing applications of priority categories defined by
Registration Board in its 257th meeting
c. Import applications of priority categories defined by Registration
Board in its 257th meeting
i. Human
ii. Veterinary
Case No. 06 Registration applications of import cases
a. New Cases (Human)
b. New Cases (Veterinary)
c. Deferred cases
i. Human
ii. Veterinary
Case No. 07 Registration applications of drugs for which stability study data is
submitted
a. New cases
b. Deferred cases
c. Verification of stability study data
d. Exemption from onsite verification of stability data
Case No. 08 Miscellaneous cases
a. Manufacturing facility for steroidal and non-steroidal hormones
b. Common Technical Document (CTD)
c. Case of Genix Pharmaceuticals in which stability study data was
rejected by Registration Board.
In addition to routine agenda, Registration Board also deliberated following points:
a. Registration of drugs containing Angiotensin Receptor Antagonists (ARB’s)
including Valsartan and Irbesartan:
Registration Board deliberated the withdraw of valsartan and irbesartan containing
medicine by EMA and USFDA for which the Active Pharmaceutical Ingredient (API) was
manufactured by Zhejiang Huahai and Zhejiang Tianyu. The Registration Board further
discussed that all finished product manufacturers of valsartan and irbesartan shall ensure use
of API for which the API manufacturer has conducted impurity profiling for N-
Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). The Board also
discussed that only those API’s shall be allowed for which impurity profiling has been
performed by the API manufacturer evident from their certificate of analysis.
Registration Board was apprised of the recent GMP inspection report of Zhejiang Huahai
Pharmaceuticals Linhai, China conducted by European Medicine Agency (EMA)/ European
Directorate for the Quality of Medicines (EDQM) (available online at:
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do?ctrl=searchG
MPCResultControlList&action=Drilldown&param=50430) on 13-09-2018 which concludes
that the manufacturer i.e. Zhejiang Huahai Pharmaceutical Co. Ltd, Chuannan Duqiao, Linhai
Zhejiang China does not comply with Good Manufacturing Practice requirements referred
to in the principles of GMP for active substances referred to in Article 47 of Directive
2001/83/EC.
Registration Board was further apprised of the GMP inspection of Zhejiang Huahai
Pharmaceuticals Linhai, China conducted by United States Food and Drug Administration
(USFDA) (available online at:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERF
OIAElectronicReadingRoom/UCM621162.pdf) on 23-07-2018 to 28-07-2018 and 30-07-
2018 to 03-08-2018 on the basis of which USFDA placed Zhejiang Huahai on import alert on
28-09-2018. As per the the update available on USFDA website
(https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm) The import alert stops all API
made by Zhejiang Huahai and finished drug products made using ZHP’s API from legally
entering the United States.
Decision: Registration Board after thorough discussion decided as follows:
 Advised to inform QA & LT Division to evaluate cases for import of ARB’s
including valsartan and irbesartan while considering the impurity profiling
based on pharmacopoeial standards and any other impurities if declared by
reference regulatory authorities.
 All finished product manufacturers of valsartan and irbesartan shall ensure use
of API for which the impurity profiling for N-Nitrosodimethylamine (NDMA)
and N-Nitrosodiethylamine (NDEA) and N-Nitrosodiethylamine (NDEA)
respectively has been performed.
 Advised to refer the case of Zhejiang Huahai Pharmaceutical China along with
the inspection reports and decision of EMA and USFDA to QA & LT Division
for further necessary action.
b. Consideration of GMP inspection report for 3 years for registration of drugs
Registration Board deliberated that the Authority in its 61st meeting “advised that for local
registration of allopathic drugs, GMP report for the last three (03) years shall also be used for
assessing compliance level of the applicant. However, Division of QA & LT was directed to
take necessary measures to ensure that compliance level is maintained by the manufacturers.
Incase of availability of two GMP reports of applicant in a tenure of three years, latest report
may be considered for compliance purpose”.
Decision: Registration Board decided to consider advisory of the Authority in its
61st meeting for consideration of GMP conducted during last three (03)
years for assessing GMP compliance level of the applicant. The Board
further advised that applicant shall be responsible to provide the latest
GMP inspection report conducted during last 3 years.
c. Import of finished products for performing comparative dissolution profile
Registration Board provided guidelines for the firms for conducting stability studies for new
molecules and its subsequent generics to in 251st and 278th meeting. The Board advised the
firms to perform comparative dissolution profile of their products against the reference /
innovator product and submit the data along with registration application.
Decision: Registration Board advised the QA & LT Division to allow the import of
finished product for performing comparative dissolution profile and
submission of data along with the registration application.
d. Import of Active Pharmaceutical Ingredients (APIs) / Drug Substances for
product development & stability studies
Registration Board provided guidelines for the firms for conducting stability studies for new
molecules and its subsequent generics to in 251st and 278th meeting. The Board further
discussed the matter in its 264th meeting and also issued a circular No.F.l-10/2016-Add:Dir
(R.l)/M-264 dated 30th March 2017 stating that all pharmaceutical manufacturers are required
to import APIs/drug substances of pharmaceutical grade only from sources/manufacturers
having valid API manufacturing licenses and GMP certificates by respective drug regulatory
authority. The Board observed that manufacturers are still importing / purchasing APIs/drug
substances through DHL / courier service without getting prior approval from relevant DRAP
offices.
Decision: Registration Board directed the firms to import APIs/drug substances of
pharmaceutical grade only from sources/manufacturers having valid API
manufacturing licenses and GMP certificates by respective drug
regulatory authorities and get endorsement / clearance for such imports
from relevant DRAP office. The Board further advised to again issue an
advisory for compliance of aforementioned decision with copy to PPMA,
Pharma Bureau and DRAP’s field offices and also place the same on
DRAP’s website.
e. Use of methylene chloride, sodium cyclamate and other organic solvents in
formulation of pharmaceutical products
Registration Board deliberated and showed reservations on the use of methylene chloride and
other organic solvents in the formulation of various pharmaceutical products. The Board also
deliberated that methylene chloride is a banned excipient as per FDA regulations 21 CFR
700.19 (Available online:
https://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm127406.htm).
The Board further deliberated the matter for the use of sodium cyclamate as a sweetener
which is banned by USFDA.
(https://www.fda.gov/food/ingredientspackaginglabeling/foodadditivesingredients/ucm39771
6.htm)
Decision: Registration Board decided as:
 Prohibit the use of methylene chloride and sodium cyclamate in the
formulation of pharmaceutical products on the basis of ban imposed by
USFDA.
 Registration Board further advised to send the same reference to QA & LT
division for further necessary action.
 Registration Board further advised the firms to use all excipients in the safe
range as defined in the FDA database of inactive ingredients (Ref:
https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm) or handbook of
pharmaceutical excipients.
Case No. 01: Registration applications for local manufacturing of (Human) drugs.
a. New cases
Evaluator PEC-I
1. Name and Address of the Kanel Pharmaceuticals, Plot#6-road SS-3.National Indust.
Manufacturer/ Applicant Zone. Rawat, Rawalpindi.
Brand Name+ Dosage form+ Strength CARKEN 6.25mg Tablets
Composition Each Tablet contains:
Carvedilol ………………………………….6.25mg
Diary No. Date of R&I & Fee Dy:23206, 05-12-2017; Fee in PKR: 20,000/-28-11-2017
Pharmacological Group Beta-blocker
Type of Form Form-5
Finished Product Specification USP
Packed Size and Demanded Price 3 x 10’s, 1 x 10’s / As per policy of DRAP.
Approval status of product in CARVEDILOL , 6.25mg , Tablet; Oral,
Reference Regulatory Authorities USFDA Approved.
Me-too Status Cardil 6.25mg Tablets by Tabros Pharmceuticals, Karachi.
(Reg. # 035656)
GMP Status GMP certificate issued and valid till: 20-12-2018.
On the basis of inspection conducted on: 20-12-2017.
Remarks of Evaluator  You have not applied on prescribed application format
as per Schedule-A of Drugs (Licensing, Registering,
and Advertising) Rules, 1976.
 Master formulation describing quantities of actives and
in-actives not in accordance with the testing
specifications, clarification is required.
 Outline of method of manufacturing do not contains all
particulars for subject products.
 Finished product specification is submitted for film
coated tablet while you have applied for “uncoated
tablet” justification/clarification is required in this
regard. (In case of revision of formulation submit the
requisite fee, as applicable).
Decision: Deferred for following:
i. Submission of relevant details of enclosures as per Form 5 of Schedule-A of Drugs
(Licensing, Registering, and Advertising) Rules, 1976
ii. For the clarification of applied dosage form since firm has mentioned “uncoated
tablet” on Form 5 while finished product specifications declare applied formulation as
film coated tablet and re-submission of master formulation & method of
manufacturing accordingly.
Brand Name+ Dosage form + Strength CARKEN 12.50mg Tablets
Carvedilol ………………………………….12.50mg
Type of Form Form-5
Finished Product Specification Kanel’s Specifications.
Packed Size and Demanded Price 1 x 10’s / As per policy of DRAP.
Approval status of product in CARVEDILOL , 12.50mg , Tablet; Oral
Me-too Status Arvid 12.5Mg Tablets by Global Pharmceuticals,
Islamabad. (Reg. # 035969).
Brand Name+ Dosage form + Strength CARKEN 25mg Tablets
Carvedilol ………………………………….25mg
Type of Form Form-5
Finished Product Specification Kanel’s Specifications.
Approval status of product in Carvedilol, 25mg , Tablet; Oral; USFDA Approved.
Reference Regulatory Authorities
Me-too Status Arvid 25mg Tablets by Global Pharmceuticals, Islamabad.
(Reg. # 035970).
4. Name and Address of the KANEL PHARMACEUTICALS.

Manufacturer/ Applicant Plot#6-road SS-3.National Indust. Zone. Rawat,
Rawalpindi.
Brand Name+ Dosage form + Strength FLOXAPINE 3+25 mg Capsules
Composition Each Hard Gelatin capsule contains:
Olanzapine ………….……………………...…..3mg
Fluoxetine HCl equivalent to Fluoxetine……. 25 mg
Pharmacological Group SSRI/Thienbenzodiazepine
Type of Form Form-5
Finished Product Specification Kanel Specifications
Approval status of product in Fluoxetine HCl; Olanzapine, Capsule; Oral;
Me-too Status Olanco Capsules by Genome Pharma. (Reg. # 079388)
Remarks of Evaluator BOXED WARNING: SUICIDAL THOUGHTS AND
BEHAVIORS; AND INCREASED MORTALITY IN
ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS.
• Increased risk of suicidal thinking and behavior in
children, adolescents, and young adults taking
antidepressants. SYMBYAX is not approved for use in
children less than 10 years of age.
• Monitor for worsening and emergence of suicidal
thoughts and behaviors.
• Elderly patients with dementia-related psychosis treated
with antipsychotic drugs are at an increased risk of death.
 The applied product submitted with incorrect label
claim i.e., Fluoxetine, while the correct label claim is
“Fluoxetine HCl equivalent to Fluoxetine”.
Accordingly you are advised to submit the requisite
documents with correct label claim along with
applicable fee.
 You have not applied on prescribed application format
ii. For the submission of requisite documents with correct label claim.
iii. For the submission of master formulation in accordance with the testing specifications,
clarification is required.
iv. For the clarification/justification of outline of method of manufacturing that does not
contains all particulars for subject product.
Olanzapine ………….……………………….....6mg
Type of Form Form-5
Remarks of Evaluator BOXED WARNING: SUICIDAL THOUGHTS AND
BEHAVIORS; AND INCREASED MORTALITY IN
ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS.
• “Increased risk of suicidal thinking and behavior in
The applied product submitted with incorrect label claim
i.e., Fluoxetine, while the correct label claim is
“Fluoxetine HCl equivalent to Fluoxetine”. Accordingly
you are advised to submit the requisite documents with
correct label claim along with applicable fee.”
(Licensing, Registering, and Advertising) Rules, 1976.
Olanzapine ………….………………………...12mg
Type of Form Form-5
Remarks of Evaluator BOXED WARNING: Suicidal Thoughts And Behaviors;
And Increased Mortality In Elderly Patients With
Dementia-Related Psychosis.
• Increased risk of suicidal thinking and behavior in
claim i.e., Fluoxetine, while the correct label claim is
“Fluoxetine HCl equivalent to Fluoxetine”.
Accordingly you are advised to submit the requisite
documents with correct label claim along with
applicable fee.

Brand Name+ Dosage form + Strength KANBESARTAN 75 mg Tablets
Irbesartan…………………………………..…75 mg
Pharmacological Group ARBs
Type of Form Form-5
Approval status of product in Irbesartan, tablet; Oral; by Sanofi. USFDA Approved.
Me-too Status Accord By CCL Pakistan. (Reg. # 042705)
ii. For the clarification of finished product specification i.e., submitted for film coated
tablet while you have applied for “uncoated tablet”.
Irbesartan…………………………………..…150mg
Type of Form Form-5
Irbesartan…………………………………..…300mg
Type of Form Form-5
Brand Name+ Dosage form + Strength KANABIS 5mg tablets
Bisprolol Fumarate……………………….… 5 mg
Pharmacological Group Cardioselective Beta-blocker.
Type of Form Form-5
Approval status of product in Bisoprolol 5 mg Tablets MHRA Approved
Me-too Status Bisolol By CCL Pakistan. (Reg. # 033951)
Remarks of Evaluator  Revalidation program of the system submitted in the
dossier/application is in-correct; accordingly you are
advised to submit the revised re-validation program.
 You have not applied on prescribed application format as
per Schedule-A of Drugs (Licensing, Registering, and
Advertising) Rules, 1976.
 The applied drug has been approved as “film coated”
while you have applied the drug without film coating,
justification/clarification is required in this regard (In
case of revision of formulation submit the requisite fee,
as applicable).
ii. For the clarification regarding the approved product in reference regulatory authority
is film coated tablet while you have applied for “uncoated tablet”.
Brand Name+ Dosage form + Strength KANABIS 10mg tablets
Bisprolol Fumarate…………………….……….… 10mg
Pharmacological Group Cardioselective Beta-blocker.
Type of Form Form-5
Approval status of product in Bisoprolol 5 mg Tablets MHRA Approved
Me-too Status Bisolol By CCL Pakistan. (Reg. # 033952)
Remarks of Evaluator  Revalidation program of the system submitted in the
case of revision of formulation submit the requisite
fee, as applicable).
Brand Name+ Dosage form + Strength KANCAND 8 mg tablets
Candesartan cilexetil ………………………....8 mg
Pharmacological Group Angiotensin II Receptor Antagonist
Type of Form Form-5
Approval status of product in Amias 8mg Tablets Takeda UK; MHRA Approved
Me-too Status Candera (film coated tablet) Parke-Davis, Karachi.
(Reg.#067393)
claim i.e., Candesartan, while the correct label claim is
“Candesartan celexetil”. Accordingly you are advised
to submit the requisite documents with correct label
claim along with applicable fee.
v. For the submission of requisite documents with correct label claim.
Brand Name+ Dosage form + Strength KANCAND 16mg tablets
Candesartan cilexetil …………………….……....16mg
Type of Form Form-5
Packed Size and Demanded Price 2 x 7’s, 1 x 14’s, 1 x 20’s / As per policy of DRAP.
Approval status of product in Amias 16mg Tablets Takeda UK; MHRA Approved
Me-too Status Candera (film coated tablet) Parke-Davis, Karachi.
(Reg. # 067394)
claim i.e., Candesartan, while the correct label claim is
“Candesartan celexetil”. Accordingly you are advised
to submit the requisite documents with correct label
claim along with applicable fee.
v. For the submission of requisite documents with correct label claim.
Brand Name+ Dosage form + Strength LOSAP 25mg Tablet
Losartan Potassium……………………………. 25mg
Type of Form Form-5
Approval status of product in COZAAR 25 mg tablet ,Merck Sharp & Dohme UK
Reference Regulatory Authorities MHRA Approved
Me-too Status Xavor by Ferozsons pharma., Nowshehra. (Reg. # 079742)
The applied drug has been approved as “film coated” while
you have applied the drug without film coating,
justification/clarification is required in this regard (In case
of revision of formulation submit the requisite fee, as
applicable).
(Licensing, Registering, and Advertising) Rules, 1976.
iv. For the clarification/ justification of outline of method of manufacturing that does not
Brand Name+ Dosage form + Strength LOSAP 50mg Tablet
Losartan Potassium……………………………. 50mg
Diary No. Date of R&I & Fee Dy:23189, 05-12-2017; Fee in PKR: 20,000/-28-11-2017.
Type of Form Form-5
Approval status of product in COZAAR 50 mg tablet ,Merck Sharp & Dohme UK
Reference Regulatory Authorities MHRA Approved.
Me-too Status Xavor by Ferozsons pharma., Nowshehra. (Reg. # 079743)
The applied drug has been approved as “film coated” while
you have applied the drug without film coating,
justification/clarification is required in this regard (In case
of revision of formulation submit the requisite fee, as
applicable).
Brand Name+ Dosage form + Strength MASLAKANE 800mg Tablet
Composition Each enteric coated Tablet contains:
Mesalamine ………………. 800mg
Diary No. Date of R&I & Fee Dy: 23193, 05-12-2017; Fee in PKR: 20,000/- 28-11-2017.
Pharmacological Group aminosalicylate anti-inflammatory
Type of Form Form-5
Approval status of product in MESALAMINE TABLET, DELAYED RELEASE;
Reference Regulatory Authorities ORAL ZYDUS PHARMS USA INC USFDA Approved.
Me-too Status Generic status could not be confirmed.
Remarks of Evaluator
The Board was apprised that the application is deficient of following information which has already
been communicated to the firm:
i. Not applied on prescribed application format as per Schedule-A of Drugs (Licensing,
Registering, and Advertising) Rules, 1976.
ii. Master formulation describing quantities of actives and in-actives not in accordance with the
testing specifications, clarification is required.
iii. Outline of method of manufacturing do not contains all particulars for subject products.
iv. Finished product specification is submitted for film coated tablet while you have applied for
“enteric coated tablet” justification/clarification is required in this regard. (In case of
revision of formulation submit the requisite fee, as applicable).
v. Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm, not submitted.
ii. Master formulation describing quantities of actives and in-actives not in accordance
with the testing specifications, clarification is required.
iii. Outline of method of manufacturing do not contains all particulars for subject
products.
iv. Finished product specification is submitted for film coated tablet while you have
applied for “enteric coated tablet” justification/clarification is required in this
regard. (In case of revision of formulation submit the requisite fee, as applicable).
v. Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm, not
submitted.
Brand Name+ Dosage form + Strength TELKAN 20mg Tablet
Telmisartan ………………………..20mg
Type of Form Form-5
Packed Size and Demanded Price 1 x 10’s, / As per policy of DRAP.
Approval status of product in Telmisartan 20mg tablet;oral prinston Inc. USFDA
Reference Regulatory Authorities Approved
Me-too Status Tasmi Tablets by Getz Pharma, karachi. (Reg. # 047481)
Remarks of Evaluator BOXED WARNING. FETAL TOXICITY
• When pregnancy is detected, discontinue MICARDIS as
soon as possible.
• Drugs that act directly on the renin-angiotensin system
can cause injury and death to the developing fetus.
ii. For the submission of master formulation in accordance with the testing specifications,
iii. For the clarification/justification of outline of method of manufacturing that does not
Telmisartan ………………………..40mg
Type of Form Form-5
soon as possible.
 Revalidation program of the system submitted in the
Telmisartan ……………………………………..80mg
Type of Form Form-5
soon as possible.
 Revalidation program of the system submitted in the
Brand Name+ Dosage form + Strength OLMEKAN 20mg Tablet
Composition Each film coated Tablet contains:
Olmesartan medoxomil……………….… 20mg
Type of Form Form-5
Approval status of product in Olmesartan Medoxomil Tablet Teva Pharms USA,
Reference Regulatory Authorities US-FDA Approved. (film coated Tablet)
Me-too Status Olesta Searle karachi. (Reg.# 050736)
GMP Status GMP certificate issued and valid till 20-12-2018.
Brand Name+ Dosage form + Strength OLMEKAN 40mg Tablet
Olmesartan medoxomil……………….… 40mg
Type of Form Form-5
th
| 32
Approval status of product in Olmesartan Medoxomil Tablet Teva Pharms USA,
Reference Regulatory Authorities US-FDA Approved. (film coated Tablet)
Me-too Status Olesta Searle karachi. (Reg.# 050737)
GMP Status GMP certificate issued and valid till 20-12-2018.
Brand Name+ Dosage form + Strength SOLIFKAN 10mg Tablets
Solifenacin Succinate……………….….10 mg
Pharmacological Group Antimuscarinic
Type of Form Form-5
Approval status of product in Giraxine 10mg (film coated Tablet) MHRA Approved.
Me-too Status FENASO Highnoon Laboratories, Lahore. (Reg.# 069313)
Remarks of Evaluator  The applied product submitted with incorrect label
claim i.e., Solifenacin Succinate, while the correct label
claim is “Solifenacin Succinate equivalent to
Solifenacin”. Accordingly you are advised to submit the
requisite documents with correct label claim along with
applicable fee.
as per Schedule-A of Drugs (Licensing, Registering, and
as applicable).
 Submission of revised Form 5 with label claim as per reference product declaring the salt
form & equivalency of Solifenacin with requisite fee.
 Master formulation describing quantities of actives and in-actives not in accordance with
the testing specifications, clarification is required.
 Outline of method of manufacturing do not contains all particulars for subject products.
 The applied drug has been approved as “film coated” while you have applied the drug
without film coating, justification/clarition is required in this regard (In case of revision of
formulation submit the requisite fee, as applicable).
Brand Name+ Dosage form + Strength SOLIFKAN 5mg Tablets
Solifenacin Succinate………………………….….5 mg
Pharmacological Group Antimuscarinic
Type of Form Form-5
Approval status of product in Giraxine 5mg (film coated Tablet) MHRA Approved.
Me-too Status FENASO Highnoon Laboratories, Lahore. (Reg.# 069314)
Remarks of Evaluator  The applied product submitted with incorrect label
claim i.e., Solifenacin Succinate, while the correct
label claim is “Solifenacin Succinate equivalent to
Solifenacin”. Accordingly you are advised to submit
the requisite documents with correct label claim
alongwith applicable fee.
justification/ clarification is required in this regard (In
as applicable).
 Submission of revised Form 5 with label claim as per reference product declaring the salt
form & equivalency of Solifenacin with requisite fee.
 Master formulation describing quantities of actives and in-actives not in accordance with
the testing specifications, clarification is required.
 Outline of method of manufacturing do not contains all particulars for subject products.
 The applied drug has been approved as “film coated” while you have applied the drug
without film coating, justification/clarition is required in this regard (In case of revision of
formulation submit the requisite fee, as applicable).
24. Name and Address of the Kanel Pharmaceuticals, Plot#6-road SS-3. National Indust.
Brand Name+ Dosage form + Strength ORKAN 120mg Capsule
Orlistat pellets………………….……….…… 120mg
Pharmacological Group Lipase Inhibitor
Type of Form Form-5
Packed Size and Demanded Price 1 x 10’s, 3x 10’s, / As per policy of DRAP.
Approval status of product in Xenical, orlistat120mg, capsule;oral, USFDA Approved.
Me-too Status Trimzak 120mg Capsule BY Schazoo Zaka (Pvt) Ltd,
Lahore. (Reg.# 071105)
as per Schedule A of Drugs (Licensing, Registering,
 Packaging material of the applied drug is not correctly
mentioned in form-5.
 It is claimed in form-5(18.b) that the production
capacity per shift is 150,000 capsules while the
equipment mentioned in form-5(18.a) have the max.
Capacity of 80,000-100,000 cap./ per shift,
clarification is required in this regard.
 Outline of method of manufacturing do not contain
steps for subject products as per approved product.
 The applied drug has been approved as “orlistat
pellets” while you have applied the drug “orlistat
powder”, justification/clarification is required in this
regard (in case of revision of formulation submit the
 Confirmation for source of pellets, along with stability
studies data, GMP certificate of supplier and
differential fee in case of import of pellets.
i. Submission of revised Form 5 with label claim as per reference product declaring the
salt form & equivalency of Solifenacin with requisite fee.
ii. For clarification of remarks mentioned above.
25. Name and Address of the Atco Laboratories Limited, B-18, S.I.T.E., Karachi.
Manufacturer/ Applicant
Brand Name+ Dosage form + Strength TIOCARDIS-AM 40mg/5mg Tablet
Composition Each bilayered tablet contains:
Amlodipine (as amlodipine besylate).……….…… 5mg
Telmisartan………………………………………..40mg
Pharmacological Group Anti-Hypertensive
Type of Form Form-5
Packed Size and Demanded Price As per policy of DRAP.
Approval status of product in Telmisartan and Amlodipine Tablets 5mg/40mg by M/s
Reference Regulatory Authorities Mylan Pharms Inc. (USFDA Approved).
Me-too Status Amtas 5mg + 40mg Tablet of M/s Getz Pharma (Pvt) Ltd.
Karachi. (Reg. # 066943)
GMP Status Latest GMP inspection: 09-02-2018.
Conclusion: “Overall GMP of the firm is rated as GOOD.”
Remarks of Evaluator Availability of Bilayered compression tablet facility have
to confirmed?
Decision: Deferred for submission of Installation Qualification & Performance Qualification
Reports of required manufacturing equipment i.e. tablet biayered machine.
26. Name and Address of the Atco Laboratories Limited,
Manufacturer/ Applicant B-18, S.I.T.E., Karachi.
Amlodipine (as amlodipine besylate).……….…... 10mg
Type of Form Form-5
Reference Regulatory Authorities Mylan Pharms INC (USFDA Approved)
Me-too Status Amtas 10mg + 40mg Tablet of M/s Getz Pharma (Pvt) Ltd
(Reg. # 066945)
Remarks of Evaluator Status of Availability of Bilayered compression tablet
facility have to confirmed?
Amlodipine (as amlodipine besylate).……….…... ..5mg
Type of Form Form-5
Me-too Status Amtas 5mg + 80mg Tablet of M/s Getz Pharma (Pvt) Ltd
(Reg. # 0669434)
Amlodipine (as amlodipine besylate).……….…... 10mg
Type of Form Form-5
Me-too Status Misar-Am 80/10mg Tablet of M/s Highnoon Pharma (Pvt)
Ltd (Reg. # 069151)
Brand Name+ Dosage form + Strength CO-TIOCARDIS 40mg/12.5mg Tablet
Hydrochlorthiazide………………….……….….... 12.5mg
Telmisartan…………………………………………..40mg
Type of Form Form-5
Approval status of product in Micardis HCT. (USFDA Approved)
Me-too Status Misar-H 40/12.5 Tablets of 'Highnoon Laboratories,
Lahore. (Reg. # 065688)
Brand Name+ Dosage form + Strength CO-TIOCARDIS 80mg/25mg Tablet
Hydrochlorthiazide………………….……….…... 25mg
Type of Form Form-5
Me-too Status Misar-H 40/12.5 Tablets of 'Highnoon Laboratories,
Lahore. (Reg. # 065684)
Brand Name+ Dosage form + Strength CO-TIOCARDIS 80mg/12.5mg Tablet
Hydrochlorthiazide………………….……….…... 12.5mg
Telmisartan…………………………………………..80mg
Type of Form Form-5
Me-too Status Misar-H 40/12.5 Tablets of M/s Highnoon Laboratories,
Lahore. (Reg. # 065685)
facility have to confirmed
Evaluator PEC-II
32. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot # 25 & 26,
Applicant Street S-3,RCCI, National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Navodic Gel 1%w/w
Composition "Each gram Contains:
Diclofenac Diethylamine ……11.6mg eq.to Diclofenac
Sodium…….10mg
Diary No. Date of R& I & fee Dy.No 23155 dated 05-12-2017 Rs. 20,000/- 05-12-2017
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specification Manufacturer specifications
Pack size & Demanded Price 20gm, 5gm; as per SRO
Me-too status Kciflonic Gel of M/s Karachi Chemical Industrial
(Reg.# 058438)
GMP status Last inspection report dated 25-10-2018 with following
recommendations:
“As the operations have not started as of yet at M/s Evolution
Pharmaceuticals, Rawat the GMP status can only be
ascertained upon the start of active pharmaceutical; however ,
keeping in view the facility inspected the firm has requisite
manufacturing facility for manufacturing of Pharmaceuticals.
Remarks of the Evaluator2 No USP or BP monograph is available for applied
formulation
Decision: Approved with Inovator’s specifications
Brand Name +Dosage Form + Strength Pyroxal Gel 0.5%w/w
Composition Each gram Contains:
Piroxicam….…5mg
Type of Form Form-5
Pack size & Demanded Price 25gm; as per SRO
Approval status of product in Approved by MHRA of UK
Me-too status Pioxi Gel 0.5% of M/s Linta pharmaceuticals (Pvt.) Limited ,
Islamabad (Reg.# 080263)
recommendations:
ascertained upon the start of active pharmaceutical; however ,
Remarks of the Evaluator2 No USP or BP monograph is available for applied
formulation
Brand Name +Dosage Form + Strength Ostofen Gel 2.5% w/w
Composition Each gram Contains:
Ketoprofen….…25mg
Diary No. Date of R& I & fee Dy. No 23158 dated 05-12-2017 Rs. 20,000/- 05-12-2017
Type of Form Form-5
Finished product Specification BP
Me-too status Ticon 2.5 % w/w Gel of M/s Amarant, Karachi
(Reg.# 070499)
recommendations:
ascertained upon the start of active pharmaceutical , however
, keeping in view the facility inspected the firm has requisite
Decision: Approved.
Brand Name +Dosage Form + Strength Synflam 550mg Tablet
Composition Each Film Coated Tablet Contains:
Naproxen Sodium…550mg
Type of Form Form-5
Pack size & Demanded Price 20;s & 30’s; as per SRO
Approval status of product in Approved by Health Canada
Me-too status Eziflam Tablet 550 mg by M/s Danas Pharmaceutical (Pvt)
Ltd (Reg. No. 038647)
recommendations:
“As the operations have not started as of yet at M/s
Evolution Pharmaceuticals, Rawat the GMP status can only
be ascertained upon the start of active pharmaceutical ,
however , keeping in view the facility inspected the firm has
requisite manufacturing facility for manufacturing of
Pharmaceuticals.
Decision: Approved.
Brand Name +Dosage Form + Strength Evofenac 50mg Tablet
Diclofenac Potassium…50mg
Type of Form Form-5
Pack size & Demanded Price 10’s,20;s & 100’s; as per SRO
Me-too status Dicota 50 Tablet of M/s Linz Karachi, (Reg.# 073524)
recommendations:
ascertained upon the start of active pharmaceutical , however
, keeping in view the facility inspected the firm has requisite
Decision: Approved.
Brand Name +Dosage Form + Strength Navodic SR 100mg Tablet
Composition Each Sustained Release Tablet Contains:
Diclofenac Sodium…100mg
Type of Form Form-5
Pack size & Demanded Price 30’s,20;s & 100’s;200’s as per SRO
Me-too status Medifenac SR 100mg Tablet of M/s M/s. Mediate
Pharmaceuticals, Karachi (Reg.# 048703)
recommendations:
ascertained upon the start of active pharmaceutical, however ,
Decision: Approved.
Brand Name +Dosage Form + Strength Vofen 200mg Tablet
Ibuprofen…200mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 250’s, 500’s; as per SRO
Me-too status Suprofen Tablet 200mg of M/s Kohs Hyderabad (Reg.#
070618)
recommendations:
Pharmaceuticals.
Decision: Approved with change of brand name.
Ibuprofen…400mg
Type of Form Form-5
Me-too status Suprofen Tablet 400mg of M/s Kohs Hyderabad
(Reg.# 070619)
recommendations:
Pharmaceuticals.
2
Remarks of the Evaluator
Ibuprofen…600mg
Type of Form Form-5
Me-too status Fenbru 600mg Tablets of M/s Platinum (Reg.# 042105)
recommendations:
ascertained upon the start of active pharmaceutical; however,
2
Brand Name +Dosage Form + Strength Vofen Retard 800mg Tablet
Ibuprofen…800mg
Type of Form Form-5
Pack size & Demanded Price 24’s,36’s; as per SRO
Me-too status Xiben-SR Tablet of M/s Pacific Pharma (Reg.# 062797)
recommendations:
Brand Name +Dosage Form + Strength Lenor 4mg Tablet
Lornoxicam…4mg
Pharmacological Group Anti-inflammatory
Type of Form Form 5
Finished product Specification Manufacturers specification
Pack size & Demanded Price 5’s,10’s,20’s; as per SRO
Approval status of product in Xefo 4 mg Filmtabletten by M/s Takeda Pharma AG,
Reference Regulatory Authorities. (Swiss Medic approved)
Me-too status Acabel 4mg Tablet by M/s Continental Pharma
(Reg No:061603)
recommendations:
Brand Name +Dosage Form + Strength Acufen 100mg Tablet
Aceclonefac…100mg
Pharmacological Group Rheumatoid arthritis
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s & 30’s; as per SRO
Me-too status Aclofen Tablets by M/s Alliance Pharmaceuticals (Pvt) Ltd,
(Reg.# 068419)
recommendations:
Brand Name +Dosage Form + Strength Evodol 500mg Tablet
Composition Each Tablet Contains:
Paracetamol……..500mg
Pharmacological Group Analgesic
Type of Form Form-5
Pack size & Demanded Price 100’s, 200’s,250’s & 500’s; as per SRO
Me-too status Parari Tablets by Lawari International, (Reg.# 062382)
recommendations:
be ascertained upon the start of active pharmaceutical;
however, keeping in view the facility inspected the firm has
Pharmaceuticals.
Decision: Approved.
Brand Name +Dosage Form + Strength Evoprin 75mg Tablet
Composition Each Gastro Resistant Tablet Contains:
Aspirin…..75mg
Type of Form Form-5
Pack size & Demanded Price 30’s & 100’s; as per SRO
Me-too status Glorin Tablets 75mg by M/s Global Pharmaceuticals
(Reg.# 056287)
recommendations:
2
Decision: Approved.
46. Name and address of manufacturer / M/s Evolution Pharmaceuticals Pvt. Ltd. Plot # 25 & 26, Street
Applicant S-3, RCCI, National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Evoprin 300mg Dispersible Tablet
Composition Each dispersible Tablet Contains:
Aspirin…300mg
Type of Form Form-5
Finished product Specification
Pack size & Demanded Price 100’s,200’s,300’s & 600’s; as per SRO
Me-too status --
recommendations:
ascertained upon the start of active pharmaceutical , however ,
Remarks of the Evaluator 2
 Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
Brand Name +Dosage Form + Strength Mevlox 7.5mg Tablet
Meloxicam…7.5mg
Type of Form Form-5
Me-too status MIWS 7.5 mg Tablets of M/s Weather folds (Reg.#078486)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Mevlox 15mg Tablet
Meloxicam…15mg
Type of Form Form-5
Me-too status MIWS plus 15 mg Tablets of M/s Weather folds
(Reg.#078489)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Navodic 75mg Tablet
Composition Each Delayed Release Tablet Contains:
Type of Form Form-5
Pack size & Demanded Price 20’s,100’s & 200’s; as per SRO
Approval status of product in Voltaren approved by USFDA
Me-too status Torelief 75mg Tablet of M/s Maple Pharmaceuticals, Karachi
(Reg.# 058203)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Navodic 50mg Tablet
Type of Form Form-5
Pack size & Demanded Price 20’s,100’s & 200’s; as per SRO
Me-too status Dicmaf 50mg Tablet of M/s Mafins, Karachi (Reg.# 079884)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Tramex Plus 37.5/325mg Tablets
Tramadol hydrochloride…37.5mg
Paracetamol…325mg
Pharmacological Group Analgesic/ Opioid Analgesic
Type of Form Form 5
Pack size & Demanded Price As per SRO.
Ultracet by Janssen (USFDA)
Me-too status Distalgesic Tablets by Atco laboratories, Karachi
(R.No. 073865)
recommendations:
Pharmaceuticals, Rawat the GMP status can only be ascertained
upon the start of active pharmaceutical , however , keeping in
view the facility inspected the firm has requisite manufacturing
facility for manufacturing of Pharmaceuticals.
Decision: Approved.
Brand Name +Dosage Form + Strength Tramex SR 100mg Tablets
Composition Each sustained Release Tablet Contains:
Tramadol hydrochloride …100mg
Pharmacological Group Analgesic/ Opioid Analgesic
Type of Form Form 5
Approved by USFDA
Me-too status Codogesic-SR tablet by M/s Wilson’s Pharmaceutical
(R. No. 077750)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Flofen 100mg Tablet
Flurbiprofen……100mg
Type of Form Form 5
Me-too status Strefen Tablets of Healers Pharmaceuticals (Reg.# 069733)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Dexpril 20mg Tablet
Piroxicam-beta-cyclodextrin…..191.2mg Corresponding to
Piroxicam……20mg
Diary No. Date of R& I & fee Dy.No 23535 dated 08-12-2017 Rs. 20,000 Dated 08-12-2017
Type of Form Form 5
Pack size & Demanded Price 10’s,20’s;As per SRO.
Approval status of product in Approved by ANSM of France
Me-too status Achway Tablets of M/s Getz Pharma (Reg.#047355)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Progesic 450/35mg Tablet
Paracetamol...…450mg
Orphenadrine Citrate…35mg
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s;As per SRO.
Approval status of product in Norgesic of M/s iNova Pharmaceuticals Australia Pvt. Ltd
Reference Regulatory Authorities. approved by TGA of Australia
Me-too status Rid-All Forte by M/s Stanley Pharma (Reg.#069786)
recommendations:
Decision: Approved with Inovator’s specifications.
Brand Name +Dosage Form + Strength Loxefin 60mg Tablet
Loxoprofen Sodium as Hydrate….…60mg
Diary No. Date of R& I & fee Dy. No 23538 dated 08-12-2017; Rs. 20,000/- 08-12-2017
Type of Form Form 5
Finished product Specification JP
Pack size & Demanded Price 10’s, 20’s; As per SRO.
Approval status of product in Approved by PMDA
Me-too status Renox tablets of M/s Curative Pharmaceuticals, Rawalpindi
(Reg.#039849)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Evonim 100mg Tablet
Nimesulide ….100mg
Diary No. Date of R& I & fee Dy. No 23537 dated 08-12-2017; Rs. 20,000/- 08-12-2017
Type of Form Form 5
Finished product Specification Manufacturer’s specification
Pack size & Demanded Price 10’s, 15’s, 20’s & 30’s; As per SRO.
Approval status of product in Approved by EMA
Me-too status Nims tablet by M/s Sami
recommendations:
Remarks of the Evaluator2  No USP or BP monograph is available for applied
formulation.
 Registration Board in its 271st meeting keeping in view the
approval status of Nimesulide 100mg tablet in EMA, the
Registration Board approved the formulation of
Nimesulide Tablets 100mg with a pack size for 15 days as
per recommendations of EMA only for the following
clinical indications as a second-line choice.
a) Treatment of acute pain
b) Primary dysmenorrhea
 Decision: Approved with Innovator’s specifications and with a pack size for 15 days as per
recommendations of EMA only for the following clinical indications as a second-line choice.
a) Treatment of acute pain
b) Primary dysmenorrhea
Brand Name +Dosage Form + Strength Evodol Extra 500/65mg Tablet
Paracetamol…500mg
Caffeine…65mg
Pharmacological Group Analgesic combination
Type of Form Form 5
Pack size & Demanded Price 10’s, 15’s, 20’s & 30’s; As per SRO.
Me-too status Acetofeb Extra Tablets of M/s Vision Pharmaceuticals
(Reg.#038900)
recommendations:
Remarks of the Evaluator2  In contrary to reference product approved by MHRA
of UK, which is available as film coated tablet, firm
has applied for uncoated tablet.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
Brand Name +Dosage Form + Strength Lenor 8mg Tablet
Lornoxicam…8mg
Type of Form Form 5
Approval status of product in Approved by EMA
Me-too status Recam Tablet 8mg by M/s Regal Pharmaceuticals
(Reg.#081952)
recommendations:
Brand Name +Dosage Form + Strength Tramex 50mg Tablet
Tramadol hydrochloride…50mg
Pharmacological Group Opiate analogue
Type of Form Form 5
Approval status of product in Tradom Hydrochloride tablets of M/s EG NV approved by
Reference Regulatory Authorities. MHRA of UK
Me-too status Tramed- Tablets by M/s Platinum Pharmaceuticals (Pvt) Ltd,
(Reg#024457)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Xibra 60mg Tablet
Etoricoxib……60mg
Type of Form Form 5
Me-too status Etoria 60mg Table of M/s Hygeia Pharmaceuticals, Islamabad
(Reg.# 080818)
recommendations:
Brand Name +Dosage Form + Strength Evogesic Forte 500mg Tablet
Mefenamic Acid…500mg
Type of Form Form 5
Me-too status Inflanil Forte Tablets of M/s Vision Pharmaceuticals,
Islamabad. (Reg.# 033761)
recommendations:
Decision: Approved with BP specifications.
Brand Name +Dosage Form + Strength Tenox 20mg Tablet
Tenoxicam…20mg
Type of Form Form 5
Pack size & Demanded Price 20’s; as per SRO
Me-too status Tenax Tablets of M/s Robins Pharmaceuticals,
(Reg.# 035541)
recommendations:
64. Name and address of manufacturer / "M/s Tabros Pharma Pvt Ltd.L-20/B,Sector-22, Federal B
Applicant Industrial Area, Karachi contract manufacturing by M/s
Hiranis Pharmaceuticals Pvt Ltd. Plot No. E-145 to E-149,
North Western Industrial Zone, Port Qasim, Karachi, Pakistan"
Brand Name +Dosage Form + Strength Rapicort 15mg/5ml Syrup
Composition Each 5ml Contains:
Prednisolone…..15mg
Pharmacological Group Glucocorticoid
Type of Form Form 5
Pack size & Demanded Price 60ml; as per PRC
Me-too status Persolon Syrup 60ml of M/s Shaheen Pharma (Reg.#054852)
GMP status Last inspection report of M/s Hiranis Pharmaceuticals Pvt.
Ltd. Karachi dated 07-09-2017 with GMP compliance status.
2
Decision: Approved.
Brand Name +Dosage Form + Strength Vofen Gel
Composition "Each gram Contains:
Ibuprofen…100mg"
Type of Form Form 5
Me-too status Ibusoft gel 10% w/w of M/s Martin Dow, Karachi
(Reg.# 032062)
recommendations:
Decision: Approved with BP specifications and change of brand name.
66. Name and address of manufacturer / "M/s The Searle Company Limited.F-319 SITE, Karachi,
Applicant Pakistan."
Brand Name +Dosage Form + Strength Xafir 550mg Tablets
Composition Each film coated Tablet Contains:
Rifaximin…….550mg
Pharmacological Group Antibiotics
Type of Form Form 5
Pack size & Demanded Price 10’s,14’s & 28’s; as per DPC
Me-too status Rixago 550mg Tablet by M/s OBS Pharma Karachi
(Reg#081073)
GMP status GMP certificate valid upto 05-2019, issued by Abdul Rasool
Sheikh (Additional Director, DRAP, Karachi) has been
submitted.
2
67. Name and address of manufacturer / "M/s The Searle Company Limited.F-319 SITE, Karachi,
Applicant Pakistan."
Brand Name +Dosage Form + Strength Xafir 200mg Tablets
Rifaximin…….200mg
Type of Form Form 5
Pack size & Demanded Price 10’s,14’s & 28’s; as per DPC
Me-too status Normix Tablets by M/s Sanital Pharmaceutical Rawalpindi.
(Reg#022656)
GMP status GMP certificate valid upto 05-2019, issued by Abdul Rasool
Sheikh (Additional Director, DRAP , Karachi) has been
submitted.
68. Name and address of manufacturer / "M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Applicant Karachi, 75190, Pakistan"
Brand Name +Dosage Form + Strength Proride 50mg Tablets
Itopride Hydrochloride…50mg
Pharmacological Group Prokinetic
Type of Form Form-5
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 10’s,20’s & 30’s;as per PRC
Approval status of product in Ganaton of M/s Abbott Laboratories (PMDA) Japan Approved
Me-too status Itoguard Tablet of M/s Macter International Karachi
(Reg.#055753)
GMP status Last GMP inspection report dated 16-02-2018 concluding
“satisfactory level of compliance with cGMP guidelines as of
today. The management was also suggested to further
strengthen stability and analytical sections.”
69. Name and address of manufacturer / "M/s Genix Pharma Pvt Ltd.
Applicant 44,45-B, Korangi Creek Road, Karachi, 75190, Pakistan"
Brand Name +Dosage Form + Strength Thioside 4mg Injection
Composition "Each 2ml Ampule Contains:
Thiocholchicoside……..4mg"
Pharmacological Group Muscle relaxant
Type of Form Form-5
Pack size & Demanded Price as per PRC
Me-too status Itoguard Tablet of M/s Macter International Karachi
(Reg.#055753)
Brand Name +Dosage Form + Strength Desgen 0.5mg Syrup
Composition "Each ml Contains:
Desloratadine…..…0.5mg"
Diary No. Date of R& I & fee Dy. No 26681 dated 29-12-2017 Rs. 20,000 Dated 29-12-2017
Pharmacological Group Anti-histamine
Type of Form Form 5
Pack size & Demanded Price 60ml,120ml;as per PRC
Approval status of product in Aerius For Children Syrup desloratadine 2.5mg/5mL oral
Reference Regulatory Authorities. liquid bottle by M/s Bayer Australia Ltd (TGA approved)
Me-too status Desora 0.5mg/ml syrup by M/s Continental Pharma.
(Reg.# 055192)
Remarks of the Evaluator2 No USP or BP monograph is available for applied formulation.
Brand Name +Dosage Form + Strength Epirac XR 500mg Tablets
Composition "Each Extended Release Tablet Contains:
Levetiracetam…500mg"
Type of Form Form-5
Pack size & Demanded Price 10’s,20’s & 30’s; as per PRC
Approval status of product in USFDA approved
Me-too status Elicia ER 750mg tablet of M/s Martin Dow (Reg.# 085591)
Decision: Approved.
Brand Name +Dosage Form + Strength Thioside 4mg Capsule
Composition "Each Capsule Contains:
Thiocholchicoside…4mg"
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, & 30’s; as per PRC
Approval status of product in MYOPLEGE 4 mg hard capsule of M/s GENEVRIER SA
Reference Regulatory Authorities. Laboratories approved by ANSM of France
Me-too status Myogen Capsules 4 mg by M/s Nimrall Pharmaceuticals,
(Reg.# 066700)
Remarks of the Evaluator2 No USP or BP monograph is available for applied formulation.
Brand Name +Dosage Form + Strength Epirac 500mg/5ml Solution for Infusion
Composition "Each 5ml Contains:
Type of Form Form-5
Pack size & Demanded Price 5ml x 1’s, 5ml x 5’s, 5ml x 10’s; as per PRC
Me-too status Eplipsa 500mg/5ml Injection of M/s Helix (Reg.#075918)
Decision: Approved.
Brand Name +Dosage Form + Strength Epirac XR 750mg Tablets
Composition "Each Extended Release Tablet Contains:
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s & 30’s; as per PRC
Me-too status Elicia 750mg Tablet of Martin Dow Ltd. Karachi.
(Reg.#081156)
Decision: Approved.
Brand Name +Dosage Form + Strength Lidol 50mg/5ml, 1% Injection IM
Lidocaine Hydrochloride…50mg"
Pharmacological Group Local anesthetic
Type of Form Form-5
Pack size & Demanded Price 5ml x 5’s, 5ml x 10’s; as per PRC
Me-too status Lidocaine HCl 1% Injection (5ml) of Healthtek, Karachi.
(Reg.#079939)
Decision: Approved.
Brand Name +Dosage Form + Strength Lidol 40mg/2ml 2% Injection IM
Lidocaine Hydrochloride………40mg"
Type of Form Form-5
Pack size & Demanded Price 2ml x 5’s, 2ml x 10’s; as per PRC
Me-too status Lignox 2% injection (2ml) of M/s Novamed (Reg.#076968)
Decision: Approved.
Brand Name +Dosage Form + Strength Lidol 35mg/3.5ml 1% Injection IM
Composition "Each 3.5ml Contains:
Lidocaine Hydrochloride…35mg"
Type of Form Form-5
Pack size & Demanded Price 3.5ml x 5’s, 3.5ml x 10’s; as per PRC
Approval status of product in Approved by Medicine Evaluation Board of Netherland as
Reference Regulatory Authorities. diluent for Ceftriaxone 1gm injection.
Me-too status Anacaine 1% injection (3.5ml) of M/s Cirin Pharma
(Reg.#046999)
Decision: Approved.
Brand Name +Dosage Form + Strength Epirac 100mg Oral Solution
Composition "Each ml Contains:
Levetiracetam……100mg"
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml; As per PRC
Me-too status Tamlev 100mg/ml oral solution of M/s Medisure Lab.
(Reg.#081613)
Decision: Approved.
79. Name and address of manufacturer / "M/s Akhai Pharmaceuticals Pvt Ltd. Plot # A-248 & A-256 to
Applicant A-259, H.I.T.E. Lasbela Balochistan, Pakistan"
Brand Name +Dosage Form + Strength Clinda-Jel Gel
Composition "Each gm Contains:
Clindamycin Phosphate Eq. to Clindamycin…1% w/w"
Pharmacological Group Anti-biotic
Type of Form Form-5
Pack size & Demanded Price 10gm; As per SRO
Me-too status Sixil 10mg/g Gel of M/s Sigma Pharma Karachi (Reg.#079912)
GMP status GMP Certificate issued based on inspection dated 15 March,
2018. GMP inspection report dated 15-03-2018 rated GMP as
Good.
Decision: Approved.
80. Name and address of manufacturer / M/s Reign Pharmaceuticals PCSIR-KLC (Pvt.) Limited, TBIC
Applicant Building-I, PCSIR Laboratories Complex, Shahra-e-Dr. Salim-
uz-Zaman Siddiqui, Off University Road, Karachi
Brand Name +Dosage Form + Strength Sufit Oral Suspension
Composition Each 5ml contains:
Sucralfate……………....1gm
Diary No. Date of R& I & fee Dy. No 71 dated 31-01-2014, Rs. 20,000 (Duplicate Dossier)
Pharmacological Group Cytoprotective agent
Type of Form Form-5
Finished product Specification Manufacture specs.
Pack size & Demanded Price As per SRO
Me-too status Sucralate Oral Liquid suspension of M/s Regal Pharma
(Reg.#081988)
GMP status Last GMP inspection report dated 08-11-2017 concluding as
under:
All relevant activities in process areas, QC and ware house
were found as good level of GMP compliance as per Drugs
Act, 1976 and rules framed under. Based on the current
inspection of M/s Reign Pharmaceuticals PCSIR-RLC Pvt. Ltd.
all the observations/recommendations were discussed with
management and an earlier compliance was assured from
firm’s management
Decision: Approved with Inovator’s specifications. Registration Board further decided that
verification of fee challan may be done as per decision of 285th meeting of Registration Board.
81. Name and address of manufacturer / M/s Goodman Laboratories No. 5, Street No. S-5, National
Applicant Industrial Zone, Rawat, Rawalpindi.
Brand Name +Dosage Form + Strength Letrazone tablet 2.5mg
Composition Each film coated tablet contains:
Letrozole……………........2.5mg
Diary No. Date of R& I & fee Dy. No.10445; 21-03-2018; Rs.20,000/- (21-03-2018)
Pharmacological Group Aromatase inhibitor
Type of Form Form-5
Pack size & Demanded Price 1x10’s; As per SRO
Me-too status Femara tablet 2.5mg of M/s Novartis pharma
GMP status Last GMP inspection report dated 08-08-2018 recommending
renewal of DML.
2
Decision: Approved being application of priority category.
82. Name and address of manufacturer / M/s Wellborne Pharmachem and Biologicals, Plot No.51/1 –
Applicant 52/1, Phase-II, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Le-One 750mg Tablets
Levofloxacin hemihydrate equivalent to Levofloxacin
….…750mg
Pharmacological Group Antibacterial
Type of Form Form-5
Pack size & Demanded Price As fixed by Govt.
Me-too status Oliza 750 Tablets by M/s UniMark Pharmaceuticals
(Reg.#038004)
renewal of DML.
Decision: Approved.
83. Name and address of manufacturer / "M/s Pakistan Pharmaceutical Products Pvt Ltd.
Applicant D-122, Sindh Industrial Trading Estate, Karachi"
Brand Name +Dosage Form + Strength Co-Salvan 160/25mg Tablets
Valsartan…160mg
Hydrochlorothiazide…25mg
Pharmacological Group Antihypertensive
Type of Form Form-5
Pack size & Demanded Price As per PCA
Me-too status CO-DIOVAN film coated tablets 160/25 by M/s Novartis
Pharma Karachi (Reg.#028458)
GMP status Last GMP inspection report dated 12-12-2017 with following
recommendations:
“Based on the people met, focused areas visited, documents
reviewed and observations made it is concluded that the firm
has complied improved according to the directions of the FID,
Panel was satisfied for the improvements undertaken by the
firm to comply with the observations dated 1st and 2nd August
2017. The panel advised the firm to continue the improvements
process as per GMP guidelines.”
Decision: Approved.
Brand Name +Dosage Form + Strength Co-Salvan 160/12.5mg Tablets
Valsartan…160mg
Hydrochlorothiazide…12.5mg
Type of Form Form-5
Me-too status CO-DIOVAN film coated tablets 160/12.5 by M/s Novartis
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Co-Salvan 80/12.5mg Tablets
Valsartan…80mg
Type of Form Form-5
Me-too status CO-DIOVAN film coated tablets 80/12.5 by M/s Novartis
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Salvan 160mg Tablets
Valsartan…160mg
Type of Form Form-5
Me-too status DIOVAN tablets 160 by M/s Novartis Pharma Karachi
(Reg.#027347)
recommendations:
Decision: Approved.
Brand Name +Dosage Form + Strength Salvan 80mg Tablets
Valsartan…80mg
Type of Form Form-5
Me-too status DIOVAN tablets 80 by M/s Novartis Pharma (Reg.#027346)
recommendations:
Decision: Approved.
88. Name and address of manufacturer / "M/s Axis Pharmaceuticals. Value Addition City, 3-B, 1.5km,
Applicant Khurrianwala-Sahianwala Road, Faisalabad"
Brand Name +Dosage Form + Strength Triflex 325/37.5mg Tablets
Paracetamol…325mg
Tramadol hydrochloride…37.5mg
Diary No. Date of R& I & fee Dy. No 22900 dated 04-12-2017 Rs.20,000 Dated 04-12-2017
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per SRO
Ultracet by Janssen (USFDA)
Me-too status Distalgesic Tablets by Atco Laboratories, Karachi
(R.No. 073865)
GMP status Last GMP inspection report dated 19-09-18 & 03-10-2018
recommending as under:
“Based on the areas inspected, the people met and the
documents reviewed and considering the findings of the
inspection M/s Axis Pharma Faisalabad was considered to be
operating at fair level of compliance with GMP guidelines as
per Drugs Act, 1976 and rules framed there under.
The panel recommends considering the firm for grant of cGMP
certificate in respect of all sections.”
Decision: Approved.
Brand Name +Dosage Form + Strength Emaldin 10mg Tablets
Amlodipine as Besylate…10mg
Pharmacological Group Antihypertension
Type of Form Form-5
Pack size & Demanded Price 20’s; As per SRO
Me-too status Amlokeu 10 mg Tablet of M/s High-Q (Reg.#047243)
Decision: Approved.
Brand Name +Dosage Form + Strength Emaldin 5mg Tablets
Pharmacological Group Antihypertension
Type of Form Form-5
Me-too status Amlokeu 5 mg Tablet of M/s High-Q (Reg.#047242)
Decision: Approved.
Brand Name +Dosage Form + Strength Megromax 400/60mg Tablets
Ibuprofen…….400mg
Pseudoephedrine HCl……60mg
Pharmacological Group NSAID & Decongestant
Type of Form Form-5
Approval status of product in Lasynac Max Strength 400mg/60mg film coated tablets
Reference Regulatory Authorities. approved by MHRA of UK
Me-too status Irofen Forte Tablets of M/Searle Pakistan Karachi
(Reg.#042233)
Decision: Approved.
Brand Name +Dosage Form + Strength Cinolox 750mg Tablets
Ciprofloxacin as hydrochloride…750mg
Pharmacological Group Anti bacterial
Type of Form Form-5
Me-too status Cipropar Tablets 750mg of Neomedix, P No.5, Street N-5
RCCI, Industrial Estate, Rawat (Reg.#081412)
Decision: Approved.
93. Name and address of manufacturer / "M/s Medisave Pharmaceuticals, Lahore.
Applicant
Brand Name +Dosage Form + Strength Medbirox dry suspension 250mg
Cefadroxil (as monohydrate)………250mg
Diary No. Date of R& I & fee Rs. 8,000 04-06-2012 (photocopy) Rs.12,000/- 19-11-2014
(photocopy)
Pharmacological Group Anti-bacterial
Type of Form Form-5 (Duplicate dossier)
Pack size & Demanded Price 60ml; As per SRO
Me-too status Fasirox 250mg Dry Suspension of M/s Fassgen
Pharmaceuticals (Reg.#060298)
GMP status Copy of GMP certificate valid upto 01-2019 has been
submitted.
2
Remarks of the Evaluator Duplicate dossier was received from Registration-V section
vide letter no. F.8-6/2013-Reg-V dated 07-11-2018.
Decision: Approved. Registration Board further decided that verification of fee challan may be
done as per decision of 285th meeting of Registration Board.
Applicant
Brand Name +Dosage Form + Strength Olexa 5mg tablet
Olanzapine………5mg
Diary No. Date of R& I & fee Rs. 8,000 08-06-2012 (photocopy) Rs. 12,000/- 19-11-2014
(photocopy)
Me-too status Olifass 5mg Tablets of M/s Fassgen Pharmaceuticals
(Reg.#056614)
submitted.
Remarks of the Evaluator2 Duplicate dossier was received from Registration-V section
Decision: Approved. Registration Board further decided that verification of fee challan may be
done as per decision of 285th meeting of Registration Board.
Applicant
Brand Name +Dosage Form + Strength Neocon capsules 100mg
Composition Each capsule contains:
Itraconazole (as immediate release pellets) ………100mg
Source of pellets: M/s Vision Pharmaceuticals (Pvt.) Ltd.
(photocopy)
Pharmacological Group Anti-fungal
Me-too status Mukil Capsule 100mg of M/s. Dyson Research Laboratories
(Pvt) Ltd (Reg.# 055356)
submitted.
Decision: Approved with innovator’s specifications. Board further decided that verification of fee challan
may be done as per decision of 285th meeting of Registration Board.
Applicant
Brand Name +Dosage Form + Strength Alendro tablet 70mg
Composition Each tablet contains:
Sodium Alendronate trihydrate eq. to Alendronic acid
………..….…70mg
(photocopy)
Pharmacological Group Osteoporosis
Me-too status Ostim Tablets. of M/s. Genome Pharmaceuticals (Pvt) Ltd
(Reg.# 054917)
submitted.
2
Remarks of the Evaluator Duplicate dossier was received from Registration-V section
Decision: Approved. Board further decided that verification of fee challan may be done as per
decision of 285th meeting of Registration Board.
Applicant
Brand Name +Dosage Form + Strength Falcim tablet 80/480mg
Artemether…….80mg
Lumefantrine…480mg
Diary No. Date of R& I & fee Rs. 8,000 08-06-2012 (photocopy) Rs.12,000/- 19-11-2014
(photocopy)
Pharmacological Group Antimalarial
Finished product Specification IP
Approval status of product in WHO recommended formulation
Me-too status Artem-DS Plus Tablets 80/480 of M/s Hilton Pharma,
Karachi (Reg.# 066843)
submitted.
Applicant
Brand Name +Dosage Form + Strength Ciprozan 250mg dry suspension
Composition When reconstituted, each 5ml contains:
Ciprofloxacin (as taste masked granules)........250mg
Source of granules: M/s Surge Laboratories Pakistan
(photocopy)
Pharmacological Group Fluoroquinolone antibiotic
Me-too status Quash 250mg/5ml suspension of M/s Wilshire Laboratories
Pvt. Ltd.
submitted.
Manufacturing requirement for diluent for reconstitution of product shall be discussed in
Registration Board.
99. Name and address of manufacturer / M/s N.S Pharma, Plot no. 576, 577 Sunder Industrial
Applicant Estate, Lahore
Brand Name +Dosage Form + Strength Omesid 40mg Capsule
Omeprazole (as enteric coated pellets)...…40mg"
Source of pellets: M/s Vision Pharmaceuticals, Islamabad
Pharmacological Group Antacid
Type of Form Form-5
Approval status of product in Approved by MHRA
Me-too status Acizole Capsule 40mg by M/s Cirin Pharma, (Reg# 034369)
GMP status
Remarks of the Evaluator2 Last inspection dated 08-06-2017 for Grant of new DML,
wherein Panel had recommended grant of new DML. CLB in
its 255th meeting held on 16-17 August, 2017 approved the
grant of New DML to the firm.
Decision: Approved.
100. Name and address of manufacturer / M/s Novamed Pharmaceuticals (Pvt.) Ltd, Lahore contract
Applicant manufacturing by M/s Bio-labs (Pvt.) ltd., Islamabad.
Brand Name +Dosage Form + Strength Arithro 500mg injection
Composition "Each vial contains:
Clarithromycin (as lactobionta)…….. 500mg
Diary No. Date of R& I & fee Dy. No 2064 dated 29-04-2016 Rs. 50,000/- Dated 27-04-2016
Type of Form Form-5
Me-too status Maclacin 500mg Injection by M/s Bosch, Karachi
(Reg#061080)
GMP status M/s Bio-Labs (Pvt.) Ltd., Islamabad was granted GMP
certificate based on inspection conducted on 5&06th -12-2017.
Decision: Deferred since the firm has informed that section Lyophilized vial (general) is not ready
for inspection due to ongoing upgradation activities as per approved layout. The firm further
requested to hold the contract products till the section is ready.
Brand Name +Dosage Form + Strength Laprazole 30mg injection
Lansoprazole …….. 30mg
Pharmacological Group Proton pump inhibitor
Type of Form Form-5
Approval status of product in Prevacid IV Injection, Takeda Pharmaceuticals USA,
Reference Regulatory Authorities. (USFDA approved)
Me-too status Belenz Injection 30mg by M/s Wellborne Pharmachem Hattar.
(Reg#054894)
certificate based on inspection conducted on 05 & 06th
December, 2017.
Brand Name +Dosage Form + Strength Zygrel 500mg injection
Azithromycin…….. 500mg
Type of Form Form-5
Me-too status Zithromax Injection by M/s Biocare Pharmaceutica, Lahore
(Reg.#053895)
certificate based on inspection conducted on 5 & 6th -12-2017.
2
103. Name and address of manufacturer / M/s Lisko Pakistan Pvt Ltd. L-10-D, Block 21, Shaheed Rashid
Applicant Minhas Road, F.B. Industrial Area, Karachi
Brand Name +Dosage Form + Strength Voltrex 50mg Tablet
Composition Each enteric coated tablet Contains:
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s;30’s, 100’s, 200’s ,500’s; Rs. 15 per tablet
Me-too status Dicmaf 50mg Tablet of M/s Mafins, Karachi (Reg.# 079884)
GMP status Last inspection report dated 24-4-2018 confirms satisfactory
compliance to GMP.
2
Decision: Approved.
Brand Name +Dosage Form + Strength Zonix 50mg Capsule
Composition Each Capsule Contains:
Zonisamide…50mg
Pharmacological Group Antiepileptic
Type of Form Form-5
Pack size & Demanded Price 14’s/ As per SRO
Me-too status Seizof 50mg Capsule of M.s OBS Karachi (Reg.#073643)
compliance to GMP.
Decision: Approved.
Brand Name +Dosage Form + Strength Rosvital 20mg Tablet
Rosuvastatin Calcium Eq. to Rosuvastatin…20mg
Pharmacological Group Cholestrol lowering medicine
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s
Me-too status Rosunext Tablets 20mg by M/s Novamed Pharma.
(Reg.# 064848)
compliance to GMP.
Decision: Approved.
Brand Name +Dosage Form + Strength Domlis 10mg Tablet
Domperidone as Maleate………10mg
Pharmacological Group Peripheral dopamine receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 30’s,50’s,60’s
Me-too status Motilium 10mg tablet of M/s Janssen-Cilag
compliance to GMP.
Decision: Approved.
Brand Name +Dosage Form + Strength Zonix 100mg Capsule
Zonisamide…100mg
Type of Form Form-5
Pack size & Demanded Price 14’s
Me-too status Seizof 100mg Capsule of M.s OBS Karachi (Reg.#073644)
compliance to GMP.
Decision: Approved.
108. Name and address of manufacturer / "M/s Bloom Pharmaceuticals Pvt Ltd. Plot # 30, Phase I & II,
Applicant Industrial Estate, Hattar, Pakistan"
Brand Name +Dosage Form + Strength Blucid Cream
Composition Each Gram Contains:
Fusidic Acid…20mg
Pharmacological Group Antibiotic/Corticosteroid
Type of Form Form-5
Pack size & Demanded Price 5gm & 15gm; As per SRO
Approval status of product in Fucidin H cream of M/s LEO Laboratories Limited, approved
Reference Regulatory Authorities. by MHRA of UK
Me-too status Mirazym Cream of M/s Hiranis Karachi (Reg.# 076516)
GMP status GMP inspection conducted on 07-04-2018 with conclusive
remarks that firm is operating at good level of cGMP.
Decision: Approved.
109. Name and address of manufacturer / "M/s Mcolson Research Laboratories Pvt Ltd. 26 km Lahore-
Applicant Sheikhupura Road, Sheikhupura"
Brand Name +Dosage Form + Strength Amsartan-H 10/160/25mg Tablets
Valsartan…160mg
Hydrochlorothiazide……25mg
Type of Form Form-5
Me-too status Sofvasc –HCT Tablet of Wilson’s Pharmaceuticals, 387-388,
I-9, Sector, Industrial Area, Islamabad. (Reg.# 077753)
GMP status Last GMP inspection report dated 15-02-2018 declaring
following “ General Observations”:
“HVAC system is properly installed and functional in all
production areas. Overall cleanliness of the plant is good. Flow
of personal movement, material movement and process is as
per cGMP. The firm has sufficient production capacities for
manufacturing of different products in all sections. However
the firm was advised to improve documentation system
regarding validation of testing procedure and manufacturing
procedure.
Decision: Approved.
Valsartan…160mg
Hydrochlorothiazide……25mg
Type of Form Form-5
Me-too status Aldric-H 5/160/25mg Tablet of M/s Martin Dow Ltd. Karachi
(Reg.# 081148)
procedure.
Decision: Approved.
Valsartan…160mg
Hydrochlorothiazide……12.5mg
Type of Form Form-5
Me-too status Aldric-H 5/160/12.5mg of M/s Martin Dow Ltd. Karachi.
(Reg.# 081152)
manufacturing of different products in all sections. However,
procedure.
Decision: Approved.
Brand Name +Dosage Form + Strength Amsartan-H 10/160/12.5mg Tablets
Valsartan…160mg
Hydrochlorothiazide……12.5mg
Type of Form Form-5
Me-too status Sofvasc –HCT Tablet of Wilson’s Pharmaceuticals, 387-388,
I-9, Sector, Industrial Area, Islamabad. (Reg.# 077749)
procedure.
Decision: Approved.
113. Name and address of manufacturer / "M/s Brookes Pharma Pvt Ltd.
Applicant 58 & 59, Sector 15, Korangi Industrial Area, Karachi"
Brand Name +Dosage Form + Strength Claron 250mg Tablet
Composition Each Film Coated tablet Contains:
Clarithromycin…250mg
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per Brand leader price
Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status Klarinor 250 mg Tablets by M/S Nortech Pharmaceuticals
(Pvt) Ltd (Reg#077969)
GMP status GMP certificate valid till 07-05-2019
Decision: Approved.
114. Name and address of manufacturer / "M/s Brookes Pharma Pvt Ltd.
Applicant 58 & 59, Sector 15, Korangi Industrial Area, Karachi"
Brand Name +Dosage Form + Strength Claron 500mg Tablet
Composition Each Film Coated tablet Contains: Clarithromycin…500mg
Diary No. Date of R& I & fee Dy. No 23816 dated 12-12-2017 Rs. 20,000 Dated 12-12-2017
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per Brand leader price
Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status Klarinor 500 mg Tablets by M/s Nortech Pharmaceuticals (Pvt)
Ltd (Reg#077970)
GMP status GMP certificate valid till 07-05-2019
Decision: Approved.
115. Name and address of manufacturer / M/s WnsField Pharmaceuticals, Plot No. 122, Block-A, Phase-
Applicant V, Hattar Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Lignowin 2% injection IM
Composition Each 2ml ampoule contains:
Lignocaine hydrochloride….......40mg
Pharmacological Group Local anesthesia
Type of Form Form-5
Pack size & Demanded Price 2ml x 1’s; As per SRO
Approval status of product in MHRA approved
Me-too status Lignox 2% Injection 2ml by M/s Novamed (Reg#076968)
GMP status Last GMP inspection conducted on 18-01-2018, and the
report concludes that keeping in view of overall GMP
compliance, the panel recommend the Renewal of DML.
Remarks of the Evaluator2  Firm has applied for injection containing 40mg lidocaine
base while the reference product approved in MHRA
contains 40mg lidocaine hydrochloride salt as the active
ingredient, clarify.
 Upon communication of above observation firm has
submitted revised Form 5 & master formulation with
following composition:
“Each 2ml ampoule contains:
Lignocaine hydrochloride….......40mg”
 Firm has also submitted fee of Rs. 5,000/- (vide deposit
slip# 0793281) dated 12-11-2018 for revise of formulation.
Decision: Approved.
Evaluator PEC-III
116. Name and address of manufacturer / M/s Aulton Pharmaceuticals. Plot No. 84/1, Block A, Phase
Applicant V, Industrial Estate, Hattar, K.P.K
Brand Name +Dosage Form + Strength Tinidazole 500mg Tablets
Tinidazole…500mg
Diary No. Date of R& I & fee Dy No. 24687: 15-12-2017 PKR 20,000/-: 15-12-2017
Pharmacological Group Nitroimidazole derivatives
Type of Form Form 5
Finished Product Specification Firm has claimed in house specification
Pack size & Demanded Price 10’s, 20’s, 30’s, 40’s: As per SRO
Approval status of product in Reference FASIGYN 500mg film-coated tablets by Pfizer Limited
Regulatory Authorities. (MHRA Approved)
Me-too status Fasigyn 500mg tablets by Pfizer Limited (Reg# 003478)
GMP status Last inspection dated 13-02-2018 confirms good level of

GMP compliance.
3
Remarks of the Evaluator . 
Brand Name +Dosage Form + Strength Amit 25mg Tablets
Amitriptyline hydrochloride……25mg
Pharmacological Group Antidepressants
Type of Form Form 5
Pack size & Demanded Price 20’s, 30’s, 100’s: As per SRO
Approval status of product in Reference Amitriptyline 25 mg film coated tablets by Bristol
Regulatory Authorities. Laboratories (MHRA Approved)
Me-too status Tryptanol 25mg Tablet by MSD (Reg# 000315)

GMP compliance.
Remarks of the Evaluator3. 
Decision: Approved.
Brand Name +Dosage Form + Strength Adyzil 600mg Tablets
Linezolid…….600mg
Pharmacological Group Other antibacterials
Type of Form Form 5
Approval status of product in Reference Zyvox 600 mg film-coated tablets by Pharmacia Limited
Me-too status Zyvox Tablets 600mg by Pharmacia (Reg# 028440)
GMP compliance
Brand Name +Dosage Form + Strength Adyzil 400mg Tablets
Linezolid…….400mg
Diary No. Date of R& I & fee Dy No. : 15-12-2017 PKR 20,000/-: 15-12-2017
Type of Form Form 5
Regulatory Authorities. (USFDA Approved and discontinued but for reasons other
than safety and efficacy as per USFDA website)
Me-too status Linzor 400mg Tablets by Hilton Pharma
th
| 71
GMP compliance
3
Brand Name +Dosage Form + Strength Orli 60mg Capsules
Orlistat…………………….60mg
Source of pellets: Vision Pharmaceuticals, Islamabad
Pharmacological Group Peripherally acting antiobesity products
Type of Form Form 5
Pack size & Demanded Price 10’s: As per SRO
Approval status of product in Reference Beacita 60mg Capsules by Actavis Group (MHRA
Regulatory Authorities. Approved)
Me-too status Orslim 60 mg Capsule by PharmEvo (Reg#058456)
GMP compliance
Remarks of the Evaluator3. Accelerated stability study data of pellets is not provided.
Decision: Registration Board deferred the case for submission of accelerated stability study data
of pellets by M/s Vision Pharmaceuticals, Islamabad.
Brand Name +Dosage Form + Strength Orli 120mg Capsule
Orlistat………120mg
Source of pellets: Vision Pharmaceuticals, Islamabad
Pharmacological Group Peripherally acting antiobesity products
Type of Form Form 5
Pack size & Demanded Price 1x10’s: As per SRO
Approval status of product in Reference Beacita 120mg Capsules by Actavis Group (MHRA
Me-too status Orslim 120 mg Capsule by PharmEvo (Reg# 042334)
GMP compliance
Remarks of the Evaluator3. Accelerated stability study data of pellets is not provided.
Decision: Registration Board deferred the case for submission of accelerated stability study data
of pellets by M/s Vision Pharmaceuticals, Islamabad.
Brand Name +Dosage Form + Strength Pro 5mg Tablets
Procyclidine hydrochloride…5mg
Pharmacological Group Anti-Parkinson Drugs
Type of Form Form 5
Pack size & Demanded Price 10’s, 100’s: As per SRO
Approval status of product in Reference Kemadrin (uncoated) Tablets 5mg by Aspen Pharma
Me-too status Kemadrin Tablet by GSK (Reg# 000363)
GMP compliance.
Remarks of the Evaluator3. Firm has initially applied for film coated tablet, later firm
has requested to change the formulation to uncoated tablets
as per the reference product. Firm has also submitted fee
PKR 5,000/- for revision of formulation.
Decision: Approved.
Brand Name +Dosage Form + Strength Lamotrigine 50mg Tablets
Lamotrigine………….…50mg
Pharmacological Group Other antiepileptics
Type of Form Form 5
Approval status of product in Reference Lamictal 50 mg (uncoated) tablets by GlaxoSmithKline
Me-too status Lamictal Tablets 50mg by GSK (Reg# 014919)
GMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Co-Vels 100mg Tablets
Lamotrigine…100mg
Type of Form Form 5
Approval status of product in Reference Lamictal 100 mg (uncoated) tablets by GlaxoSmithKline
Me-too status Lamictal Tablets 50mg by GSK (Reg# 014921)
GMP compliance
Decision: Approved.
Brand Name +Dosage Form + Strength Top 50mg Tablets
Topiramate…50mg
Type of Form Form 5
Pack size & Demanded Price 3x10’s, 6x10’s: As per SRO
Approval status of product in Reference Topiramate Teva 50mg film-coated tablets by TEVA UK
Regulatory Authorities. Limited (MHRA Approved).
Me-too status Topamax Tablets 50mg by Johnson & Johnson (Reg#
025253)
GMP compliance
Brand Name +Dosage Form + Strength Losa 50mg Tablets
Lacosamide…50mg
Type of Form Form 5
Approval status of product in Reference Trelema 50 mg film-coated tablets by G.L. Pharma
Me-too status Lalap 50mg Tablet by Genix Pharma (Reg# 070470)
GMP compliance
3
127. Name and address of manufacturer / M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle,
Applicant Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Solinate 5mg Tablet
Solifenacin Succinate…5mg (corresponding to 3.8mg
solifenacin)
Pharmacological Group Drugs for urinary frequency and incontinence
Type of Form Form 5
Approval status of product in Reference Giraxine 5 mg film-coated tablet by MEDREICH PLC
Me-too status Solifen Tablet 5mg by Getz Pharma (Reg# 061202)
GMP status The firm was granted GMP certificate based on inspection
conducted on 5th& 06-12-2017.
3
Brand Name +Dosage Form + Strength Solinate 10mg Tablet
Solifenacin Succinate…10mg (corresponding to 7.5mg
Solifenacin)
Pharmacological Group Drugs for urinary frequency and incontinence
Type of Form Form 5
Approval status of product in Reference Giraxine 10 mg film-coated tablet by MEDREICH PLC
Me-too status Solifen Tablet 10mg by Getz Pharma (Reg# 061203)
conducted on 5th& 06-12-2017.
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Brand Name +Dosage Form + Strength Epion-50 Tablets
Eperisone hydrochloride…50mg
Diary No. Date of R& I & fee Dy No. : 18-12-2017 PKR 20,000/-: 18-12-2017
Pharmacological Group Other centrally acting agents
Type of Form Form 5
Approval status of product in Reference Expose 50mg film coated tablets by ALFASIGMA S.P.A.
Regulatory Authorities. (AIFA Italy Approved)
Me-too status Perispa 50 Mg Tablets by Platinum Pharma (Reg# 039302)
conducted on 5th & 6th December 2017.
130. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Plot # 1 & 2, Street S-2,
Applicant National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Xifarax 200mg Tablets
Rifaximin…200mg
Type of Form Form 5
Approval status of product in Reference Xifaxanta 200 mg film-coated tablets by Norgine
Regulatory Authorities. Pharmaceuticals (MHRA Approved)
Me-too status Rifaxa 200mg Tablets by Ferozesons Labs (Reg# 068205)
GMP status Date of latest Inspection: 17-10-2017,
Firm compliant to GOOD level of GMP.
Remarks of the Evaluator3.
131. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Plot # 1 & 2, Street S-2,
Brand Name +Dosage Form + Strength Xifarax 550mg Tablets
Rifaximin…550mg
Type of Form Form 5
Approval status of product in Reference REFERO 550 mg film-coated tablets by Alfasigma S.p.A
Me-too status Xifaxa 550mg Tablet by Brookes Pharm (Reg#070438)-
GMP status Date of latest Inspection: 17-10-2017,
Firm compliant to GOOD level of GMP.
3
Remarks of the Evaluator .
132. Name and address of manufacturer / M/s Rock Pharmaceuticals Laboratories (Pvt) Ltd. 134-B &
Applicant 135-B Nowshehra Industrial Estate, Risalpur, Pakistan
Brand Name +Dosage Form + Strength Cardil 6.25mg Tablet
Carvedilol…………………6.25mg
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Pharmacological Group Alpha and beta blocking agents
Type of Form Form 5
Approval status of product in Reference Carvedilol 6.25 mg film-coated tablets by Milpharm
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Karvid Tablets 6.25mg by Hilton Pharma (Reg#027688)
recommending the grant of cGMP certificate
Decision: Approved.
Brand Name +Dosage Form + Strength Cardil 12.5mg Tablet
Carvedilol……………..12.5mg
Type of Form Form 5
Approval status of product in Reference Carvedilol 12.5 mg Film-coated Tablets by Generics [UK]
Me-too status Karvid Tablets 12.5mg by Hilton Pharma (Reg#027689)
recommending the grant of cGMP certificate
Decision: Approved.
134. Name and address of manufacturer / M/s Seraph Pharmaceuticals. Plot No. 210, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Pirobeta 20mg Tablet
Piroxicam (as Beta Cyclodextrin)……….…20mg
Pharmacological Group Oxicams
Type of Form Form 5
Approval status of product in Reference BREXIN 20 mg scored tablet by Pierre Fabre Medicament
Regulatory Authorities. (ANSM France Approved)
Me-too status Brexin Tablets 20mg by Chiesi (Reg#10637)
dated 11-06-2018.
Brand Name +Dosage Form + Strength Seropin XR 150mg Tablets
Composition Each extended release film coated tablet contains:
Quetiapine as Fumarate……………..150mg
Pharmacological Group Antipsychotics
Type of Form Form 5
Approval status of product in Reference Alaquet XL 150 mg prolonged-release tablets by Generics
Regulatory Authorities. [UK] Limited (MHRA Approved)
Me-too status Qusel XR 150mg Tablet by Hilton Pharma (Reg# 067501)
dated 11-06-2018.
Brand Name +Dosage Form + Strength Zithroser 250mg Tablets
Azithromycin as Dihydrate…………250mg
Pharmacological Group Macrolides
Type of Form Form 5
Approval status of product in Reference Azithromycin 250 mg film-coated tablets by Milpharm
Me-too status Zetro 250mg Tablet by Getz Pharma (Reg# 066913)
dated 11-06-2018.
3
Decision: Approved.
Brand Name +Dosage Form + Strength Zithroser 500mg Tablets
Azithromycin as dihydrate…500mg
Type of Form Form 5
Approval status of product in Reference Azithromycin 500 mg Film-Coated Tablets by TEVA UK
Me-too status Zetro 500mg Tablet by Getz Pharma (Reg# 053120)
dated 11-06-2018.
Decision: Approved.
Brand Name +Dosage Form + Strength Sertral Gel
Composition Each gram of Gel Contains:
Diclofenac Diethylammonium…11.6mg (1.16%w/v)
Pharmacological Group Anti-inflammatory preparations, non-steroids for topical use.
Type of Form Form 5
Finished Product Specification BP Specs
Pack size & Demanded Price 20g: As per SRO
Approval status of product in Reference Voltarol 1.16% Emulgel, gel by GlaxoSmithKline
Me-too status Voltaren emul. Gel by Ciba-Geigy (Reg# 012145)
dated 11-06-2018.
Decision: Approved.
139. Name and address of manufacturer / M/s Well & Well Pharma Pvt Ltd. Plot 7, Street S-8, RCCI,
Brand Name +Dosage Form + Strength Ramivel 1.25mg Tablets
Ramipril…1.25mg
Pharmacological Group ACE inhibitors
Type of Form Form 5
Approval status of product in Reference Tritace 1.25 mg (uncoated) Tablets by Aventis Pharma
Me-too status Ramoril Tablets 1.25mg by Werrick Pharma(Reg# 027037)
GMP status Last inspection conducted on 08-02-2018; firm is operating
at fair level of cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Ramivel 2.5mg Tablets
Ramipril…2.5mg
Type of Form Form 5
Approval status of product in Reference Tritace 2.5 mg (uncoated) Tablets by Aventis Pharma
Me-too status Ramoril Tablets 2.5mg by Werrick Pharma (Reg# 027038)
3
Decision: Approved.
Brand Name +Dosage Form + Strength Ramivel 5mg Tablets
Ramipril……5mg
Type of Form Form 5
Pack size & Demanded Price 2X14’S: As per SRO
Approval status of product in Reference Tritace 5 mg (uncoated) Tablets by Aventis Pharma
Me-too status Hyperace Tablets 5mg by Werrick Pharm (Reg#015230)
Decision: Approved.
Brand Name +Dosage Form + Strength Bisovel 2.5mg Tablets
Bisoprolol Fumarate………….2.5mg
Pharmacological Group Beta blocking agents
Type of Form Form 5
Approval status of product in Reference Cardicor 2.5mg film coated tablets by Merck
Me-too status Biscot Tablets 2.5mg by Scotmann Pharm (Reg#028240)
Decision: Approved.
Brand Name +Dosage Form + Strength Bisovel 5mg Tablets
Bisoprolol Fumarate…………..5mg
Type of Form Form 5
Pack size & Demanded Price 14’S: As per SRO
Approval status of product in Reference Cardicor 5mg film coated tablets by Merck
Me-too status Biscot Tablets 5mg by Scotmann Pharm (Reg# 028241)
Decision: Approved.
Brand Name +Dosage Form + Strength Bisovel 10mg Tablets
Bisoprolol Fumarate………….10mg
Type of Form Form 5
Approval status of product in Reference Cardicor 10mg film coated tablets by Merck
Me-too status Biscot Tablets 10mg by Scotmann Pharm (Reg#028242)
3
Decision: Approved.
Brand Name +Dosage Form + Strength Montevel 4mg Sachets
Composition Each Sachet Contains:
Montelukast as Sodium……….4.00mg
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Approval status of product in Reference Singulair Paediatric 4 mg Granules by Merck Sharp &
Regulatory Authorities. Dohme Limited (MHRA Approved)
Me-too status Singulair 4mg Oral Granules by Merck (Reg# 031377)
Decision: Approved.
Brand Name +Dosage Form + Strength Bonevel 2gm Sachets
Strontium Ranelate…2gm
Pharmacological Group Other drugs affecting bone structure and mineralization
Type of Form Form 5
Approval status of product in Reference PROTOS strontium ranelate 2g granules for oral suspension
Regulatory Authorities. sachet by Servier Laboratories (TGA Australia Approved)
Me-too status Onita Sachet by PharmEvo( (Reg# 057746)
Brand Name +Dosage Form + Strength D-Well 60000 IU Sachets
Cholecalciferol (Vitamin D3) .…60000 IU
Pharmacological Group Vitamin
Type of Form Form 5
Approval status of product in Reference Could not be confirmed
Regulatory Authorities.
Me-too status Could not be confirmed
Remarks of the Evaluator3.  Evidence of approval of applied formulation in reference
regulatory authorities which were approved by
Registration Board in its 275th meeting could not be
confirmed.
 Evidence of me-too status provided by the firm (Min-D
sachet of Hiranis Pharma) could not be confirmed.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.
 Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were adopted by the Registration Board.
Brand Name +Dosage Form + Strength Lenzovel 100mg/5ml Dry Suspension
Linezolid…………….100mg
Type of Form Form 5
Pack size & Demanded Price 60ml: As per SRO
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Approval status of product in Reference Zyvox Dry Suspension by Pharmacia (USFDA Approved)
Me-too status Nezolid 100mg Suspension by Searle (Reg# 050326)
149. Name and address of manufacturer / M/s Wilson's Pharmaceuticals. 387-388, I-9, Industrial
Applicant Area, Islamabad
Brand Name +Dosage Form + Strength Nib 10mg Tablets
Nebivolol as Hydrochloride…10mg
Pharmacological Group Beta blocking agents, selective
Type of Form Form 5
Approval status of product in Reference Bystolic 10mg (uncoated tablet) by Allergan
Regulatory Authorities. (USFDA Approved)
Me-too status Nebix tablets 10mg by Highnoon Laboratories
(Reg#062778)
remarks that firm is operating at good level of GMP
compliance.
150. Name and address of manufacturer / M/s Titlis Pharma. 528-A, Sundar Industrial Estate,
Applicant Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Sitaformin 50/1000mg Tablet
Sitagliptin (as phosphate monohydrate) …50mg
Metformin hydrochloride…1000mg
Pharmacological Group Antidiabetic
Type of Form Form 5
Approval status of product in Reference Janumet 50/1000 mg film coated Tablet by Merck
Me-too status Treviamet 50mg + 1000mg Tablet by Getz (Reg# 055444)
GMP status Issued cGMP Certificate based on the evaluation conducted
on 11-7-2018.
151. Name and address of manufacturer / M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205,
Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Iso-Fer Injection
Iron (III) Isomaltoside Eq. to Elemental Iron…….100mg
Pharmacological Group Iron preparation
Type of Form Form 5
Pack size & Demanded Price 5 x 1ml: As per SRO
Approval status of product in Reference Monofer 100mg/ml solution for injection/infusion by
Regulatory Authorities. Pharmacosmos UK (MHRA Approved)
Me-too status Monofer Injection by Universal Enterprises (Reg# 072501).
GMP status Issued cGMP Certificate based on the evaluation conducted
on 11-7-2018.
3
152. Name and address of manufacturer / M/s Bryon Pharmaceuticals Pvt Ltd. 48-Hayatabad
Applicant Industrial Estate, Peshawar, K.P.K
Brand Name +Dosage Form + Strength Carval 5/80mg Tablets
Amlodipine Besylate as Amlodipine…….…5mg
Valsartan………….80mg
Type of Form Form 5
Approval status of product in Reference Exforge 5 mg/80 mg film-coated tablets by Novartis
Regulatory Authorities. (EMA Approved)
Me-too status Exforge 5/80mg tablets by Novartis (Reg# 047569)
GMP status Last inspection report dated 15-02-2017 confirms
satisfactory compliance to GMP.
Decision: Approved.
Amlodipine Besylate as Amlodipine…5mg
Valsartan…………….160mg
Type of Form Form 5
Decision: Approved.
154. Name and address of manufacturer / M/s Bryon Pharmaceuticals (Pvt) Ltd. 48-Hayatabad
Amlodipine Besylate as Amlodipine…10mg
Valsartan………..160mg
Type of Form Form 5
Decision: Approved.
Brand Name +Dosage Form + Strength Zepep Plus 40/1100mg Capsules
Omeprazole……………..40mg
Sodium Bicarbonate……1100mg
Pharmacological Group Drugs for peptic ulcer
Type of Form Form 5
Approval status of product in Reference Zegerid Capsule 40/1100mg by Santarus Inc
Me-too status Faast Plus Capsule by CCL Pharma (Reg# 060325)
Decision: Approved.
Brand Name +Dosage Form + Strength Myolip 10mg Tablets
Atorvastatin as Calcium Trihydrate ..…10mg
Pharmacological Group Antihyperlipidemic
Type of Form Form 5
Finished Product Specification JP Specs
Approval status of product in Reference Lipitor 10mg film coated Tablets by Pfizer
Me-too status Lipitor 10mg Tablets by Pfizer (Reg# 023620)
Remarks of the Evaluator3. Firm has applied for the formulation of uncoated tablet
while reference product is approved as film coated tablet.
Decision: Deferred for revision of formulation to film coated tablet as per the reference product
along with submission of fee for revision of formulation.
Atorvastatin as Calcium Trihydrate …20mg
Type of Form Form 5
Remarks of the Evaluator3.  Firm has applied for the formulation of uncoated tablet
while the reference product is approved as film coated
tablet.
Atorvastatin as Calcium Trihydrate …40mg
Type of Form Form 5
Remarks of the Evaluator3.  Firm has applied for the formulation of uncoated tablet
while reference product is approved as film coated tablet.
Brand Name +Dosage Form + Strength Cloxidil AP 75/75mg Tablets
Clopidogrel (as Clopidogrel Bisulfate)……….…75mg
Aspirin…………………75mg
Pharmacological Group Anticoagulant/ platelet aggregation inhibitor
Type of Form Form 5
Approval status of product in Reference APO-CLOPIDOGREL/ASPIRIN 75/75 film coated tablet
Regulatory Authorities. by Apotex Pty Ltd (TGA Australia Approved)
Me-too status CoPlavix Tablets 75/75mg by Sanofi (Reg#075978)
Decision: Registration Board deferred the case for detailed deliberation regarding the TGA
approved formulation and already registered similar fomrulations.
160. Name and address of manufacturer / M/s Genetics Pharmaceuticals Pvt. Ltd. 539-A, Sundar
Applicant Industrial Estate,Raiwind, Lahore
Brand Name +Dosage Form + Strength Selvir 75mg Capsule
Oseltamivir phosphate equivalent to oseltamivir…75mg
Pharmacological Group Neuraminidase inhibitors
Type of Form Form 5
Approval status of product in Reference Tamiflu 75mg Capsule by Roche
Me-too status Tamiflu 75mg Capsule by Roche (Reg# 039619)
GMP status New DML granted: 25/8/16
GMP dated 12-2-2018, the GMP compliance status of firm
can’t be verified because firm was not operational at the
time of inspection however premises were found well
maintained and at satisfactory level.
Decision: Approved.
161. Name and address of manufacturer / M/s High-Q Pharmaceuticals. Plot No.224, Sector 23,
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Cetrine 5mg Tablets
Levocetirizine dihydrochloride…5mg
Pharmacological Group Antihistamines For Systemic Use
Type of Form Form 5
Approval status of product in Reference Xyzal 5mg Film Coated Tablet by Sanofi Aventis
Me-too status Levrix Tablets 5mg by AGP (Reg# 034675)
GMP status Last GMP inspection was conducted on 10-04-2018 and the
report concludes a satisfactory level of GMP compliance.
Decision: Approved.
162. Name and address of manufacturer / M/s High-Q Pharmaceuticals. Plot No.224, Sector 23,
Applicant Korangi Industrial Area, Karachi.
By: M/s Surge Laboratories (Pvt) Ltd. 10 km, Faisalabad
Road, Bikhi, District Sheikhupura
Brand Name +Dosage Form + Strength Ondron 8mg/4ml Solution for Injection
Composition Each 4ml ampoule contains:
Ondansetron (as hydrochloride dehydrate)…8mg
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form 5
Pack size & Demanded Price 8ml x 1’s, 8ml x 5’s: As per SRO
Approval status of product in Reference Ondansetron 2 mg/ml Solution for Injection by Generics
Regulatory Authorities. UK (MHRA Approved)
Me-too status Zofran Injection 8mg / 4ml by GSK (Reg# 020669)
GMP status
Remarks of the Evaluator3. GMP inspection report within last 1 year is required
Decision: Deferred for confirmation of already approved products for contract manufacturing
from the applicant firm.
163. Name and address of manufacturer / M/s Medisure Laboratories Pakistan Pvt Ltd. A-115,
Applicant S.I.T.E, Super Highway, Karachi, Pakistan
Brand Name +Dosage Form + Strength Januet 50/500mg Tablet
Sitagliptin…………….50mg
Metformin……………500mg
Type of Form Form 5
Pack size & Demanded Price
GMP status GMP certificate issued based on inspection of 28-6-2018
Remarks of the Evaluator3. Firm has applied for the formulation containing sitagliptin
phosphate monohydrate 50mg and metformin 500mg, while
the USFDA approved reference product contains sitagliptin
phosphate monohydrate equivalent to sitagliptin 50mg and
metformin hydrochloride 500mg.
Decision: Deferred for revision of salt forms of the API in the formulation as per the reference
product along with submission of fee for revision of formulation.
Brand Name +Dosage Form + Strength Zertralin 50mg Tablet
Sertraline (as hydrochloride )…..50mg
Pharmacological Group Selective serotonin reuptake inhibitors
Type of Form Form 5
Approval status of product in Reference LUSTRAL 50 mg film coated tablets by Pfizer Limited
Me-too status Zoloft Tablets 50mg by Pfizer (Reg#020855)
3
Decision: Approved.
Brand Name +Dosage Form + Strength Zertralin Plus 100mg Tablet
Sertraline (as hydrochloride) …100mg
Type of Form Form 5
Approval status of product in Reference LUSTRAL 100 mg film coated tablets by Pfizer Limited
Me-too status Zoloft Tablets 100mg by Pfizer (Reg#020856)
Decision: Approved.
Brand Name +Dosage Form + Strength Rosuvasure 5mg Tablet
Rosuvastatin (as calcium) …5mg
Pharmacological Group HMG CoA reductase inhibitors
Type of Form Form 5
Finished Product Specification Firm has claimed inhouse specification
Approval status of product in Reference Crestor 5 mg film-coated tablets by AstraZeneca UK
Me-too status Rovista 5mg Tablets by Getz (Reg# 044043)
3
167. Name and address of manufacturer / M/s Olive Laboratories. Plot No. 52, Street S-6, National
Applicant Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Amlosartan 10/12.5/160mg Tablets
Amlodipine Besylate Eq. to Amlodipine…10mg
Valsartan…160mg
Type of Form Form 5
Pack size & Demanded Price 2 x 7’s: As per SRO
Approval status of product in Reference Exforge HCT film coated Tablets by Novartis (USFDA
Me-too status Exforge HCT 10/160/12.5mg tablets by Novartis (Reg#
069550)
GMP status GMP certificate granted based on inspection of 03-11-2017
Decision: Approved.
Brand Name +Dosage Form + Strength Amlosartan Plus 10/25/160mg Tablets
Valsartan…160mg
Type of Form Form 5
Me-too status Exforge HCT 10/160/25mg tablets by Novartis (Reg#
069551)
Decision: Approved.
Brand Name +Dosage Form + Strength Amlosartan Forte 10/25/320mg Tablets
Valsartan…320mg
Type of Form Form 5
Me-too status Exforge HCT 10/230/25mg tablets by Novartis (Reg#
069552)
Decision: Approved.
Brand Name +Dosage Form + Strength Papra 10mg Tablets
Aripiprazole……………..10mg
Pharmacological Group Other antipsychotics
Type of Form Form 5
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Approval status of product in Reference ARPOYA 10 mg uncoated Tablets by Torrent Pharma
Me-too status Ariza 10 Mg Tablet by Hilton Pharma (Reg#037686)
Decision: Approved.
Brand Name +Dosage Form + Strength Papra 15mg Tablets
Aripiprazole…15mg
Pharmacological Group Other antipsychotics
Type of Form Form 5
Approval status of product in Reference ARPOYA 15 mg uncoated Tablets by Torrent Pharma
Me-too status Ariza 15 Mg Tablet by Hilton Pharma (Reg#037687)
3
Decision: Approved.
Brand Name +Dosage Form + Strength Netapride 1mg/5ml Syrup
Composition Each 5ml syrup contains:
Cinitapride hydrogen tartrate eq. to cinitapride…1mg
Pharmacological Group Propulsives
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Approval status of product in Reference Cidine 1 mg / 5 ml Oral solution by ALMIRALL, SA
Regulatory Authorities. (Spain Approved)
Me-too status Cidine syrup by Highnoon Lab (Reg#069457)
Brand Name +Dosage Form + Strength Netapride 1mg Tablets
Cinitapride hydrogen tartrate eq. to cinitapride…1mg
Pharmacological Group Propulsives
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s, 5 x 10’s: As per SRO
Approval status of product in Reference Cidine 1 mg uncoated tablet by ALMIRALL, SA (Spain
Me-too status Cidine Tablets by Highnoon Lab (Reg#052940)
Brand Name +Dosage Form + Strength Olipride 50mg Tablets
Itopride Hydrochloride…50mg
Pharmacological Group Gastroprokinetic
Type of Form Form 5
Pack size & Demanded Price 1x7’s, 1x10’s, 3x10’s: As per SRO
Approval status of product in Reference Ganaton film coated Tablets 50mg by Mylan EPD G.K.
Regulatory Authorities. (PMDA Japan Approved)
Me-too status Ganaton Tablets 50mg by Abbott (Reg# 028429)
Brand Name +Dosage Form + Strength Nizolid 100mg/5ml Dry Suspension
Composition Each 5ml suspension contains:
Linezolid…100mg
Type of Form Form 5
Pack size & Demanded Price 60ml / 120ml: As per SRO
Approval status of product in Reference Zyvox Dry Suspension by Pharmacia (USFDA Approved)
Me-too status Nezolid 100mg Suspension by Searle (Reg# 050326)
Remarks of the Evaluator3.  Firm has applied for liquid suspension, while
USFDA approved reference product along with me-too is
available as dry suspension. Moreover the firm do not
possess “Dry Powder suspension” section as evident from
GMP certificate dated 04-01-2018 issued by Additional
Director, QA&LT Islamabad.
Decision: Deferred for revision of formulation to dry suspension in line with reference product
along with submission of fee.
Brand Name +Dosage Form + Strength Nizolid 600mg Tablets
Linezolid…600mg
Pharmacological Group Other antibacterial
Type of Form Form 5
Me-too status Zyvox Tablets 600mg by Pharmacia (Reg# 028440)
Brand Name +Dosage Form + Strength Larcame 8mg Tablets
Lornoxicam…8mg
Pharmacological Group Oxicams
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Type of Form Form 5
Pack size & Demanded Price 1x10’s: 1x5’s: 3x10’s: As per SRO
Approval status of product in Reference Acabel 8 mg film-coated tablets by Grünenthal Pharma,
Regulatory Authorities. S.A. (Spain Approved)
Me-too status Zafon 8mg Tablet by Getz Pharma (Reg# 058589)
GMP status GMP certificate granted based on inspection dated 03-11-
2017
Brand Name +Dosage Form + Strength Moxilive 400mg Tablets
Moxifloxacin (as hydrochloride)…400mg
Pharmacological Group Fluoroquinolones
Type of Form Form 5
Approval status of product in Reference Avelox 400 mg film-coated tablets by Bayer plc (MHRA
Me-too status Avelox Tablets by Bayer (Reg#024653)
3
Brand Name +Dosage Form + Strength Linzapine 5mg Capsule
Olanzapine…5mg
Type of Form Form 5
Pack size & Demanded Pricse 1x10’s: As per SRO
Approval status of product in Reference Zolafren 5 mg hard capsules EFG. By Adamed
Regulatory Authorities. Laboratorios, SLU (Spain Approved)
Me-too status Schezonil Capsule by Werrick Pharma (Reg# 026658)
Brand Name +Dosage Form + Strength Linzapine 10mg Tablets
Olanzapine…10mg
Type of Form Form 5
Approval status of product in Reference Olanzapine Sandoz 5 mg film-coated tablets EFG by
Regulatory Authorities. Sandoz Farmacéutica, SA (Spain Approved)
Me-too status Zyprexa Tablets 10mg by Eli Lilly (Reg#023616)
Brand Name +Dosage Form + Strength Setamol 500mg Tablets
Paracetamol…500mg
Pharmacological Group Antipyretic / Analgesic
Type of Form Form 5
Approval status of product in Reference Ardimol 500 mg uncoated Tablets by Chelonia Healthcare
Me-too status Paracetamol Tablets by Sharex Pharma (Reg# 002140)
Decision: Approved.
Brand Name +Dosage Form + Strength Olixat CR 12.5mg Tablets
Composition Each enteric, film coated controlled release tablet contains:
Paroxetine as HCL…12.5mg
Type of Form Form 5
Approval status of product in Reference Paxil CR Tablet by M/s Apotex Technologies (USFDA
Me-too status Panox CR Tablet 12.5 mg by Regal Pharma (Reg#081953)
Remarks of the Evaluator3. Firm has initially applied for formulation of controlled
release tablet, later firm has requested to change their
formulation as per the reference product. Firm has also
submitted fee PKR 5,000/- for revision of formulation.
Decision: Approved.
Brand Name +Dosage Form + Strength Olixat CR 25mg Tablets
Paroxetine as HCL…25mg
Type of Form Form 5
Me-too status Panox CR Tablet 25 mg by Regal Pharma (Reg#081954)
Decision: Approved.
Brand Name +Dosage Form + Strength Olixat CR 37.5mg Tablets
Paroxetine as HCL…37.5
Type of Form Form 5
Me-too status Deroxat CR 37.5mg Tablets by Global Pharma
(Reg#069948)
Decision: Approved.
Brand Name +Dosage Form + Strength Faximine 550mg Tablets
Rifaximin…550mg
Type of Form Form 5
Approval status of product in Reference REFERO 550mg film-coated tablets by Alfasigma S.p.A
Me-too status Xifaxa 550mg Tablet by Brookes Pharm (Reg#070438)-
Remarks of the Evaluator3. Firm has initially applied for formulation of uncoated tablet,
later firm has requested to change their formulation as per
the reference product. Firm has also submitted fee PKR
5,000/- for revision of formulation.
Brand Name +Dosage Form + Strength Vesta 10mg Tablet
Type of Form Form 5
Me-too status Rolip 10mg Tablets by Hilton Pharma (Reg# 042353)
3
Brand Name +Dosage Form + Strength Vesta 20mg Tablets
Type of Form Form 5
Me-too status Rolip 20mg Tablets by Hilton Pharma (Reg# 042354)
Brand Name +Dosage Form + Strength Jenmef Plus 50/500mg Tablets
Sitagliptin Phosphate Monohydrate Eq. to
Sitagliptin…50mg Metformin Hydrochloride…500mg
Type of Form Form 5
Brand Name +Dosage Form + Strength Jenmef Plus 50/1000mg Tablets
Sitagliptin…50mg Metformin Hydrochloride…1000mg
Type of Form Form 5
Brand Name +Dosage Form + Strength Fangal 125mg Tablets
Terbinafine (as hydrochloride)…125mg
Pharmacological Group Antifungals for systemic use
Type of Form Form 5
Approval status of product in Reference TERBINAFINE 125 mg uncoated tablets Stada
Regulatory Authorities. Arzneimittel AG (MHRA Approved)
Me-too status Lamisil 125mg Tablet by Sandoz (Reg# 013208)
Decision: Approved.
Brand Name +Dosage Form + Strength Thiocide 4mg Capsule
Thiocolchicoside…4mg
Pharmacological Group Muscle Relaxants
Type of Form Form 5
Pack size & Demanded Price Muscor Capsule by Genome Pharma (Reg#064162)
Approval status of product in Reference MYOPLEGE 4 mg capsule by Laboratoires GENEVRIER
Regulatory Authorities. SA (ANSM France Approved)
Me-too status 1x10’s: As per SRO
Brand Name +Dosage Form + Strength Madol 50mg Capsule
Tramadol Hydrochloride…50mg
Pharmacological Group Other opioids
Type of Form Form 5
Finished Product Specification BP
Approval status of product in Reference Adolonta 50 mg hard capsules by Grünenthal Pharma, SA
Regulatory Authorities. (Spain Approved)
Me-too status Trumed Capsule by Neutro Pharma (Reg#065759)
Decision: Approved.
Brand Name +Dosage Form + Strength Termidol SR 100mg Tablets
Type of Form Form 5
Approval status of product in Reference Adolonta retard 100 mg prolonged-release tablets by
Regulatory Authorities. Grünenthal Pharma, SA (Spain Approved)
Me-too status Adolan SR Tablets by Siza International (Reg# 027099)
3
Decision: Approved.
Brand Name +Dosage Form + Strength Vildamef 50/500mg Tablets
Vildagliptin………………50mg
Metformin hydrochloride……..500mg
Type of Form Form 5
Approval status of product in Reference GALVUMET 50/500 film coated tablet by Novartis
Regulatory Authorities. Pharmaceuticals (TGA Australia Approved)
Me-too status Galvus Met 50/500mg Tablets by Novartis (Reg# 078106)
Remarks of the Evaluator3.  Firm has initially applied for formulation of
uncoated tablet, later firm has requested to change their
Brand Name +Dosage Form + Strength Vildamed Plus 50/1000mg Tablets
Vildagliptin…50mg
Metformin Hydrochloride…1000mg
Type of Form Form 5
Approval status of product in Reference GALVUMET 50/1000 film coated tablet by Novartis
Regulatory Authorities. Pharmaceuticals (TGA Australia Approved)
Me-too status Galvus Met 50/1000mg Tablets by Novartis (Reg# 066107)
3
Evaluator PEC-IV
196. Name and address of manufacturer / M/s Epharm Laboratories. A-40, Road No. 1, S.I.T.E. Super
Applicant Highway Industrial Area, North Karachi
Brand Name +Dosage Form + Strength Rustatin-5mg Tablets
Rosuvastatin as Calcium………5mg
Diary No. Date of R& I & fee Dy.No;25219 19-12-2017 Rs. 20,000-(18-12-2017)
Pharmacological Group HMG CoA reductase inhibitor/Antihyprlipidemic
Type of Form Form 5
Finished product Specifications Manufacturer’s specifications
Approval status of product in CRESTOR tablet of (USFDA approved)
Reference Regulator Authorities
Me-too status (with strength and dosage RosuBar 5mg Tablet by M/s Barrett Hodgson
form)
GMP status The last GMP inspection conducted on 01-03-2018 and
report concludes that current level of compliance was noted
as satisfactory.
Brand Name +Dosage Form + Strength Valpharm-40mg Tablets
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Type of Form Form 5
Finished product Specifications USP
Approval status of product in Diovan Of ( USFDA Approved)
Me-too status (with strength and Converge 40mg Tablet by M/s Scotmann Pharmaceuticals
dosage form)
GMP status The last GMP inspection conducted on 01-03-2018 & report
concludes that current level of compliance was noted as
satisfactory.
Decision: Approved.
Type of Form Form 5
dosage form)
as satisfactory.
Decision: Approved.
Type of Form Form 5
dosage form)
as satisfactory.
Decision: Approved.
Brand Name +Dosage Form + Strength Sita-50mg Tablets
Sitagliptin………..50mg
Pharmacological Group Antihyperglycemic
Type of Form Form 5
Approval status of product in Januvia tablets of (FDA approved)
Me-too status (with strength and A-Glip Tablets of M/s Atco Labs
dosage form)
as satisfactory.
Decision: Approved.
Brand Name +Dosage Form + Strength Sita-100mg Tablets
Sitagliptin………..100mg
Pharmacological Group oral blood glucose lowering drugs
Type of Form Form-5
Approval status of product in Sitagliptin 25 mg film-coated tablets by M/s Laboratoires
Reference Regulatory Authorities Biogaran (MHRA Approved)
Me-too status (with strength and A-Glip 25mg Tablets by M/s Atco Laboratories Ltd
dosage form) (Reg#053096)
as satisfactory.
Decision: Approved.
Brand Name +Dosage Form + Strength Sitamin-50/500mg Tablets
Sitagliptin…50mg
Type of Form Form-5
Pack size & Demanded Price As per DPC
Approval status of product in Janumet tablets of (TGA approved)
Me-too status (with strength and S-Gliptin Plus Tablets of M/s Barrett Hodgson
dosage form)
as satisfactory.
Brand Name +Dosage Form + Strength Sitamin-50/1000mg Tablets
Sitagliptin Phosphate Monohydrate eq. to Sitagliptin…50mg
Metformin Hydrochloride………..1000mg
Type of Form Form 5
Me-too status (with strength and Silmax-M 50mg/1000mg Tablet by M/s High-Q
dosage form) Pharmaceuticals
as satisfactory.
204. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Applicant Karachi, 75190, Pakistan
Brand Name +Dosage Form + Strength Seipil 50mg Capsule
Pregabalin………..50mg
Type of Form Form 5
Finished product Specifications Manufacturer’s specification
Pack size & Demanded Price 14’s, ; As per SRO
Approval status of product in Lyrica of (USFDA approved)
Me-too status (with strength and Gabica Capsule by M/s Getz Pharma
dosage form)
GMP status Date of latest Inspection: 16-02-2018
Conclusion:
"In the light of inspected areas, facilities status of equipment
and hygiene and sanitation of area and equipment, control
procedures and documentations, internal and external
inspection and audit reports safety of the workers, stability
protocols and data, product development, recalls and
complaints handling & other CGMP issues, M/s Genix
Pharma Pvt. Ltd Karachi was considered at an satisfactory
level of compliance with CGMP GUIDLINES as of today.
The management was also suggested to further strengthen
stability and analytical sections.”
Brand Name +Dosage Form + Strength Epirac 250mg Tablets
Levetiracetam………250mg
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s ; As per SRO
Approval status of product in KEPPRA of (USFDA approved)
Me-too status (with strength and Fitzloc 250mg Tablet by M/s OBS Pharma
dosage form)
Conclusion:
Decision: Approved.
Type of Form Form 5
dosage form)
Conclusion:
Decision: Approved.
Type of Form Form 5
dosage form).
Conclusion:
Decision: Approved.
Type of Form Form 5
Me-too status (with strength and Elicia 1000mg Tablet by M/s Martin Dow
dosage form)
Conclusion:
Decision: Approved.
Brand Name +Dosage Form + Strength Leucoarte CA 15mg/2ml Solution for Injection
Composition Each 2ml of ampule Contains:
Folinic Acid as Calcium Folinate………15mg/2ml
Pharmacological Group Detoxifying agent for antineoplastic treatment
Type of Form Form 5
Finished product Specifications Manufacturers specification
Pack size & Demanded Price 1’s, 10’s, ; As per SRO
Approval status of product in Leucovorin Calcium Of (Tga Approved)
Me-too status (with strength and Leucovorin Calcium By M/S Atco Lab
dosage form).
Conclusion:
Brand Name +Dosage Form + Strength Leucoarte CA 50mg/5ml Solution for Injection
Composition Each 5ml of ampule Contains:
Folinic Acid as Calcium Folinate………50mg
Type of Form Form 5
Pack size & Demanded Price 1’s, 10’s, ; As per SRO
Approval status of product in Leucovorin Calcium Of (Tga Approved)
Me-too status (with strength and Kunyrin 50mg/5ml Injection By Al-Habib
dosage form) (Reg. No. 021041)
Conclusion:
Applicant 135-B Nowshehra Industrial Estate, Risalpur,Pakistan
Brand Name +Dosage Form + Strength Click 250mg Tablet
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form 5
Pack size & Demanded Price 10’s ; As per SRO
Approval status of product in Biaxin Of ( USFDA Approved)
Me-too status (with strength and Clarmark 250mg tablet Of M/S Wel Mark
dosage form) Pharmaceutical
GMP status Last inspection conducted on 18-07-2018 and report
concludes that “During Inspection, various facilities like the
storage areas, the Equipments, the environmental control,
technical personal employed, documentation and quality
control testing were critically analyzed and reviewed.
From the observations, it is concluded that the firm M/s
Rock Pharma Risalpur is complying the cGMP and is
recommend for the grant of cGMP certificate by the panel.”
Applicant 135-B Nowshehra Industrial Estate, Risalpur,Pakistan
Brand Name +Dosage Form + Strength Click 500mg Tablet
Type of Form Form 5
Me-too status (with strength and Clarmark 500mg tablet Of M/S Wel Mark
dosage form) Pharmaceutical
GMP status Last inspection conducted on 18-07-2018 and report
concludes that
“During Inspection, various facilities like the storage
areas, the Equipments, the environmental control, technical
personal employed, documentation and quality control
testing were critically analyzed and reviewed.
From the observations, it is concluded that the firm M/s
Rock Pharma Risalpur is complying the cGMP and is
recommend for the grant of cGMP certificate by the panel.”
4
213. Name and address of manufacturer / M/s Sami Pharmaceuticals Pvt Ltd. F-95, S.I.T.E. Karachi,
Applicant Pakistan
Brand Name +Dosage Form + Strength Itaglip Plus 50/850mg Tablets
Sitagliptin Phosphate Eq. to Sitagliptin…50mg
Metformin HCL…850mg
Type of Form Form-5
Pack size & Demanded Price 14’s and 28’s; As per DPC
dosage form)
GMP status Last GMP Inspection dated 26-04-2018.
Panel recommended renewal of DML.
214. Name and address of manufacturer / M/S Scilife Pharma (Pvt) Ltd. FD-57/58-A2, Korangi
Applicant Creek Industrial Park (Kcip), Karachi
Brand Name +Dosage Form + Strength Metfor 250mg Tablet
Metformin HCl………250mg
Diary No. Date of R& I & fee Dy.No.25254; 19-12-2017; Rs.20,000/- (18-12-2017)
Pharmacological Group Blood glucose lowering agent(Biguanides)
Type of Form Form 5
Approval status of product in Approved in TGA
Me-too status (with strength and GLUCOPHAGE 250MG M/s BOOTS
dosage form) PHARMACEUTICALS
GMP status Last inspection report 5-12-2017 Manufacturer’s
overall rating is good compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Metfor 500mg Tablet
Type of Form Form 5
Approval status of product in Glucophage of USFDA approved
Me-too status (with strength and Glucophage tablet 500mg of Merck
dosage form)
GMP status Last inspection report 5-12-2017 Manufacturer’s overall
rating is good compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Metfor MR 500mg Tablet
Composition Each modified release tablet contains:
Type of Form Form 5
Approval status of product in Glucophage XR of USFDA approved
Me-too status (with strength and dosage Metwil-XR Tablets of M/s Wilson’s Pharmaceuticals
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Metfor MR 750mg Tablets
Composition Each modified release tablet contains:
Type of Form Form 5
Approval status of product in Glucophage XR of USFDA approved
Me-too status (with strength and dosage D-Formin MR 750mg Tablet of M/s Getz
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Metfor 850mg Tablets
Type of Form Form 5
Me-too status (with strength and Gluchk 850mg Tablets of M/s. Dyson Research
dosage form) Laboratories
Decision: Approved.
Brand Name +Dosage Form + Strength Metfor 1gm Tablets
Metformin Hydrochloride…1gm
Type of Form Form 5
Me-too status (with strength and Metfor 1g Tablets of M/s Valor Pharmaceuticals,
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Metfor MR 1gm Tablets
Composition Each Modified Release Tablet Contains:
Metformin Hydrochloride…1gm
Pharmacological Group Blood glucose lowering agent (Biguanides)
Type of Form Form 5
Approval status of product in Glumetza of USFDA approved
Me-too status (with strength and Diabescot-XR 1000mg Tablets of M/s Scotmann
dosage form) Pharmaceuticals,
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GMP status Last inspection report 5-12-2017 Manufacturer’s
overall rating is good compliance.
Decision: Approved.
Evaluator PEC-V
221. Name and address of manufacturer / M/s Sami Pharmaceuticals Pvt. Limited,
Applicant F-95, SITE Karachi, Pakistan
Brand Name +Dosage Form + Strength Ebzy 10 mg Tablets
Ebastine…10mg
Diary No. Date of R& I & fee Dy. No. 25709; 22-12-2017; Rs.20,000/- (22-12-2017)
Pharmacological Group Antihistamine
Type of Form Form 5
Approval status of product in EBASTINE ARROW 10 mg film-coated tablets
Reference Regulatory Authorities. ANSM Approved
Me-too status 031820. Nosetine Tablets by Technovision Pharmaceuticals
GMP status 26-04-2018; Very Good level of compliance.
Remarks of the Evaluator. AD PEC V
Decision: Approved.
222. Name and address of manufacturer / M/s Sami Pharmaceuticals Pvt. Limited,
Applicant F-95, SITE Karachi, Pakistan
Brand Name +Dosage Form + Strength Ebzy 20 mg Tablets
Ebastine…20mg
Type of Form Form 5
Approval status of product in Kestine
Reference Regulatory Authorities. Netherlands Approved
Me-too status 068792
Antine Tablets 20 mg by Wise Pharmaceuticals Rawat"
GMP status 26-04-2018
Very Good level of compliance.
Remarks of the Evaluator. AD PEC V
Decision: Approved.
223. Name and address of manufacturer / M/s British Pharmaceuticals
Applicant 23-Km Sheikhupura Road, Lahore
Brand Name +Dosage Form + Strength Briphen Syrup 2mg/5ml
Diary No. Date of R& I & fee Diary No:19893, 2/11/2017, Rs: 20,000/- Dated 2/11/2017
Composition Each 5ml syrup contains:
Chlorpheniramine Maleate….2mg
Type of Form Form 5
Finished product Specification In-house
Pack size & Demanded Price 120ml, 450ml, As per SRO
Approval status of product in Piriton Syrup
Reference Regulatory Authorities. MHRA Approved
"Colen Syrup by Alliance Pharmaceuticals (Pvt) Ltd, 112-A,
Hayatabad Industrial Estate Jamrud Road, Peshawar.
GMP status Last inspection: 06-12-2017
Conclusion:
Lot of observation were made by undersigned during
inspection. They were directed to submit compliance report
regarding to said observation to this office so re-inspection
could be conducted accordingly.
Latest inspection:07-09-2018
Firm showed improvement regarding to previous GMP
inspection. They also did lot of civic work regarding to paint
on walls /ceiling. Furnished corridor/Production area with
tiles and replacement of door with new one in production
area.
Remarks of the Evaluator. The product is present in USP (oral solution).
Decision: Approved with USP Specification.
Brand Name +Dosage Form + Strength Briclop Syrup 5mg/5ml
Composition Each 5ml contains: -
Metoclopramide HCl…5mg
Pharmacological Group Dopamine receptor antagonist, antiemetic
Type of Form Form 5
Finished product Specification USP(Oral solution)
Pack size & Demanded Price 60ml, 20ml drops, As per SRO
Approval status of product in MHRA Approved
Me-too status 046388. "Mexoram Syrup.
Meditech Pharmaceuticals,
Conclusion:
area.
Remarks of the Evaluator.
Decision: Approved.
Brand Name +Dosage Form + Strength Bronconil Syrup 2mg/5ml
Composition Each 5ml contains
Salbutamol as sulphate………2mg
Pharmacological Group Bronchodilator
Type of Form Form 5
Finished product Specification Available in BP as oral solution.
Pack size & Demanded Price 60ml,450ml
Approval status of product in Ventolin Syrup of (MHRA approved)
Me-too status 064242. Ezibreath Syrup of M/s Rock Pharmaceuticals
Conclusion:
area.
Decision: Approved.
Brand Name +Dosage Form + Strength Brizine Syrup 5mg/5ml
Composition Each ml contains
Cetirizine dihydrochloride…1mg
Type of Form Form 5
Pack size & Demanded Price 60ml, 450ml,
Approval status of product in Children's Zyrtec Allergy By J and J Consumer Inc
Reference Regulatory Authorities. USFDA
Olair 5mg/5ml syrup
"Gulf Pharmaceuticals,
Conclusion:
area.
Decision: Approved.
Brand Name +Dosage Form + Strength Paracetamol 6+ Suspension 250mg/5ml
Diary No. Date of R& I & fee Diary No:19894, 2/11/2017, Rs: 20,000/- 2/11/2017+
Rs.5,000/- Dated 19/09/2018
Composition Each 5 ml contains:
Paracetamol…250mg
Pharmacological Group Analgesic/ Antipyretic
Type of Form Form 5
Finished product Specification Present In IP.
Pack size & Demanded Price 60ml
Approval status of product in Boots Paracetamol 6 Years Plus
Reference Regulatory Authorities. 250mg/5ml Oral Suspension
MHRA Approved
Me-too status 490944 "Parasol Plus Suspension.
"Z-JANS Pharmaceuticals,
Conclusion:
area.
Decision: Approved.
228. Name and address of manufacturer / M/s Cunningham Pharmaceuticals Pvt. Ltd.
Applicant Plot No. 81 Sunder Industrial Estate ,Raiwind Lahore
Brand Name +Dosage Form + Strength Aquajet
Diary No. Date of R& I & fee Diary No:25726, 22/12/2017, Rs: 20,000/-
Composition Each 10 ml contains:
Sterile Water for Injection
Pharmacological Group N/A
Type of Form Form 5
Pack size & Demanded Price 1’s, 10’s, 100’s
Approval status of product in USFDA Approved
Water for Injection 10ml by Healthtek Karachi . .
GMP status GMP certificate issued based on inspection conducted on
31.01.2018.
Remarks of the Evaluator. Firm has Liquid ampoule general section and SVP(1cc , 2cc,
3 and 5 CC ampoule filling machine) as per FID report dated:
17-03-2016.
Decision: Approved.
Evaluator PEC-VI
Brand Name +Dosage Form+ Strength Piotryl 30/4mg tablets
Pioglitazone HCl eq to Pioglitazone…….30mg
Glimipride………4mg
Pharmacological Group Sulphonyl Urea
Type of Form Form-5
Pack size & Demanded Price 2x7’s, As per SRO
Me-too status Dazemep plus Tablet 4/30 Reg # 080841
the grant of cGMP certificate
Decision: Approved.
Brand Name+Dosage Form + Strength Piotryl 30/2mg tablets
Glimipride………2mg
Type of Form Form-5
Me-too status Dazemep plus Tablet 2/30 Reg # 080840
Decision: Approved.
Brand Name+Dosage Form + Strength Pious-M 15/500mg tablets
Metformin…….500mg
Type of Form Form-5
Pack size & Demanded Price 14’s, As per SRO
Approval status of product in Metformin HCl/Pioglitazone HCl 500/15mg by SANDOZ
Reference Regulatory Authorities. (USFDA approved)
Me-too status Glitos Plus 500/15mg by Searle Pakistan
Decision: Approved.
Brand Name+Dosage Form + Strength Pious-M 15/850mg tablets
Metformin…….850mg
Type of Form Form-5
Approval status of product in Competact 15mg/ 850mg film-coated tablets of M/s Takeda,
Reference Regulatory Authorities. UK (MHRA Approved)
Me-too status Zolid Plus of M/s Getz Pharma (Reg. # 047480)
Decision: Approved.
233. Name and address of manufacturer / M/s Arsons Pharmaceuticals Industries Pvt Ltd., 22-km
Applicant Multan Road, Off 4 KM Defence Road, Lahore.
Brand Name+Dosage Form + Strength Arsocold tablets
Pseudoephedrine HCl…..60mg
Chlorphenaramine maleate…….4mg
Type of Form Form-5
Finished product Specification Mfg
Approval status of product in Alka-Seltzer Plus Cold USA (Not confirmed)
Me-too status Panadol CF Tablet by M/s GSK (Reg#013113)
GMP status Copy of inspection report dated 02-01-2018 concluding
satisfactory level of cGMP compliance
Remarks of Evaluator International availability could not be confirmed.
authorities/agencies which were adopted by the Registration Board in its 275th meeting
Brand Name+Dosage Form + Strength Tenolol 100mg tablets
Atenolol……100mg
Type of Form Form-5
Pack size & Demanded Price 2 x 10’s, 2 x 7’s, As per SRO
Me-too status Medi-Heart Tablets Reg # 056136
Decision: Approved with change of Brand name.
Brand Name+Dosage Form + Strength Tenolol 50mg tablets
Composition Each tabet contains:
Atenolol……50mg
Type of Form Form-5
Pack size & Demanded Price 2 x 10’s, 2 x 7’s, As per SRO
Me-too status Medi-Heart Tablets Reg # 056135
Brand Name+Dosage Form + Strength Arsocam 7.5mg tablet
Meloxicam….7.5mg
Type of Form Form-5
Pack size & Demanded Price 2 x 10’s, As per SRO
Approval status of product in Meloxicam 7.5 mg Tablets by M/s TEVA UK Limited
Reference Regulatory Authorities. (MHRA Approved)
Me-too status Mevox 7.5mg Tablets by M/s Hilton Pharma (Pvt) Ltd
(Reg#023928)
Decision: Approved.
237. Name and address of manufacturer / M/s Sami Pharmaceuticals (Pvt.) Limited, F-95, S.I.T.E.
Applicant Karachi
Brand Name+Dosage Form + Strength Fertilan 50mg tablet
Clomiphene Citrate……50mg
Pharmacological Group Slective Estrogen receptor Modulator, Ovulator Stimulant
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s, 2 x 10’s As per SRO
Approval status of product in Clomid 50mg Tablets by M/s Sanofi ,
Reference Regulatory Authorities. (MHRA approved)
Me-too status Ovafin 50 mg tablet by M/s OBS (Reg#019173)
GMP status Issued Certificate of CGMP based on the evaluation
conducted on 26 April 2018.
238. Name and address of manufacturer / M/s Zafa Pharmaceuticals Laboratories Private Limited.
Applicant L1/B Block-22, Federal B industrial Area, Karachi
Brand Name+Dosage Form + Strength Ursochole Capsules 500mg
Ursodeoxycholic acid…500mg
Pharmacological Group Bile acid
Type of Form Form-5
Approval status of product in Ursochol 500 mg capsule, hard
Reference Regulatory Authorities. By Orifarm Generics A/S (Sweden Approved)
Me-too status Urso capsule by AGP
GMP status “GMP certificate issued on 23-05-2018.”
Decision: Approved.
Evaluator PEC-VII
239. Name and address of manufacturer /
Medisynth Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. 55, Street S-5, NIZ, Rawat, Islamabad, Pakistan.
Brand Name +Dosage Form + Strength
Itrazin 100mg Capsule
Composition Each capsule Contains:
Itraconazole …………… 100 mg
Diary No. Date of R& I & fee Dy. No.771; 27-4-2017; Rs.20,000/-(02-05-2017)
Pharmacological Group Antifungal
Type of Form Form 5
Finished product Specifications Innovator specs
Pack size & Demanded Price 1x4; As per PRC
Approval status of product in Itraconazole 100 mg capsules, hard by M/s Sandoz
Reference Regulatory Authorities Limited (MHRA Approved)
Me-too status (with strength and Itcap of Bio Labs (Pvt) Ltd
dosage form)
GMP status Last inspection conducted on 5-10-2017 for renewal of DML
Remarks of the Evaluator Source: Vision Pharmaceuticals
240. Name and address of manufacturer / M/s Schazoo Zaka Pvt Ltd, 20 Km Lahore-Jaranwala road.
Applicant Sheikhupura
Brand Name +Dosage Form + Strength Eslopress 5 mg tablet
Composition Each Film coated tablet contains:
Escitalopram Oxlate eq to Escitalopram……5 mg
Diary No. Date of R& I & fee D#14654, 12-9-2017; Rs. 20,000/-
Pharmacological Group Selective Serotonin Reuptake Inhibitors
Form Form-5
Approval status of product in CIPRALEX 5 mg film-coated tablets (MHRA)
Me-too status Citanew by Hilton Pharma
GMP status Last GMP inspection of conducted on 26-6-2018, 27-6-2018
and the GMP certificate is submitted.
Remarks of evaluator
Decision: Approved.
241. Name and address of manufacturer / M/s Barrett Hodgson Pakistan Pvt Ltd.
Applicant F/423, SITE, Karachi.
Brand Name +Dosage Form + Strength Barlev 750mg Tablet
Diary No. Date of R& I & fee Form-5 Dy.No 26344 28-12-2017 Rs. 20,000/- 28-11-2017
Levetiracetam…750mg
Type of Form Form-5
Pack Size & Demanded Price 10’s Rs 850
30’s Rs. 2550
Approval Status of Product in USFDA approved
Me-too Status Elicia 750mg tablet of M/s Martin Dow Ltd.
GMP status Last GMP inspection Date: 16- 28 Aug 2018, with good
cGMP compliance
Decision: Approved.
Brand Name +Dosage Form + Strength Barlev 1000 mg Tablet
Diary No. Date of R& I & fee Form-5 Dy.No.26345 28-12-2017 Rs.20,000/- 28-11-2017
Levetiracetam........1000mg
Type of Form Form-5
Pack Size & Demanded Price 10’s Rs 850 30’s Rs. 2550
Approval Status of Product in KEPPRA USFDA approved
Me-too Status Elicia 1000mg tablet of M/s Martin Dow Ltd.
cGMP compliance
Decision: Approved.
Diary No. Date of R& I & fee Form-5 Dy.No 26343 dated 28-12-2017
Rs. 20,000 Dated 28-11-2017
Levetiracetam…500 mg
Type of Form Form-5
Pack Size & Demanded Price 10’s Rs 850 30’s Rs. 2550
Approval Status of Product in KEPPRA USFDA approved
Me-too Status Elicia tablet of M/s Martin Dow Ltd.
cGMP compliance
Decision: Approved.
Rs. 20,000 Dated 28-11-2017
Levetiracetam…250 mg
Type of Form Form-5
Pack Size & Demanded Price 10’s Rs 400/- 30’s Rs. 1200/-
Approval Status of Product in Keppra tablets (USFDA Approved)
Me-too Status Keppra tablets 250mg of M/s AGP Pvt. Ltd.
cGMP compliance
Decision: Approved.
Brand Name +Dosage Form + Strength Barlev oral solution 100 mg/ml
Rs. 20,000 Dated 28-11-2017
Composition Each ml contains:
Levetiracetam …100 mg
Type of Form Form-5
Pack Size & Demanded Price 10ml Rs. 90/- 15ml Rs. 135/-
30ml Rs. 270/- 60ml Rs. 540/-
120 ml Rs. 1080/-
Approval Status of Product in Keppra 100mg/ml oral solution ( USFDA approved)
Me-too Status Klevra of Pharm Evo
GMP status Last GMP inspection Date: 16-28 Aug 2018, with good
cGMP compliance
Decision: Approved.
246. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot No.224, Sector 23,
Brand Name +Dosage Form + Strength Zyto 500 mg tablet
Composition Each film-coated tablet contains:
Azithromycin (as dihydrate).…500mg
Diary No. Date of R& I & fee D#15753, 20-9-2017; Rs. 20,000/-
Pharmacological Group Macrolide (Antibiotics)
Form Form-5
Pack size & Demanded Price 3,6,12, 10’s/ As per SRO
Approval status of product in Azithromycin 500 mg Film-coated Tablets
Reference Regulatory Authorities Approved in MHRA
Me-too status Azogil of Glitz Pharm
acceptable GMP
Remarks of evaluator
Decision: Approved.
247. Name and address of manufacturer / M/s Caraway pharmaceuticals, Plot # 12, street# N-3,
Applicant National industrial zone, Rawat
Brand Name +Dosage Form + Strength Carazone injection 2 g powder injection.
Composition Each vial contains:
Ceftriaxone as sodium……2gm
Diary No. Date of R& I & fee Dy.No. 12050, 15-8-2017, Rs.20,000/=
Pharmacological Group Cephalosporin
Type of Form Form-5
Approval status of product in Rocephin IV Injection 2gm By M/s Roche Products Limited
Me-too status Titan 2gm IV Injection by M/s Macter Pharma
(R.No.075825)
report concluded that the overall GMP compliance is Good
as of today.
Decision: Approved.
248. Name and address of manufacturer / M/s Fozan Pharmaceuticals (Pvt.) Ltd. 36A- Industrial Estate,
Applicant Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength Acti-P Tablet
Paracetamol…300mg
Pseudoephedrine (HCL)…36mg
Triprolidine (HCL)…1.5mg
Diary No. Date of R& I & fee Form-5 Dy.No 26402 (28-12-2017) Rs.20,000 (28-12-2017)
Type of Form Form-5
Finished Product Specification Innovators
Pack Size & Demanded Price 10x10’s/ As per SRO
Approval Status of Product in NA
Me-too Status Actifed-P Of Glaxosmithkline
GMP status Last inspection conducted on 25 May 2018 and report
concludes that firm is found complying satisfactory GMP.
Remarks of the Evaluator. Provided reference of Panadol cold & Flu (TGA) is different
than the applied formulation.
Brand Name +Dosage Form + Strength Para Doll CF Tablet
Paracetamol………………500mg
Pseudoephedrine HCL…….60mg
Chlorphenarmine Maleate…4mg
Diary No. Date of R& I & fee Form-5 Dy.No 26397 dated 28-12-2017 Rs. 20,000
Dated 28-12-2017
Type of Form Form-5
Me-too Status CAFIMOL CF of zinta Pharma
Remarks of the Evaluator. Reference in RRA
Brand Name +Dosage Form + Strength Venlafoz 37.5mg Tablet
Venlafaxine as HCL…37.5mg
Dated 28-12-2017
Pharmacological Group Antidepressant
Type of Form Form-5
Pack Size & Demanded Price 2x10’s; As per SRO
Approval Status of Product in EFFEXOR of Pfizer (USFDA)
Me-too Status EFEXOR of Pfizer
251. Name and address of manufacturer / M/s. Siam Pharmaceutical Industrial triangle kahuta road,
Applicant Islamabad
Brand Name +Dosage Form + Strength Cell Cox 60 mg
Dated 28-12-2017
Etoricoxib…60mg
Type of Form Form-5
Pack Size & Demanded Price 1 x10’s
2 x10’s; As per SRO
Approval Status of Product in Acoxxel approved by MHRA of UK
Me-too Status Etoria 60mg Table of M/s Hygeia Pharmaceuticals,
GMP status Last GMP inspection was conducted on 16-02-2018 for grant
of DML
252. Name and address of manufacturer / M/s. Roryan Pharmaceutical Industries (Pvt) Ltd. Plot# 85/B,
Applicant Hayatabad Industrial Estate, Peshawar
Brand Name +Dosage Form + Strength Ruberol BP 35/450mg Tablets
Diary No. Date of R& I & fee Form-5 Dy.No 26385 dated 28-12-2017 Rs. 20,000/-
Dated 28-12-2017
Orphenadrine Citrate…35mg
Paracetamol…450mg
Pharmacological Group Analgesic/Skeletal muscle relaxant
Type of Form Form-5
Approval Status of Product in Norgesic Tablet by iNova Pharmaceuticals (TGA Approved)
Me-too Status Orthoflex Tablets by Noa Hemis
GMP status Last GMP inspection Date 19-9-2018 with satisfactory
cGMP compliance
Brand Name +Dosage Form + Strength Panacid-CF Tablet
Diary No. Date of R& I & fee Form-5 Dy.#26384 (28-12-2017) Rs.20,000/- 28-12-2017
Paracetamol…500mg
Pseudoephedrine HCL…60mg
Chlorphenarmine Maleate…4mg
Pharmacological Group Analgesic/Antipyretic/Anti-allergic
Type of Form Form-5
Me-too Status CAFIMOL CF of zinta Pharma
cGMP compliance
Remarks of the Evaluator. Provided reference is Panadol Cold & Flu (MHRA) does not
contain chlorphenarmine. The provided reference of TGA is
not same as the above formulation (2mg chlorphenaramine &
30mg pseudoephidrine)
Brand Name +Dosage Form + Strength Ronic Forte Tablet
Dated 28-12-2017
Ibuprofen …400mg
Pseudoephedrine HCL…60mg
Type of Form Form-5
Me-too Status Rhinaoff Forte of Atco
cGMP compliance
Remarks of the Evaluator. Evidence of formulation in reference regulatory authority.
Provided reference of RHINADVIL can’t be verify from
UDFDA
Lasynac Max Strength 400mg/60mg is film coated tablets
255. Name and address of manufacturer / M/s. Macter International Limited, F-216, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Strength Phenib 30 mg tablet
Dated 19-12-2017
Composition Each film coated tablet contains
Phenobarbital….30mg
Pharmacological Group Anti-epileptic (Barbiturates and derivatives)
Type of Form Form-5
Pack Size & Demanded Price 60’s, 100’s
300/60’s
500/100’s
Approval Status of Product in MHRA Approved
Me-too Status Phenobarbitone 30mg Tab of Convell (001409)
GMP status Last GMP inspection Date: 23-5-2018 , with good cGMP
compliance
Remarks of the Evaluator. In form 5 film coated is mentioned but this drug is approved
as uncoated in RRA
 Evidence of approval from CLB of required manufacturing facility i.e. tablet
(psychotropic section).
 Revision of formulation to uncoated tablet as per the reference product along with
submission of fee for revision of formulation.
256. Name and address of manufacturer / M/s. Macter International Limited, F-216, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Strength Phytin 250 mg/5 ml
Dated 19-12-2017
Composition Each ampoule contains:
Phenytoin sodium…250 mg
Pharmacological Group Anti-epileptic (Barbiturates and derivatives)
Type of Form Form-5
Pack Size & Demanded Price 1’s 5ml
1500/10’s
Approval Status of Product in PHENYTOIN INJECTION BP 250mg/5mL ampoule (TGA)
Me-too Status Epigran injection of Atco
GMP status Last GMP inspection Date: 23-5-2018 , with good cGMP
compliance
Decision: Approved.
257. Name and address of manufacturer / M/s Aspin Pharma (Pvt.) Limited, Plot # 10 & 25, Sector 20,
Brand Name +Dosage Form + Strength Xalium 1mg Tablet
Dated 04-12-2017
Alprazolam…1mg
Pharmacological Group Benzodiazepine Derivative/ Psychotherapeutic
Type of Form Form-5
Pack Size & Demanded Price 30’s/ As per SRO
Approval Status of Product in Alprazolam Mylan 1 mg, tablet by M/s Mylan Sas (ANSM
Reference Regulatory Authorities. France Approved)
Me-too Status Alprazolam 1 mg Tablets by M/s Heal Pharmaceuticals
(Reg.# 079392)
report concludes satisfactory level of GMP compliance.
Remarks of the Evaluator. Alternative brand name: Alrax and Xalprax
Brand Name +Dosage Form + Strength Xalium 0.5 mg Tablet
Dated 04-12-2017
Alprazolam………….0.5 mg
Type of Form Form-5
Approval Status of Product in Xanax 500 microgram Tablets by M/s Pfizer Limited
Me-too Status Alprazolam 0.5mg Tablets by M/s Heal Pharmaceuticals
Brand Name +Dosage Form + Strength Xalium 0.25 mg Tablet
Dated 04-12-2017
Alprazolam…0.25 mg
Type of Form Form-5
Approval Status of Product in Xanax 250 microgram Tablets by M/s Pfizer Limited
Me-too Status Alprazolam 0.25mg Tablets by M/s Heal Pharmaceuticals
(Reg#079390)
260. Name and address of manufacturer / M/s Cherwel Pharmaceuticals (Pvt) Ltd Plot # 20, phase 4,
Applicant Hattar industrial estate, KPK Pakistan
Brand Name +Dosage Form + Strength Esocure 20mg Capsule
Dated 04-12-2017
Esomeprazole (enteric coated pellets)…20mg
Type of Form Form-5
Pack Size & Demanded Price As per SRO
Approval Status of Product in Esomeprazole 20 mg Capsule by Generics UK (MHRA
Reference Regulatory Authorities. Approved)
Me-too Status Nexum Capsule by Getz Pharma
GMP status Last GMP inspection was conducted on …..and the report
concludes satisfactory level of GMP compliance.
Remarks of the Evaluator. Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP inspection
of Firm on priority.
261. Name and address of manufacturer / M/s Cherwel Pharmaceuticals (Pvt) Ltd Plot # 20, phase 4,
Applicant Hattar industrial estate, KPK Pakistan
Brand Name +Dosage Form + Strength Nafzole 40 mg
Dated 04-12-2017
Omeprazole (as 22.5%w/w enteric coated pellets)….. 40mg
Type of Form Form-5
Approval Status of Product in Approved by MHRA
Me-too Status Acizole Capsule 40mg by M/s Cirin Pharmaceuticals
(Reg# 034369)
GMP status Last GMP inspection was conducted on …..and the report
concludes satisfactory level of GMP compliance.
Remarks of the Evaluator. Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
GMP needed
of firm on priority.
Applicant 135-B Nowshera Industrial Estate, Risalpur.
Brand Name +Dosage Form + Strength Docomo 75mg Tablet
Dated 21-12-2017
Composition Each tablet contains;
Diclofenac sodium …75mg
Misoprostol …………200mcg
Pharmacological Group NSAID + Prostaglandin analogue
Type of Form Form-5
Approval Status of Product in NA (In USFDA only in Delayed release)
Me-too Status DYCLO-M of INDUS PHARMA (PVT) LTD.
GMP status Last GMP inspection Date: , with cGMP compliance
Remarks of the Evaluator. Approved in USFDA with Box Warning.
 The formulation contains misoprostol 1% HPMC
dispersion and contains inner enteric coated layer
surrounded by misoprostol dispersion coating in innovator
product.
 Evidence of availability of requisite manufacturing
equipment by area FID not provided by the firm.
 Firm claim that USFDA diclofenic is delayed released not
misoprostol and same is applied by us.
 Availability of Misoprostol as 1 % HPMC could not be
verified from Form 5.
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Decision: Deferred for revision of formulation and label claim as per the USFDA approved
reference product.
Applicant 135-B Nowshera Industrial Estate, Risalpur.
Brand Name +Dosage Form + Strength Docomo 50 mg Tablet
Dated 21-12-2017
Misoprostol…0.20mg
Pharmacological Group NSAID + Prostaglandin analogue
Type of Form Form-5
Pack Size & Demanded Price 2x10’s As per SRO
Approval Status of Product in NA (In USFDA only in Delayed release)
Me-too Status DYCLO-M of INDUS PHARMA (PVT) LTD.
GMP status Last GMP inspection date: , with cGMP compliance
Remarks of the Evaluator. Approved in USFDA with Box Warning.
 The formulation contains misoprostol 1% HPMC
dispersion and contains inner enteric coated layer
surrounded by misoprostol dispersion coating in
innovator product.
 Evidence of availability of requisite manufacturing
equipment by area FID not provided by the firm.
 Firm claim that USFDA diclofenic is delayed
released not misoprostol and same is applied by us.
 Availability of Misoprostol as 1 % HPMC could not
be verified from Form 5.
reference product.
264. Name and address of manufacturer / M/s Regal Pharmaceuticals. Plot # 2A St.# S-5, National
Applicant Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Leco 50mg Tablet
Dated 22-12-2017
Lacosamide ………………………50mg
Type of Form Form-5
Finished Product Specification Manufacturer
Pack Size & Demanded Price 1x14’s, 2x 14’s As per SRO
Approval Status of Product in Vimpat 50mg tablet of M/s UCB INC Pharmaceuticals,
Reference Regulatory Authorities. (USFDA Approved)
Me-too Status Lalap 50mg tablet of M/s Genix Pharma (Reg. # 070458)
GMP status Last GMP Inspection of Conducted on 11-10-2018, firm is
cGMP compliant as per today.
Remarks of the Evaluator. Applied formulation is not present in Available USP & BP.
Applicant Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Febix 80mg Tablet
Dated 22-12-2017
Febuxostat …80mg
Pharmacological Group Anti-gout
Type of Form Form-5
Approval Status of Product in Approved by MHRA of UK
Me-too Status Febuxin by M/s AGP, Karachi (Reg. No. 081105)
Applicant Industrial Zone, Rawat,Islamabad
Brand Name +Dosage Form + Strength Febix 40mg Tablet
Dated 22-12-2017
Febuxostat …40mg
Pharmacological Group Anti-gout
Type of Form Form-5
Approval Status of Product in Approved by USFDA
Me-too Status Febuxin by M/s AGP, Karachi (Reg. No. 081105)
Brand Name +Dosage Form + Strength Rifix 550 mg tablet
Dated 22-12-2017
Composition Each Film coated Tablet Contains:
Rifaximin…550 mg
Pharmacological Group Intestinal anti-infective
Type of Form Form-5
Approval Status of Product in Refero 550mg Film-Coated Tablets by (MHRA)
Me-too Status Rixabac 550mg Tablet (Reg#076259) by Pharmevo Karachi
Brand Name +Dosage Form + Strength Panto 40mg Tablet
Dated 22-12-2017
Composition Each enteric Coated Tablet Contains:
Pantoprazole(as sodium sesquihydrate)…40mg
Pharmacological Group Antipeptic Ulcerant /Proton Pump Inhibitor
Type of Form Form-5
Pack Size & Demanded Price 1x14’s, 1x 10’s / As per SRO
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Approval Status of Product in Pantoprazole 40 mg gastro-resistant tablets by M/s Generics
Reference Regulatory Authorities. [UK] Limited t/a Mylan (MHRA approved)
Me-too Status Cantrofast 40mg enteric coated tablet by M/s Candid
pharmaceutical (Reg#082031)
Decision: Approved.
Brand Name +Dosage Form + Strength Diren 50mg Capsules
Dated 22-12-2017
Diacerein….......50mg
Pharmacological Group Antirheumatic, anti-inflammatory
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Approval Status of Product in DIACEREIN BIOGARAN 50 mg hard capsule by M/s
Reference Regulatory Authorities. BIOGARAN (ANSM, France Approved)
Me-too Status Dibro 50mg capsules by M/s Winbrain Research
Laboratories (Reg#071639)
Brand Name +Dosage Form + Strength Cobal 500mcg Tablet
Dated 22-12-2017
Composition Each Sugar Coated Tablet Contains:
Mecobalamin…500mcg
Pharmacological Group Coenzyme –type Vitamin B12
Type of Form Form-5
Finished Product Specification JP
Pack Size & Demanded Price 3x10’s, 5x10’s As per SRO
Approval Status of Product in Approved by PMDA of Japan
Me-too Status Elgin 500 mcg tablet of M/s Novartis Pharma (Pvt)
Limited (Reg. # 032638)
Decision: Approved.
Brand Name +Dosage Form + Strength Kast 10mg Tablet
Dated 22-12-2017
Montelukast (Sodium)..............................10mg
Pharmacological Group Leukotriene receptor antagonist
Type of Form Form-5
Approval Status of Product in Singulair tablets 10mg of M/s Merck Sharp & Dohme,
Reference Regulatory Authorities. Australia (TGA Approved)
Me-too Status Montiget 10mg tablets of M/s Getz Pharma
(Reg. # 034838)
Brand Name +Dosage Form + Strength Leco 100 mg Tablet
Dated 22-12-2017
Lacosamide ………………………100 mg
Type of Form Form-5
Pack Size & Demanded Price 1x14’s, 2x 14’s As per SRO
Approval Status of Product in Vimpat 100mg tablet of M/s UCB INC
Reference Regulatory Authorities. Pharmaceuticals,(USFDA Approved)
Me-too Status Lalap 100mg Tablet. (Reg.# 070471)
273. Name and address of manufacturer / M/s Demont Research Laboratories. 20km, Lahore-Sharikpur
Applicant Road, Sheikhupura, Pakistan
Brand Name +Dosage Form + Strength Histaset 5mg Tablet
Dated 28-12-2017
Levocetirizine (Dihydrochloride)…5mg
Pharmacological Group Piperazine derivatives
Type of Form Form-5
Pack Size & Demanded Price 1x10’s / Rs. 60/-
Approval Status of Product in Levocetirizine dihydrochloride 5 mg Film-coated Tablets by
Reference Regulatory Authorities. M/s Hexal AG (MHRA Approved)
Me-too Status Scientilla Tablet 5mg by M/s Macter (Reg#048585)
GMP status Last GMP Inspection of Conducted on 23/2/2018, 26/2/2018
and report shows satisfactory cGMP level.
Brand Name +Dosage Form + Strength Delanz 30mg Capsule
Dated 28-12-2017
Enteric Coated Pellets (22.5%) Equivalent to
Lansoprazole…………..30mg
Pharmacological Group Proton pump inhbitor
Type of Form Form-5
Approval Status of Product in Levocetirizine dihydrochloride 5 mg Film-coated Tablets by
Reference Regulatory Authorities. M/s Hexal AG (MHRA Approved)
Me-too Status Scientilla Tablet 5mg by M/s Macter (Reg#048585)
Decision: Approved.
Brand Name +Dosage Form + Strength Linzo 600mg Tablet
Dated 28-12-2017
Linezolid…600mg
Type of Form Form-5
Approval Status of Product in Zyvox 600 mg film-coated tablets by M/s Pharmacia
Reference Regulatory Authorities. Limited, MHRA approved.
Me-too Status Ecasil 600mg tablet by M/s Sami (Reg#066904)
Decision: Approved.
Brand Name +Dosage Form + Strength Valsam 10/160mg Tablet
Dated 28-12-2017
Amlodipine (as amlodipine besylate)……10mg
Valsartan……..160mg
Type of Form Form-5
Approval Status of Product in Exforge by Novartis Pharma GmbH, (USFDA)
Me-too Status Exforge by Novartis Pharma. Karachi (R. No. 047571)
Decision: Approved.
Brand Name +Dosage Form + Strength Demnac 75/200mg Tablet
Dated 28-12-2017
Misoprostol…200Ug
Pharmacological Group (Cytoprotactant/NSAID)
Type of Form Form-5
Approval Status of Product in NA. (Arthrotec 75 modified-release tablets (MHRA) but as
Reference Regulatory Authorities. gastro resistant)
Me-too Status ARTHO PLUS of Shaigan
Remarks of the Evaluator. Each tablet consists of a gastro-resistant core containing 75
mg diclofenac sodium surrounded by an outer mantle
containing 200 micrograms misoprostol But firm applied as
film coated tablet
reference product.
Brand Name +Dosage Form + Strength Irbasta-HCT 150/12.5mg Tablet
Dated 28-12-2017
Irbesartan……………….….150mg
Hydrochlorothiazide……….12.5mg
Pharmacological Group Angiotensin receptor blockers/diuretics
Type of Form Form-5
Approval Status of Product in Avalide (USFDA)
Me-too Status Co-Aprovel 150/12.5mg tablets of M/s Sanofi Aventis
Remarks of the Evaluator. Approved in USFDA with boxed warning of fatal toxicity.
Decision: Approved with innovators specifications.
Brand Name +Dosage Form + Strength Mezlo 15mg Capsule
Dated 28-12-2017
Composition Each extended release Capsule contains:-
Cyclobenzaprine HCl Pellets equivalent to
Cyclobenzaprine………15mg
Type of Form Form-5
Approval Status of Product in Armix ER capsule by Cephalon- USFDA approved
Me-too Status Skelebenz capsule of M/s Nexus Pharma
Remarks of the Evaluator. Source of Cyclobenzaprine HCl SR Pellets is M/s Vision
Pharmaceuticals
 Decision: Deferred for clarification of specification of pellets by M/s Vision Pharmaceuticals
Islamabad, since the firm initially submitted certificate of analysis with Innovator’s specification
and later submitted certificate of analaysis of the same batch with USP specification.
Brand Name +Dosage Form + Strength Lotense-H 50/12.5mg Tablet
Diary No. Date of R& I & fee Form-5 Dy.#26424 (28-12-2017) Rs.20,000/- 28-12-2017
Losartan Potassium…50mg
Type of Form Form-5
Approval Status of Product in Cozaar Comp Tablet by MSD (MHRA Approved)
Me-too Status DIU-Tansin by Pharmevo
Decision: Approved.
Brand Name +Dosage Form + Strength Ondison 8mg Tablet
Dated 28-12-2017
Ondansetron Hydrochloride Dihydrate…8mg
Pharmacological Group Selective serotonin 5-HT3 receptor antagonist
Type of Form Form-5
Approval Status of Product in Ondansetron 8 mg film-coated tablets (MHRA Approved)
Me-too Status Zofran tablet of M/s GSK
Decision: Approved.
Brand Name +Dosage Form + Strength Delta Ren SR 100mg Tablet
Dated 28-12-2017
Composition Each SR Tablet Contains:
Pharmacological Group Selective serotonin 5-HT3 receptor antagonist
Type of Form Form-5
Approval Status of Product in Voltarol Retard Tablets 100mg of MHRA approved
Me-too Status Ufenac-SR 100mg Tablets of M/s Valor Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Rabi 20mg Tablet
Dated 28-12-2017
Composition Each GR Tablet Contains:
Rabeprazole Sodium…20mg
Pharmacological Group Proton Pump Inhibitor
Type of Form Form-5
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Pack Size & Demanded Price 1x30’s / As per SRO
Approval Status of Product in Rabeprazole 20mg GR tablets of M/s Actavis , UK (MHRA
Me-too Status Rabecid tablets 20mg of M/s Highnoon (Reg. # 028360)
Brand Name +Dosage Form + Strength Demzoflex 2mg Tablet
Dated 28-12-2017
Tinzanidine as Hydrochloride…2mg
Pharmacological Group Muscle Relaxant
Type of Form Form-5
Reference Regulatory Authorities. Tizanidine 2mg uncoated Tablets Actavis UK Ltd (MHRA)
Me-too Status Analar by AGP
Remarks of the Evaluator. Tablet is approved as uncoated tablet in reference regulatory
authority.
Decision: Deferred for submission of evidence of approval of applied formulation as “film coated
tablets” in reference regulatory authorities/agencies which were adopted by the Registration
Board in its 275th meeting or else the formulation may be revised in accordance with reference
product along with submission of requisite fee.
Brand Name +Dosage Form + Strength Lossan 50 mg
Dated 28-12-2017
Losartan Potassium…50mg
Type of Form Form-5
Pack Size & Demanded Price 1x10’s / As per SRO
Approval Status of Product in Cozaar by MSD (MHRA Approved)
Me-too Status Cozaar by OBS
Decision: Approved.
Brand Name +Dosage Form + Strength Vanit 400mg Tablet
Dexibuprofen…400mg
Type of Form Form-5
Finished Product Specification Manufacturer’s Specs.
Approval Status of Product in Seractil 400 mg film-coated tablets Dexibuprofen MHRA
Reference Regulatory Authorities. Approved.
Me-too Status Sibet 400mg Tablet. (Reg.# 058639)
Brand Name +Dosage Form + Strength Demzoflex 4mg Tablet
Tizanidine as Hydrochloride…4mg
Pharmacological Group Skeletal Muscle relaxant
Type of Form Form-5
Approval Status of Product in Tizanidine of MHRA approved
Me-too Status Musidin of M/s Martin Dow
Brand Name +Dosage Form + Strength Mezlo 30mg Capsule
Dated 28-12-2017
Cyclobenzaprine Hydrochloride (Extended release
pellets)…………30mg
Pharmacological Group Skeletal Muscle relaxant
Type of Form Form-5
Approval Status of Product in Amrix extended release capsule of Teva Pharms intl,
Reference Regulatory Authorities. (USFDA)
Me-too Status Emrix-SR of Getz Pharma
Remarks of the Evaluator. Source of pellets is vision pharmaceuticals SR pellets 22%
Diary No. Date of R& I & fee Form-5 Dy.No 26440 dated 28-12-2017 Rs. 20,000 Dated
28-12-2017
Valsartan…80mg
Type of Form Form-5
Approval Status of Product in Exforge by Novartis (MHRA)
Me-too Status Me-too status Amodip-V by Mass Pharma.
Decision: Approved.
Diary No. Date of R& I & fee Form-5 Dy.No 26441 dated 28-12-2017 Rs. 20,000/- Dated
28-12-2017
Valsartan…160 mg
Type of Form Form-5
Approval Status of Product in Amlodipine/Valsartan 5mg/160 mg tablet (MHRA
Me-too Status Exforge Tablet of M/s Novartis Pharma (Reg.#047570)
Decision: Approved.
Brand Name +Dosage Form + Strength Xifaxsan 200mg Tablet
Diary No. Date of R& I & fee Dy.No 26434 dated 28-12-2017 Rs. 20,000
Dated 28-12-2017
Rifaximin…200mg
Type of Form Form-5
Approval Status of Product in Xifaxanta 200 mg film-coated tablets by Norgine
Reference Regulatory Authorities. Pharmaceuticals Limited (MHRA approved)
Me-too Status Rifaxa 200mg Tablets by Ferozsons (Reg . No. 068205)
Brand Name +Dosage Form + Strength Xifaxsan 550 mg Tablet
Dated 28-12-2017
Rifaximin…550 mg
Type of Form Form-5
Approval Status of Product in Refero 550mg Film-Coated Tablets by (MHRA)
Me-too Status Rixabac 550mg Tablet (Reg#076259) by Pharmevo Karachi
Brand Name +Dosage Form + Strength Duron 60mg Capsule
28-12-2017
Duloxetine as HCl(enteric coated pellets)…..60mg
Pharmacological Group Selective serotonin and norepinephrine reuptake inhibitor
Type of Form Form-5
Approval Status of Product in Approved by USFDA
Me-too Status Dulan capsules of M/s Hilton Pharma (Pvt.) Limited Karachi
(Reg.# 055448)
Remarks of the Evaluator. Source of pellets is vision pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Duron 30mg Capsule
28-12-2017
Duloxetine as HCl(enteric coated pellets)…..30mg
Type of Form Form-5
Approval Status of Product in Cymbalta (USFDA approved)
Me-too Status Swenta 30mg Capsule by M/s Martin Dow
Remarks of the Evaluator. Source of pellets is vision pharma
295. Name and address of manufacturer / M/s. Kaizen Pharmaceuticals (Pvt) LTd., E-127-129, North
Applicant western Industrial Zone, Bin Qasim Karachi
Brand Name +Dosage Form + Strength Dolotec SR Tablet
Diary No. Date of R& I & fee Form-5 Dy.No 25409 dated 21-12-2017 Rs. 50,000/- Dated
28-12-2017
Naproxen Sodium…825mg Eq. to Naproxen…750mg
Type of Form Form-5
Pack Size & Demanded Price 10’s, 20’s, 30’sAs per SRO
Approval Status of Product in Naprelan 750 mg tablet (USFDA)
Me-too Status Noral SR of Alson Pharmaceuticals
GMP status Last GMP inspection Date: , with cGMP compliance
Decision: Approved.
Evaluator PEC-VIII
296. Name and address of Manufacturer / M/s. Pulse Pharmaceuticals (Pvt.) Ltd.
Applicant Mozay Badoke, Raiwind Road, Lahore, Pakistan
Brand Name +Dosage Form +Strength Olped Tablet 25mg
Pentazocine hydrochloride…25mg
Diary No. Date of R&I & fee Duplicate dossier: Duplicate fee challan of Rs.12,000/-
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Pharmacological Group Analgesic/Narcotic Antagonist
Type of Form Form 5
Finished Product Specification USP Specifications
Approval status of product in Approved in MHRA
Me-too status Penfred Tablet (Pentazocine as hydrochloride) of M/s Friends
Pharma
GMP status Panel inspection conducted on 29-08-2018 for renewal of
DML in respect to all approved sections, except liquid
infusion section.
The above stated panel inspection confirms the tablet
psychotropic section of M/s. Pulse Pharmaceuticals.
Remarks of Evaluator  Monograph for analysis of applied formulation is not
present in USP, which was claimed by the firm;
instead, it is present in BP.
 Duplicate dossier of applied formulation is forwarded
by R-V vide its letter No. F.8-6/2013-Reg-V, dated
11th of October, 2018 for evaluation.
Brand Name+DosageForm+Strength Lipaz Tablet 2mg
Composition EachTablet Contains:
Lorazepam…2mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Pharmacological Group Benzodiazepine
Type of Form Form 5
Approval status of product in Approved in US-FDA
Me-too status Gtvan 2mg Tablets of M/s Glitz Pharmaceuticals
infusion section.
Remarks of Evaluator Duplicate dossier of applied formulation is forwarded by R-V,
vide its letter No. F.8-6/2013-Reg-V, dated 11th of October,
2018 for evaluation.
Brand Name+DosageForm+Strength Lipaz Tablet 1mg
Composition EachTablet Contains:
Lorazepam…1mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Type of Form Form 5
Me-too status Approved in US-FDA
infusion section.
Brand Name +Dosage Form +Strength Delica Tablet 5mg
Diazepam…5mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Type of Form Form 5
Me-too status Rorpam 5mg Tablet of Roryan Pharmaceutical Industries
(Pvt) Ltd,
infusion section.
Initially the Applicant has applied for diazepam 1mg tablet
which is not approved by the reference agencies; They then
changed the strength of tablet from “Diazepam 1mg tablet” to
“Diazepam 5mg tablet” which is approved by US-FDA.
Now the applicant has submitted the following:
 Revised Form 5, master formulation, manufacturing
method for applied strength.
 Fee challan of Rs. 20,000/- dated 16-10-18 for the
revision of strength.
Brand Name +Dosage Form +Strength Delica Tablet 2mg
Diazepam…2mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Type of Form Form 5
Me-too status Diazepam 2 mg Tablets of Heal Pharmaceuticals
infusion section. The above stated panel inspection confirms
the tablet psychotropic section of M/s. Pulse Pharmaceuticals.
Brand Name+DosageForm+Strength Tamlov Capsule 50mg
Tramadol hydrochloride…50mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Pharmacological Group Opiate Analogue
Type of Form Form 5
Finished Product Specification Manufacturer’s Specifications
Me-too status Volpan 50mg Capsules of M/s. Rotex Pharma (Pvt) Ltd.
infusion section.
Monograph for the analysis of applied formulation is present
in BP 2016.
Decision: Approved with BP specifications. Board further decided that verification of fee challan
may be done as per decision of 285th meeting of Registration Board.
Brand Name+DosageForm+Strength Beprelax Tablet 0.2mg
Composition Each Sublingual Tablet Contains:
Buprenorphine (hydrochloride) …0.2mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Pharmacological Group Analgesic/Opiate
Type of Form Form 5
Reference Regulatory Authorities (EQ 2MG BASE **Federal Register determination that
product was not discontinued or withdrawn for safety or
efficacy reasons**)
Me-too status M-Gesic Tablet of Mediate Pharmaceuticals, Karachi
infusion section.
Brand Name+DosageForm+Strength B.Pam Tablet 3mg
Bromazepam…3mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Pharmacological Group Benzodiazepines
Type of Form Form 5
Me-too status Lexgit 3mg Tablets of Glitz Pharmaceuticals
infusion section.
Remarks of Evaluator Monograph for analysis of applied formulation is neither
present in USP, as claimed by the firm, nor in BP.
Duplicate dossier of applied formulation is forwarded by R-V,
Brand Name+DosageForm+Strength Cod.P Tablet 15/500 mg
Composition Each Uncoated Tablet Contains:
Codine Phosphate…15mg
Paracetamol…500mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Type of Form Form 5
Me-too status Codar Tablets 15/500mg tablet of Polyfine Chem Pharma.
infusion section.
Brand Name+DosageForm+Strength Altanid Tablet 0.5mg
Alprazolam……………0.5mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Type of Form Form 5
Approval status of product in Approved In US-FDA
Me-too status Jibrone 0.5mg Tablet of Martin Dow Ltd. Karachi
infusion section.
Brand Name+DosageForm+Strength Dexipar Tablet 32.5/325 mg
Dextropropoxyphene HCL eq.to Dextropropoxyphene…30mg
Paracetamol…325mg
(15-11-2015) & Rs. 8,000/- (15-11-2010)
Type of Form Form 5
Approval status of product in Could not be confirmed
infusion section.
Decision: Registration Board rejected the application as the applied formulation is banned in
reference regulatory authorities/agencies as well as in pakistan owing to its potentially life-
threatening effects.
307. Name And Address Of Manufacturer / M/S. Bajwa Pharma 36 Km Gt Road, Khori, Mureedke,
Applicant Sheikhupura.
Brand Name+Dosage Form+ Strength Betamine Injection 50mg/10ml
Diary No. Date Of R& I & Fee Duplicate dossier : duplicate fee challan of Rs. 20,000/-
(27-01-2017)
Composition Each ml Contains:
Ketamine (as hydrochloride)…. 50mg
Pharmacological Group General Anaesthetic
Type Of Form Form-5
Finished Product Specification USP Specification
Pack Size & Demanded Price 1’s (10ml) ; As Per SRO
Approval Status Of Product In Approved in US-FDA
Me-Too Status Calsamin Injection of Swiss Pharma, Karachi
GMP Status Last GMP inspection was conducted on 21-02-2018 and the
report concludes:
“Overall hygienic condition of the firm was satisfactory at the
time of inspection. They were advised to improve their
documentation as mentioned in above. They agreed.”
Remarks Of The Evaluator. R-V Vide Its Letter No. F.8-6/2013-Reg-V Dated 3rd
September, 2018 Forwarded Duplicate Dossier Of This Drug
Product For Evaluation & Further Action In The Matter.
Step of terminal sterilization has not been mentioned in
manufacturing outline. Clarify or justify the same.
(They have submitted the master formulation containing the
step of terminal sterilization).
308. Name And Address Of Manufacturer / M/S. Bajwa Pharma 36 Km Gt Road, Khori, Mureedke,
Applicant Sheikhupura.
Brand Name+Dosage Form + Strength Pivacain Injection 5mg/1ml
Diary No. Date Of R& I & Fee Duplicate dossier : duplicate fee challan of Rs. 20,000/-
(27-01-2017)
Bupivacaine hydrochloride…. 5mg
Pharmacological Group Local Anesthetic
Type Of Form Form-5
Pack Size & Demanded Price 10’s (10ml) ; As Per SRO
Approval Status Of Product In Approved In MHRA
Me-Too Status Sensocain Spinal of Brookes Pharmaceuticals
report concludes:
“Overall hygienic condition of the firm was satisfactory at the
time of inspection. They were advised to improve their
documentation as mentioned in above. They agreed.”
Remarks Of The Evaluator. R-V Vide Its Letter No. F.8-6/2013-Reg-V Dated 3rd
September, 2018 Forwarded Duplicate Dossier Of This Drug
Product For Evaluation & Further Action In The Matter.
Step of terminal sterilization has not been mentioned in
manufacturing outline. Clarify or justify the same.
(They have submitted the master formulation containing the
step of terminal sterilization).
309. Name and address of manufacturer / M/s Ameer & Adnan Pharmaceuticals (Pvt) Ltd.
Applicant
Brand Name+Dosage Form + Strength Adephene injection 20mg/ml
Diary No. Date of R& I & fee Duplicate dossier: duplicate fee challan of Rs. 20,000/-
(11-03-2015)
Nalbuphine…20mg
Pharmacological Group Opioid analgesic
Type of Form Form-5
Finished Product Specification Manufacturer’s Specification

Me-too status N-Bine 20mg/ml Injection of Uni-Tiech Pharmaceuticals
remarks that firm is GMP compliant as per DRAP guidelines
Decision: Approved with innovator’s specification. Board further decided that verification of fee
challan may be done as per decision of 285th meeting of Registration Board.
Evaluator PEC-IX
310. Name and address of manufacturer / Berlex Lab. International, 10 Km Nangshah Chowk Karachi
Applicant Road, Multan
Brand Name +Dosage Form + Strength Levolex Tablet 50mg
Levosulpiride……. 50mg
Diary No. Date of R& I & fee Dy No. 1640: 29.03.2017 PKR 20,000/-: 29.03.2017
Pharmacological Group Antipsychotic
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer’s specs
Pack size & Demanded Price 2x10’s; Rs. 200/-
Approval status of product in Reference LEVOPRAID® 50 mg Tablets by TEOFARMA Srl.
Regulatory Authorities. Approved by AIFA
Me-too status Hipride 50 mg Tablets by M/s Bloom Pharmaceuticals
(Pvt) Ltd; Reg. No. 77424
GMP status The firm was last inspected on 05.07.2018, wherein the
panel recommended renewal of DML
Decision: Approved with innovator’s specifications.
Brand Name +Dosage Form + Strength Bercocin Capsule 500mg
Lincomycin as HCl monohydrate……. 500mg
Diary No. Date of R& I & fee Dy No. 4054: 21.04.2017
PKR 20,000/-: 21.04.2017
Pharmacological Group Lincosamides
Type of Form Form 5
Approval status of product in Reference Lincocine 500 mg capsule (Lincomycin as HCl hydrate) by
Regulatory Authorities. Pfizer Holding France. Approved by ANSM France
Me-too status Linnco 500mg Capsule (Lincomycin as HCl) by Mafins
Pharmaceuticals (Pvt) Ltd., Karachi. Reg. No. 79898
Remarks of the Evaluator.  The USP has specified Raman spectroscopy for
dissolution study of Lincomycin capsules. However, upon
clarification, the firm did not provide proof of provision of
Raman spectrophotometer.
 The firm revised the formulation to Lincomycin
as HCl monohydrate (in Master Formula) from
Lincomycin HCl without submission of fee. However,
Form 5 still has Lincomycin HCl.
Decision: Deffered for following submissions:
 Justification for performance of dissolution test without requisite equipment mentioned
in USP monograph of applied formulation.
 Revised Form 5 with label claim as per the reference product.
Brand Name +Dosage Form + Strength Gabalex Capsule 300mg
Gabapentin (USP)……. 300mg
Type of Form Form 5
Approval status of product in Reference Gabapentin 300mg Capsules by Sandoz Limited. Approved
Regulatory Authorities. by MHRA
Me-too status Pentowan 300mg Capsule by Nawan Lab. Karachi. Reg. No.
82103
Decision: Approved.
Brand Name +Dosage Form + Strength Prebalex Capsule 150mg
Pregabalin ……. 150mg
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications
Approval status of product in Reference Alzain 150 mg Capsules, Hard by Dr. Reddy’s Laboratories
Regulatory Authorities. (UK) Ltd. Approved by MHRA
Me-too status Scirica 150mg Capsule by Scilife, Karachi. Reg. No. 82184
Remarks of the Evaluator. 
Brand Name +Dosage Form + Strength Tramalex SR tablet 100mg
Composition Each sustained release tablet contains:
Tramadol HCl……. 100mg (USP)
Type of Form Form 5
Approval status of product in Reference Brimisol PR 100 mg Prolonged-Release Tablet by Bristol
Regulatory Authorities. Laboratories Limited. Approved by MHRA
Me-too status Volpan SR 100mg tablets by Rotex Pharma (Pvt) Ltd,
Islamabad. Reg. No. 80368
 Decision: Approved.
315. Name and address of manufacturer / Swiss Pharmaceuticals (Pvt) Ltd. A/159, S.I.T.E., Super
Applicant Highway, Karachi
Brand Name +Dosage Form + Strength Nervpower 500 mcg Tablet
Composition Each sugar-coated tablet contains:
Mecobalamin ……….500mcg
Diary No. Date of R& I & fee Dy No. NIL: 11.09.2018
PKR 8,000/-: PKR 12,000/-: 31.07.2013 (Duplicate Dossier)
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Type of Form Form 5
Finished Product Specification The firm claimed Manufacturer’s spec. (available in JP)
Pack size & Demanded Price 10’s, 20’s, 30’s; As per SRO
Approval status of product in Reference Methicobide tablet 500 mcg sugar-coated, by Daito
Regulatory Authorities. Corporation. Approved by PMDA Japan
Me-too status Balin 500mcg Tablet (sugar-coated) by Cibex Pharma
Karachi. Reg. No. 74877
GMP status The firm was last inspected on 15.09.2017, wherein the Fid
rated the GMP as GOOD
Remarks of the Evaluator.  Verification of dossier fee by Budget and
Account Division is required.
 The firm revised the formulation to sugar-
coating without submission of fee
Decision: Deferred for change of brand name and submission of fee for revision of formulation.
316. Name and address of manufacturer / Saffron Pharmaceuticals (Pvt) Ltd. 19 km Sheikhupura Road
Applicant Faisalabad
Brand Name +Dosage Form + Strength Esofil Tablet 20 mg
Composition Each enteric coated tablet contains:
Esomeprazole Magnesium Trihydrate (USP) eq. to
Esomeprazole…….20mg
Pharmacological Group Proton pump inhibitors
Type of Form Form 5
Finished Product Specification The firm has claimed Manufacturer’s spec.
Pack size & Demanded Price Rs. 300/-; 14’s
Approval status of product in Reference Nexium 20mg gastro-resistant tablets by Lexon (UK)
Regulatory Authorities. Limited. Approved by MHRA
Me-too status Exzium 20mg Tablet by Medisure Laboratories Pakistan
(Pvt.) Ltd, Karachi. Reg. No. 66773
GMP status The firm was last inspected on 03.10.2018, .wherein the
panel recommended the grant of GMP certificate
317. Name and address of manufacturer / Saffron Pharmaceuticals (Pvt) Ltd. 19 km Sheikhupura Road
Applicant Faisalabad
Brand Name +Dosage Form + Strength Esofil Tablet 40 mg
Esomeprazole Magnesium Trihydrate (USP) eq.to
Esomeprazole…….40mg
Diary No. Date of R& I & fee Dy.No.29686: 05.9.2018 PKR 20,000/- 02.5.2017
(Duplicate dossier)
Type of Form Form 5
Finished Product Specification The firm has claimed Manufacturer’s spec.
Pack size & Demanded Price Rs. 600/-; 14’s
Approval status of product in Reference Nexium 20mg gastro-resistant tablets by Sam Pharma Ltd.
Regulatory Authorities. Approved by MHRA
Me-too status Exzium 40mg Tablet by Medisure Laboratories Pakistan
(Pvt.) Ltd, Karachi. Reg. No. 66772
GMP status The firm was last inspected on 03.10.2018, .wherein the
panel recommended the grant of GMP certificate
 Decision: Approved with innovator’s specifications.
318. Name and address of manufacturer / Wnsfield Pharmaceuticals Plot No. 122, Block A, Phase V,
Applicant Industrial Estate Hattar KPK
Brand Name +Dosage Form + Strength Mirtawin 30mg Tablet
Mirtazapine (USP) ……….30mg
Type of Form Form 5
Approval status of product in Reference Mirtazapine 30 mg film-coated tablets by Medreich Plc.
Regulatory Authorities. Approved by MHRA
Me-too status Valta 30mg Tablets by Getz Pharma Karachi 44074
panel recommended the renewal of DML no. 000610 by way
of formulation
Brand Name +Dosage Form + Strength Mirtawin 15mg Tablet
Mirtazapine (USP) ……….15mg
Type of Form Form 5
Approval status of product in Mirtazapine 30 mg film-coated tablets by Accord Healthcare
Reference Regulatory Authorities. Limited. Approved by MHRA
Me-too status Actizipine 15mg Tablet by Zanctok Hyderabad. Reg. No.
76547
GMP status The firm was last inspected on 18.01.2018, wherein the panel
recommended the renewal of DML no. 000610 by way of
formulation
Brand Name +Dosage Form + Strength Zolmiwin 2.5mg Tablet
Zolmitriptan (USP) ……….2.5mg
Pharmacological Group Selective serotonin (5HT1) agonists
Type of Form Form 5
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Approval status of product in Zolmitriptan 2.5 mg film-coated tablets by Teva UK Ltd.
Reference Regulatory Authorities. Approved by MHRA
Me-too status Xoming 2.5mg Tablet by Nabiqasim Reg. No. 81782
formulation
Brand Name +Dosage Form + Strength Zolmiwin 5mg Tablet
Zolmitriptan (USP) ……….5mg
Pharmacological Group Selective serotonin (5HT1) agonists
Type of Form Form 5
Approval status of product in Zolmitriptan 5 mg film-coated tablets by Teva UK Ltd.
Me-too status Xoming 5mg Tablet by Nabiqasim Karachi. Reg. No. 81783
formulation
Brand Name +Dosage Form + Strength Zelowin 10mg Tablet
Donepezil hydrochloride (USP) ……….10mg
Pharmacological Group Anticholinesterases
Type of Form Form 5
Approval status of product in DONEPEZIL 10mg film coated tablets by Eisai Ltd.
Me-too status Nepezil 10mg Tablet by Genix Pharma. R.No. 83286
formulation
Remarks of the Evaluator.  The firm revised the API to ‘Donepezil
hydrochloride’ from ‘Donepezil as hydrochloride’ with
submission of Rs. 5000/- fee.
Brand Name +Dosage Form + Strength Benzowin 30mg Capsule
Composition Each extended release capsule contains:
Cyclobenzaprine extended release pellets (22%) eq. to
Cyclobenzaprine HCl (USP) ……….30mg
Pharmacological Group Muscle relaxants, centrally acting agents
Type of Form Form 5
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Approval status of product in AMRIX® (cyclobenzaprine hydrochloride extended-release
Reference Regulatory Authorities. capsules), for oral use by Teva Pharmaceuticals USA, Inc.
Approved by US-FDA
Me-too status Comforta-XR 30mg Capsules by Genome Pharmaceuticals
(Pvt,) Ltd. Reg. No. 84615
formulation
Remarks of the Evaluator.  The source of pellets is “Vision
Pharmaceuticals, Islamabad, Pakistan, which has been
issued GMP certificate on the demand of importing country
and on the basis of inspection dated 26.01.2018.
 The COA and stability data of pellets are as per
innovator’s specifications; however, the product is
available in USP. Upon clarification firm submitted new
COA of the same batch mentioning USP specification.
Brand Name +Dosage Form + Strength Benzowin 15mg Capsule
Composition Each extended release capsule contains:
Cyclobenzaprine extended release pellets (22%) eq. to
Cyclobenzaprine HCl (USP)……….15mg
Pharmacological Group Muscle relaxants, centrally acting agents
Type of Form Form 5
Approval status of product in AMRIX® (cyclobenzaprine hydrochloride extended-release
Reference Regulatory Authorities. capsules), for oral use by Teva Pharmaceuticals USA, Inc.
Approved by US-FDA
Me-too status Comforta-XR 15mg Capsules by Genome Pharmaceuticals
(Pvt,) Ltd. Reg. No. 84615
formulation
Remarks of the Evaluator.  The source of pellets is “Vision
Pharmaceuticals, Islamabad, Pakistan, which has been
issued GMP certificate on the demand of importing country
and on the basis of inspection dated 26.01.2018.
 The COA and stability data of pellets are as per
innovator’s specifications; however, the product is
available in USP. Upon clarification firm submitted new
COA of the same batch mentioning USP specification.
Brand Name +Dosage Form + Strength Ziprowin 60mg Capsule
Ziprasidone as hydrochloride monohydrate (USP)….60mg
Type of Form Form 5
Approval status of product in GEODON® (ziprasidone HCl) capsules by PFIZER.
Reference Regulatory Authorities. Approved by US-FDA
Me-too status Zap 60mg capsules by Vision Pharmaceuticals.Reg.No.
77598
formulation
Brand Name +Dosage Form + Strength Ziprowin 40mg Capsule
Ziprasidone as hydrochloride monohydrate (USP)….40mg
Type of Form Form 5
Approval status of product in GEODON® (ziprasidone HCl) capsules by PFIZER.
Reference Regulatory Authorities. Approved by US-FDA
Me-too status Zap 40 mg capsules by Vision Pharma. R. No. 77597
formulation
327. Name and address of manufacturer / Crystolite Pharmaceuticals, Plot # 1 & 2, Street S-2, National
Applicant Industrial Zone, Rawat Islamabad
Brand Name +Dosage Form + Strength Sezin Tablet 25mg
Cinnarizine……25mg
Pharmacological Group Antivertigo preparations
Type of Form Form 5
Finished Product Specification The firm has claimed in house specifications
Approval status of product in Stugeron 25mg Tablets by Johnson & Johnson (Ireland)
Reference Regulatory Authorities. Limited. HPRA approved
Me-too status Novertige Tablet 25mg by Medisure Laboratories. R.#29248
GMP status The firm was last inspected on 17.10.2017, wherein the FID
recommended that the firm was operating at GOOD level of
cGMP, suggestion for improvement have been agreed upon
by the management.
328. Name and address of manufacturer / Crystolite Pharmaceuticals, Plot # 1 & 2, Street S-2, National
Applicant Industrial Zone, Rawat Islamabad
Brand Name +Dosage Form + Strength Prodil Tablet 50mg
Itopride HCl…..50mg
Pharmacological Group Drugs for functional gastrointestinal disorders
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer’s specifications
Approval status of product in Itopride hydrochloride tablet 50 mg by Shiseido
Reference Regulatory Authorities. Pharmaceutical Co., Ltd. PMDA approved
Me-too status Itoride Tablet by Lexicon Pharmaceutical. Reg No. 42040
recommended that the firm was operating at GOOD level of
cGMP, suggestion for improvement have been agreed upon
by the management
329. Name and address of manufacturer / M/s Convell Laboratories, Saidu Sharif Swat: Contract
Applicant Manufacturing by M/s EG Pharmaceuticals, Plot No. 13-A,
Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Velzone Injection 250 mg I.M.
Ceftriaxone sodium eq. to Ceftriaxone…….250mg
Pharmacological Group Third generation cephalosporins
Type of Form Form 5
Approval status of product in Ceftriaxone 250mg (IM) by Lupin Pharmaceuticals Inc. US-
Reference Regulatory Authorities. FDA approved
Me-too status Unixone Injection (ceftriaxone Sodium) 250mg IM by
Caliph Pharmaceuticals (Pvt.) Ltd. Reg. No. 82556
GMP status The firm was last inspected on 29.08.2018 & 03.09.2018,
wherein the firm was considered operating in compliance
with GMP guidelines as per Drugs Act, 1976 and rules
framed there under
Remarks of the Evaluator.  The firm was asked to provide list of already approved and
applied products for contract manufacturing. In response
the firm submitted that they have never applied for contract
manufacturing.
 The firm (M/s EG Pharmaceuticals) was asked to provide
list of all approved sections. In response, the firm
submitted that they have the following approved sections:
1. Tablet section (General) 2. Capsule section (General) 3.
Dry Powder section (General) 4. Liquid section (General)
5. Psychotropic section 6. Capsule section (cephalosporin)
7. Dry powder section (cephalosporin).
The firm has also submitted the inspection report dated
13.12.2014, wherein the panel has inspected the following
sections and has recommended the grant of renewal of
DML by way of formulation:
1. Tablet General/antibiotic 2. Capsule (General) 3. Dry
Powder section General/antibiotic 4. Liquid syrup
(General) 5. Tablet Psychotropic 6. Capsule
(cephalosporin) 7. Dry powder (cephalosporin) 8. Penicillin
dry powder 9. Penicillin capsule
 Decision: Registration Board deferred the case for assessment and confirmation of
manufacturing capacity of M/s EG Pharmaceuticals, Industrial Triangle Kahuta road,
Islamabad by panel to be constituted by Chairman Registration Board for further granting
contract manufacturing permission as the firm has already been granted approval for contract
manufacturing of numerous products.
Brand Name +Dosage Form + Strength Velzone Injection 250 mg I.V.
Type of Form Form 5
Approval status of product in Ceftriaxone 250mg (IV) by Lupin Pharmaceuticals Inc. US-
Me-too status Ceftirains 250mg (ceftriaxone Sodium) I.V Injection by
Sunrise Pharma (Pvt) Ltd. Reg. No. 78655
GMP status The firm (M/s EG Pharmaceuticals) was last inspected on
29.08.2018 & 03.09.2018, wherein the firm was considered
operating in compliance with GMP guidelines as per Drugs
Act, 1976 and rules framed there under
manufacturing.
 The firm was asked to provide list of all approved sections.
In response, the firm submitted that they have the following
approved sections: 1. Tablet section (General) 2. Capsule
section (General) 3. Dry Powder section (General) 4.
Liquid section (General) 5. Psychotropic section 6. Capsule
section (cephalosporin) 7. Dry powder section
(cephalosporin).
Brand Name +Dosage Form + Strength Velzone IM Injection 500mg
Type of Form Form 5
Approval status of product in Ceftriaxone 500mg (IM) by Lupin Pharmaceuticals Inc. US-
Me-too status Wincef 500 mg (Ceftriaxone sodium) IM injection by
Wnsfeild Pharmaceuticals. Reg. No. 68371
manufacturing.
(cephalosporin).
Brand Name +Dosage Form + Strength Velzone I.V. Injection 500mg
Type of Form Form 5
Approval status of product in Ceftriaxone 500mg (IV) by Lupin Pharmaceuticals Inc. US-
Me-too status Wincef 500 mg (Ceftriaxone sodium) IV by Wel Wink
Pharmaceuticals. Reg. No. 78097
manufacturing.
(cephalosporin).
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Brand Name +Dosage Form + Strength Velzone I.V. Injection 1g
Ceftriaxone sodium eq. to Ceftriaxone…….1g
Type of Form Form 5
Approval status of product in Ceftriaxone 1 g (IV) by Lupin Pharmaceuticals Inc. US-FDA
Reference Regulatory Authorities. approved
Me-too status Martixon 1gm (Ceftriaxone sodium) I.V Dry powder
Injection by Alkemy Pharma. Reg. No. 70663
Act, 1976 and rules framed there under;
manufacturing.
(cephalosporin).
Brand Name +Dosage Form + Strength Subac IV Injection 1g
Cefoperazone sodium…….500mg
Sulbactam sodium……….500mg
Diary No. Date of R& I & fee Dy No. 26896: 29.12.2017 PKR 50,000/- 29.12.2017
Pharmacological Group Third generation cephalosporins and beta-lactamase
inhibitors
Type of Form Form 5
Approval status of product in Sulperazon Injection by Pfizer Inc. PMDA Approved
Me-too status Ectafin Injection 1gm IV by Hi-Medic Pharmaceuticals (Pvt)

Ltd. Reg. No. 80028
manufacturing.
(cephalosporin).
Brand Name +Dosage Form + Strength Subac IV Injection 2g
Cefoperazone sodium…….1g
Sulbactam sodium……….1g
Pharmacological Group Third generation cephalosporins and beta-lactamase
inhibitors
Type of Form Form 5
Approval status of product in Approved in 03 European countries, i.e., Czech Republic,
Reference Regulatory Authorities. Poland and Slovakia
Me-too status Ectafin Injection 2gm IV by Hi-Medic Pharmaceuticals (Pvt)
Ltd. Reg. No. 80027
manufacturing.
(cephalosporin).
Brand Name +Dosage Form + Strength Convell D IM/Oral
Composition Each 1 ml ampoule contains:
Cholecalciferol……5mg
Pharmacological Group Vitamin D3 analogue
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer specifications
Approval status of product in Vitamin D3 Good 200,000 IU / 1 ml, oral solution in
Reference Regulatory Authorities. ampoule and Vitamin D3 Good 200,000 IU / 1 ml, solution
for injection IM in ampoule by Bouchara-Recordati. ANSM
Approved
Me-too status ORA-D3 Injection by Ameer & Adnan Pharmaceuticals
(Pvt.) Ltd. Reg. No. 78639
manufacturing.
(cephalosporin).
337. Name and address of manufacturer / M/s EG Pharmaceuticals, Pl dot No. 13-A, Industrial
Brand Name +Dosage Form + Strength Acitrin Capsule 25mg
Acitretin…….25mg
Pharmacological Group Retinoids for treatment of psoriasis
Type of Form Form 5
Approval status of product in Acitretin 25 mg Capsules by Genus Pharmaceuticals. MHRA
Me-too status Citarin 25mg Capsule by Wellness Pharmaceuticals (Pvt)
Ltd. Reg. No. 78735
framed there under
338. Name and address of manufacturer / Regal Pharma Plot # 2-A St # S-5 National Industrial Zone
Applicant Rawat Islamabad
Brand Name +Dosage Form + Strength Nitox Tablet 500mg
Nitazoxanide…..500mg
Pharmacological Group Agents against amoebiasis and other protozoal diseases
Type of Form Form 5
Approval status of product in ALINIA® (nitazoxanide) film-coated tablets, for oral use by
Reference Regulatory Authorities. Romark L.C. US-FDA approved
Me-too status Trinide 500mg Tablet by Ferozsons Laboratories Ltd. Reg.
No. 80594
stated that the firm “is operating in compliance to GMP
guidelines as of today. However, the points of improvement
have been discussed and agreed by the representative of the
firm”
Brand Name +Dosage Form + Strength Bexin Tablet 20mg
Piroxicam as betacyclodextrin…..20mg
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroids
(oxicams)
Type of Form Form 5
Approval status of product in BREXIN 20 mg scored tablet by Pierre FABRE
Reference Regulatory Authorities. MEDICAMENT. ANSM approved
Me-too status Piram-BX Tablets 20mg by Ferozsons Laboratories Ltd.
Reg. No. 80594
firm”
Remarks of the Evaluator.  The Master Formula depicted that the formulation is
uncoated. The firm mentioned coating process in Form 5.
Upon clarification, the firm revised Form 5 and removed
coating process.
Brand Name +Dosage Form + Strength Rebo Tablet 20mg
Composition Each enteric-coated tablet contains:
Rabeprazole sodium…..20mg
Type of Form Form 5
Approval status of product in ACIPHEX®(rabeprazole sodium) delayed-release tablets, for
Reference Regulatory Authorities. oral use by EISAI INC. US-FDA approved
Me-too status Rager Tablets by Shaheen Pharmaceuticals. Reg. No. 49335
stated that firm “is operating in compliance to GMP
guidelines as of today. However, points of improvement
have been discussed and agreed by representative of firm”
Brand Name +Dosage Form + Strength Serox Tablet 8mg
Composition Each uncoated tablet contains:
Betahistine dihydrochloride…..8mg
Pharmacological Group Antivertigo preparations
Type of Form Form 5
Approval status of product in SERC® 8mg uncoated Tablets by Mylan Health Pty Ltd.
Reference Regulatory Authorities. TGA approved
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Me-too status VR-Tigo Tablets 8mg by Himont Pharmaceuticals (Pvt) Ltd.
Reg. No. 79703
have been discussed and agreed by the representative of
firm”
Remarks of the Evaluator.  The Master Formula depicted that the formulation is
uncoated. The firm mentioned coating process in Form 5.
Upon clarification, the firm revised Form 5 and removed
coating process.
 The firm has changed the brand name to Regatine Tablet
8mg
Brand Name +Dosage Form + Strength Regofer-F Tablet
Composition Each chewable tablet contains:
Iron (III) hydroxide polymaltose complex eq. to elemental
iron……………100mg
Folic Acid……0.35mg
Pharmacological Group Iron in combination with folic acid
Type of Form Form 5
Approval status of product in Not confirmed
Me-too status Miroton Plus Chewablet Tablet by Mission Karachi. Reg.
No.80327
firm”
Remarks of the Evaluator.  The firm was asked to provide proof of
International availability of same dosage form with same
strength in reference regulatory authority as defined in
275th meeting of the Registration Board. In response the
firm submitted that Iron preparation are not considered as
drug by various reference regulatory authorities and
Registration Board approved the case in 284th meeting.
Brand Name +Dosage Form + Strength Regofer-F Capsule 150mg
Iron polysaccharide complex eq. to elemental iron….150mg
Pharmacological Group Iron in combination with folic acid
Type of Form Form 5
Finished Product Specification The firm has claimed manufactuer’s specifications
Approval status of product in iFEREX Capsules 150mg by Nnodum Pharmaceuticals.
Reference Regulatory Authorities. Available at dailymed.nlm.nih.gov
Me-too status Sakride 150mg Capsule by Winthrox Pharmaceuticals. Reg.
No. 80536.
firm”
344. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt) Ltd. Plot# 25 & 26,
Applicant Street S-3,RCCI, National Industrial Zone, Rawat,
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Pyroxal Capsule 10mg
Piroxicam…..10mg
(oxicams)
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 50’s, 100’sAs per SRO
Approval status of product in FELDENE 10mg Capsules by Pfizer Ltd, MHRA approved
Me-too status FELDEN 10MG CAP by Pfizer Karachi. Reg. No. 5445
recommended that “As the operations have not started as of
yet at M/s Evolution Pharmaceuticals Rawat, the GMP status
can only be ascertained upon the start of active production,
requisite facility for manufacturing of pharmaceuticals.”
345. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt) Ltd. Plot #: 25 & 26,
Applicant Street S-3, RCCI, National Industrial Zone, Rawat,
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Pyroxal Capsule 20mg
Piroxicam…..20mg
(oxicams)
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 50’s, 100’sAs per SRO
Approval status of product in FELDENE 20mg CAPSULES by Pfizer Limited. MHRA

Islamabad.
Brand Name +Dosage Form + Strength Fenolip Capsule 67mg
Fenifibrate (micronized)…..67mg
Pharmacological Group Lipid modifying agents, plain
Type of Form Form 5
Approval status of product in Fenofibrate 67 mg capsules by Actavis UK Limited. MHRA
Me-too status Lipidof 67 Capsule by ACME LABORATORIES
PAKISTAN (PVT) LTD. Reg. No. 33164
Islamabad, Pakistan
Type of Form Form 5
Approval status of product in Fenofibrate 134mg capsules by Rhodes Pharms. US-FDA
Me-too status Zibrate 134mg Capsules by Wilshire Laboratories (Pvt) Ltd.
Reg. No. 55345
Islamabad, Pakistan
Type of Form Form 5
Approval status of product in Fenofibrate 200mg capsules by Rhodes Pharms. US-FDA
Me-too status Felip 200mg Capsule by Bosch Pharmaceuticals (Pvt) Ltd.
Reg. No. 55918
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Luvista Capsule 20mg
Fluvastatin sodium eq. to Fluvastatin…..20mg
Type of Form Form 5
Pack size & Demanded Price 14’s, 28’s; As per SRO
Approval status of product in Fluvastatin 20 mg Capsules by TEVA UK Limited. MHRA
Me-too status Lescol Capsules 20mg by Sandoz Karachi. Reg. No. 14959
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Luvista Capsule 40mg
Fluvastatin sodium eq. to Fluvastatin…..40mg
Type of Form Form 5
Approval status of product in Fluvastatin 40 mg Capsules by TEVA UK Limited. MHRA
Me-too status Lescol Capsules 40mg by Sandoz Karachi. Reg. No. 14960
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Coaxid Capsule 100mg
Celecoxib BP…..100mg
Type of Form Form 5
Approval status of product in Celebrex 100 mg capsules, hard by Pfizer Limited. MHRA
Me-too status Bexicox 100 Capsule by Medipak Ltd, Lahore. Reg. No.
23946
Remarks of the Evaluator.  Celecoxib also lies in L01 class with ATC code L01XX33,
for which a dedicated or self-contained facility is required
as per decision of 282nd meeting of Registration Board.
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Coaxid Capsule 200mg
Celecoxib BP…..200mg
Type of Form Form 5
Approval status of product in Celecoxib 200 mg capsules, hard by Macleods Pharma UK
Reference Regulatory Authorities. Limited. MHRA approved
Me-too status Bexicox 200 Capsule by Medipak Ltd, Lahore. Reg. No.
23947
Remarks of the Evaluator. Celecoxib also lies in L01 class with ATC code L01XX33,
for which a dedicated or self-contained facility is required
as per decision of 282nd meeting of Registration Board.
 Decision: Approved with innovator’s speficiations.
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Ostofen Capsule 100mg
Ketoprofen…..100mg
Type of Form Form 5
Approval status of product in Ketoprofen Capsules BP 100mg by Ennogen Pharma
Me-too status Orudis 100mg cap by Rhone Poulenc Wah. Reg. No. 6633
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Ravera Tablet 10mg
Composition Each delayed-release tablet contains:
Rabeprazole Sodium JP…..10mg
Type of Form Form 5
Approval status of product in PARIET™ 10mg gastro-resistant tablet by Eisai Ltd. MHRA
Me-too status Procon Tablets 10mg by Mass Pharmaceuticals.
Reg.No.51159
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Ravera Tablet 20mg
Rabeprazole Sodium JP…..20mg
Type of Form Form 5
Approval status of product in ACIPHEX®(rabeprazole sodium) delayed-release tablets, for
Reference Regulatory Authorities. oral use by EISAI INC. US-FDA approved
Me-too status Rager Tablets by Shaheen Pharmaceuticals. Reg. No. 49335
Islamabad.
Brand Name +Dosage Form + Strength Kestox Tablet 1mg
Ketotifen hydrogen fumarate eq. to Ketotifen BP…..1mg
Pharmacological Group Other antihistamines for systemic use
Type of Form Form 5
Approval status of product in ZADITEN Tablets 1mg by Alfasigma S.p.A. MHRA
Me-too status Ketovent Tablets 1mg by Barrett Hodgson Pakistan (Pvt)
Ltd. Reg No. 30977
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Estivan Tablet 10mg
Ebastine…..10mg
Type of Form Form 5
Approval status of product in KESTIN 10 mg film-coated tablets by Almirall SAS. ANSM
Me-too status Ebasil Tablets by Silver Oak Corporation. Reg. No. 42519
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Neo-Zypril Tablet 5mg
Desloratadine BP…..5mg
Type of Form Form 5
Approval status of product in Desloratadine 5 mg film-coated tablets by Bristol
Reference Regulatory Authorities. Laboratories Ltd. MHRA approved
Me-too status Larinex Tablets 5mg by Getz Pharma. Reg. No. 39175
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Avocid Tablet 40mg
Pantoprazole sodium sesquihydrate equivalent to
Pantoprazole …………....40mg
Type of Form Form 5
Approval status of product in PROTONIX (pantoprazole sodium) delayed-release tablets,
Reference Regulatory Authorities. for oral use by Wyeth Pharms. US-FDA approved
Me-too status Pantasa Tablets by Platinum Pharmaceuticals. Reg.No.30205
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Alvin Tablet 5mg
Levocetirizine dihydrochloride…..5mg
Pharmacological Group Antihistamines for systemic use
Type of Form Form 5
Pack size & Demanded Price 10’’s, 100’s, 200’s; As per SRO
Approval status of product in Levocetirizine dihydrochloride 5 mg film-coated tablets by
Reference Regulatory Authorities. Generics [UK] Limited. MHRA approved
Me-too status Levrix Tablets 5mg by AGP Karachi. Reg. No. 34675
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Alervin Tablet 10mg
Cetirizine hydrochloride…..10mg
Pharmacological Group Antihistamines for systemic use
Type of Form Form 5
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Approval status of product in Cetec 10 mg film-coated tablets by Bristol Laboratories Ltd.
Reference Regulatory Authorities. MHRA approved
Me-too status Cetrovil Tablets 10mg by Drugpharm. Reg. No. 36250
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Zypril Tablet 10mg
Loratadine…..10mg
Type of Form Form 5
Approval status of product in Roletra 10 mg Tablets by Ranbaxy (UK) Limited. MHRA
Me-too status Latadine 10mg Tablets by Pulse Pharmaceuticals. Reg. No.
36569
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Fexova Tablet 60mg
Fexofenadine hydrochloride…..60mg
Type of Form Form 5
Approval status of product in ALLEGRA® (fexofenadine hydrochloride) 60mg tablets by
Reference Regulatory Authorities. Sanofi Aventis US. US-FDA approved
Me-too status Vigil Tablets by Tabros Pharma. Reg. No. 39776

Islamabad, Pakistan
Type of Form Form 5
Approval status of product in Fexofenadine 120 mg film-coated tablets by Teva UK
Me-too status Fenadrin Tablets 120mg by Noa Hemis Pharma. Reg. No.
42118
Islamabad, Pakistan
Type of Form Form 5
Approval status of product in Fexofenadine 180 mg film-coated tablets by Teva UK
Me-too status Fenadrin Tablets 180mg by Noa Hemis Pharma. Reg. No.
42119
366. Name and address of manufacturer / CKD Pharmaceuticals Pakistan (Pvt) Ltd Plot 50/28 Korangi
Applicant Industrial Area Karachi
Brand Name +Dosage Form + Strength Synapse 75mg Capsule
Composition Each Capsule contains:
Pregabalin ……….75mg
Pharmacological Group Antiepileptics
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specifications
Pack size & Demanded Price 7’s, 10’s, 14’s, 28’s; As per SRO
Approval status of product in Alzain 75 mg Capsules, Hard by Dr. Reddy’s Laboratories
Reference Regulatory Authorities. (UK) Ltd, approved by MHRA of UK
Me-too status Lyrica Capsule 75mg by Pfizer Pakistan Reg.# 44817
GMP status Last GMP inspection of CKD Pharmaceuticals was
conducted on 04.09.2018, wherein the compliance level of
the firm was rated Good.
 Decision: Approved with change of brand name
Type of Form Form 5
Me-too status Zeegap 100mg Capsules by Hilton Pharma, Karachi Reg.
No. 47360
Type of Form Form 5
Me-too status Zeegap 50mg Capsules by Hilton Pharma Reg. No.47358
Brand Name +Dosage Form + Strength Harmony Tablets 500mg
Divalproex sodium eq. to valproic acid ……….500mg
Type of Form Form 5
Approval status of product in Depakote (divalproex sodium) tablets, delayed release by
Reference Regulatory Authorities. AbbVie Ltd, Barcelona for AbbVie Inc, USA. approved by
US-FDA
Me-too status Valrox Tab by Polyfine Chemical Pharmaceuticals,
Peshawar Reg. No. 41615
Remarks of the Evaluator.  The me-too product does not depict whether it is
enteric-coated or otherwise.
 Decision: Approved with change of brand name.

Brand Name +Dosage Form + Strength Harmony Tablets 250mg
Divalproex sodium eq. to valproic acid ……….250mg
Type of Form Form 5
Approval status of product in Depakote (divalproex sodium) tablets, delayed release by
Reference Regulatory Authorities. AbbVie Ltd, Barcelona for AbbVie Inc, USA. approved by
US-FDA
Me-too status Zalprocid Tablets 250mg by Mass Pharma, Reg. No. 41643
Brand Name +Dosage Form + Strength Depnill Tablets 10mg
Escitalopram (as escitalopram oxalate)……….10mg
Type of Form Form 5
Approval status of product in CIPRALEX 10 mg film-coated tablets, by H. Lundbeck A/S.
Reference Regulatory Authorities. approved by MHRA
Me-too status Zavesca 10mg Tablets by Getz Pharma, Reg. No. 45279
PKR 20,000/-: 22.11.2017
Type of Form Form 5
Approval status of product in Escitalopram 15 mg film-coated tablets, by Morningside
Reference Regulatory Authorities. Healthcare Ltd. approved by MHRA
Me-too status Zavesca 15mg Tablets by Getz Pharma, Karach, Reg. No.
45280
Type of Form Form 5
Approval status of product in Escitalopram 20 mg film-coated tablets, by Teva UK
Reference Regulatory Authorities. Limited. approved by MHRA
Me-too status Zavesca 20mg Tablets by Getz Pharma, Karachi,
Reg.#45281
Brand Name +Dosage Form + Strength Rovastin Tablets 5mg
Rosuvastatin (as calcium salt)……….5mg
Type of Form Form 5
Approval status of product in Crestor 5mg film-coated tablets by AstraZeneca UK Ltd.
Me-too status Loster 5mg Tablets by Helix Pharma, Karachi Reg.No.
45333
Brand Name +Dosage Form + Strength Rovastin Tablets 10mg
Rosuvastatin (as calcium salt)……….10mg
Type of Form Form 5
Approval status of product in Crestor 10mg film-coated tablets by AstraZeneca UK Ltd.
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Me-too status Loster 10mg Tablets by Helix Pharma, Reg.No.45334
Brand Name +Dosage Form + Strength AMTRA Tablet
Tramadol HCl……37.5mg
Type of Form Form 5
Approval status of product in Tramadol Hydrochloride/ Paracetamol 37.5mg /325mg film-
Reference Regulatory Authorities. coated tablets by Strandhaven Ltd t/a Somex Pharma.
approved by MHRA
Me-too status Tramafaas Tablets by FAAS Pharma Karachi, approved in
283rd meeting
Brand Name +Dosage Form + Strength Acofen 50 mg Tablet
Diclofenac Sodium……..50mg
Type of Form Form 5
Approval status of product in Fenactol Tablets 50mg by Dexcel®-Pharma Ltd. Approved
Reference Regulatory Authorities. by MHRA
Me-too status Vorenac 50mg Tablet (enteric coated) by Mission Pharma,
Karachi, Reg. No. 80324
Remarks of the Evaluator.  The firm revised the formulation to enteric
coated from film-coated with submission of fee Rs. 5000/-.

Brand Name +Dosage Form + Strength Sanity 10 mg Tablet
Memantine HCl……..10mg
Pharmacological Group Anti-dementia drugs
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s,; As per SRO
Approval status of product in Memantine 10 mg film-coated tablets by Aristo Pharma
Reference Regulatory Authorities. GmbH. Approved by MHRA
Me-too status Memlip 10mg Tablets by WnsFeild Pharmaceuticals. Hattar.
Reg. No. 84222
Brand Name +Dosage Form + Strength Omel capsule 20 mg
Omeprazole enteric coated pellets eq. to
omeprazole……..20mg
Type of Form Form 5
Approval status of product in Losec 20 mg hard gastro-resistant capsules by AstraZeneca
Reference Regulatory Authorities. UK Ltd., Approved by MHRA
Me-too status Omecap Capsule by Next Pharmaceutical Products (Pvt) Ltd,
Lahore. Reg. No. 84493
Remarks of the Evaluator.  The source of enteric coated pellets is Vision
Pharmaceuticals.
 The chromatographic conditions for analysis and stability
studies of Omeprazole pellets are not in accordance with
the USP 39 monograph
Brand Name +Dosage Form + Strength Omel capsule 40 mg
Omeprazole enteric coated pellets eq. to
omeprazole…..40mg
Type of Form Form 5
Approval status of product in Losec 40 mg hard gastro-resistant capsules by AstraZeneca
Reference Regulatory Authorities. UK Ltd. Approved by MHRA
Me-too status Omecap Capsule by Next Pharmaceutical Products (Pvt)
Ltd, Lahore. Reg. No. 84494
Remarks of the Evaluator.  The source of enteric coated pellets is Vision
Pharmaceuticals.
 The chromatographic conditions for analysis and stability
studies of Omeprazole pellets are not in accordance with
the USP 39 monograph
Brand Name +Dosage Form + Strength Olantine capsule 6/25mg
Olanzepine ……..6mg
Fluoxetine as hydrochloride…….25mg
Pharmacological Group Antipsychotics and selective serotonin reuptake inhibitors
Type of Form Form 5
Approval status of product in SYMBYAX (olanzapine and fluoxetine) capsules by Eli
Reference Regulatory Authorities. Lilly and Company. Approved by US-FDA
Me-too status Co-Depricap 6/25 Capsule by NabiQasim Reg. No.76135
Remarks of the Evaluator.  The formulation was revised to Fluoxetine (as
hydrochloride) from Fluoxetine hydrochloride with
submission of fee Rs.5000/-.
Brand Name +Dosage Form + Strength Ripe 1mg/ml Solution
Risperidone ……..1mg
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml; As per SRO
Approval status of product in RISPERDAL 1mg/ml oral solution by Janssen-Cilag Ltd.
Me-too status Risperdal Oral Solution (30 ml) by JOHNSON & JOHNSON
LTD. Reg. No. 27396
Remarks of the Evaluator.  The firm initially submitted Master Formula with quantity
of API (1mg/5ml) and excipients per 5ml. However, the
label claim was 1mg/ml. Upon clarification, the firm
revised the Master formulation for 1 ml of solution without
submission of fee.
Decision: Deferred for submission of fee for revision of formulation.
Brand Name +Dosage Form + Strength Sanity 10mg/5ml Syrup
Composition Each 5 ml contain:
Memantine HCl……..10mg
Pharmacological Group Anti-dementia drugs
Type of Form Form 5
Finished Product Specification The firm did not provide the reference for finished product
specifications
Pack size & Demanded Price 60ml, 120ml; As per SRO
Approval status of product in Not confirmed
Me-too status Zexa Syrup by English Pharma. Reg. No. 71544
Remarks of the Evaluator.  The firm had applied for Sanity 10mg/5ml Syrup and had
mentioned 200mg/5ml in Form 5, which corresponds to
10mg/ml. Upon clarification, the firm revised the Form 5
to 10mg/5ml without submission of fee.
 The international product, to which the firm has referred,
has been discontinued by US-FDA.
 Evidence of approval of applied formulation in reference regulatory authorities/ agencies
which were adopted by the Registration Board
 Submission of fee for revision of formulation.
384. Name and address of manufacturer / Next Pharmaceutical Products Private Limited Plot No 44 A-
Applicant B, Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Nonauz Tablet 50mg
Dimenhydrinate……50mg
Pharmacological Group Antihistamines
Type of Form Form 5
Pack size & Demanded Price 10’s; As per PRC regarding the applied product
Approval status of product in Dimenhydrinate 50mg un-coated tablets by Chelonia
Reference Regulatory Authorities. Healthcare Limited. MHRA approved
Me-too status Dynate Tablets 50mg by Jafson Pharmaceutical (Pvt) Ltd.
Reg. No. 29278
stated the firm had four sections but only two sections
(Tablet and capsules) are operational at the time of
inspection, and rated the GMP compliance as satisfactory.
Remarks of the Evaluator.  The firm has revised the formulation to un-
coated tablet with submission of fee Rs. 5000/-.
 Decision:Approved.
Brand Name +Dosage Form + Strength Carvedilol Tablet 6.25mg
Carvedilol ……6.25mg
Type of Form Form 5
Pack size & Demanded Price As per PRC regarding the applied product
Approval status of product in Carvedilol 6.25 mg Film-coated Tablets by Generics [UK]
Reference Regulatory Authorities. Limited t/a Mylan. MHRA approved
Me-too status Carlol 6.25mg Tablets by Nabiqasim Industries. Reg.#39707
Brand Name +Dosage Form + Strength Carvedilol Tablet 25mg
Carvedilol ……25mg
Type of Form Form 5
Approval status of product in Carvedilol 25 mg Film-coated Tablets by Generics [UK]
Me-too status Carlol 25mg Tablets by Nabiqasim Industries. Reg.No.39405
Type of Form Form 5
Approval status of product in Carvedilol 12.5 mg Film-coated Tablets by Generics [UK]
Me-too status Carlol 12.5mg Tablets by Nabiqasim Industries.
Reg.No.39708
Type of Form Form 5
Approval status of product in Carvedilol 3.125 mg Film-coated Tablets by Milpharm
Me-too status Delaware 3.125mg Tablet by Efroze Chemical Industries.
Reg. No. 55009.
Brand Name +Dosage Form + Strength Glyvil Tablet 50mg
Vildagliptin……50mg
Pharmacological Group Dipeptidyl peptidase 4 (DPP-4) inhibitors
Type of Form Form 5
Approval status of product in GALVUS vildagliptin 50 mg tablets un-coated by Novartis
Reference Regulatory Authorities. Pharmaceuticals Australia Pty Ltd. TGA approved
Me-too status Glavil 50mg Tablet by Atco Laboratories. Reg. No. 67245
Remarks of the Evaluator.  The firm has revised the formulation to un-
coated tablet with submission of fee Rs. 5000/-.
 The brand name has been changed to Vildanext.
 Decision: Approved with innovator’s specifications and new brand name.
Brand Name +Dosage Form + Strength Varox Tablet 10mg
Rivaroxaban……10mg
Pharmacological Group Factor Xa inhibitor
Type of Form Form 5
Approval status of product in Rivaroxaban 10 mg film-coated tablets by Milpharm
Me-too status Xaroban 10mg Tablet by Searle Company Ltd.
Reg.No.76284
Type of Form Form 5
Me-too status Rivaxo 15mg film-coated Tablet by Getz Pharma
Reg.#80790
Type of Form Form 5
Me-too status Rivaxo 20mg film-coated Tablet by Getz Pharma
Reg.#80791
GMP status
Brand Name +Dosage Form + Strength Doara Tablet 5mg
Desloratadine……5mg
Type of Form Form 5
Pack size & Demanded Price 10’s; As per PRC regarding the applied product
Approval status of product in Desloratadine 5 mg film-coated tablets by Bristol
Reference Regulatory Authorities. Laboratories Ltd. MHRA approved
Me-too status Larinex Tablets 5mg by Getz Pharma. Reg. No. 39175
Evaluator PEC-XIII
394. Name and address of manufacturer / E- Pharm Laboratories, A-40, Road No. 1, S.I.T.E, Super
Applicant Highway Industrial Area, North Karachi.
Brand Name +Dosage Form + Strength Xylopharm nasal spray
Xylometazoline HCl………..........…....1mg
Diary No. Date of R& I & fee Dy. No. 19717 ; 01-11-2017; Rs.20,000/- (31-10-2017)
Pharmacological Group Sympathomimetic
Type of Form Form- 5
Finished product Specification U.S.P.
Pack size & Demanded Price 1x 15ml & as per SRO
Approval status of product in Reference MHRA Approved
Regulatory Authorities
Me-too status Xylomet Nasal Spray of M/s Krka Pak Pharmaceuticals,
(Reg. # 039120)
Remarks of the Evaluator  Relevant section of the firm could not be confirmed as:
 According to the latest inspection report dated 01-3-
2018, firm has Sterile Ophthalmic Drops Section.
 While according to the GMP inspection report dated 15-
07-2017, firm has ENT/Ophthalmic (General) Section.
Decision: Registration Board referred the case to Licensing Division for confirmation of requisite
section for manufacturing of above product.
395. Name and address of manufacturer / M/s CKD Pharmaceuticals Pakistan (Pvt.) Limited, Plot #
Applicant 50/28, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Cktin syrup 100mg/5ml 2%
Carbocisteine……………….100mg
DUPLICATE
Pharmacological Group Mucolytic agent
Finished product Specification Manufacturers
Pack size & Demanded Price 120ml & Rs. 50/-
Approval status of product in Reference Could not be confirmed
Me-too status Rhinex 100mg/ 5ml syrup of M/s Platinum Pharma (Reg. #
075960)
report concludes good level of GMP compliance.
Remarks of the Evaluator  Firm has oral liquid (general) section.
 The evidence of approval in reference agencies
could not be confirmed.
 The official monograph of the applied formulation
is not available in USP and BP.
Brand Name +Dosage Form + Strength Ecrolim Ointment 0.03% w/w
Composition Each gram contains:
Tacrolimus as Monohydrate………0.3mg (0.03% w/w)
DUPLICATE
Pharmacological Group Agent for dermatitis excluding corticosteroids
Pack size & Demanded Price 5gm, 10gm & Rs.150/- per pack of 5g, Rs. 275/- per pack
of 10gm
Me-too status Prolimus ointment 0.03% of M/s Kaizen Pharma
(Reg.#073752)
Remarks of the Evaluator  Firm has Cream/ Ointment/ Gel (General) section as
mentioned in the submitted section approval letter.
 The official monograph of the applied formulation is
not available in USP and BP.
Brand Name +Dosage Form + Strength Ecrolim Ointment 0.1% w/w
Tacrolimus as Monohydrate………0.1mg (0.1% w/w)
DUPLICATE
Pharmacological Group Agent for dermatitis, excluding corticosteroids
Pack size & Demanded Price 5gm, 10gm
Rs. 425/- per pack of 5g ,
Rs. 825/- per pack of 10gm
Me-too status Aimus ointment of M/s Aims Pharmaceuticals (Reg.#
069939)
Remarks of the Evaluator  Firm has Cream/ Ointment/ Gel (General) section as
 The official monograph of the applied formulation is
not available in USP and BP.
Brand Name +Dosage Form + Strength Luecas Cream 0.05% w/w
Fluticasone Propionate………………0.5mg (0.05%w/w)
DUPLICATE
Pharmacological Group Corticosteroid
Pack size & Demanded Price 5gm, 10gm & Rs. 55/- per pack of 5gm , Rs. 105/- per pack
of 10gm
Me-too status Ticovate Ointment 0.05% w/w of M/s Saffron
Pharmaceuticals (Pvt.) Ltd, (Reg. # 046434)
Remarks of the Evaluator Firm has Cream/ Ointment/ Gel (General) section as
Decision: Approved.
Brand Name +Dosage Form + Strength Luecas Ointment 0.005%w/w
Fluticasone Propionate………………0.05mg (0.005%w/w)
DUPLICATE
Pack size & Demanded Price 5gm, 10gm & Rs. 55/- per pack of 5gm , Rs. 105/- per pack
of 10gm
Me-too status Cultivate ointment 0.005% of M/s GSK (Reg. # 045446)
Remarks of the Evaluator  Firm has Cream/ Ointment/ Gel (General) section
as mentioned in the submitted section approval
letter.
Decision: Approved.
400. Name and address of manufacturer / M/s Bajwa Pharmaceuticals (Pvt.) Limited, 36-km, GT Road,
Applicant Khori Mureedke (Sheikhupura).
Brand Name +Dosage Form + Strength Baladol Injection 2ml
Tramadol HCl……………...50mg
Pharmacological Group Opiate analogue
Type of Form Form-5
Finished product Specification Not claimed
Pack size & Demanded Price 2ml x 5ml Glass Ampoule & as per PRC
Me-too status Mictra Injection of M/s Bosch Pharma
report concludes “Overall hygienic condition of firm is
satisfactory at the time of inspection. They were advised to
improve further their documentation as mentioned above.
They agreed.”
Remarks of the Evaluator  Firm has liquid Injection ampoule (General) section.
 No USP or BP monograph is available for the applied
fornmulation.
401. Name and address of manufacturer / M/s Theramed Pharmaceutical (Pvt.) Ltd., 45-Km, Multan
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Ivamed 5mg tablet
Ivabradine as Hydrochloride …………………….5mg
Pharmacological Group Anti-anginal
Type of Form Form 5
Finished product Specification Innovator’s specification
Pack size & Demanded Price 14’s, 28’s & as per SRO
Me-too status Iva Tablet 5 mg of M/s CSH Pharma (Reg.# 081685)
GMP status GMP Inspection Certificate dated 10.10.2017 Panel
recommended renewal of DML and additional section.
Remarks of the Evaluator  The official monograph of the applied formulation
is not available USP, BP and JP.
Decision : Approved.
Brand Name +Dosage Form + Strength Ivamed 7.5mg tablet
Ivabradine as Hydrochloride ………………….7.5mg
Pharmacological Group Antianginal
Type of Form Form 5
Me-too status Ivatab 7.5mg Tablet of M/s Nabiqasim (Reg# 076155)
is not available USP, BP and JP.
Applicant Road, Lahore
Brand Name +Dosage Form + Strength Rifmed 200mg tablet
Rifaximin …………….....200mg
Pharmacological Group Antibiotic
Type of Form Form 5
Me-too status Rixabac 200mg tablet of M/s Pharmevo (Reg.# 076260)
Brand Name +Dosage Form + Strength Rifmed 550mg tablet
Composition Each film- coated tablet contains:
Rifaximin …………….....550mg
Type of Form Form 5
Me-too status Rixabac 550mg tablet of M/s Pharmevo (Reg.# 076259)
Brand Name +Dosage Form + Strength Vilip 50mg Tablet
Vildagliptin …………...50mg
Pharmacological Group Antidiabetic/ Hypoglycemic
Type of Form Form 5
Finished product Specification Innovators
Pack size & Demanded Price 10’s,14’s,28’s & as per SRO
Me-too status Vildos 50mg tablet of M/s High-Q (Reg. # 067549)
report concludes renewal of DML and grant of additional
sections.
is not available in USP, BP, IP and JP.
Brand Name +Dosage Form + Strength Nimed 30mg tablet
Nimodipine.........................30mg
Pharmacological Group Calcium channel blocker
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s & as per SRO
Me-too status Nimotop 30mg tablets of M/s Siatex (Reg. # 013983)
sections.
Brand Name +Dosage Form + Strength Febus 40mg Tablet
Febuxostat ………………..40mg
Pharmacological Group Antigout agent
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s & as per SRO
Approval status of product in Reference USFDA Approved
Me-too status Zurig 40mg tablet of M/s Getz Pharma (Reg. # 067290)
sections.
Remarks of the Evaluator  No official monograph of the applied formulation
exists in available editions of USP/BP/IP and JP.
Brand Name +Dosage Form + Strength Febus 80mg Tablet
Febuxostat ……………....80mg
Pharmacological Group Antigout agent
Type of Form Form 5
Pack size & Demanded Price 10’s,20’s, 30’s & as per SRO
Me-too status Zurig 80mg tablet of M/s Getz Pharma(Reg. # 067291)
GMP status Last GMP inspection was conducted on 10-10-2017 &
sections.
Remarks of the Evaluator  No official monograph of the applied formulation
exists in available editions of USP/BP/IP and JP.
Brand Name +Dosage Form + Strength Vimin 50/500mg Tablet
Vidagliptin ……………....50mg
Metformin HCI ….…..…500mg
Type of Form Form 5
Pack size & Demanded Price 30’s & as per SRO
Approval status of product in Reference Galvumet 50mg/ 500mg film-coated tablet of M/s
Regulatory Authorities Novartis Pharmaceuticals Pty Limited (Australia Approved)
Me-too status Galvus Met 50/500mg Tablets of M/s Novartis (Reg. #
078106)
GMP status GMP Inspection Certificate dated 10.10.2017. Panel
Brand Name +Dosage Form + Strength Vimin 50/1000mg Tablet
Vidagliptin ……………...50mg
Metformin HCl ………1000mg
Type of Form Form 5
Approval status of product in Reference Galvumet 50mg/ 1000mg film-coated tablet by M/s
Regulatory Authorities Novartis Pharmaceuticals Australia Pty Limited
Me-too status Galvus Met 50/1000mg tablet of M/s Novartis
(Reg. # 066107)
411. Name and address of manufacturer/ M/s Pakistan Pharmaceutical Products (Pvt.) Limited, D-
applicant 122, S.I.T.E., Karachi
Brand Name + Dosage Form + Strength Arcofen DS Suspension 200mg/ 5ml
Ibuprofen……………………200mg
Diary no. Date of R&I & Fee Dy. No. 25651; 22-12-2017; Rs.20,000/- (22-12-2017)
Finished Product Specifications Not claimed
Pack size & Demanded Price 1’s & As per PCA
Approval Status of Product in ReferenceNurofen for children 6 Plus oral suspension of M/s Reckitt
regulatory Authorities Benckiser (Approved in Ireland)
Me-too status Brufen DS 200mg/ 5ml of M/s Abbott (Reg. # 070851)
report concludes a good level of GMP compliance.
Remarks of Evaluator  Firm has oral liquid syrup section.
is availbale in USP.
Decision: Approved with USP specifications.
412. Name and address of manufacturer/ M/s Pakistan Pharmaceutical Products (Pvt.) Limited, D-
applicant 122, S.I.T.E., Karachi
Brand Name + Dosage Form + Strength Neclof emulgel 20g (1% w/w)
Composition Each tube contains:
Diclofenac Diethylamine ……1.16% w/w, corresponding to
1g Diclofenac Sodium per 100g of emulgel
Finished Product Specifications Manufacturer’s
Pack size & Demanded Price 20g & As per PCA
Approval Status of Product in Reference Approved in US-FDA
regulatory Authorities (Voltaren gel 1% 50grams/20grams)
Me-too status Voltral emulgel of M/s GSK OTC (Pvt.) Ltd. (Reg.#
083991)
report concludes a good level of GMP compliance.
Remarks of Evaluator  Firm has ointment/ cream section.
is available in BP.
Decision : Approved with BP specifications.
413. Name and address of manufacturer/ M/s Magns Pharmaceuticals, Plot # 7-B, Value Addition
applicant City, Faisalabad.
Brand Name + Dosage Form + Strength Leumef tablet 40/240mg
Artemether ……………………. 40 mg
Lumefantrine………………… 240 mg
Pharmacological Group Anti-malarial
Type of Form Form-5
Finished Product Specifications Manufacturers
Pack size & Demanded Price 1x 8’s & as per SRO
Approval Status of Product in Reference WHO approved formulation
regulatory Authorities
Me-too status Arceva tablet of M/s Sami Pharmaceuticals (Reg.# 053226)
report concludes good compliance.
Remarks of Evaluator  The official monograph of the applied formulation
is available in International Pharmacopoeia.
Decision : Approved with International Pharmacopoeia’s specifications.
Brand Name + Dosage Form + Strength Leumef tablet 80/ 480mg
Artemether ……………………. 80 mg
Lumefantrine…………………. 480 mg
Pharmacological Group Anti-malarial
Type of Form Form-5
Approval Status of Product in Reference WHO Approved formulation
Me-too status Arceva tablet of M/s Sami Pharmaceuticals (Reg.# 058381)
is available in International Pharmacopoeia.
Decision : Approved with International Pharmacopoeia’s specifications.
Brand Name + Dosage Form + Strength Clithrocin Tablet 500 mg
Clarithromycin ………...500 mg
Type of Form Form 5
Finished Product Specifications USP
Pack size & Demanded Price 1 x 10’s & as per SRO
Approval Status of Product in Reference USFDA Approved
regulatory Authorities.
Me-too status Klaricid Tablets of M/s Abbott
Brand Name + Dosage Form + Strength Clithrocin Tablet 250 mg
Clarithromycin ………...250 mg
Type of Form Form-5
Me-too status Klaricid Tablets of M/s Abbott
Brand Name + Dosage Form + Strength Dermafin Tablet 250mg
Terbinafine as HCl…………….……250 mg
Pharmacological Group Anti-fungal
Type of Form Form 5
Me-too status Terbicil 250mg tablets M/s Saffron Pharmaceuticals
Brand Name + Dosage Form + Strength Stelopam Tablets 10mg
Escitalopram as Oxalate…………….. 10mg
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Pharmacological Group Antidepressant (Selective Serotonin Reuptake Inhibitor)
Type of Form Form-5
Finished Product Specifications U.S.P.
Approval Status of Product in Reference MHRA Approved
Me-too status Zavesca tablet 10mg of Getz Pharma. (Reg.# 045279)
Brand Name + Dosage Form + Strength Tiz tablet 2mg
Tizanidine as HCl ……… 2mg
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s as per SRO
Me-too status Analar of M/s AGP (Pvt.) Limited (Reg. # 035422)
Brand Name + Dosage Form + Strength Setalin Tablet 50mg
Sertraline as HCl………...50 mg
Pharmacological Group Selective Serotonin Reuptake Inhibitor (Anti-Depressant)
Type of Form Form-5
Approval Status of Product in Reference Lustral 50mg film coated tablet of M/s Pfizer Limited
regulatory Authorities (MHRA Approved)
Me-too status Zoloft Tablets 50mg of M/s Pfizer (Reg. # 020855)
Brand Name + Dosage Form + Strength Setalin Tablet 100mg
Sertraline as HCl………………….100 mg
Pharmacological Group Selective Serotonin Reuptake Inhibitor (Anti-Depressant)
Type of Form Form 5
Pack size & Demanded Price 2 x 10’s as per SRO
Approval Status of Product in Reference Lustral 100mg film-coated tablet of M/s Pfizer Limited
regulatory Authorities. (MHRA Approved)
Me-too status Zoloft Tablets 100mg by M/s Pfizer (Reg.# 020856)
Brand Name + Dosage Form + Strength Allervit tablet 10mg
Loratadine …………10 mg
Pharmacological Group Antihistamine (Anti- Allergic)
Type of Form Form-5
Me-too status Antial of M/s Sami Pharmaceuticals
Brand Name + Dosage Form + Strength Lezet Tablet 5mg
Levocetirizine Dihydrochloride ………..5mg
Pharmacological Group Antihistamine (anti-allergy)
Type of Form Form-5
Me-too status Leozin of M/s Hilton Pharma Pakistan (Reg. # 035652)
Brand Name + Dosage Form + Strength Lipid tablet 10mg
Atorvastatin as Calcium Trihydrate…………10 mg
Pharmacological Group Lipid Lowering Agent
Type of Form Form-5
Me-too status Lipiget 10mg Tablet M/s Getz Pharma (Reg.#029956)
Decision : Approved with innovator’s specifications and change of brand name.
Brand Name + Dosage Form + Strength Lipid Tablet 20mg
Atorvastatin Calcium Trihydrate eq. to Atorvastatin
…………………………………….…………20 mg
Pharmacological Group Lipid lowering agent
Type of Form Form-5
Me-too status Lipiget 10mg Tablet of M/s Getz Pharma (Reg. # 029957)
Decision : Approved with innovator’s specifications and change of brand name.
Brand Name + Dosage Form + Strength Magadol Tablet 325mg/37.5mg
Paracetamol …………...325 mg
Tramadol HCl…………37.5 mg
Pharmacological Group Narcotic Analgesic
Type of Form Form-5
Me-too status Misadol Plus tablet of M/s Mission Pharma (Reg. #
081607)
Brand Name + Dosage Form + Strength Pantop Tablet 40mg
Composition Each enteric- coated tablet contains:
Pantoprazole as Sodium………...…40 mg
Type of Form Form-5
Me-too status Pantopraz 40mg tablet of M/s Klifton Pharma
(Reg.#058314)
Decision: Approved.
Brand Name + Dosage Form + Strength Xarafer Tablet 100mg III/ 0.35mg Folic Acid
Composition Each Chewable tablet contains:
Iron-III Hydroxy Polymaltose Complex eq. to
Elemental Iron ………………………. 100 mg
Folic Acid……….…………………… 0.35 mg
Pharmacological Group Anti- anaemic
Type of Form Form-5
Approval Status of Product in Reference N/A
Me-too status Polymalt Plus chewable tablet of M/s High- Q Pharma
(Reg. # 073606)
Brand Name + Dosage Form + Strength Ensulid tablet 100mg
Nimesulide………………100mg
Pharmacological Group Selective COX-2 Inhibitor
Type of Form Form 5
Approval Status of Product in Reference Approved in Italy as uncoated tablet
Me-too status Nims uncoated tablet of M/s Sami Pharma (Reg. # 026657)
Remarks of Evaluator  The firm has applied film-coated while it is
approved in reference regulatory authority (Italy) as
uncoated tablet.
 No USP or BP monograph is available for the
applied formulation.
Brand Name + Dosage Form + Strength Feptic Tablet 40mg
Famotidine ………………..40mg
Pharmacological Group H-2 receptor antagonist
Type of Form Form-5
Approval Status of Product in Reference TGA (Australia) Approved
Me-too status Fammo 40 mg tablet of M/s Mafins Pharma (Reg.#
079890)
Decision: Approved.
Evaluator PEC-XIV
431. Name and address of manufacturer / M/s. Lisko Pakistan (Pvt) Ltd. L-10-D Block-21 Shaheed
Applicant Rashid Minhas Road, F.B. Industrial Area, Karachi
Brand Name +Dosage Form + Strength Glucomin V Tablet
Vildagliptin …………………….50mg
Metformin Hydrochloride………….1000mg
Diary No. Date of R& I & fee 17563, 10-10-2017, 20,000/-, 25-09-2017
Type of Form Form-5
Finished product Specification As per innovator
Pack size & Demanded Price 14’s & 30’s; As per SRO
Approval status of product in Galvumet Tablet Of (TGA Approved)
Me-too status Galvusmet 50mg/1000mg Tablet of M/s Novartis
GMP status  GMP inspection conducted on 27-09-2018 concluded that
all relevant activities in process areas, QC and ware house
were found at good level of GMP compliance.
 Area FID vide letter No.F.SAA.02-06/2018-FID-V dated
30-08-2018 has confirmed that firm has purchased two
stability chambers with capacity of 250L (accelerated) and
800L (Real time), placed in their QC department.
Remarks of the Evaluator.  The firm has revised Form-5 and master formulation with
fee challan of Rs.5,000/- (deposit slip#0619134) dated 26-
10-2018.
Decision: Approved with innovator’s specification & shelf life of 18 months.
Brand Name +Dosage Form + Strength Glucomin V Tablet
Vildagliptin …………………….50mg
Metformin Hydrochloride……….850mg
Type of Form Form-5
Finished product Specification As per innovator
Pack size & Demanded Price 14’s & 30’s; As per SRO
Approval status of product in Galvumet Tablet Of (TGA Approved)
Me-too status Galvusmet 50mg/850mg Tablet of M/s Novartis
10-2018.
Decision: Approved with innovator’s specification & shelf life of 18 months.
Brand Name +Dosage Form + Strength LOWPID 10mg Tablet
Simvastatin ……………….10mg
Pharmacological Group HMG-CoA reductase inhibitor
Type of Form Form-5
Me-too status Simkeu 10mg tablet of High-Q Pharma (Reg#047461)
Decision: Approved.
Brand Name +Dosage Form + Strength Medeno Capsule 4mg
Thiocolchicoside………………4mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s; Not mentioned
Approval status of product in Myoplege (ANSM approved)
Me-too status Muscoril capsule of sanofi aventis
Decision: Approved.
Brand Name +Dosage Form + Strength SIPRO Dry suspension 125mg/5ml
Composition Each 5ml contains :
Ciprofloxacin base……………125mg
Type of Form Form-5
Pack size & Demanded Price 60ml; Not mentioned
Approval status of product in Not available
Me-too status Ciprin 125mg/5ml suspension of M/s Werrick
pharmaceuticals
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10-2018.
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
b. Deferred cases
Evaluator PEC-II
436. Name and address of manufacturer / M/s Medicraft Pharmaceuticals (Pvt.) Ltd., 126-B
Applicant Hayatabad Industrial Estate, Peshawar. Contract
manufacturing by M/s Bio-Labs (Pvt.) Ltd., Plot No. 145,
Brand Name +Dosage Form + Strength Esobest injection 40mg
Esomeprazole as sodium….......40mg
Type of Form Form-5
Pack size & Demanded Price 1’s; As per PRC
Approval status of product in Nexium IV(USFDA approved)
Me-too status Nexum 40mg Injection of M/s Getz
GMP status Last GMP inspection dated 05-12-2017 and 06-12-2017;
fair compliance to GMP level.
Remarks of the Evaluator. M/s Medicraft Pharmaceuticals (Pvt.) Ltd has 9 approved
sections and the firm has no product already registered
under the contract manufacturing as confirmed by relevant
registration section. M/s Bio-Labs (Pvt.) Ltd. has approved
Lyophilization vial section.
Previous Decision: Registration Board in its 283rd meeting deferred the case for
assessment and confirmation of manufacturing capacity of
M/s Biolabs by panel to be constituted by Chairman
Registration Board for further granting contract
manufacturing permission as the firm has already been
granted approval for contract manufacturing of numerous
products.
Evaluation by PEC: Firm has requested to change the contract manufacturer
from M/s Bio-Labs (Pvt.) Ltd., Plot No. 145, Industrial
Triangle, Kahuta Road, Islamabad to M/s Aries
Pharmaceuticals (Pvt.) 1-W, Industrial Estate Hayatabad
Peshawar. Firm has submitted following:
 Valid contract agreement between M/s Medicraft
Pharmaceuticals (Pvt.) Ltd., 126-B Hayatabad Industrial
Estate, Peshawar and M/s Aries Pharmaceuticals (Pvt.)
1-W, Industrial Estate Hayatabad Peshawar.
 Revised Form-5 with manufacturer mentioned as M/s
Aries Pharmaceuticals (Pvt.) 1-W, Industrial Estate
Hayatabad Peshawar.
 Section approval letter for M/s Aries Pharmaceuticals
(Pvt.) 1-W, Industrial Estate Hayatabad Peshawar
mentioning approval of Dry Powder Injection
(General).
 Copy of GMP Inspection report of M/s Aries
Pharmaceuticals (Pvt.) 1-W, Industrial Estate
Hayatabad Peshawar conducted on 4th June 2018
confirms satisfactory level of GMP
Decision: Registration Board approved the application with innovator’s specifcations and
change of brand name for contract manufacturing by M/s Aries Pharmaceuticals (Pvt.) 1-W,
Industrial Estate Hayatabad Peshawar.
Brand Name +Dosage Form + Strength Vancobest injection 500mg
Vancomycin as hydrochloride….......500mg
Pharmacological Group Anti-infective
Type of Form Form-5
Approval status of product in Vancomycin 500mg powder for concentrate for solution for
Reference Regulatory Authorities. infusion vials (MHRA approved)
Me-too status Vancotech 500mg dry powder for injection, of Fynk
Pharmaceuticals.
registration section. M/s Bio-Labs (Pvt.) Ltd. has approved
Lyophilization vial section.
products.
Hayatabad Peshawar.
(General).
Hayatabad Peshawar conducted on 4th June, 2018
Brand Name +Dosage Form + Strength Vancobest injection 1gm
Vancomycin as hydrochloride….......1000mg
Pharmacological Group Anti-infective
Type of Form Form-5
Approval status of product in Vancomycin 1gm powder for concentrate for solution for
Reference Regulatory Authorities. infusion vials (MHRA approved)
Me-too status Vancotech 1gm dry powder for injection, of Fynk
Pharmaceuticals.
registration section.
M/s Bio-Labs (Pvt.) Ltd. has approved Lyophilization vial
section.
products.
Hayatabad Peshawar.
(General).
Brand Name +Dosage Form + Strength Omed injection 40mg
Omeprazole as sodium….......40mg
Type of Form Form-5
Me-too status Fymezole Dry Powder Injection IV 40mg of M/s Fynk
pharmaceuticals
section.
products.
Hayatabad Peshawar.
(General).
Decision: Registration Board approved the application with innovator’s specifcations for
contract manufacturing by M/s Aries Pharmaceuticals (Pvt.) 1-W, Industrial Estate Hayatabad
Peshawar.
Brand Name +Dosage Form + Strength Ultomed injection 40mg
Pantoprazole as sodium….......40mg
Type of Form Form-5
Me-too status Pazole Dry Powder Injection IV 40mg of M/s Fynk
pharmaceuticals
section.
products.
Hayatabad Peshawar.
(General).
Peshawar.
Brand Name +Dosage Form + Strength Ultomed injection 40mg
Pantoprazole as sodium sesquihydrate….......40mg
Type of Form Form-5
Me-too status Pazole Dry Powder Injection IV 40mg of M/s Fynk
pharmaceuticals
section.
products.
Hayatabad Peshawar.
(General).
Peshawar.
442. Name and address of manufacturer / M/s Venus Pharma Lahore

Applicant
Brand Name +Dosage Form + Strength Formet Tablet
Fomotidine……….40mg
Pharmacological Group Antipeptic Ulcerant
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s; Rs.210/-
Me-too status Antidine 40mg Tablet by M/s. Mediate Pharmaceuticals,
Karachi (Reg#048700)
GMP status
Remarks of the Evaluator. Clarification is required for applied dosage form as
reference product is available as film coated tablet whereas
firm has applied as uncoated tablet.
Upon communication of above observation firm has
submitted revised formulation for film coated tablets
Previous Decision: Registration Board in its 283rd meeting deferred for
following:
 Submission of requisite fee for change of formulation
 Latest GMP inspection report conducted within the
period of last one year.
Evaluation by PEC: Firm has submitted following:
 Fee of Rs. 5000/- (vide deposit slip# 0795644) dated
18-10-2018 for change of formulation to film coated
tablets.
 Copy of GMP inspection report dated 09-07-2018 rating
fair level of compliance and concluding that the firm
was considered to be operating at a satisfactory level of
GMP compliance at the time of inspection. Therefore
the panel of inspectors recommends the firm for grant of
cGMP certificate for export purposes.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Viocam-20 Tablet
Composition Each orodispersible tablet contains:
Piroxicam……….20mg
Pharmacological Group Antirheumatic
Type of Form Form 5
Me-too status Oxipro Tablets by M/s Shrooq Pharmaceuticals (Pvt) Ltd.
(Reg#055219)
GMP status GMP certificate issued based upon the evaluation
conducted on 18-12-2014.
Remarks of the Evaluator. Clarification is required for applied dosage form as
reference product is available as oro-dispersible tablet
whereas firm has applied otherwise.
Upon communication of above observation firm has
submitted revised Form 5 & master formulation detailed as
under:
Each tablet contains:
Piroxicam as beta cyclodextrin …… 20 mg
No USP or BP monograph is available for applied
formulation.
following:
 Submission of requisite fee for change of formulation
Evaluation by PEC: Firm has submitted following:
 Fee of Rs. 5000/- (vide deposit slip# 0795645) dated
18-10-2018 for change of formulation to oro-dispersible
tablets.
 Copy of GMP inspection report dated 09-07-2018 rating
fair level of compliance and concluding that the firm
was considered to be operating at a satisfactory level of
GMP compliance at the time of inspection. Therefore
the panel of inspectors recommends the firm for grant of
cGMP certificate for export purposes.
Decision: Approved with innovator’s specifcations.
Applicant
Brand Name +Dosage Form + Strength D-Verine Injection
Drotaverine hydrochloride……….40mg
Pharmacological Group Antispasmodic
Type of Form Form 5
Pack size & Demanded Price 2ml x 25’s; Rs.450/-
Approval status of product in Not verifiable
Me-too status No-spa by Sanofi aventis
GMP status
Remarks of the Evaluator. Evidence of approval for applied formulation by RRA.
following:
 Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
declared/approved by the Registration Board in its
275th meeting.
Evaluation by PEC: Following reference for drotaverine 40mg/2ml injection in
three European countries along with reference weblink.
1. NO-SPA 40 mg solution for injection by Sanofi Aventis

(OGYEI Hungary Approved)
(Link:https://www.ogyei.gov.hu/gyogyszeradatbazis/index.
php?action=show_details&item=11235)
Date of access: 09-11-2018
2. NO-SPA 40 mg / 2 ml solution for injection by Sanofi
Romania (NAMMD Romania Approved)
(Link:https://www.anm.ro/_/_RCP/RCP_6973_10.10.14.pdf)
3. No-Spa 20 mg/ml solution for injection by Chinoin
Pharmaceutical and Chemical Works Co. Ltd (Executive
Agency For Medicinal Products, Bulgaria Approved)
(Link:http://www.bda.bg/images/stories/documents/register/
drugs/details/lf2120.htm)
Decision: Approved with innovator’s specifcations.
445. Name and address of manufacturer / M/s Hicon Pharmaceuticals, 131-Industrial Estate,
Applicant Hayatabad.
Brand Name +Dosage Form + Strength D-Lor 5mg tablets
Desloratadine ….......5mg
Type of Form Form-5
Pack size & Demanded Price 1x10’s; As- per SRO
Approval status of product in ANSM, USFDA approved
Me-too status Desdine 5mg tablet of M/s Hygeia Pharmaceuticals
GMP status Last GMP inspection dated 26-07-2017; satisfactory level of
cGMP compliance.
Remarks of the Evaluator.  No official monograph of the applied formulation exists
in available editions of USP/BP/IP/JP.
 Firm has revised formulation from uncoated to film
coated tablets without submission of requisite fee for
formulation revision.
Previous Decision:  Registration Board in its 283rd meeting deferred for
submission of fee for revision of formulation.
Evaluation by PEC: Firm has submitted fee of Rs. 5,000/- (vide deposit
slip#0508648) dated 09-10-2018 for revision of formulation
to film coated tablet. Copy of last inspection report dated
26-07-2018 recommending the renewal of DML
Decision: Approved.
446. Name and address of manufacturer / M/s Medicraft Pharmaceuticals Pvt Ltd, 126-B, Industrial
Applicant Estate Jamrud Road, Peshawar.
Brand Name +Dosage Form + Strength Zolpimed 10mg Tablet
Zolpidem tartrate …… 10 mg
Diary No. Date of R& I & fee Dy.No 19044 dated 25-10-2017 Rs.20,000/- 25-10-2017
Pharmacological Group Hypnotic
Type of Form Form-5
Pack size & Demanded Price 2 x 10’s
Me-too status Olida 10mg Tablets of M/s Glitz Pharmaceuticals,
GMP status Last GMP Inspection conducted on 30-1-2018 with
conclusive remarks of cGMP compliance.
Remarks of the Evaluator.  In contrary to reference product approved by USFDA &
MHRA of UK, which is available as film coated tablet,
you have applied for uncoated tablet. Clarification shall
be submit in this regard.
 Upon communication of above cited observation firm
has submitted revised Form 5 & master formulation for
film coated tablets.
 Requisite fee for change of formulation has not been
submitted.
submission of requisite fee for change of formulation
slip#0728479) dated 08-11-2018 for revision of formulation
to film coated tablet
Decision: Approved.
447. Name and address of manufacturer / M/s. Medicraft Pharmaceuticals, 126-B, industrial estate,
Brand Name +Dosage Form + Strength Neostamed 0.5 mg/ml Injection
Composition Dy.No. 283, 3-8-2016, Rs.20,000/-
Diary No. Date of R& I & fee Each Ampoule Contains:-
Neostigmine methylsulfate equal to Neostigmine…..0.5mg
Pharmacological Group Anti-cholinesterase
Type of Form Form-5
Pack size & Demanded Price 1’s ampoule / As per PRC
Approval status of product in Neostigmine Methylsulfate of Fresenius Kabi (USFDA)
Me-too status Stigen of Fassgen pharma (Reg # 056452)
GMP status Last GMP Inspection conducted on 30-1-2018 with
conclusive remarks of cGMP compliance.
Remarks of the Evaluator. ● The firm has submitted revised Form-5 in line with
reference country as follows:
Each Ampoule Contains:-
Neostigmine methylsulfate………..0.5 mg
Previous Decision: Registration Board in its 284th meeting deferred the case for
submission of requisite fee for change of formulation
slip#0803471) dated 08-11-2018 for revision of
formulation.
Decision: Registration Board approved the application with following revised composition:
“Each Ampoule Contains:-
Neostigmine methylsulfate………..0.5 mg”
448. Name and address of manufacturer / "M/s Welmark Pharmaceuticals.
Applicant Plot #122 Phase 5, Block B, Industrial Hattar"
Brand Name +Dosage Form + Strength Welrox 15mg Tablets
Composition Each film Coated Tablet Contains:
Rivaroxaban…15mg
Pharmacological Group Antithrombic agent
Type of Form Form-5
Pack size & Demanded Price As per policy of MOH
Approval status of product in Xarelto of M/s Bayer healthcare approved by EMA
Me-too status Xarelto 15mg Tablet by M/s. Bayer Pakistan (private)
limited (Reg#072549)
that firm is GMP compliant
Previous Decision: Registration Board in its 285th meeting referred the case to
QA & LT Division to conduct GMP inspection of Firm on
priority.
Evaluation by PEC: Firm has submitted copy of GMP inspection report
conducted on 04-09-2018 & 26-09-2018 recommending
renewal of DML.
Rivaroxaban…10mg
Type of Form Form-5
limited (Reg#059057).
priority.
renewal of DML.
Rivaroxaban…20mg
Type of Form Form-5
limited (Reg#072550)
priority.
renewal of DML.
Brand Name +Dosage Form + Strength Midazowel Injection 15mg/3ml
Composition Each Ampoule (3ml) contains:
Midazolam as hydrochloride ….…15mg
Pharmacological Group Hypnotics
Type of Form Form-5
Me-too status Domi injection 15mg of M/s Al-Hameed Agencies
Rawalpindi (Reg.# 021972)
priority.
renewal of DML.
Decision: Deferred for confirmation of manufacturing facility for the applied formulation from
Licensing Division.
Brand Name +Dosage Form + Strength Etorwel 60mg Tablet
Etoricoxib…….60mg
Type of Form Form-5
Me-too status Etoria 60mg Table of M/s Hygeia Pharmaceuticals,
priority.
renewal of DML.
Brand Name +Dosage Form + Strength Glemiwel 4mg Tablets
Glimepiride…………4mg
Type of Form Form-5
Me-too status Amarox 4mg Tablet of M/s Lisko Karachi (Reg.#
080340)
priority.
renewal of DML.
Decision: Approved.
Brand Name +Dosage Form + Strength Glemiwel 2mg Tablets
Glimepiride………..2mg
Type of Form Form-5
Me-too status Amarox 2mg Tablet of M/s Lisko Karachi (Reg.# 080338)
priority.
renewal of DML.
Decision: Approved.
Brand Name +Dosage Form + Strength Wivast 3mg Capsule
Rivastigmine as Tartrate………….3mg
Pharmacological Group Cholinesterase inhibitors
Type of Form Form-5
Me-too status Riveme 3mg Capsule of M/s Genix Karachi (Reg.#079952)
satisfactory level of GMP compliance
priority.
renewal of DML.
Decision: Approved.
Brand Name +Dosage Form + Strength Wivast 6mg Capsule
Rivastigmine as Tartrate………..…6mg
Type of Form Form-5
Me-too status Riveme 6mg Capsule of M/s Genix Karachi (Reg.#079954)
priority.
renewal of DML.
Decision: Approved.
Brand Name +Dosage Form + Strength Dopzil 10mg Tablet
Donepezil hydrochloride……….10mg
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s & 30’s ; As per PRC
Me-too status Remembrin Tablets 10mg of M/s PharmEvo, Karachi (Reg.#
045402)
priority.
renewal of DML.
Decision: Approved.
Brand Name +Dosage Form + Strength Dopzil 5mg Tablet
Donepezil hydrochloride………….5mg
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s & 30’s ; As per PRC
Me-too status Remembrin Tablets 5mg of M/s PharmEvo, Karachi (Reg.#
045401)
priority.
renewal of DML.
Decision: Approved.
Evaluator PEC-III
459. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot. No. 122, Block B,
Applicant Phase V, Industrial Estate, Hattar, KPK
Brand Name +Dosage Form + Strength Welbux 40 mg Tablet
Febuxostat…40mg
Pharmacological Group Anti-gout preparation
Type of Form Form 5
Approval status of product in Reference Uloric tablets by Takeda
Me-too status Zurig by Getz
GMP status Last GMP Inspection conducted on 16-09-2017 concluded
that overall the firm was GMP compliant as per DRAP
guidelines.
Remarks of the EvaluatorIII. 
Decision of previous meeting of Registration Board referred the case to QA & LT Division to
Registration Board conduct GMP inspection of Firm on priority (M-285).
Evaluation by PEC  Firm has submitted Panel inspection report dated 4th and
26th September 2018 in which the panel recommended
renewal of DML.
Brand Name +Dosage Form + Strength Welbux 120 mg Tablet
Febuxostat…120mg
Pharmacological Group Anti-gout preparation
Type of Form Form 5
Approval status of product in Reference Febuxostat 120mg Tablet by Rivopharm
Me-too status Degouric 120mg Tablet by Atco
guidelines.
Evaluation by PEC  Firm has submitted Panel inspection report dated 4th and 26th
September 2018 in which the panel recommended renewal
of DML.
Brand Name +Dosage Form + Strength Zolmip 2.5mg Tablet
Zolimitriptan…2.5mg
Pharmacological Group Antimigraine
Type of Form Form 5
Approval status of product in Reference Zomig tablets by Astrazaneca
Me-too status Zomig by ICI
guidelines.
Evaluation by PEC  Firm has submitted Panel inspection report dated
4th and 26th September 2018 in which the panel
recommended renewal of DML.
Brand Name +Dosage Form + Strength Zolmip 5mg Tablet
Composition Each film tablet contains:
Zolimitriptan…5mg
Pharmacological Group Anti-migraine preparation
Type of Form Form 5
Approval status of product in Reference Zomig tablets by IPR Pharma
Me-too status Engzol Tablet by English Pharma
guidelines.
III
Brand Name +Dosage Form + Strength Ivadine 5mg Tablet
Ivabradine (as hydrochloride)…5mg
Pharmacological Group Other cardiac preparation
Type of Form Form 5
Approval status of product in Reference Corlanor by Amgen
Me-too status Sivab by Getz
guidelines.
Remarks of the EvaluatorIII.
Evaluation by PEC  Firm has submitted Panel inspection report dated 4th and
26th September 2018 in which the panel recommended
renewal of DML.
Brand Name +Dosage Form + Strength Ivadine 7.5mg Tablet
Ivabradine (as hydrochloride)…7.5mg
Pharmacological Group Other cardiac preparation
Type of Form Form 5
Approval status of product in Reference Corlanor by Amgen
Me-too status Sivab by Getz
guidelines.
Brand Name +Dosage Form + Strength Welsartan 150mg Tablet
Irbesartan…150mg
Pharmacological Group (Angiotensin II receptor antagonist)
Type of Form Form 5
Approval status of product in Reference Avapro tablets by Sanofi
Me-too status Irba tablets by Hilton
guidelines.
4 and 26th September 2018 in which the panel
th

Decision: Approved.
Brand Name +Dosage Form + Strength Welsartan 300mg Tablet
Irbesartan…300mg
Pharmacological Group (Angiotensin II receptor antagonist)
Type of Form Form 5
Approval status of product in Reference Avapro tablets by Sanofi
Me-too status Irba tablets by Hilton
guidelines.
Decision: Approved.
Brand Name +Dosage Form + Strength Welsartan-HZ 300/25 mg Tablet
Irbesartan…300mg
Pharmacological Group Angiotensin II antagonists and diuretics
Type of Form Form 5
Approval status of product in Reference Irbesartan and Hydrochlorthiazide Tablets by Aurobindo
Regulatory Authorities. Pharm (USFDA Approved)
Me-too status Irecon – H Tablet by Barret Hodgson
guidelines.
Decision: Approved.
468. Name and address of manufacturer / M/s Festel Laboratories, Jinnah Industrial Estate, Link
Applicant Kattarband Road, Thokar Niaz Baig, Multan Road, Lahore
contract manufacturing by
M/s. English Pharmaceutical Industries, Link Kattar Bund
Road, Thokar Niaz Baig, Multan Road , Lahore
Brand Name +Dosage Form + Strength Esotac Injection 40mg
Esomeprazole as sodium……40mg
Diary No. Date of R& I & fee 2132, 05-05-2016, Rs. 50,000/- (04-05-2016)
Type of Form Form 5
Finished product Specification Innovator
Approval status of product in Reference USFDA approved
Me-too status Nexum IV 40mg infusion of M/s Getz Pharma
(Reg.#050651)
GMP status Not provided
Remarks of the Evaluator.  Last GMP inspection report of both the firms.
 The Form-5/application for registration of drug has not
been signed by the applicant/any authorized personnel.
 Justification of 5% overage on the basis of scientific data.
Decision of previous meeting of Decision: Deferred for submission of the following:
Registration Board  Last GMP inspection report of both the firms (which
should have been conducted within the period of last one
year).
 Signed Form-5/application for registration of drug by the
applicant/any authorized personnel.
 Justification of 5% overage on the basis of scientific
data. (M-274)
Decision: Deferred for scientific justification for addition of
5% overage. (M-285).
Evaluation by PEC Firm has submitted following documents:
 GMP certificate of M/s English Pharmaceuticals issued
on the basis of inspection conducted on 26-01-2018
 GMP inspection report of M/s Festel Laboratories
recommending renewal of DML conducted on 24-1-2016.
This inspection report is not conducted within a period of
last 1 year.
 Form 5 signed by authorized and technical persons.
 After being deferred in 285th meeting of Registration
Board, the firm has submitted revised master formulation
without overage.
Decision: Registration Board deferred the case for assessment of manufacturing capacity of M/s.
English Pharmaceutical Industries, Link Kattar Bund Road, Thokar Niaz Baig, Multan Road ,
Lahore by panel to be constituted by Chairman Registration Board for further granting contract
manufacturing permission
Brand Name +Dosage Form + Strength Omefin Injection 40mg
Omeprazole as sodium……40mg
Type of Form Form 5
Approval status of product in Reference Omeprazole IV of sandoz (TGA)
Me-too status Loprot of Nabiqasim
year).
data. (M-274)
last 1 year.
without overage.
Brand Name +Dosage Form + Strength Taq-D Injection 200,000 IU
Vitamin D3 (Cholecalciferol)…200,000 IU
Diary No. Date of R& I & fee 2130, 05-05-2016, Rs. 50,000/-, (04-05-2016)
Pharmacological Group Vitamin D
Type of Form Form 5
Pack size & Demanded Price (1x1’s),1 cc ampoule blistered in Alu-PVC, As per SRO
Approval status of product in Reference Vitamin D3 GOOD 200,000 IU/ml drinkable
Regulatory Authorities. solution in ampoule by Bouchara Pharm
(ANSM France Approved)
Me-too status Bio D-3 by Biolabs
year).
data. (M-274)
last 1 year.
without overage.
Brand Name +Dosage Form + Strength Fespan Injection 40mg
Pantoprazole as sodium……40mg
Type of Form Form 5
Approval status of product in Reference Protonix by wyeth (USFDA
Me-too status Neege by Sami
year).
data. (M-274)
last 1 year.
without overage.
Brand Name +Dosage Form + Strength Naplin Injection 1g
Vancomycin as Hydrochloride ……1 g
Pharmacological Group Glycopeptide antibacterial
Type of Form Form 5
Approval status of product in Reference Vancomycin 1g of Fresenius Kabi, USA (USFDA
Me-too status Vinjec injection by Bosch
GMP status
 The Form-5/application for registration of drug has
not been signed by the applicant/any authorized
personnel.
data.
year).
data. (M-274)
last 1 year.
without overage.
Brand Name +Dosage Form + Strength Naplin Injection 500mg
Vancomycin as Hydrochloride ……500 mg
Pharmacological Group Glycopeptide antibacterial
Type of Form Form 5
Approval status of product in Reference Vancomycin 500mg of Fresenius Kabi, USA (USFDA
Me-too status Vinjec injection by Bosch
year).
data. (M-274)
last 1 year.
without overage.
474. Name and address of manufacturer / M/s. Medley Pharmaceuticals Wah Cantt, Rawalpindi
Applicant
Brand Name +Dosage Form + Strength Cinitamed 1mg Tablets
Cinitapride hydrogen tartrate eq. to cinitapride……..1mg
Diary No. Date of R& I & fee Dy.No.2356, 11-04-2011 Rs: Rs.8000/=
Rs.12,000/; 06-04-2015
Pharmacological Group Gastroprokinetic Agent
Type of Form Form-5
Pack size & Demanded Price 1x10’s; As Per SRO
Approval status of product in Spanish Agency of Medicines and Health Products
Me-too status Cinita Tablet 1mg of Novamed Pharma (Reg#064845)
Previous remarks of the Evaluator.  Firm has stated In-house specs for applied product
 Firm has not submitted following:
 Commitments as per 251st RB meeting
Previous decision(s) Deferred in 268th meeting of Registration Board for the
following submission:
 Commitments as per 251st RB meeting
Deferred for evidence of approval of applied formulation in
declared/approved by the Registration Board in its 249th
meeting. (M-273)
Deferred for following submission:
 Change in formulation to uncoated tablet as per the
reference product in Spain.
 Fee for change of formulation.
 Clarification of salt form of API of the product since the
reference product contains Cinitapride as acid tartarate. (M-
277)
Deferred for submission of fee for revision of formulation.
(M-283)
Evaluation by PEC  Firm has submitted following:
 The approval status has been confirmed from Spanish
medicine agency.
 GMP inspection conducted on 01-10-2018 concluded that
the establishment has made rectifications to comply with
good manufacturing practices.
 Firm has submitted fee PKR 5,000/- (Deposit slip No.
0789632) for revision to following formulation:
Each tablet contains
Cinitapride hydrogen tartrate eq. to cinitapride……..1mg
Applicant
Brand Name +Dosage Form + Strength Phloromed 80mg Tablet
Composition Each film coated Tablet contains
Phloroglucinol dihydrate….. 80mg
Trimethyl Phloroglucinol……..80mg
Diary No. Date of R& I & fee Dy.No.3827, 11-04-2011 Rs: Rs.8000/=
Rs.12,000/; 06-04-2015
Type of Form Form-5
Pack size & Demanded Price 3x10’s;As Per SRO
Approval status of product in ANSM –France approved
Me-too status Anafortan plus tablet by AGP Pharma
Previous remarks of the Evaluator.  Firm has stated In-house specs for applied product
 Undertaking of Form 5 is a photocopy.
 Firm has not submitted following:
Commitments as per 251st RB meeting
Previous decision(s) Deferred in 268th meeting of Registration Board for the
following submissions:
 Undertaking of Form 5.
 Submission of commitments as per decision of 251st
Registration Board meeting.
 Evidence of approval of applied formulation by
reference regulatory authorities as ANSM France
approved product is sugar coated
meeting. (M-273)
 Firm has submitted documents along with fee PKR 5,000/-
(Deposit slip No. 0789634) for revision to following
formulation:
Each sugar coated Tablet contains
Phloroglucinol dihydrate….. 80mg
Trimethyl Phloroglucinol……..80mg
Applicant
Brand Name +Dosage Form + Strength FYLO Tablets
Doxofyllin………400mg
Diary No. Date of R& I & fee Dy. No. 867: 08-11-10 Rs.8000/- dated : 10-11-10
12000/- dated: 19-07-13
Pharmacological Group Antiasthmatic
Type of Form Form 5
Finished product Specification Manufacturer
Pack size & Demanded Price As per SRO/ Pack of 1x10’s
Approval status of product in AIFA, Italy Approved
Me-too status Unifylline tablet of Platinum Pharma Karachi
GMP status GMP inspection conducted on 01-10-2018 concluded that the
establishment has made rectifications to comply with good
manufacturing practices.
Previous remarks of the Evaluator.
Previous decision(s) Deferred for confirmation of availability in Reference
Regulatory Authority. (M-248)
Deferrred for for the following submission:
Change in formualation to uncoated (plain) tablet as per the
reference product in Italy.
Fee for change of formulation (M-277)
formulation:
Doxofyllin………400mg
Applicant
Brand Name +Dosage Form + Strength Clomed Tablets
Composition Each film coated tablet Contains
Clomiphene Citrate ….50mg
Diary No. Date of R& I & fee Dy.No.2353: 11-04-2011 Rs.8000/-: 11-04-2011
Rs.12,000/: 06-04-2015
Pharmacological Group (Gonadotrophin and ovulation stimulant)
Type of Form Form 5
Finished product Specification USP specifications
Pack size & Demanded Price 1x10’s: As Per SRO
Approval status of product in USFDA approved.
Me-too status Cerophene tablet by Hilton Pharma
GMP status GMP inspection conducted on 01-10-2018 concluded that the
establishment has made rectifications to comply with good
manufacturing practices.
Previous decision(s) Deferred for clarification for requirement of manufacturing
facility for Clomiphene Citrate along with submission of
commitments as per decision of 251st Registration Board
meeting. (M-268)
 Decision of 271st meeting of Registration Board regarding
manufacturing requirement of clomiphene citrate
formulation:
Each tablet Contains
Clomiphene Citrate ….50mg
Evaluator-PEC-VI
478. Name and address of manufacturer / M/s Getz Pharma Karachi, contract manufacturing from M/s
Applicant Novamed Pharmaceuticals, Lahore
Brand Name +Dosage Form + Strength Lenwin powder for injection 250mg
Cephradine monohydrate eq to cephradine…..250mg
Type of Form Form-5
Pack size & Demanded Price 1’s, Rs.150/-
Approval status of product in USFDA approved but discontinued
Me-too status Cefrinex by Bosch
GMP status Last inspection report (Novomed Pharmaceuticals) 5th and
27th December 2017,firm is compliant to Good cGMP
guideline at the time of inspection.
Remarks of the Evaluator. Firm (Novamed) has cephalosporin injectable section.
Previous Decision: Decision of 282nd
 Deferred for evidence of approval of applied formulation
in reference regulatory authorities/agencies which were
meeting
Evaluation by PEC: Firm has submitted that product is approved in USFDA and
its discontinuation means that the product is not withdrawn
for safety or effectiveness reasons
Brand Name +Dosage Form + Strength Lenwin powder for injection 500mg
Type of Form Form-5
Approval status of product in VELOSEF 500mg Injection by M/s APOTHECON (USFDA

Reference Regulatory Authorities. Discontinued)
Me-too status V-Sef Injection 500mg by M/s Z-JANS Pharmaceuticals
(Reg#024068)
meeting.
for safety or effectiveness reasons
Brand Name +Dosage Form + Strength Lenwin powder for injection 1gm
Cephradine monohydrate eq to cephradine…..1gm
Type of Form Form-5
Approval status of product in VELOSEF 1000mg Injection by M/s APOTHECON

Reference Regulatory Authorities. (USFDA Discontinued)
Me-too status V-Sef Injection 1000mg by M/s Z-JANS Pharmaceuticals
(Reg#024069)
meeting
for safety or effectiveness reasons.
Brand Name +Dosage Form + Strength Lenwin powder for Suspension 125mg/5ml
Type of Form Form-5
Pack size & Demanded Price 60ml, Rs.150/-
Approval status of product in VELOSEF '125' of Apothecon (USFDA) “Discontinued”
Me-too status Velosef of GSK
27th December 2017, firm is compliant to Good cGMP
Remarks of the Evaluator. Firm (Novamed) has cephalosporin oral suspension
section(dry powder).
meeting
for safety or effectiveness reasons.
482. Name and address of manufacturer / M/s Focus & Rulz Pharmaceuticals Pvt Ltd Islamabad
Applicant
Brand Name +Dosage Form + Strength Pantazole 40mg tablet
Pantoprazole sodium….40mg
Diary No. Date of R& I & fee Dy. No.21073, 12-6-2018; Rs.20,000/- (12-6-2018)
Pharmacological Group PPI
Type of Form Form-5
Approval status of product in Pantoprazole 40mg Delayed release tablet USFDA Approved
Me-too status Cantrofast Tablets 40mg of Candid Pharmaceuticals
GMP status 25-1-2018 Firm was considered to be operating at Fair
compliance with GMP Guidelines.
Remarks of the Evaluator. Approved as (Pantoprazole sodium eq to
Pantoprazole…20mg )Delayed release tablet in Reference
Regulatory Authority.
Previous Decision: Decision of 283rd
 Deferred for clarification of formulation, since the
reference produt contains pantoprazole sodium
equivalent to pantoprazole 40mg, along with applicable
fee for revision of formulation.
Evaluation by PEC: Firm has revised formulation with the submission of Fee of
Rs. 5,000 dated 12-september 2018, Deposit Slip No
0786028 as
Each enteric coated tablet contains:
Pantoprazole Sodium sesquihydrate equivalent to
Pantoprazole...40mg
Decision: Approved.
483. Name and address of manufacturer / M/s Focus & Rulz Pharmaceuticals Pvt Ltd Islamabad
Applicant
Brand Name +Dosage Form + Strength Pantazole 20mg tablet
Pantoprazole sodium….20mg
Diary No. Date of R& I & fee Dy. No.21072, 12-6-2018; Rs.20,000/- (12-6-2018)
Type of Form Form-5
Approval status of product in Protonix 20mg Delayed Release Tablet by M/s Wyeth
Reference Regulatory Authorities. Pharms INC, approved by USFDA
Me-too status Pantocare DR 20mg Tablet by M/s Aims Pharmaceuticals
GMP status 25-1-2018 Firm was considered to be operating at Fair
compliance with GMP Guidelines.
Remarks of the Evaluator. Approved as (Pantoprazole sodium eq to
Pantoprazole…20mg )Delayed release tablet in Reference
Regulatory Authority.
 Deferred for clarification of formulation, since the
reference produt contains pantoprazole sodium
equivalent to pantoprazole 40mg, along with applicable
fee for revision of formulation.
Evaluation by PEC: Firm has revised formulation with the submission of Fee of
Rs. 5,000 dated 12-september 2018, Deposit Slip No
0786027 as
Pantoprazole Sodium sesquihydrate equivalent to
Pantoprazole...20mg
Decision: Approved.
484. Name and address of manufacturer / M/s Pakistan Pharmaceuticals products (Pvt) Ltd. D-
Applicant 122,Sindh Industries Trading estate, Karachi,
Brand Name +Dosage Form + Strength Zipress 20mg capsule
Ziprasidone HCl eq to Ziprasidone…..20mg
Diary No. Date of R& I & fee Dy:1371, 21-08-2017 , Rs.20,000/- (17-08-2017)
Type of Form Form-5
Finished product Specification Manufacturer’s
Pack size & Demanded Price 10’s x 2 ,As per PRC
Me-too status Zpras 40mg Capsule Reg # 081213
GMP status Last GMP inspection conducted on 12-12-2017 and the
report concludes that firm overall ratings are GOOD.
Remarks of the Evaluator. Firm has initially applied as:
Each capsule contains:
Ziprasidone HCl …..20mg.
Now firm has changed formulation as per Innovators
product:
Without submitting fee.
Previous Decision: Decision of 284th
 Deferred for submission of fee as applicable.
Evaluation by PEC: Firm has submitted fee of Rs. 5,000 dated 17-10-2018
Deposit Slip No. 0762530
Type of Form Form-5
Me-too status Zopeka 80mg Capsule Reg # 079552
product:
Type of Form Form-5
product:
Type of Form Form-5
product:
Without submitting fee
488. Name and Address of Manufacturer / M/s Bio-Mark Pharmaceuticals.
Applicant Plot No. 527, Sunder Indusrial Estate, Lahore.
Brand Name+ Dosage Form + Strength Ecoxib 60mg Tablets
Diary No. Date of R & I & fee Diary No:7728, 06/07/2017, Rs: 20,000/-
Composition Each film coated tablet contains;
Etoricoxib…60mg
Pharmacological Group Antiinflammatory and Antirheumatic Products, Non Steroids
(Coxibs)
Type of Form Form-5
Finished Product Specification Innovator’s Specifications
Approval Status of Product in ARCOXIA 60 mg film-coated tablet by M/s Grunenthal Ltd,
Me-too Status Arcox 60 mg tablet by M/s MAQ Pharmaceuticals
(Reg No: 076808)
GMP Status 10-03-2017; Grant of DML
Panel recommends grant of DML.
Remarks of the Evaluator.  Inspection report older than 1 year
 Firm has submitted reply that:
‘We submitted dossiers in June & July 2017.
We received Registrations in Oct, Nov, 2017 & Feb 2018.
We started production in Feb 2018.’
 Registration Board referred the case to QA & LT
Division to conduct GMP inspection of Firm on priority.
Evaluation by PEC: Firm has submitted cGMP certificate based upon the
evaluation conducted on 16-8-2018.
Brand Name+ Dosage Form + Strength Trimet MR 35mg Tablets
Composition Each modified release film-coated tablet contains:
Trimetazidine dihydrochloride …35mg
Pharmacological Group Other cardiac preparations
Type of Form Form-5
Approval Status of Product in Vastarel 35 mg - modified-release film-coated tablets by M/s
Reference Regulatory Authorities. SERVIER AUSTRIA GmbH (AGES Austria Approved)
Me-too Status Trikat MR Tablets 35mg by M/s Novamed Pharmaceuticals
(Reg#64849)
Decision: Approved.
Brand Name+ Dosage Form + Strength Azith 250mg Tablets
Azithromycin (as dihydrate) …250mg
Type of Form Form-5
Approval Status of Product in Azithromycin 250 mg film-coated tablets by M/s Milpharm
Reference Regulatory Authorities. Limited (MHRA Approved)
Me-too Status Plazo Tablets 250mg by M/s Platinum Pharmaceuticals (Pvt)
Ltd (Reg#025507)
Remarks of the Evaluator.  Inspection report older than 1 year.
Decision: Approved.
Brand Name+ Dosage Form + Strength Azith 500mg Tablets
Azithromycin (as dihydrate) …500mg
Type of Form Form-5
Approval Status of Product in Azithromycin Tablets 500mg by M/s Aurobindo Pharma
Me-too Status Zetro 500mg Tablets by M/s Getz Pharma (Pvt.) Ltd
(Reg#053120)
Decision: Approved.
Brand Name+ Dosage Form + Strength Eslor 5mg Tablets
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Desloratadine …5mg
Type of Form Form-5
Approval Status of Product in Desloratadine 5 mg Film-Coated Tablets by M/s Crescent
Reference Regulatory Authorities. Pharma Ltd (MHRA Approved)
Me-too Status Mdisin 5mg Tablet by M/s Metro Pharmaceuticals
(Reg#081672)
Decision: Approved.
Brand Name+ Dosage Form + Strength Febuxo 40mg Tablets
Febuxostat …40mg
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form-5
Approval Status of Product in ULORIC 40mg tablet by M/s Takeda Pharma (USFDA
Me-too Status Febuxin 40mg Tablet by M/s AGP Pvt. Ltd. (Reg# 081104)
GMP Status 10-03-2017
Grant of DML
Decision: Approved.
Brand Name+ Dosage Form + Strength Febuxo 80mg Tablets
Febuxostat …80mg
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form-5
Approval Status of Product in Febuxostat 80 mg Film-coated Tablets by M/s TEVA UK
Reference Regulatory Authorities. Limited (MHRA Approved)
Me-too Status Febuxin 80mg Tablet by M/s AGP Pvt. Ltd. (Reg# 081105)
Grant of DML
Decision: Approved.
Brand Name+ Dosage Form + Strength Fyline 400mg Tablets
Doxofylline …400mg
Pharmacological Group Other Systemic Drugs for Obstructive Airway Diseases
(Xanthines)
Type of Form Form-5
Finished Product Specification Innovator’s specifications.
Approval Status of Product in DOXOFILLINA ABC 400mg tablet by M/s ABC
Reference Regulatory Authorities. FARMACEUTICI S.p.A (Italian Medicine Agency
approved)
Me-too Status Profylline Tablet 400mg by M/s Kaizen (Reg# 073744)
Decision: Approved.
Brand Name+ Dosage Form + Strength Mivab 7.5mg Tablets
Ivabradine (as hydrochloride) …7.5mg
Pharmacological Group Other cardiac preparations
Type of Form Form-5
Approval Status of Product in PROCORALAN 7.5 mg film-coated tablets by M/s
Reference Regulatory Authorities. SERVIER LABORATORIES (ANSM approved)
Me-too Status Ivatab 7.5mg Tablet by M/s Nabiqasim (Reg# 076155)
Decision: Approved.
Brand Name+ Dosage Form + Strength Miflox 400mg Tablets
Composition Each film coated tablet contains;
Moxifloxacin (as hydrochloride) ...400mg
Pharmacological Group Fluoroquinolones
Type of Form Form-5
Pack Size & Demanded Price 5’s / As per SRO
Approval Status of Product in Avelox 400 mg film-coated tablets by M/s Bayer plc,(MHRA
Reference Regulatory Authorities. approved)
Me-too Status Metoxim 400mg Tablet by M/s Foray Pharmaceutica (Reg
No:056083)
Decision: Approved.
Brand Name+ Dosage Form + Strength Dextine 30mg Capsules
Diary No. Date of R & I & fee Diary No:6118,14/06/2017, Rs: 20,000/-
Composition Each hard gelatin capsule contains:
Enteric coated Pellets (17%) of Duloxetine hydrochloride
equivalent to Duloxetine…30 mg
Pharmacological Group Other antidepressants
Type of Form Form-5
Approval Status of Product in Cymbalta (Duloxetine 30 mg capsule) by M/s Eli Lilly,
Me-too Status Dulan (Duloxetine 30 mg capsule) by M/s Hilton
Pharma.(Reg#055447)
Remarks of the Evaluator.  Source of pellets: Vision Pharmaceuticals, Islamabad.
 Inspection report older than 1 year
Decision: Aproved.
Brand Name+ Dosage Form + Strength Dextine 60mg Capsules
Composition Each hard gelatin capsule contains:
Enteric coated Pellets (17%) of Duloxetine hydrochloride
equivalent to Duloxetine…60 mg
Pharmacological Group Other antidepressants
Type of Form Form-5
Approval Status of Product in Cymbalta (Duloxetine 60 mg capsule) by M/s Eli Lilly,
Me-too Status Dulan (Duloxetine 60 mg capsule) by M/s Hilton
Pharma.(Reg#055448)
Remarks of the Evaluator.  Source of pellets: Vision Pharmaceuticals, Islamabad.
Decision: Approved.
Brand Name+ Dosage Form + Strength Pediz Sachet
Composition Each sachet contains:
Sodium chloride…2.6g
Tri sodium citrate dihydrate …2.9g
Potassium chloride…1.5g
Glucose anhydrous…13.5g
Pharmacological Group Oral Rehydration Salts
Type of Form Form-5
Finished Product Specification International Pharmacopeia Specifications
Approval Status of Product in Reduced Osmolarity Oral Rehydration Slat (WHO
Me-too Status Orsol Sachet by M/s Kaizan (Reg#073897)
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GMP Status Last inspection report dated 10-03-2017 for the Grant of
DML. Panel recommends grant of DML.
Decision: Approved.
Brand Name+ Dosage Form + Strength Neo-Choline Oral Drops
Citicoline (as sodium) …100mg
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form-5
Pack Size & Demanded Price 30ml/ As per SRO
Approval Status of Product in Not confirmed
Me-too Status Somazina Drops By M/s Alina (Reg#016974)
Remarks of the Evaluator.  Packaging in dropper container closure system not
confirmed from RRA, but the applied formulation is
approved by Spanish Health Agency.
Decision: Deferred for approval of applied container closure system in reference regulatory
Brand Name+ Dosage Form + Strength Neo-Choline Oral Solution 100 mg/ml
Citicoline (as sodium) …100mg
Type of Form Form-5
Pack Size & Demanded Price 30ml, 60ml/ As per SRO
Approval Status of Product in CITICOLINA FERRER 100mg/ml SOLUCION ORAL EFG
Reference Regulatory Authorities. by M/s FERRER INTERNACIONAL,S.A (Spain Approved)
Me-too Status Citolin Syrup by M/s Global Pharmaceuticals
(Reg#029540)
Decision: Approved.
Brand Name+ Dosage Form + Strength Fyline Oral Syrup 100mg/5ml
Doxofylline …100mg
Pharmacological Group Other Systemic Drugs for Obstructive Airway Diseases
(Xanthines)
Type of Form Form-5
Approval Status of Product in DOXOFILLINA ABC 200 mg / 10 ml Syrup by M/s ABC
Reference Regulatory Authorities. FARMACEUTICI SpA - Corso Vittorio (Italian Medicine
Agency (AIFA) Italy Approved)
Me-too Status Unifyline Syrup 100mg/5ml by M/s Platinum
Pharmaceuticals (Reg# 047180)
Remarks of the Evaluator.  Inspection report older than 1 year Firm has submitted
reply that:
Decision: Approved.
Brand Name+ Dosage Form + Strength Bamtil Oral Syrup 5mg/5ml
Diary No. Date of R & I & fee Diary No:6184 ,14/06/2017, Rs: 20,000/-
Bambuterol hydrochloride …5mg
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of Form Form-5
Approval Status of Product in Bambuterol juice 1mg/ml by AstraZaneca

Reference Regulatory Authorities. (Germany Approved)
Me-too Status Btno 5mg/5ml syrup by M/s Genix (Reg# 057873)
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We started production in Feb 2018.
Decision: Approved.
505. Name and address of manufacturer / M/s Neutro Pharma, 9.5km Sheikhupura raod,Lahore
Applicant
Brand Name +Dosage Form + Strength Neumethoxate 10mg tablet
Methotrexate………10mg
Pharmacological Group Cytostatic
Type of Form Form-5
Pack size & Demanded Price 1x10’s, 5x10’s, 10x10’s, As SRO
Me-too status METHOTREXATE TABLET 10MG Reg# 066009
GMP status Last inspection report 18-7-2017 Firm has maintained a fair
level of compliance with GMP.
Previous Decision: Decision of 281st
 Deferred for deliberation upon manufacturing
requirements of anti-cancer/cytotoxic drugs
Evaluation by PEC: Firm has submitted that registration board in its M-282nd
decided to grant registration of these products in General
manufacturing areas with protective measures.
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
Applicant
Brand Name +Dosage Form + Strength Neucitabin 500mg tablet
Capecitabine………500mg
Type of Form Form-5
Pack size & Demanded Price 120’ As SRO
Approval status of product in Capecitabine Sandoz 500mg film coated tablet by Sandoz Pty
Reference Regulatory Authorities. Ltd (TGA Approved)
Me-too status Xelocel 500mg Tablet by Hakimsons (Reg. No. 078107)
Previous Decision of 281st meeting:  Deferred for deliberation upon manufacturing
manufacturing areas with protective measures..
Decision: Deferred for confirmation of requisite section for the applied product.
507. Name and address of manufacturer / M/s Neutro Pharma, 9.5km Sheikhupura raod, Lahore
Applicant
Brand Name +Dosage Form + Strength Neuhydrox 500mg capsule
Hydroxyurea….500mg
Type of Form Form-5
Approval status of product in HYDREA 500mg capsule by Bristol-Myers Squibb Australia
Reference Regulatory Authorities. Pty Ltd(TGA Approved)
Me-too status Hydra 500mg Capsule by M/s Medinet (Reg. No. 028484)
Decision: Deferred for confirmation of requisite section for the applied product
Applicant
Brand Name +Dosage Form + Strength Neumethoxate 2.5mg tablet
Methotrexate………2.5mg
Type of Form Form-5
Pack size & Demanded Price 30’s, 10x10’s, As SRO
Me-too status Methotrexate 2.5mg Reg #066008
Evaluator PEC-VIII
511. Name and address of Manufacturer / M/s Medisure Laboratories Pakistan (Pvt.) Ltd. A-115,
Applicant S.I.T.E, Super Highway, Karachi.
Brand Name+Dosage Form +Strength Rosuvasure tablet 10mg
Rosuvastatin (as calcium) … 10mg
Diary No. Date of R&I & fee DyNo.11110; 04-08-2017; Rs. 20,000/-
Type of Form Form-5
Pack Size & Demanded Price 10’s; As per SRO
Me-too status Rostin Tablet 10mg of Regal Pharmaceuticals,
GMP status Certificate of cGMP is issued to the firm based on evaluation
conducted on 10th May, 2017 which is valid for a period of
one year from the date of issue i.e. 7th September, 2017.
Previous decision Registration Board in its 284th meeting deferred the case for
following reason:
For submission of latest GMP inspection report conducted
within the period of last one year.
Evaluation by PEC Now the firm has submitted GMP Certificate based on
evaluation conducted on 28th June, 2018.
512. Name and address of Manufacturer / M/s Medisure Laboratories Pakistan (Pvt.) Ltd. A-115,
Applicant S.I.T.E, Super Highway, Karachi.
Brand Name+Dosage Form +Strength Rosuvasure tablet 20mg
Rosuvastatin (as calcium) … 20mg
Diary No. Date of R&I & fee DyNo.11111; 04-08-2017; Rs. 20,000/-
Type of Form Form-5
Pack Size & Demanded Price 10’s; As per SRO
Me-too status Rosan 20mg Tablet of Sante Karachi.
Previous decision Registration Board in its 284th meeting deferred the case for
following reason:
For submission of latest GMP inspection report conducted
within the period of last one year.
Evaluation by PEC Now the firm has submitted GMP Certificate based on
evaluation conducted on 28th June, 2018.
Brand Name+DosageForm+Strength Tamlov Capsule 100mg
Composition Each Extended Release Capsule Contains:
Diary No. Date of R&I & fee Dy No.33564; 10-10-2018; Rs.12,000/-;Rs. 8,000
Pharmacological Group Opiate Analogue
Type of Form Form 5
Approval status of product in Approved in Us-FDA
Me-too status Tonoflex SR Capsule of Sami
Previous decision Registration Board in its 284th Meeting deferred the case for
following reasons:
i. Evidence of approval of manufacturing facility /
section of the manufacturer by licensing division.
ii. Justify the formulation of tramadol hydrochloride
plain (immediate release) capsule, since the product
approved by reference regulatory authorities and by
DRAP is tramadol sustained release capsule.
iii. For tramadol hydrochloride sustained release pellets,
provide
 Source of pellets.
 GMP of manufacturer of pellets.
 Certificate of Analysis of Pellets.
 Stability study data of 3 batches of pellets.
 Differential fee (if pellets are imported).
Evaluation by PEC Now the firm has submitted the following:
i. Panel inspection report verifying the required
manufacturing facility i.e. “Capsule Section(general)”
ii. Clarification that applied formulation is sustained
release capsule & submitted Form 5, Master
formulation & manufacturing method accordingly.
iii. For COA, GMP of pellet manufacturer, stability study
data of three batches of pellets, they submitted that
tramadol hydrochloride extended release pellets are not
being manufactured in Pakistan and outside so they
will prepare extended release granules in house as per
US-FDA recommendations.
Reference product is approved as mentioned below:
CONZIP capsules contain a total dose of tramadol
hydrochloride 100, 200, and 300 mg in a combination of
Immediate-release and extended-release components.
Dosage Immediate release Extended release
100mg 25 mg 75 mg
200 mg 50 mg 150mg
300 mg 50 mg 250mg
CONZIP capsules are white in color. Inactive ingredients
include gelatin, titanium dioxide, shellac, FD & C Blue #2
aluminum lake (E132), D & C Red #7 calcium lake (E180), D
& C Yellow #10 aluminum lake, lactosemonohydrate 200
mesh, microcrystalline cellulose, povidone K30, corn starch,
sodium starch glycolate,magnesium stearate, sucrose stearate,
hypromellose, talc, polysorbate 80, Eudragit NE 30D, and
simethicone emulsion.
Decision: Registration Board deferred the case for justification on scientific grounds that how it
will be ensured that in applied formulation i.e. “Tramadol hydrochloride 100mg SR capsule”
25milligrams of the drug will be released immediately & 75 milligrams of drug will be released
over an extended period of time & what dissolution method will be used for confirming the fact
that the drug release profile of applied formulation is in-line with the reference product.
Evaluator PEC-IX
514. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Factory Plot # 122, Block B,
Applicant Phase V, Industrial Estate, District Hattar, Pakistan
Brand Name +Dosage Form + Strength Sirox Tablets 500mg
Composition Each dispersible tablet contains:
Deferasirox ……….500mg
Pharmacological Group Iron chelating agents
Type of Form Form 5
Finished Product Specification Firm has claimed in-house spec.
Approval status of product in Reference EXJADE 500 mg Tablets for oral suspension by Novartis
Regulatory Authorities. Pharma. Approved by US-FDA
Me-too status Arefed 500 mg dispersible tablets, 500 mg by Genome
Pharmaceuticals, Hattar, Reg. No. 85093
wherein the panel recommended the renewal of DML
Remarks of the Evaluator. Brand name is matching with Fasirox and Dasirox
priority.
Evaluation by PEC: The firm submitted the inspection report dated 14.09.2018 &
26.09.2018, wherein the panel recommended the renewal of
DML
 Decision: Approved with innovtor’s specifications and change of brand name
515. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Factory Plot # 122, Block B,
Applicant Phase V, Industrial Estate, Hattar, District Haripur, Pakistan
Brand Name +Dosage Form + Strength Zeka Tablets 600mg
Telbivudine ……….600mg
Pharmacological Group Nucleoside and nucleotide reverse transcriptase inhibitors
Type of Form Form 5
Finished Product Specification Firm has claimed manufacturer’s spec.
Approval status of product in Reference SEBIVO (Tablets 600 mg) by Novartis Europharm Ltd
Regulatory Authorities. Approved by Swedish Medical Products Agency
Me-too status Telzek Tablets, 600 mg by M/s CCL Pharmaceuticals (Pvt)
Ltd., Lahore Reg. No. 62768
Remarks of the Evaluator. The brand name is matching with Vizeka of Wnsfield
Pharmaceutical, Hattar.
priority.
Evaluation by PEC: The firm submitted the inspection report dated 14.09.2018 &
26.09.2018, wherein the panel recommended the renewal of
DML
 Decision: Approved with innovtor’s specifications and change of brand name.
Evaluator PEC-XIII
516. Name and address of manufacturer / M/s Tabros Pharma (Pvt) limited, L-20/B, Sector-22, Federal
Applicant B Industrial Area, Karachi
Brand Name +Dosage Form + Strength Cresar AM tablet 5mg/ 40mg
Amlodipine Besylate eq. to Amlodipine……5mg
Telmisartan …………….......……………...40mg
Diary No. Date of R& I & fee Dy. No. 4552, 01-06-2017; Rs.20,000/- (01-06-2017)
Pharmacological Group Angiotensin-II Antagonist and Calcium Channel Blocker
Type of Form Form-5
Finished product Specification As per Innovators’ specifications
Pack size & Demanded Price 14’s & Rs. 600/- for 14’s
Me-too status Amtas tablet 5mg/40mg of M/s Getz Pharma, (Reg.# 066945)
GMP status Latest GMP inspection was conducted on 07-02-2018 and the
report concludes that the firm has rectified all the
observations noted during last GMP inspection.
Previous remarks of the Evaluator The applied formulation is non- pharmacopoeial.
Previous decision Deferred in 282nd meeting for confirmation of installation of
Bilayered machine and submission of DQ, IQ, OQ and PQ
data.
Evaluation by PEC  Firm has submitted following documents for proof of
“Double layer compression machine”:
i. Brochure of # ZP31/ZP29/ZP27 mentioning that it is also
for double layer.
ii. Packing list
iii. Invoice
iv. GD (Bill of entry)
v. Bill of lading
vi. Photographs
 Firm has submitted IQ and OQ data.
Decision: Approved with innovator’s specifications
Amlodipine Besylate eq. to Amlodipine....10mg
Telmisartan ……………………………...40mg
Type of Form Form-5
Pack size & Demanded Price 14’s & Rs. 620/- for 14’s
Me-too status Amtas tablet 10mg/ 40mg of M/s Getz Pharmaceutical,
Pakistan (Reg. # 066943)
data.
i. Brochure of # ZP31/ZP29/ZP27 mentioning
that it is also for double layer.
ii. Packing list
iii. Invoice
v. Bill of lading
vi. Photographs
Amlodipine Besylate eq. to Amlodipine…….5mg
Telmisartan ………………………………..80mg
Type of Form Form-5
Pack size & Demanded Price 14’s & Rs. 85/- per tablet
Me-too status Amtas tablet 5mg/ 80mg of M/s Getz Pharmaceutical,
Pakistan (Reg. # 066944)
data.
ii. Packing list
iii. Invoice
v. Bill of lading
vi. Photographs
Amlodipine Besylate eq. to Amlodipine…..10mg
Telmisartan ………………………………..80mg
Type of Form Form-5
Pack size & Demanded Price 14’s & Rs. 85.71/- per tablet
Me-too status Am-Telsan of M/s Hilton Pharma
data.
ii. Packing list
iii. Invoice
v. Bill of lading
vi. Photographs
520. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot # 122, Block-B, Phase-
Applicant V, Industrial Estate, Hattar, KPK
Brand Name +Dosage Form + Strength Buprowel oral granules 600mg
Ibuprofen …………..... 600mg
Pharmacological Group NSAIDs
Type of Form Form-5
Pack size & Demanded Price As per SRO & as per SRO
Approval status of product in Brufen Granules 600mg by M/s BGP Products Ltd. (MHRA
Me-too status Brufen 600mg Sachet by Abbott Laboratories (Pakistan)
Limited (Reg. # 044414)
GMP status Last GMP inspection was conducted on 16-09-2017and the
report concludes that overall the firm was cGMP compliant
as per DRAP guidelines.”
Previous remarks of the Evaluator
Previous decision Deferred in 285th meeting for the submission of latest GMP
inspection report conducted within a period of last one year.
Evaluation by PEC  Firm has submitted its latest inspection report dated 04-9-
2018 & 26-09-2018 and the report concludes renewal of
DML.
 Firm has sachet section as mentioned in the GMP report.
Decision: Approved.
Brand Name +Dosage Form + Strength Ornimark Oral Granules 3gm
L-Ornithine L-Aspartate …………….…. 3gm
Pharmacological Group Hepatoprotective, Lipotropic
Type of Form Form-5
Finished product Specification Innovator Specifications
Approval status of product in Approved in Austria
Me-too status Hepaser Sachet 3gm of M/s Panacea Pharmaceutical
(Reg.#075403)
Evaluation by PEC  Firm has submitted its latest inspection report; dated: 04-
09-2018 & 26-09-2018 and the report concludes renewal of
DML.
 Firm has sachet section as mentioned in the GMP report.
Brand Name +Dosage Form + Strength Ziprawel Capsules 40mg
Ziprasidone as Hydrochloride ……….....40mg
Type of Form Form-5
Me-too status Zeldox 40mg capsule of M/s Pfizer Laboratories Ltd.
(Reg.#041196)
09-2018 & 26-09-2018 and the report concludes renewal of
DML.
 Firm has non-antibiotic capsule section.
Decision: Approved.
Brand Name +Dosage Form + Strength Ziprawel capsule 80mg
Ziprasidone as Hydrochloride ……….....80mg
Type of Form Form-5
Me-too status Prazip 80mg tablet of M/s Shrooq Pharma(Reg. # 606391)
Evaluation by PEC  Firm has submitted its latest inspection report; dated:
04-09-2018 & 26-09-2018 and the report concludes
renewal of DML.
 Firm has non-antibiotic capsule section.
Decision: Approved.
Brand Name +Dosage Form + Strength Clozapine Tablet 25mg
Clozapine…………….25 mg
Type of Form Form-5
Me-too status Clozaril 25mg Tablet of M/s Novartis Pharma (Reg.#016329)
Evaluation by PEC  Firm has submitted its latest inspection report; dated:
04-09-2018 & 26-09-2018 and the report concludes
renewal of DML.
 Firm has non-antibiotic tablet section.
Decision: Approved.
Brand Name +Dosage Form+ Strength Metowel Injection 1mg/ml
Metoprolol Tartrate……………5mg (1mg/ml)
Pharmacological Group Beta 1- adrenoreceptor Blocking Agent
Type of Form Form-5
Pack size & Demanded Price 1x 5’s (5ml) & as per SRO
Approval status of product in Lopressor Injection of M/s Novartis Pharmaceuticals
Reference Regulatory Authorities (USFDA approved)
Me-too status Lopresor Injection of M/s Novartis Pharma (Pak) Ltd. (Reg. #
012846)
report concludes that overall the firm was cGMP compliant as
per DRAP guidelines.”
Previous remarks of the Evaluator  Firm has General injection section.
09-2018 & 26-09-2018 and the report concludes renewal
of DML.
 Firm has relevant section i.e. Ampoules/ liquid injection
(Non-Antibiotic) as mentioned in the GMP report.
Decision of 286th meeting: Approved.
Brand Name+Dosage Form + Strength Nalbuwel Injection 10mg
Nalbuphine HCl......................10mg (10mg/ml)
Diary No. Date of R& I & fee Dy.No.16925;04-10-2017;Rs.20,000/-(02-10-2017)
Pharmacological Group Morphinan derivatives /Opioid /Analgesic
Type of Form Form-5
Finished product Specification Innovator’s Specifications
Me-too status Sonotic Injection by Brookes Pharmaceutical Laboratories
(Pak) Ltd. (Reg. # 057729)
report concludes that overall the firm was cGMP compliant as
per DRAP guidelines.”
Previous remarks of the Evaluator  No U.S.P. or B.P. monograph is available for applied
formulation.
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09-2018 & 26-09-2018 and the report concludes renewal
of DML.
 Firm has relevant section i.e. Ampoules/ liquid injection
(Non-Antibiotic) as mentioned in the GMP report.
Evaluator PEC-XIV
527. Name and address of manufacturer / M/s. Rakaposhi Pharmaceuticals, 97-K Industrial Estate,
Applicant Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Rothin 250mg tablet
Azithromycin as (dihydrate)………..250 mg
Pharmacological Group Macrolide Antibiotic
Type of Form Form 5
Pack size & Demanded Price 10’s, RS; 250/
Approval status of product in Reference Azithromycin tablet of (MHRA approved)
Me-too status Azic 250mg Tablet by M/s NabiQasim
GMP status Last GMP inspection conducted on 28-11-2016 the report
concludes that overall firm has improved GMP
compliance.
Previous remarks of the Evaluator. 
Previous decision(s) Registration Board referred the case to QA & LT Division
to conduct GMP inspection of Firm on priority. (M-279)
Evaluation by PEC The firm was conducted panel inspection dated 19-09-2018
which recommended the grant of cGMP certificate to firm.
Decision: Approved.
528. Name and address of manufacturer / M/s. Rakaposhi Pharmaceuticals, 97-K Industrial Estate,
Applicant Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Lozamep 40 Capsule
Diary No. Date of R& I & fee Dy. No.63, 16-01-2015, Rs.20,000/- (15-01-2015)
Composition Each capsule contains:-
Omeprazole enteric coated pellets eq. to Omeprazaole
…..….40mg
Type of Form Form-5
Approval status of product in Reference Losec by AstraZeneca MHRA
Me-too status Risek by Getz
GMP status Last inspection conducted on 08.09.16 and report shows
that firm is operating at satisfactory level of GMP
compliance.
Previous remarks of the Evaluator.  Firm has claimed BP Specifications but product is also
available in USP.
 Source of pellets: Vision pharma
 GMP of Vision is submitted.
 COA of Esomeprazole is submitted after tempering it for
Omeprazole.
 Stability studies of pellets conducted by the source is not
submitted.
Previous decision(s) Registration Board deferred the case for submission of
COA and stability studies of Omeprazole pellets.(M-271)
Deferred for submission of latest GMP inspection report
conducted within a period of last one year. (M-274)
Evaluation by PEC The firm has now submitted the COA and data of stability
studies as per conditions of zone IV-A for Omeprazole
pellets.
The firm was conducted panel inspection dated 19-09-2018
which recommended the grant of cGMP certificate to the
firm.
Decision: Approved.
529. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25/26,
Applicant St.#S-3, RCCI, Industrial Estate, Rawat,Islamabad
Brand Name +Dosage Form + Strength Movate Lotion 0.1% w/w
Diary No. Date of R& I & fee Each gram contains:
Mometasone furoate…1mg
Composition Diary No:14569, 11/09/2017, Rs: 20,000/-
Pharmacological Group Corticosteroid, potent (group III)
Type of Form Form 5
Pack size & Demanded Price 20ml/ As per SRO
Approval status of product in Reference Elocon Scalp Lotion 0.1% w/w by M/s Merck Sharp &
Regulatory Authorities. Dohme (MHRA Approved)
Me-too status Hivate Lotion 0.1% by M/s Saffron (Reg#046430)
GMP status New License (Inspection Date: 07th June 2017)
Previous decision(s) Deferred for confirmation of formulation in w/w (M-277).
Registration Board deferred the case in the light of decision
of 248th meeting of Registration Board, for confirmation
and verification of segregated dispensing booths, cleaning
validation and controls studies for processes and adequate
system to minimize the potential risk of cross
contamination. (M-281)
Evaluation by PEC ● Confirmed as w/w formulation in MHRA.
● Firm has also applied in w/w composition.
The firm has submitted that
i. We have a separate dispensing booth for steroidal
products (Copy of photo of steroidal dispensing area
submitted).
ii. SOP for validation of cleaning procedure / method is
attached
Inspection conducted on 25-10-2018 concluded that as the
operations have not started as of yet at M/s Evolution
pharma and the GMP inspection can only be ascertained
upon the start of active production, however, keeping in
view the facility inspected, the firm has requisite facility for
manufacturing of pharmaceuticals.
Decision: Registration Board referred the case to area FID for verification of segregated
dispensing booth for steroidal products and confirmation of cleaning validation and control
studies to minimize the potential risk of cross contamination.
530. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25/26,
Applicant St.#S-3, RCCI, Industrial Estate, Rawat,Islamabad
Brand Name +Dosage Form + Strength Betanex Lotion 0.1% w/w
Diary No. Date of R& I & fee Each gram contains:
Betamethasone (as valerate) …1mg
Composition Diary No:14565, 11/09/2017, Rs: 20,000/-
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form 5
Pack size & Demanded Price 60ml/ As per SRO
Approval status of product in Reference Betnovate Lotion 0.1% w/w by M/s Glaxo Wellcome UK
Me-too status Betnovate Lotion 0.1% by M/s GSK (Reg#000253)
GMP status New License (Inspection Date: 07th June 2017)
Previous decision(s) Deferred for confirmation of formulation in w/w (M-277).
Registration Board deferred the case in the light of decision
of 248th meeting of Registration Board, for confirmation
and verification of segregated dispensing booths, cleaning
validation and controls studies for processes and adequate
system to minimize the potential risk of cross
contamination. (M-281)
Evaluation by PEC ● Confirmed as w/w formulation in MHRA.
● Firm has also applied in w/w composition.
The firm has submitted that
i. We have a separate dispensing booth for steroidal
products (Copy of photo of steroidal dispensing area
submitted).
ii. SOP for validation of cleaning procedure / method is
attached
Inspection conducted on 25-10-2018 concluded that as the
operations have not started as of yet at M/s Evolution
pharma and the GMP inspection can only be ascertained
upon the start of active production, however, keeping in
view the facility inspected, the firm has requisite facility for
manufacturing of pharmaceuticals.
Decision: Registration Board referred the case to area FID for verification of segregated
dispensing booth for steroidal products and confirmation of cleaning validation and control
studies to minimize the potential risk of cross contamination.
531. Name and address of manufacturer / M/s. Aries Pharmaceuticals, Peshawar
Applicant
Brand Name +Dosage Form + Strength Oscom-D Tablets
Diary No. Date of R& I & fee Each tablet contains:-
Ossein Mineral Complex….830mg
Vitamin D …………400IU
Composition Dy No. 793: 16-08-2012, Rs.8000/- 15-8-2012 Rs.12,000/-
17-07-2014
Pharmacological Group (Mineral supplements)
Type of Form Form 5
Finished product Specification Firm has claimed Mfg specs
Pack size & Demanded Price 3x10’s: As Per SRO
Approval status of product in Reference Not provided
Me-too status Bonmin tablet by S.J. & G Fazul Ellahie
GMP status Last inspection report 03-08-2016 Stated grant of additional
section and renewal of DML.
Previous remarks of the Evaluator. International availability is not confirmed
Previous decision(s) Deferred for submission of complete composition of ossein
mineral complex and confirmation of availability of atomic
absorption spectrophotometer (M-267).
declared/approved by the Registration Board (M-277).
Registration Board deferred the case for further delibration.
(M-285)
Evaluation by PEC Evaluation by PEC
Firm has submitted following documents:
 Last GMP inspection report dated 10-3-2017 confirms
presence of atomic absorption and also recommended
grant of additional section.
 Approval status in reference regulatory authorities could
not be confirmed
 Detailed formulation as
Vitamin D………..400 IU
Ossein Mineral Complex………..830mg
Corresponding to
Calcium……..177.6mg
Phosphorous….82.2mg
Residual Mineral Salt……24.9mg
Collagen…….224mg
Other proteins……..66.4mg
Trace elements F, Mg, Fe, Zn, Cu, Ni.
Corresponding to approximately 440mg hydroxyapatite
“Ossopan 600mg Film coated tablet approved in ANSM
France”.
Firm has submitted GMP inspection report dated 04-06-
2018 confirming satisfactory compliance to GMP.
Decision: Deferred for evidence of approval of applied formulation in Reference Regulatory
Authorities/Agencies which were adopted by the Registration Board.
532. Name and address of manufacturer / M/s. Aries Pharmaceuticals, Peshawar
Applicant
Brand Name +Dosage Form + Strength Oscom Tablets 830mg
Composition Each tablet contains:-
Ossein Mineral Complex……….830mg
Diary No. Date of R& I & fee Dy.#782 (16-8-2012), Rs.8000/-, 15-8-2012, Rs.12,000/-,
17-07-2014
Pharmacological Group Mineral supplements
Type of Form Form-5
Pack size & Demanded Price 3x10’s, As Per SRO
Approval status of product in Reference N/A
Me-too status Osnate-800 tablet by AGP Ltd
GMP status Firm has submitted GMP inspection report dated 04-06-
Previous decision(s) Deferred for submission of complete composition of ossein
mineral complex and confirmation of availability of atomic
absorption spectrophotometer. (M-267)
Evaluation by PEC  Detailed formulation as
Ossein Mineral Complex………..830mg
Corresponding to
Calcium……..177.6mg
Phosphorous….82.2mg
Residual Mineral Salt……24.9mg
Collagen…….224mg
Other proteins……..66.4mg
Trace elements F, Mg, Fe, Zn, Cu, Ni.
Corresponding to approximately 440mg hydroxyapatite.
“Ossopan 600mg Film coated tablet approved in ANSM
France”.
Firm has submitted GMP inspection report dated 04-06-
Decision: Deferred for evidence of approval of applied formulation in Reference Regulatory
Authorities/Agencies which were adopted by the Registration Board.
533. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Penmark 40mg tablet
Pantoprazole as sodium sesquihydrate ……40mg
Diary No. Date of R& I & fee Dy. No.30; 18-12-2010; Rs.8,000; 1-09-2010 Rs.12,000/-
(21-10-2014)
Type of Form Form-5
Finished product Specification USP Specification
Me-too status Cantrofast by Candid
GMP status Last inspection report 16-9-2017 Overall cGMP was
satisfactory as per Drap Guidelines.
Previous remarks of the Evaluator. Fee challan photocopy is attached.
Previous decision(s)  Deferred for clarification of applied dosage form as
reference product is available as enteric coated tablet
whereas firm has applied for uncoated tablet (M-275).
(M-285)
Evaluation by PEC  The firm has submitted revised Form-5 and master
formulation with following label claim:
Pantoprazole as sodium
sesquihydrate………………40mg
 Fee challan of Rs. 5000/- has been deposited (deposit
slip # 0793529) dated 10-09-2018.
 Panel inspection conducted on 08-08-2018 unanimously
recommends the renewal of DML.
Decision: Approved.
534. Name and address of manufacturer / M/s Inventor Pharma,
Applicant Plot No. K/196, S.I.T.E, (SHW) Phase-II, Karachi
Brand Name +Dosage Form + Strength In-ORS Solution 500ml
Composition Diary No: 13910, 30/08/2017, Rs: 20,000/-
Diary No. Date of R& I & fee Each 500 ml contains:
Sodium Chloride ……………………1.75gm
Trisodium Citrate Trihydrate ……..1.45gm
Potassium Chloride ……………..0.75gm
Glucose Anhydrous ……………..10gm
Pharmacological Group Electrolyte
Type of Form Form 5
Finished product Specification Manufacturer’s Specification
Pack size & Demanded Price 1’sx500ml; As per SRO
Approval status of product in Reference Standard ORS formulation
Me-too status Pedinex Oral Rehydration Solution by M/s Nexus Pharma
(Pvt) Ltd (Reg#057883)
GMP status 10-06-2017; New License
Previous decision(s) Deferred for confirmation whether applied formulation is
preservative free or not. (M-277)
Evaluation by PEC  The firm has submitted that we have removed “Sodium
benzoate” from our formulation and our new formulation
for this product is free from preservative.
 The firm has submitted fee challan of Rs.5000/-,
(Deposit slip#0808315) dated 05-11-2018 for revision of
formulation.
Decision: Deferred for confirmation of terminal sterilization method for applied formulation.
535. Name and address of manufacturer / M/s Titlis Pharma, 528-A Sundar Industrial Estate,
Applicant Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength RIFAXAT 200mg Tablet
Rifaximin……………..200mg
Type of Form Form-5
Pack size & Demanded Price 1 × 10’s; As per SRO
Approval status of product in Reference Xifaxan tablets of Salix Pharma (USFDA approved)
Me-too status Nixaf 200mg tablet of Sami Pharma (Reg#076310)
GMP status
Previous remarks of the Evaluator. GMP inspection report conducted within period of one year
is required to be submitted.
Previous decision(s) Deferred for submission of latest GMP inspection report
conducted within period of one year. (M-284)
Evaluation by PEC The firm was granted GMP certificate based on inspection
536. Name and address of manufacturer / M/s Titlis Pharma, 528-A Sundar Industrial Estate,
Applicant Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength RIFAXAT 550mg Tablet
Rifaximin……………..550mg
Type of Form Form-5
Pack size & Demanded Price 1 × 10’s; As per SRO
Approval status of product in Reference Xifaxan tablets of Salix Pharma (USFDA approved)
Me-too status Nixaf 550mg tablet of Sami Pharma (Reg#076310)
GMP status GMP inspection report conducted within period of one year
is required to be submitted.
Previous decision(s) Deferred for submission of latest GMP inspection report
conducted within period of one year. (M-284)
Evaluation by PEC The firm was granted GMP certificate based on inspection
537. Name and address of manufacturer / M/s. Metro Pharmaceuticals Plot #14, Street No.SS-2,
Brand Name +Dosage Form + Strength Metapride-50 Tablets Tablet
Composition Each film tablet contains:
Itopride Hydrohloride…………….….50mg
Diary No. Date of R& I & fee Fast Track Dy. No.6278, dated 02-10-2013, 02-10-2013,
Rs.60,000/-
Pharmacological Group Gastroprokinetic
Type of Form Form-5
Pack size & Demanded Price Blister packing of 10’s Tablets;As per SRO
Approval status of product in Reference Approved in PMDA
Me-too status Xepride Tablets 50mg of Usawa Pharmaceuticals
that firm is operating with cGMP.
Previous decision(s) Deferred for review of formulation by Review Committee
(M-243).
Deferred for confirmation of availability of formulation in
PMDA Japan (M-250).
Evaluation by PEC 
538. Name and address of manufacturer / M/s. Pacific Pharmaceuticals Ltd, 30 Km, Multan Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Acnec Cream
Composition Each gram contains:-
Azelaic acid………………...200mg (20%)
Diary No. Date of R& I & fee Dy No. 756711-08-2010, 8000/-, 11-8-2010, 12000/-,
24-10-2014
Pharmacological Group Anti-acne
Type of Form Form-5
Pack size & Demanded Price Rs.212/-10gm, Rs.390/-20gm
Me-too status Skinoren Cream by schering Asia Gmbh Pakistan
Previous decision(s) Deferred for commitments as per 251st DRB meeting &
confirmation of approved Cream section (M-268).
Evaluation by PEC The firm has submitted commitments as per 251st meeting
of Registration Board.
The firm has provided Semi Solid (Cream/Ointment/Gel)
section vide letter No.F. 1-9/89-Lic (Vol-IV) dated 30th
June, 2015.
539. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd, D-122,
Applicant S.I.T.E, Karachi
Brand Name +Dosage Form + Strength Zolot-S 75/75mg Tablet
Clopidogrel Hydrogen Phosphate……………… 75mg
Aspirin……….……………………………….75mg
Diary No. Date of R& I & fee Dy. No: 1065 dated 30.04.2011, Rs.8,000/-, 26.07.2013,
Rs.12,000/-
Pharmacological Group Antiplatelet
Type of Form Form-5
Pack size & Demanded Price Rs. 14.50/Tablet; 10’s
Approval status of product in Reference COPLAVIX 75 mg/75 mg clopidogrel (as hydrogen
Regulatory Authorities. sulfate)/aspirin tablets blister pack by M/s anofi-Aventis
Australia Pty Ltd (TGA Approved)
Me-too status CoPlavix Tablets 75/75mg by M/s Sanofi (Reg#075978)
GMP status GMP inspection conducted on 01-10-2018 concluded that
the firm is found to be complying at a good level of GMP
compliance.
Previous decision(s) Deferred for verification of bi-layered compression
machine by area FID. (M-258)
Evaluation by PEC Area FID in his inspection report dated 01-10-2018
confirmed that the firm had double-pressing automatically
revolving piece-pressing machine (Rotary tablet press
ZP420-31D).
Decision: Registration board deferred the case for further deliberation since the product
approved by reference regulatory authorities is film coated tablet prepared by mixing granules
of clopidogrel (prepared by wet granulation) and aspirin (prepared by dry granulation).
540. Name and address of manufacturer / M/s Aims Pharmaceuticals, Plot No. 291, Industrial
Applicant Triangle, Kahuta, Islamabad.
Brand Name +Dosage Form + Strength Azaim 500mg tablets
Azithromycin (as dihydrate)…………….500mg
Diary No. Date of R& I & fee Dy. No.1736;(01-12-2016); Rs.20,000/-(01-12-2016)
Type of Form Form 5
Pack size & Demanded Price Not demanded; As per SRO
Approval status of product in Reference MHRA approved
Me-too status Plivazith 500 mg tablet of M/s Pliva
report concludes that the firm is operating at reasonable
level of GMP compliance.
Previous decision(s) Deferred for submission of latest GMP inspection report as
submitted inspection report does not declare GMP
compliant status. (M-278)
Evaluation by PEC The firm was conducted panel inspection dated 31-05-2018
which recommended the grant of renewal of DML.
Decision: Approved.
541. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Plot 1&2,S-2,National
Applicant Industrial Zone, Rawat ,Islamabad
Brand Name +Dosage Form + Strength Visofin 500mcg Tablet
Mecobalamin ……………..500ug
Pharmacological Group Coenzyme-type vitamin B12
Type of Form Form 5
Approval status of product in Reference PMDA Japan Approved
Me-too status Cube 500mcg tablet by Sigma Pharma
GMP status Inspection Date:18-01-2017, Good
Previous remarks of the Evaluator. Firm has applied for film coated tablet while the product
approved by PMDA is sugar coated tablet
Previous decision(s) Deferred for clarification of formulation since the product
approved by reference regulatory authorities is sugar coated
tablet and the firm has applied for film coated tablet.
Deferred for submission of fee for change of formulation
(M-277).
Evaluation by PEC Firm has revised their formulation from film coated to
sugar coated tablets.
Fee challan of Rs. 20,000/- (deposit slip#0783379) dated
12.10.2018 has been submitted.
Decision: Approved as sugar coated tablets.
542. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Applicant Industrial Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Cyclovir Injection 250mg
Acyclovir powder for reconstitution …250mg
Diary No. Date of R& I & fee Diary No: 24087, 13-12-2017 , Rs: 20,000/-
Pharmacological Group Anti-Viral
Type of Form Form-5
Pack size & Demanded Price 1’s/ As per SRO
Approval status of product in Reference Aciclovir 250mg Powder For Solution For Infusion by M/s
Regulatory Authorities. GlaxoSmithKline UK (MHRA Approved)
Me-too status Aclovir 250mg Powder for Infusion by M/s Genix
(Reg#073690)
GMP status 13-07-2017; Grant of new DML
Panel recommends grant of new DML.
Previous remarks of the Evaluator.  Supplied as lyophilized powder for injection.
 Firm doesn’t have relevant section to manufacture applied
product.
Previous decision(s) Deferred for confirmation of manufacturing facility for
Lyophilization. (M-278)
Evaluation by PEC The firm has submitted that they will import “Acyclovir
lyophilized powder” from M/s Mac-Chem Products, India
in ready to fill form and there is no need of further
processing”
COA and details of analytical procedures has been
submitted.
Stability data of 3 batches conducted at long term storage
conditions (30oC ± 2 oC/75% ± 5%RH) was submitted for
Acyclovir for injection (Lyophilised sterile bulk).
GMP certificate issued on 11-09-2018 by Food & Drug
Administration, Maharashtra state, India certifies that the
site indicated on this certificate complies with Good
Manufacturing Practices.
Decision: Registration Board deferred the case for confirmation of details of reference product
whether available as lyophilized cake form or ortherwise.
543. Name and address of manufacturer / M/s EG Pharmaceuticals, 13-A, Industrial triangle, Kahuta
Applicant Road, Islamabad
Brand Name +Dosage Form + Strength Meloxi 15mg Tablet
Diary No. Date of R& I & fee Each tablet contains:
Meloxicam ……….15mg
Composition Dy No. 2225: 30-5-2016 PKR 20,000/-: 30-5-2016
Type of Form Form 5
Approval status of product in Reference Mobic tablets by Boehringer (USFDA Approved)
Me-too status Orthicam by Linear Pharma
reasonable level of compliance to GMP
Previous remarks of the Evaluator. Firm has applied for film coated tablet while the product
approved by reference regulatory authorities is uncoated
tablet.
Previous decision(s) Deferred for clarification of formulation since the product
approved by reference regulatory authorities is uncoated
tablet and the firm has applied for film coated tablet. (M-
274)
Registration Board referred the case to QA & LT Division
to conduct GMP inspection of Firm on priority (M-277).
Evaluation by PEC Firm has revised their formulation as uncoated tablets and
submitted the revised master formulation. Fee challan of
Rs.5000/- (deposit slip# 0782657) dated 08-11-2018 has
been submitted for revision of formulation.
GMP inspection conducted on 28-08-2018 & 03-09-2018
concluded that M/s EG Pharma may considered operating
in compliance with GMP guidelines as per Drugs Act, 1976
and rules framed thereunder.
Decision: Approved.
Brand Name +Dosage Form + Strength Excita 10 mg tablet
Diary No. Date of R& I & fee Dy.No. 1834, 19-10-16, Rs.20,000/-
Escitalopram Oxalate eq. to Escitalopram…..10mg
Pharmacological Group Anti-depressant
Type of Form Form-5
Approval status of product in Reference Escitalopram by Alpha pharma (USFDA)
Me-too status Elcit by Macter pharma
Evaluation by PEC GMP inspection conducted on 28-08-2018 & 03-09-2018
Decision: Approved.
Brand Name +Dosage Form + Strength Lunamid 20 mg tablet
Composition Each film coated tablet contains:-
Leflunomide………..…20mg
Pharmacological Group Immunosuppressant
Type of Form Form-5
Approval status of product in Reference Leflunomide 20 mg Film-coated Tablets (MHRA)
Me-too status Adira of Wilshire
Registration Board decided to grant registration of these
products in general manufacturing areas with condition that
manufacturer shall provide safety and protective measures
for workers and personnel which remain in direct contact or
are involved in close handling of these drugs
Brand Name +Dosage Form + Strength Ebastel 10 mg tablet
Ebastine……………….10 mg
Pharmacological Group Anti-allergic
Type of Form Form-5
Approval status of product in Reference Kestine 10mg tablet by M/s Almirall
Regulatory Authorities. (ANSM Approved)
Me-too status Ebofor 10mg Tablet by M/s Genome
Decision: Approved.
Brand Name +Dosage Form + Strength Gitune 50mg tablet
Diary No. Date of R& I & fee Each film coated tablet contains:
Itopride Hydrochloride……….…50mg
Composition Dy. No.332; 21-10-2016 ; Rs.20,000/- (19-10-2016)
Pharmacological Group Prokinetics
Type of Form Form-5
Approval status of product in Reference PMDA Japan
Me-too status Ganaton 50 mg Tablet by M/s Abbott. (Reg# 028429)
Brand Name +Dosage Form + Strength Lizolid 600mg tablet
Linezolid……………600mg
Pharmacological Group Oxazolidinone
Type of Form Form-5
Approval status of product in Reference Zyvox 600mg Tablet of Pharmacia & Upjohn (USFDA
Regulatory Authorities. approved)
Me-too status Linexa Tablet 600mg by M/s. Cirin Pharmaceuticals, (Reg
# 073213)
Brand Name +Dosage Form + Strength Paxton 20mg tablet
Paroxetine….20mg
Pharmacological Group Anti-depressant/SSRI
Type of Form Form-5
Me-too status Paroxin by M/s. Amarant Pharma, Karachi.
Decision: Approved.
Brand Name +Dosage Form + Strength Valdipine tablet 5/80 mg
Amlodipine…..5 mg
Valsartan……….80 mg
Pharmacological Group Anti-hypertensives (calcium channel blocker/Angiotensin
receptor antagonist)
Type of Form Form-5
Approval status of product in Reference Exforge by Novartis (MHRA)
Me-too status Amodip-V by Mass Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Valdipine 5/160mg tablet
Amlodipine as besylate………..5mg
Valsartan……………………...160mg
Pharmacological Group Calcium Channel Blocker
Type of Form Form-5
Approval status of product in Reference Amlodipine Besylate and Valsartan of Par Pharm
Regulatory Authorities. (USFDA)
Me-too status Avcard of Hilton
Decision: Approved.
Brand Name +Dosage Form + Strength Valdipine tablet 10/160 mg
Amlodipine as besylate……….10mg
Valsartan……………………...160mg
Pharmacological Group Anti-hypertensives (calcium channel blocker/Angiotensin
receptor antagonist)
Type of Form Form-5
Pack size & Demanded Price 14’s As per PRC
Approval status of product in Reference Exforge by Novartis
Regulatory Authorities. (MHRA)
Me-too status Exforge by Novartis
Decision: Approved.
553. Name and address of manufacturer / M/s NabiQasim Industries (Pvt.) Ltd;17/24, Korangi
Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Hypovir I/V 500mg Injection for infusion
Acyclovir Sodium equivalent to Acyclovir
(Lyophilized)……………………….500mg
Diary No. Date of R& I & fee Dy. No.143,R&I Dated 12.08.2014.Rs. 20,000/-
Pharmacological Group Nucleoside analogue
Type of Form Form-5
Pack size & Demanded Price 1’s x 10 ml and 5’s; as per PRC
Me-too status Aclovir 500mg powder for Infusion of Genix Pharma
(Reg#073691)
GMP status Last GMP of Nabi qasim Inspection conducted on 03-8-
2018 and report concludes that firm is considered to be
operating at an acceptable level of compliance of GMP
requirements.
Previous remarks of the Evaluator. Fee challan was provided in the form of photocopy and in
reply the firm has submitted an undertaking of correctness
of fee challan. Moreover, the firm has applied for vial
(Injection) while me-too is in the form of ampoule
(Infusion).
The firm has provided Lyophilized /vial (General) section.
Previous decision(s) Deferred for following: (M-271)
a. verification of fee challan from Budgets and Accounts
Division.
b. Confirmation of lyophilizer.
Evaluation by PEC The firm has submitted that we already have an approved
lyophilized section wherein we manufacture 6 registered
drugs. The firm has attached copy of grant of
lyophilized/vial (General) section from licensing division.
Decision: Approved.
Sr. Name and Brand Name Type of Form Approval status Previous Evaluation by
No address of (Proprietary name + Initial date, in Reference Decisions PEC
manufacturer / Dosage Form + diary regulatory
Applicant Strength) Fee including agencies /
Composition differential fee authorities
Pharmacological Demanded Me-too status/
Group Price /Pack GMP status
Finished product size
Specification
554. M/s. Levopren 25 Form-5 Italian Medicine Deferred for
Rakaposhi Tablets Dy. No.63, Agency (AIFA) evidence of
Pharmaceuti Each tablet 16-01-2015, approval in
cals, 97-K contains:- Rs.20,000/- Sulvoric 50mg reference
Industrial Levosulpiride…… (15-1-2015) Tablet of regulatory
Estate, …25mg 2 x 10’s; High-Q agencies
Hayatabad, Antipsychotics Rs.180/- (Reg # (M-271).
Peshawar 070485) Deferred for
the submission
Panel inspection of GMP
dated 19-09- inspection
2018 report
recommended conducted
the grant of within the last
cGMP certificate 01 year (M-
to the firm. 277).
555. M/s. Levopren 50 Form-5 Italian Medicine Deferred for
Rakaposhi Tablets Dy. No.57, Agency (AIFA) evidence of
Pharmaceuti Each tablet 16-01-2015, approval in
cals, 97-K contains:- Rs.20,000/- Sulvoric 25mg reference
Industrial Levosulpiride…… (15-01- Tablet of regulatory
Estate, …………50mg 2015) High-Q agencies (M-
Hayatabad, Antipsychotics 2 x 10’s; (Reg # 070484) 271).
Peshawar Rs.180/- Deferred for
Panel inspection submission of
dated 19-09- GMP
2018 inspection
recommended report
the grant of conducted
cGMP certificate within the last
to the firm. 01 year (M-
277).
556. M/s Reliance LETOREL Tablet Form 5 Fast FEMARA Deferred for The monograph
Pharma, Plot Each film coated Track As per 2.5mg tablet clarification of applied
No.8 Street tablet contains: SRO/ 1x10’s by Novartis for formulation is
No S-8 RCCI Letrozole 2.5mg & 3x10’s. Pharma (TGA requirement available in
Industrial Dy.4833 Approved) of USP.
Estate, Non-steroidal 29/07/13 manufacturing
Rawat, aromatse inhibitor Femara 2.5mg for product.
Islamabad. Tablet by (M-242)
Novartis Deferred for
(Reg#021129) submission of
latest GMP
Panel inspection inspection
dated 27-04- report
2018 conducted
recommended within a
for renewal of period of last
DML. 1 year by
DRAP. (M-
275)
Decision: Registration Board approved registration of product in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and personnel
which remain in direct contact or are involved in close handling of these drugs.
557. M/s Cinride Tablets Form-5 Spanish Deferred for The firm has
WnsFeild 1mg Fast Track Agency of review of submitted
Pharmaceuti 07-06-2012 Medicines and formulation revised Form-5
cals, Hattar. Each film coated Rs.8000/= Health by Review in line with
table contains:- (2098) 29- Products Committee. reference
Cinitapride……… 10-2013 (M-242) country with
1mg Rs.52,000/= Cinita Tablet Deferred for following label
(Gastroprokinetic) (3313) 1mg of the following claim:
(Mfg. Specs) Novamed submission:
As Per SRO Pharma (M-277) Each tablet
(Reg#064845)  Change in contains:
formulation Cinitapride
GMP to uncoated hydrogen
inspection tablet as tartrate eq. to
conducted on per the Cinitapride……
18-01-2018 reference …..1mg
concluded that product in
keeping in Spain. Fee challan of
view the  Fee for Rs. 20,000/-
overall GMP change of (yellow copy
compliance, formulation submitted)
the panel . (deposit
recommended  Clarification slip#0725725)
the Renewal of of salt form dated 11-06-
DML. of API of 2018 was
the product submitted for
since the revision of
reference formulation.
product
contains
Cinitapride
as acid
tartarate.
 GMP
inspection
report
conducted
within the
period of
last 01 year
558. M/s Fynk Cinic Syrup Form 5 Spanish Agency of Deferred The firm has
Pharmaceuti Fast Track Medicines and for review submitted
cals, Each 5ml syrup As per PRC Health Products of revised Form-5
Plant:19Km contains: Pack of formulatio in line with
G.T. Road, 60ml & n by reference
Kalashah Cinitapride (as 120ml Cidine 1mg/5ml Review country with
Kaku, Hydrogen 567 dated of M/s Highnoon Committee following label
Lahore tartrate………….. 28-05- (Reg # 069457) . (M-242) claim:
1mg 2013/Rs Deferred
60000 for Each 5ml oral
Gastroprokinetics following solution
(Mfg spec) GMP inspection submissio contains:
conducted on 20- n: (M-277) Cinitapride (as
09-2017  Change Hydrogen
concluded that in tartrate………
overall condition formulatio ….. 1mg
of the firm is n to oral
satisfactory. solution as Fee challan of
per the Rs. 20,000/-
reference (deposit slip #
product in 0572350) dated
Spain. 17-09-2018 was
 Fee for submitted for
change of revision of
formulatio formulation.
n.
559. M/s Fluzapine 3/25mg Form-5 USFDA approved Deferred The approval
Medicraft Capsule 25-03-2013 Pintin capsule by for status has been
Pharmaceuti vide diary M/s Maark the confirmed in
cals, Pvt Each capsule No. 179 R&I Pharma confirmat USFDA
Ltd, contains:- Rs.20,000. Panel inspection ion approved.
Hayatabad, Olanzapine…..3mg As per SRO. dated 30-01-2018 of
Peshawar. Fluoxetine HCl eq concluded that the approval
to Fluoxetine management of the status by
…25mg firm promised that reference
they would continue regulator
(Selective serotonin improvement. In the y
reuptake inhibitor) light of observation authoritie
at the time of s (M-
Manufacturer’s inspection, 258).
Specifications documents reviewed
and representatives
of the firm
commitment, the
firm may be
considered to be
operative in good
level of cGMP
compliance.
560. M/s Payaram Injection Form-5 Approved by Deferred for The approval
Medicraft 25-03-2013 ANSM of France the status has been
Pharmaceuti Each 1ml contains:- vide diary Salden 20mg confirmation confirmed in
cals, Pvt Piroxicam………… No. 173 R&I Injection of M/s of approval ANSM.
Ltd, 20mg Rs.20,000. Danas Pharma status by
Hayatabad, As per SRO. (Reg#080373). reference
Peshawar. (NSAID) regulatory
Panel inspection
Manufacturer authorities
dated 30-01-2018
(M-258).
concluded that the
management of the
firm promised that
they would
continue
improvement. In
the light of
observation at the
time of inspection,
documents
reviewed and
representatives of
the firm
commitment, the
firm may be
considered to be
operative in good
level of cGMP
compliance.
561. M/s Rheumed 20mg Form 5 ANSM approved Deferred for: The product
Medicraft Tablets 21-5-2012 Brexin By Chiesi (M-262) monograph is
Pharmaceuti Rs.8,000/- Pharma available in
cals, Pvt Each tablet Rs.12000/- Panel inspection Finished USP.
Ltd, contains:- Dated dated 30-01-2018 product
Hayatabad, Piroxicam-B- 29-07-2013 concluded that the specs. The firm has
Peshawar. Cyclodextrin 20’s, Rs. management of the submitted in-
191.2mg eq. to 265/- firm promised that Last GMP house
Piroxicam…..20mg they would inspection specifications
continue report for applied
(Anti-inflammatory) improvement. In conducted formulation.
the light of within 1
Mfg. Specs observation at the year.
time of inspection,
documents Commitmen
reviewed and t&
representatives of undertaking
the firm as per 251st
commitment, the DRB
firm may be meeting.
considered to be
operative in good
level of cGMP
compliance.
562. M/s. Pizen Syrup Form 5 Sanomigran Deferred Finished
Medicraft 21-5-2012 Elixir 0.25mg for: (M- product
Pharmaceuti Each 5ml contains:- Rs.8,000/- /5ml by M/s 262) specifications
cals, Pvt Pizotifen (as Rs.12000/- phoenix, (MHRA not submitted.
Ltd, hydrogen Dated 29-7- approved) Finished
Hayatabad, maleate)………… 2013, Pizotifen By product Commitments
Peshawar. ……....0.25mg 20’s, Rs. Novartis specs. as per 251st
265/- Pharma meeting not
(Antihistamine) Panel inspection Last GMP submitted.
dated 30-01-
inspection
2018 concluded
that the report
management of conducted
the firm within 1
promised that year.
they would
continue Commitme
improvement. nt &
In the light of undertaking
observation at as per 251st
the time of DRB
inspection, meeting.
documents
reviewed and
representatives
of the firm
commitment,
the firm may be
considered to be
operative in
good level of
cGMP
compliance.
 Clarification of pharmacological group.
 Submission of finished product specifications.
Case No. 02: Registration applications of newly granted DML or New section (Human)
a. New DML
Evaluator PEC-VII
M/s Trillium Pharmaceuticals PVT Ltd
CLB in its 265 meeting held on 5 January 2018 has considered and granted the Drug Manufacturing
License (DML) to M/ s Trillium Pharmaceuticals PVT Ltd and granted three (03) new sections to the firm.
Accordingly, firm has applied for following products for consideration by Drug Registration Board.
Sr. No Section No. of products No. of molecules
1 Tablet (General) Section 12 6
2 Capsule (General) Section
3 Sachet (General) Section
563. Name and address of manufacturer / M/s Trillium Pharmaceuticals PVT Ltd C-3 & C-4 value
Applicant addition city Khurrian wala
Brand Name +Dosage Form + Strength Triatroz 10/10 mg Tablets
Diary No. Date of R& I & fee Form-5 Dy.No 36216 dated 31-10-2018 Rs.20,000/-
Dated 31-10-2018
Atorvastatin Calcium 10.90mg Eq. to
Atorvastatin…10mg
Ezetimibe…10mg
Pharmacological Group Lipid lowering Agent
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s As per SRO
Approval status of product in Reference USFDA Approved.
Me-too status Atozet 10/10 Tablet. (Reg.# 055148)
GMP status Grant of DML
Decision: Approved with innovators specification.
Dated 31-10-2018
Atorvastatin…20mg
Ezetimibe…10mg
Type of Form Form-5
Me-too status Atozet 10/20 tablet of M/s Hilton Pharma (Reg.#061223)
Diary No. Date of R& I & fee Dy.No 36218 dated 31-10-2018 Rs.20,000/- Dated 31-10-
2018
Atorvastatin…40mg
th
| 252
Ezetimibe…10mg
Type of Form Form-5
Me-too status Atozet 10/40 tablet of M/s Hilton Pharma
Brand Name +Dosage Form + Strength Triclith 250mg Tablets
Type of Form Form-5
Pack size & Demanded Price 10’s As per SRO
Approval status of product in Reference Klaricid tablets by Mylan
Me-too status Claritec by Getz
Decision: Approved.
Brand Name +Dosage Form + Strength Triclith 500 mg Tablets
Dated 31-10-2018
Clarithromycin…500 mg
Type of Form Form-5
Pack size & Demanded Price 10’s As per SRO
Approval status of product in Reference Klaricid tablets by Mylan
Me-too status Claritec by Getz
Decision: Approved.
Brand Name +Dosage Form + Strength Triazit 250mg Tablets
Dated 31-10-2018
Azithromycin as Dihydrate…250mg
Type of Form Form-5
Pack size & Demanded Price 1x6’s As per SRO
Me-too status Aziomak Tablets 250 mg by M/s. Makson
th
| 253
Pharmaceuticals. (Reg. No. 070015)
Decision: Approved.
Brand Name +Dosage Form + Strength Trimoxi 400mg Tablets
Dated 31-10-2018
Moxifloxacin as HCL…400mg
Type of Form Form-5
Approval status of product in Reference Approved by MHRA of UK
Me-too status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
Decision: Approved.
Brand Name +Dosage Form + Strength Tricipro 250mg Tablet
Dated 31-10-2018
Ciprofloxacin as HCL…250mg
Type of Form Form-5
Approval status of product in Reference Cipro 250mg Tablet by M/s Bayer Health Care
Regulatory Authorities. Pharmaceuticals Inc.USA & Germany (USFDA
Approved)
Me-too status Mercip 250mg tablet by M/s Merck (Reg#024601)
Decision: Approved.
Brand Name +Dosage Form + Strength Tricipro 500 mg Tablet
Dated 31-10-2018
Type of Form Form-5
Approval status of product in Reference Cipro Tablets by Bayer Healthcare
Me-too status Ciproxin tablets by Bayer
Decision: Approved.
Brand Name +Dosage Form + Strength Tricipro 750 mg Tablet
Dated 31-10-2018
Type of Form Form-5
Approval status of product in Reference Cipro Tablets by Bayer Healthcare
Me-too status Ciprobid tablet 750mg of Nova pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Trimalt 100mg Tablet
Dated 31-10-2018
Composition Each Chewable Tablet Contains:
Iron (III) Hydroxide Polymaltose Complex Eq. to
Elemental Iron…100mg
Pharmacological Group Hematanic
Type of Form Form-5
Approval status of product in Reference NA
Me-too status Polymalt-F Chewable tablet by High-Q
Brand Name +Dosage Form + Strength Triazit 500mg Tablets
Dated 31-10-2018
Azithromycin as Dihydrate…500mg
Type of Form Form-5
Pack size & Demanded Price 1x6’s
As per SRO
Me-too status Aziomak Tablets 500 mg by M/s. Makson
Pharmaceuticals. (Reg. No. 070015)
Decision: Approved.
Evaluator PEC-IX
New DML granted vide letter dated 29.08.2018 on the basis of inspection dated 03.07.2018. The firm has
applied for 10 molecules (16 products), wherein 07 products are included in the agenda; however, 09
products were found deficient for documents for which the firm has been informed accordingly.
575. Name and address of manufacturer / Trillium Pharmaceuticals (Pvt) Ltd. Plot No. C-3 & C-4
Applicant Value Addition City, Faisalabad
Brand Name +Dosage Form + Strength Tripirox Capsule 10mg
Piroxicam……10mg
Pharmacological Group Antiinflammatory and antirheumatic products, non-
steroids (oxicams)
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 2x5’s; As per SRO
GMP status The firm has been granted DML on the basis of
inspection dated 03.07.2018
Brand Name +Dosage Form + Strength Tripirox Capsule 20mg
Piroxicam……20mg
steroids (oxicams)
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 2x5’s; As per SRO
Brand Name +Dosage Form + Strength Trifluc Capsule 50mg
Fluconazole……50mg
Pharmacological Group Antimycotics for systemic use
Type of Form Form 5
Approval status of product in Azocan 50mg Capsules by FDC International Ltd. MHRA
Me-too status Fungon Capsules 50mg by Dyson Research Laboratories.
Reg. No. 55352
Type of Form Form 5
Approval status of product in Fluconazole 150mg capsule by Bristol Laboratories
Me-too status Fungon Capsules 150mg by Dyson Research
Laboratories. Reg. No. 55353
Type of Form Form 5
Approval status of product in Azocan 200mg Capsules by FDC International Ltd.
Reference Regulatory Authorities. MHRA approved
Me-too status Fcozole 200mg Capsules by Medicraft Pharmaceuticals
(Pvt) Ltd. Reg. No. 60237
Brand Name +Dosage Form + Strength Triazit Capsule 250mg
Azithromycin as dihydrate……250mg
Type of Form Form 5
Approval status of product in Azithromycin 250 mg Capsules by Jubilant
Reference Regulatory Authorities. Pharmaceuticals nv. MHRA approved
Me-too status Azofas 250mg Capsules by Fassgen Pharmaceuticals.
Reg. No. 60291
Brand Name +Dosage Form + Strength Trimado Capsule 50mg
Tramadol HCl……50mg
Type of Form Form 5
Approval status of product in Tramadol 50mg by Milpharm Limited. MHRA approved
Me-too status Tramadol 50mg Capsule by Highnoon Pharma. Reg No.
13193
Evaluator PEC-VIII
CLB in its 265th Meeting held on 9th & 10th August, 2018 has considered & approved the grant of DML
to M/s. Nicholas Pharmaceuticals by the way of formulation with following four sections:
1. Capsule Section (Ceph)
2. Dry Suspension Section(Ceph)
3. Dry Powder Injectable Section(Ceph)
4. Dry Powder Injectable Section(Carbapenems)
Now the Applicant has applied for following molecules/products against Dry Suspension Section(Ceph)
section:
Sr. No. Sections No. of Molecules/products
4. Dry Suspension Section (Ceph) 08M/15P
Molecules; 08 : Products; 15
582. Name and address of manufacturer / M/S Nicholas Pharmaceuticals, Plot # 34 St # SS-02
Applicant National Industrial Zone Rawat Islamabad Pakistan
Brand Name +Dosage Form + Strength Nicoxime Dry Suspension 100mg/5ml
Composition Each 5ml after reconstitution contains:
Cefixime (as trihydrate)…..100mg
Diary No. Date of R& I & fee Dy.No.30606; 11-09-2018; Rs.20,000/-
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form 5
Finished product Specifications USP Specification
Pack size & Demanded Price 30ml ; As per PRC
Me-too status (with strength and Stlicef Dry Suspension 100mg/5ml of Treat Pharma
dosage form)
GMP status New DML dated 29 -08-2018
Remarks of the Evaluator  Applicant has mentioned glass bottles & Pet
bottles as a type primary packaging material
while Reference product is packed in glass bottle.
Clarification is required which container closure
system will be used for applied formulation.
(Now the applicant has submitted amber glass bottle
as a container closure system).
 The undertaking of Form 5 regarding correctness
of contents of dossier has not been signed by the
authorized personnel.
(Now the firm has submitted signed undertaking.)
Decision: Approved.
583. Name and address of Manufacturer / M/S Nicholas Pharmaceuticals, Plot # 34 St # SS-02
Brand Name+Dosage Form+Strength Nicoxime Dry Suspension 200mg/5ml
Cefixime (as trihydrate)…..200mg
Diary No. Date of R&I & fee Dy.No.30607; 11-09-2018; Rs.20,000/-
Type of Form Form 5
Pack Size & Demanded Price 30ml ; As per PRC
Approval status of product in Reference Approved in US-FDA
Me-too status Stlicef Dry Suspension 200mg/5ml of Treat Pharma
GMP status New DML (Letter Issuance Date: 29 -08-2018)
Remarks of evaluator  Applicant has mentioned glass bottles & Pet
while Reference product is packed in glass
bottle. Clarification is required which
container closure system will be used for
 The undertaking of Form 5 regarding
correctness of contents of dossier has not
been signed by the authorized personnel.
Decision: Approved.
Brand Name+DosageForm +Strength N-Prozil Dry Suspension 125mg/5ml
Cefprozil (as monohydrate)…..125mg
Type of Form Form 5
Me-too status Neuprozil Dry Suspension of M/s Neutro Pharma
Decision: Approved.
Brand Name+DosageForm +Strength N-Prozil Dry Suspension 250mg/5ml
Cefprozil (as monohydrate)…..250mg
Type of Form Form 5
Me-too status Fondam Dry Suspension 250mg of Navegal
Laboratories,
(Applicant has submitted amber glass bottle as a
container closure system).
(Now the firm has submitted signed undertaking.
Decision: Approved.
Brand Name+DosageForm +Strength N-Colex Dry Suspension 125mg/5ml
Cephalexin (as monohydrate)…..125mg
Type of Form Form 5
Approval status of product in Reference Approved in MHRA
Me-too status Vegzin 125mg Dry Powder Suspension of M/s Vega
Pharmaceuticals
Remarks of evaluator Reference Product Is Packed In HDPE Bottle But
Applicant Mentioned Pet Bottle.
Decision: Approved.
Brand Name+DosageForm +Strength N-Colex Dry Suspension 250mg/5ml
Cephalexin (as monohydrate)…..250mg
Type of Form Form 5
Approval status of product in Reference Approved in MHRA
Me-too status Vegzin 250mg Dry Powder Suspension of M/s Vega
Pharmaceuticals
Remarks of evaluator Reference Product Is Packed In HDPE Bottle But
Applicant Mentioned Pet Bottle.
Decision: Approved.
Brand Name + Dosage Form +Strength N-CEF Dry Suspension 250mg/5ml
Cephradine (as monohydrate)…..250mg
Type of Form Form 5
Approval status of product in Reference Approved in MHRA(Powder for Syrup)
Me-too status SN Sef 250 mg Dry Powder Suspension of SNB
Pharma
(Now the firm has submitted signed undertaking.
Decision: Approved.
Brand Name + Dosage Form +Strength N-Buten Dry Suspension 90mg/5ml
Ceftibuten (as dihydrate)…..90mg
Type of Form Form 5
Me-too status Xigris Dry Suspension of M/s. Wilshire Laboratories
while Reference product is packed in glass bottle.
Clarification is required which container closure
system will be used for applied formulation.
Decision: Approved.
Brand Name +Dosage Form + Strength Ndroxil 125mg/5ml Dry Suspension
Cefadroxil (as monohydrate) …..125mg
(10-09-2018)
Type of Form Form 5
Approval status of product in Oracefal 125mg/5ml powder for oral
Reference Regulatory Authorities suspension by M/s Bristol-Myers Squibb (ANSM
Approved)
Me-too status (with strength and Oxibac 125mg/5ml Dry powder Suspension M/s
dosage form) UDL
Decision: Approved.
Brand Name +Dosage Form + Strength Ndroxil 250mg/5ml Dry Suspension
Cefadroxil (as monohydrate)…..250mg
(10-09-2018)
Type of Form Form 5
Approval status of product in Cefadroxil 250 mg / 5 ml powder for oral
Reference Regulatory Authorities suspension of MHRA approved
Me-too status (with strength and Oxibac 250mg/5ml Dry powder Suspension M/s
dosage form) UDL
Decision: Approved.
Brand Name +Dosage Form + Strength Nicolor 125mg/5ml Dry Suspension
Cefaclor (as monohydrate) …..125mg
Diary No. Date of R& I & fee Dy.No.30632; 11-09-2018; Rs.20,000/- (10-09-
2018)
Type of Form Form 5
Approval status of product in Cefaclor 125mg / 5 ml powder for oral
Me-too status (with strength and Cefatek -125 Oral Suspension M/s Wellborne
dosage form) Pharmachem and Biologicals,
Decision: Approved.
Brand Name +Dosage Form + Strength Nicolor 250mg/5ml Dry Suspension
Cefaclor (as monohydrate) …..250mg
(10-09-2018)
Type of Form Form 5
Approval status of product in Cefaclor 250mg/5ml powder for oral
Me-too status (with strength and Cefatek -250 Oral Suspension M/s Wellborne
dosage form) Pharmachem and Biologicals,
Decision: Approved.
Brand Name +Dosage Form + Strength N-Podox 40mg/5ml Dry Suspension
Cefpodoxime (as proxetil)……..40mg
(10-09-2018)
Type of Form Form 5
Approval status of product in Cefpodoxime 40mg/5ml powder for oral
Me-too status (with strength and Podomax Dry Suspension of M/s Hicon
dosage form) Pharmaceuticals
Decision: Approved.
Cefpodoxime (as proxetil)……..50mg
(10-09-2018)
Type of Form Form 5
Approval status of product in Cefpodoxime proxetil 50mg / 5 ml powder for oral
Reference Regulatory Authorities suspension of USFDA approved
Me-too status (with strength and Qink Dry Suspension of M/s Wilshire Laboratories
dosage form)
Decision: Approved.
Cefpodoxime(as proxetil)……..100mg
(10-09-2018)
Type of Form Form 5
Approval status of product in Cefpodoxime proxetil 100mg / 5 ml powder for oral
Reference Regulatory Authorities suspension of USFDA approved
Me-too status (with strength and Qink Dry Suspension of M/s Wilshire Laboratories
dosage form)
Decision: Approved.
Evaluator PEC-VII
M/s Parkar Pharma, Sindh (New License)
CLB in its 259th meeting held on 29th -30th March 2018 has considered and granted the Drug
Manufacturing License (DML) to M/ s Parkar Pharmaceuticals and granted three (03) new sections to
the firm. Accordingly, firm has applied for following products for consideration by Drug Registration
Board.
Sr. No Section No. of products No. of molecules

1 Tablet (General) Section 6 4
2 Capsule (General) Section - -
3 Liquid Syrup (General) Section
597. Name and address of manufacturer / M/S Parkar Pharma Plot No.O/7-A S.I.T.E Area Kotari
Applicant Sindh.
Brand Name +Dosage Form + Strength Parkofen 200mg Tablet
Dated 16-07-2018
Composition Each sugar coated tablet contains:-
Ibuprofen ……..200mg
Type of Form Form-5
Approval status of product in Anadin Ibuprofen 200 mg Tablets (MHRA)
Me-too status Brufen 200mg of Abbott laboratories
GMP status Grant of DML Approved dated:11-04-18
Decision: Approved.
598. Name and address of manufacturer / M/S Parkar Pharma Plot No.O/7-A S..I.T.E Area Kotari
Applicant Sindh.
Brand Name +Dosage Form + Strength Drotex 40mg Tablet
Dated 16-07-2018
Drotaverine as hydrochloride………40mg
Pharmacological Group Non-anticholinergic antispasmodic
Type of Form Form-5
Approval status of product in Approved by 3 EMA member states i.e. Poland,
Reference Regulatory Authorities. Hungary, Latvia
Me-too status No-Spa 40mg tablet of M/s Sanofi Aventis
Applicant Sindh.
Brand Name +Dosage Form + Strength Thyrozole 5mg Tablet
Dated 16-07-2018
Carbimazole…5mg
Pharmacological Group Antithyroid
Type of Form Form-5
Approval status of product in MHRA (uncoated tablet)
Me-too status Carbizole of Pharmedic (Pvt) Ltd.
Remarks of the Evaluator. On form 5 both sugar coated and film coated is
mentioned. Clarify and provide reference in RRA.
Revised Form 5 for uncoated tablet has been submitted
along with feee of Rs. 5,000/- (vide deposit slip#
0808316 dated 06-11-2018) for change of formulation.
Applicant Sindh.
Brand Name +Dosage Form + Strength Drotex Forte 80mg Tablet
Dated 16-07-2018
Drotaverin HCL…80mg
Type of Form Form-5
Approval status of product in Approved by 3 EMA member states i.e.Lithuania,
Reference Regulatory Authorities. Hungary, Latvia.
Me-too status No-Spa Forte
Applicant Sindh.
Brand Name +Dosage Form + Strength Parkofen 600mg Tablet
Dated 16-07-2018
Composition Each sugar coated tablet Contains:
Ibuprofen…600mg
Type of Form Form-5
Approval status of product in Brufen tablet (MHRA)
Me-too status Actifen Of Glaxosmithkline
Remarks of the Evaluator. The firm originally applied for sugar coated tablet but
revised its formulation to film coated with 5000/- fee.
Decision: Approved.
Applicant Sindh.
Brand Name +Dosage Form + Strength Parkofen 400 mg Tablet
Dated 16-07-2018
Composition Each sugar coated tablet Contains:
Ibuprofen…400mg
Type of Form Form-5
Approval status of product in Brufen tablet (MHRA)
Me-too status Actifen Of Glaxosmithkline
Remarks of the Evaluator. The firm originally applied for sugar coated tablet but
revised its formulation to film coated with 5000/- the
fee.
Decision: Approved.
Evaluator PEC-V
M/s Parkar Pharma, Sindh (New License)
CLB in its 259th meeting held on 29th -30th March 2018 has considered and granted the Drug
Manufacturing License (DML) to M/ s Parkar Pharmaceuticals and granted three (03) new sections to
the firm. Accordingly, firm has applied for following products for consideration by Drug Registration
Board
Sr. No. Section No. of Products No. of Molecules
1. Capsule 1 1
Capsule (General) Section
Products/ 1 Molecules
603. Name and address of manufacturer / M/s Parkar Pharma Plot No.O/7-A S..I.T.E Area Kotari
Applicant Sindh.
Brand Name +Dosage Form + Strength Parkomycin Capsule 100mg
Doxycycline as doxycycline hyclate…..100mg
Diary No. Date of R& I & fee Dy.No;16429 Date:03-05-18 , Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price As per DRAP policy
8,10,14,50 cap PVC/ALU
Me-too status Cherdox by Cherwal Pharmaceuticals
GMP status Grant of DML Approved dated:11-04-18.
Decision: Approved.
Evaluator PEC-VI
604. Name and address of manufacturer / M/s Parkar Pharma. Plot No. O/7-A, S.I.T.E Area
Applicant Kotri, Sindh
Brand Name +Dosage Form + Strength Clindap 150mg Capsule
Clindamycin as HCl….…150mg
Diary No. Date of R& I & fee Dy.No 24901 dated 18-07-2018 Rs.20,000/-
Dated 16-07-2018
Pharmacological Group Lincosamide Antibiotic
Type of Form Form-5
Pack size & Demanded Price 24’s, 100’s, 16’s, As per Drap Policy
Approval status of product in Dalacin C capsule by Pfizer
Me-too status Dalacin C capsule by Pfizer
GMP status The CLB in its 259th meeting held on 29th and 30th
March 2018 has considered and approved the grant of
DML by way of formulation.
a) Tablet (General Section)
b) Capsule (General Section)
c) Liquid Syrup (General Section)
Decision: Approved.
605. Name and address of manufacturer / M/s Parkar Pharma.
Applicant Plot No. O/7-A, S.I.T.E Area Kotri, Sindh
Brand Name +Dosage Form + Strength Clindap 300mg Capsule
Clindamycin as HCl……300mg
Dated 16-07-2018
Pharmacological Group Lincosamide Antibiotic
Type of Form Form-5
Pack size & Demanded Price 24’s, 100’s, 16’s, As per Drap Policy
Me-too status Uniclin 300mg Capsule Reg # 076225
Decision: Approved.
Brand Name +Dosage Form + Strength Parkocyclin 500mg Capsule
Oxytetracycline as HCl…500mg
Dated 16-07-2018
Pharmacological Group Tetracycline Antibiotic
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per Drap Policy
Approval status of product in Not Confirmed
Me-too status Not Confirmed
Remarks of Evaluator International availability and me-too status could not
be confirmed.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm
Brand Name +Dosage Form + Strength Parkocyclin 250mg Capsule
Oxytetracycline as HCl…250mg
Dated 16-07-2018
Type of Form Form-5

Me-too status Oxytetracycline Capsules 250mg Reg#016977 Jiangsu
Pharma, China. Imported by Afzal Corp Karachi
Decision: Approved.
Brand Name +Dosage Form + Strength Parkopentin 400mg Capsule
Gabapentin…400mg
Dated 16-07-2018
Pharmacological Group Anti-convulsant
Type of Form Form-5
Approval status of product in Neurontin of ( USFDA approved)
Me-too status Notensil 400mg Capsules of M/s Pulse
Pharmaceutical
d) Tablet (General Section)
e) Capsule (General Section)
f) Liquid Syrup (General Section)
Decision: Approved.
Gabapentin…300mg
Dated 16-07-2018
Type of Form Form-5
Pharmaceutical
Decision: Approved.
Gabapentin…600mg
Dated 16-07-2018
Type of Form Form-5
Me-too status Kendis Tablets 600mg Reg # 064838
Decision: Approved.
Gabapentin…100mg
Dated 16-07-2018
Type of Form Form-5
Pharmaceutical
Decision: Approved.
Brand Name +Dosage Form + Strength Tramadox 50mg Capsule
Tramadol HCL…50mg
Dated 16-07-2018
Pharmacological Group Narcotic analgesic
Type of Form Form-5
Me-too status Magadol 50mg Capsule of Safe Pharmaceuticals,
Karachi.
d) Tablet (General Section)
e) Capsule (General Section)
f) Liquid Syrup (General Section)
Decision: Approved.
b. New/Additional section(s)
Evaluator PEC-V
th th th
The Central Licensing Board in its 265 meeting held on 09 -10 August, 2018 has considered and
approved the grant of following one (01) additional section of firm M/s. Shaheen Pharmaceuticals, 3-
K.M Murghzar Road, Siadu Sharif, Swat (Drug Manufacturing License No. 000562-Forrmulation) as
under:-
Section (01).
Psychotropic Tablet Section in place of Quinolone Tablet section and shifting of Quinolone tablet
section to tablet General Section.
14 Products/5 Molecules
613. Name and address of Manufacturer / M/s Shaheen Pharmaceuticals.
Applicant 3 km, Murghzar Road,Saidu Sharif, Swat
Brand Name+DosageForm+Strength Dipam Tablet 5mg
Diazepam…5mg
Diary No. Date of R&I & fee Dy No.30435; 10-09-2018; Rs.20,000/-
Pharmacological Group Anxiolytics
Benzodiazepine derivative
ATC Code: N05BA01
Type of Form Form 5
Pack Size & Demanded Price 3x10’s, As per PRC
Me-too status 065299; Dipam tablet
By Leads Pharma Pvt Ltd,
GMP status The Central Licensing Board in its 265th meeting held on
09th -10th August, 2018 has considered and approved the
grant of following one (01) additional section
1. Psychotropic Tablet Section in place of Quinolone
Tablet section and shifting of Quinolone tablet section to
tablet General Section.
Remarks of Evaluator Approved in USFDA with box warning.
Firm has revised their formulation from film coated to
uncoated tablet without the submission of fee.
Decision: Deferred for submission of fee of Rs. 5000/- as the formulation has been revised
from film coated to uncoated tablets.
Applicant 3 km, Murghzar Road,Saidu Sharif
Diazepam…2mg
ATC Code: N05BA01
Type of Form Form 5
Me-too status 064075; Anxosal 2mg Tablets
By Universal Pharmaceuticals (Pvt) Ltd.
Diazepam…10mg
ATC Code: N05BA01
Type of Form Form 5
Me-too status 065300; Dipam tablet
By Leads Pharma Pvt Ltd,
Brand Name+DosageForm+Strength Zepam Tablet 6mg
Composition Each tablet contains: Bromazepam…6mg
ATC Code: N05BA08
Type of Form Form 5
Finished Product Specification Inhouse
Approval status of product in TGA Approved (uncoated)
Me-too status 079326; "Normeez 6mg Tablets
By Navegal Laboratories
Remarks of Evaluator Firm has revised their formulation from film coated to
Brand Name+DosageForm+Strength Zepam Tablet 1.5 mg
Bromazepam…1.5 mg
ATC Code: N05BA08
Type of Form Form 5
Finished Product Specification In-house
Pack Size & Demanded Price 3x10’s, As per SRO.
Approval status of product in Could not be confirmed.
Me-too status 071219; Yazd 1.5mg Tablet
By M/s. Wilshire Laboratories (Pvt) Ltd;
Decision: Deferred for the following reasons:
 Submission of fee of Rs. 5000/- as the formulation has been revised from film coated
to uncoated tablets.
 Evidence of approval of applied formulation in reference regulatory authorities/
agencies which were declared/approved by the Registration Board in its 275 th
meeting.
Brand Name+DosageForm+Strength Zepam Tablet 3mg
Bromazepam…3mg
ATC Code: N05BA08
Type of Form Form 5
Pack Size & Demanded Price 3x10’s, As per SRO.
Approval status of product in TGA Approved
Me-too status 079327; "Normeez 6mg Tablets
By Navegal Laboratories
Brand Name+DosageForm+Strength Nazep Tablet 0.5mg
Composition Each tablet contains::
Clonazepam…0.5mg
Benzodiazepine derivatives
ATC Code: N03AE01
Type of Form Form 5
Me-too status 068006; "Clonazil Tablet 0.5mg
By "M/s English Pharm,

Brand Name+DosageForm+Strength Nazep Tablet 1mg
Clonazepam…1mg
ATC Code: N03AE01
Type of Form Form 5
Me-too status 065700; "Curo 1mg Tablets
"M/s. Wilshire Laboratories (Pvt) Ltd;
Brand Name+DosageForm+Strength Nazep Tablet 2mg
Clonazepam…2mg
ATC Code: N03AE01
Type of Form Form 5
Me-too status 068001; "Clonazil Tablet 2mg By "M/s English Pharm,
Brand Name+DosageForm+Strength Butone Tablet 30mg
Phenobarbitone…30mg
Barbiturates and derivatives
ATC Code: N03AA02
Type of Form Form 5
Approval status of product in MHRA Approved (uncoated)
Me-too status 065717; "Phenotone Tablets by "M/s Rasco Pharma,
Brand Name+DosageForm+Strength Alpraz Tablet 2mg
Alprazolam…2mg
ATC Code: N05BA12
Type of Form Form 5
Approval status of product in USFDA Approved (uncoated)
Me-too status 065695; Lydia 2mg Tablets by M/s. Wilshire Laboratories
(Pvt) Ltd;
Brand Name+DosageForm+Strength Alpraz Tablet 1mg
Alprazolam…1mg
ATC Code: N05BA12
Type of Form Form 5
Me-too status 065699; Lydia 1mg Tablets
by M/s. Wilshire Laboratories (Pvt) Ltd;
Brand Name+DosageForm+Strength Alpraz Tablet 0.25mg
Alprazolam…0.25mg
ATC Code: N05BA12
Type of Form Form 5
Me-too status 065697; Lydia 0.25mg Tablets
Brand Name+DosageForm+Strength Alpraz Tablet 0.5mg
Alprazolam…0.5mg
ATC Code: N05BA12
Type of Form Form 5
Me-too status 065705; Lydia 0.25mg Tablets
Evaluator PEC-VIII
CLB in its 256th Meeting held on 9th & 10th August, 2018 has considered & approved the grant of following
two additional sections of your firm M/s. Alliance Pharmaceuticals, by the way of formulation with
following four sections:
1. Capsule Section (general)
2. Dry Suspension Section (general)
Now the Applicant has applied for following molecules/products against Dry powder suspension (general)
section:
Sr. No. Sections No. of Molecules/products
1. Dry powder suspension (general) 10M/14P
Capsule Section (general): Molecules;10 Products;14
627. Name and address of Manufacturer / M/s Alliance Pharmaceuticals, Plot # 112-A, Hayatabad
Applicant Industrial Estate Peshawar.
Brand Name +Dosage Form +Strength Ezole Capsule 20mg
Esomeprazole (as magnesium trihydrate) …20mg
(Enteric Coated Pellets)
Source of pellets: Vision Pharmaceuticals
Diary No. Date of R&I & fee DyNo.33769;11-10-2018; Rs. 20,000/-
Type of Form Form-5
Pack Size & Demanded Price 10’s, 14’s: As per SRO
Me-too status Sold Capsule 20mg of M/s Regal Pharmaceuticals
GMP status New Section (letter issuance date: 19th December, 2017)
Panel Inspection conducted on 30-08-2018 recommends the
grant of cGMP Certificate to the firm. It is also mentioned
within the report that Alliance Pharmaceuticals has been
granted above stated section vide letter No. F3-1/2002-Lic
(Vol-I) on 19th December, 2017 but still there is neither any
product registered nor any activity at the time of inspection.
Decision: Approved.
Brand Name +Dosage Form +Strength Ezole Capsule 40mg
Esomeprazole (as magnesium trihydrate) …40mg
(Enteric Coated Pellets)
Type of Form Form-5
Pack Size & Demanded Price 14’s: As per SRO
Me-too status Sold Capsule 40mg of M/s Regal Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form +Strength A-Pril Capsule 20mg
Omeprazole …20mg
(Enteric coated pellets)
Type of Form Form-5
Pack Size & Demanded Price 10’s,14’s: As per SRO
Me-too status Jumep -20 Capsule of M/s Jupiter Pharma
Decision: Approved.
Brand Name +Dosage Form +Strength A-Pril Capsule 40mg
Omeprazole…40mg
(Enteric coated pellets)
Diary No. Date of R&I & fee DyNo.33763;11-10-2018: Rs. 20,000/-
Type of Form Form-5
Me-too status Jumep -40 Capsule of M/s Jupiter Pharma
Decision: Approved.
Brand Name +Dosage Form +Strength Flucoz Capsule 150mg
Fluconazole …150mg
Diary No. Date of R&I & fee DyNo.33762;11-10-2018: Rs. 20,000/-
Pharmacological Group Anti-Fungal
Type of Form Form-5
Me-too status Fiscon 150mg capsule of Fassgen
Monograph for analysis of applied formulation is not
present in USP rather it is present in BP.
Brand Name +Dosage Form +Strength Amodim Capsule 2mg
Loperamide hydrochloride…2mg
Pharmacological Group Antipropulsives
Type of Form Form-5
Finished Product Specification BP Specifications
Pack Size & Demanded Price 6×10’s: As per SRO
Me-too status Molin 2mg Capsule of Asian Continental (Pvt.) Ltd.
Remarks of Evaluator  Justification on scientific basis for addition of 3%
overage in master formulation.
(Firm has submitted the master formulation without
overage)
Decision: Approved.
Brand Name +Dosage Form +Strength Florek Capsule 20mg
Fluoxetine (as hydrochloride)…20mg
Type of Form Form-5
Me-too status Flufa 20mg Capsules of Farm Aid Group
Remarks of Evaluator  Justification on scientific basis for addition of 3%
(Firm has submitted the master formulation without
overage)
Decision: Approved.
Brand Name +Dosage Form +Strength Diclorex SR Capsule 100mg
Diclofenac sodium…100mg
Type of Form Form-5
Me-too status Fentolit-100 mg SR Capsules of Wnsfeild Pharmaceutical,
GMP status New License (letter issuance date: 29th August 2018)
Remarks of Evaluator Applicant has claimed BP Specifications & applied
formulation is also present in BP.
But pellets of Vision Pharmaceuticals comply with in-house
specifications than how can finished product comply with
BP specifications. Justify/Clarify
Decision: Registration Board deferred for clarification/Justification from the firm regarding
difference in specifications of pellets (inhouse) and finished product (BP).
Brand Name +Dosage Form +Strength Azizox Capsule 250mg
Azithromycin (as dihydrate)….250mg
Type of Form Form-5
Me-too status Azirik Capsule 250 mg of Aurik Pharmaceuticals
Remarks of Evaluator  Applied formulation is not present in BP rather it is
present in USP.
 Justification of 3% overage in master formulation.
(Firm has submitted the master formulation without overage)
Decision: Approved.
Brand Name +Dosage Form +Strength Azizox Capsule 500mg
Azithromycin (as dihydrate)….500mg
Type of Form Form-5
Approval status of product in Could not be confirmed.
Me-too status Azirik Capsule 250 mg of Aurik Pharmaceuticals
present in USP.
 Justification of 3% overage in master formulation.
 Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/
approved by the Registration Board in its 275th meeting.
 Evidence of applied formulation/drug already approved
by DRAP (generic/me-too status) alongwith registration
Decision: Registration Board deferred the case for the following reasons:
agencies which were adopated by the Registration Board in its 275th meeting.
status) alongwith registration number, brand name and name of firm.
 Justification on scientific basis for addition of overage in master formulation.
Brand Name +Dosage Form +Strength Pricam Capsule 20mg
Piroxicam …20mg
Type of Form Form-5
Approval status of product in Approved in ANSM
Me-too status Jucam 20 mg of M/s Jupiter Pharma
present in USP.
Decision: Approved with USP Specifications.
Brand Name +Dosage Form +Strength Lensozole Capsule 30mg
Lansoprazole…30mg
(Enteric coated pellets, USP)
(Source of pellets: Vision Pharmaceuticals)
Pharmacological Group PPIs
Type of Form Form-5
Me-too status Vosta capsule 30mg M/s Linta Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form +Strength Diclorex Capsule 50mg
Composition Each SR Capsule Contains:
Diclofenac acid…50mg
(Diclofenac sodium EC pellets)
Type of Form Form-5
present in USP.
 Mention type of primary packaging, material of applied
formulation.
 Firm has claimed BP specification & pellets by vision
Pharmaceuticals are of in house grade.
regulatory authorities/agencies which were
meeting.
by DRAP (generic / me-too status) alongwith registration
 You have applied for Diclofenac sodium extended release
capsule but pellets are enteric coated, justify/clarify.
 Evidence of approval of applied formulation in reference regulatory
 Mention type of primary packaging, material of applied formulation.
 Clarification/Justification is required that how can a finished product comply with BP
specifications; which is claimed by the firm, if the pellets by the source i.e. “Vision
Pharmaceuticals” comply with in-house specifications/are of in-house grade.
 Clarification is required weather the applied formulation is Diclofenac sodium
Sustained Release capsule or otherwise as application is for sustained release capsules
but pellets are Enteric Coated.
Brand Name +Dosage Form +Strength Diclorex Capsule 75mg
Composition Each SR Capsule Contains:
Diclofenac acid…75mg
(Diclofenac sodium EC pellets)
Type of Form Form-5
present in USP.
 Mention type of primary packaging, material of applied
formulation.
 Firm has claimed BP specification & pellets by vision
Pharmaceuticals are of in house grade.
 COA, GMP of pellets manufacturer, stability studies both
accelerated & real time of three batches of pellets
conducted in accordance with zone VI-A conditions.
 Mention type of primary packaging, material of applied formulation.
 Clarification/Justification is required that how can a finished product comply with BP
specifications; which is claimed by the firm, if the pellets by the source i.e. “Vision
Pharmaceuticals” comply with in-house specifications/are of in-house grade.
 Clarification is required weather the applied formulation is Diclofenac sodium
Sustained Release capsule or otherwise as application is for sustained release capsules
but pellets are Enteric Coated.
Evaluator-PEC-VI
Application was received through letter No. F 6-2/2016 (R-III)
CLB in its 252nd Meeting granted approval of new section “Soft Gelatin capsule‘ to M/s. Crystolite
Pharmaceuticals, Islamabad. The details of molecules and products already granted to firm for this
section is as under
Sr. No. Meeting No. No of molecules considered No. of Products considered
1 270th 1 2
2 271st 1 2
3 274th 1 3
Now firm has submitted 1 more molecule/ 1 product that is presented below.
Soft Gelatin Capsule----- 1 Molecule/ 1 Product
641. Name and address of manufacturer / M/s. Crystolite Pharmaceuticals (Pvt) Ltd. Plot# 1 & 2,S-
Applicant 2, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength D-Plus Soft Gelatin Capsule
Composition Each soft gelatin Capsule Contains:
Cholecalciferol (equivalent to 1.25mg Vitamin D3)
……50,000IU
Type of Form Form-5
Pack size & Demanded Price 3’s, 10’s, As per Drap Policy
Me-too status VITAMIN D3 SOFTGEL CAPSULES.
EACH CAPSULE CONTAINS:-
Cholecalciferol 50000IU.Maxcon Lahore Reg # 59290
GMP status GMP Inspection report conducted on 17th October 2017
concluded that firm is operating at good level of GMP.
Decision: Approved.
M/s Delta Pharma Pvt Ltd, Plot # 9, Nowshera, Risalpur, KPK
CLB in its 256th meeting held on 9th-10th November 2017 has considered and approved the grant of DML
(Afresh) by way of formulation for the following sections
a) Tablet section (General)
b) Capsule section (General)
Tablet section(General)
Registration Section (R-IV) had placed before the board 11 Molecules/ 13 Products in M-278th, out of
which 5 Molecules / 7 Products were approved by the Board in this meeting.
5 Molecules / 5 Products (Previously deferred in M-278th) were again placed before the board in M-281st
out of which 3 Molecules / 3 Products were Approved in this meeting.
Total of 8 Molecules / 12 Products are approved yet.
Now firm has requested (Incharge PEC, Copy is also forwarded to Registration -IV) to withdraw the
following 4- Molecules / 4- Product in order of numerical priority as.
1) Ketery 200mg tablet (Deferred in M-281st )
2) Delmol CF tablet (Deferred in M-281st )
3) Dardnil 75mg Tablet (Rejected in M-278th )
4) Nymph Tablets (Approved in M-281st )
And accordingly requested to consider the following applications 4 Molecules/ 4 Products in order of
numerical priority as
1) Betadox 20mg tablet
2) Linzodel 400mg tablet
3) Moxin 400mg tablet
4) Claricin 500mg tablet
Tablet section (General) 4 Molecules / 4 Products
642. Name and address of manufacturer / M/s Delta Pharma Pvt Ltd, Plot # 9, Nowshera, Risalpur,
Applicant KPK
Brand Name +Dosage Form + Strength Betadox tablets
Piroxicam B cyclo dextrin 191.2mg eq to
Piroxicam……20mg
Type of Form Form-5
Approval status of product in CYCLADOL 20mg Tablet ANSM France Approved
Me-too status Ripax 20mg by Hilton
GMP status CLB in its 256th meeting held on 9th-10th November 2017
has considered and approved the grant of DML (Afresh)
by way of formulation.
 Deferred for consideration on its turn with respect to
the queue.
Evaluation by PEC:
Decision: Registration Board acceded the firm’s request and decided to reject Katery 200mg
tablet and Delmol CF tablet (Deferred in M-281st ) and in leiu of that Approved Betadox tablets
20mg with innovator’s specification.
Applicant KPK
Brand Name +Dosage Form + Strength Linzodel 400mg tablet
Linezolid……..400mg
Type of Form Form-5
Me-too status Ecasil tablet of M/s Sami Pharmaceuticals
(Reg. # 067162)
the queue.
Evaluation by PEC:
Decision: Registration Board acceded the firm’s request and decided to reject Katery 200mg
tablet and Delmol CF tablet (Deferred in M-281st ) and in leiu of that Approved Linzodel
400mg tablet with innovator’s specification.
Applicant KPK
Brand Name +Dosage Form + Strength Moxin 400mg tablet
Moxifloxacin as HCl….400mg
Type of Form Form-5
Me-too status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
the queue.
Evaluation by PEC:
Decision: Deferred for consideration on its turn with respect to the queue since firm has
availed quota of 10 molecules per section for priority consideration.
Applicant KPK
Brand Name +Dosage Form + Strength Claricin 500mg tablets
Clarithromycin……500mg
Pharmacological Group Macrolide
Type of Form Form-5
Approval status of product in Clarithromycin 500mg Film-coated Tablets by M/s
Reference Regulatory Authorities. Ranbaxy (UK) Limited, (MHRA approved)
Me-too status CLARION 500MG TABLET by M/s. 'Ferozsons Labs
(Reg#0002873)
th
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the queue.
Evaluation by PEC:
Decision: Deferred for consideration on its turn with respect to the queue.
c. Deferred cases
Evaluator PEC-VIII
646. Name and address of Manufacturer / M/s Cunnigham Pharmaceuticals (Pvt) Ltd. Plot No. 81
Applicant Sundar Industrial Estate Raiwind Road, Lahore.
Brand Name+Dosage Form+Strength Tranmic 250mg Capsule
Tranexamic acid…. 250mg
Pharmacological Group Anti-fibrinolytics
Type of Form Form-5
Finished Product Specification JP specifications
Pack Size & Demanded Price 2×10’s: As per SRO
Approval status of product in Approved in Japan
Me-too status Tranex 250mg Capsule of Mission Karachi.
GMP status New License (letter Issuance Date: )
Remarks of evaluator Applicant has added 5 % overage in master formulation.
Previous Decision Registration Board in its 284th meeting deferred the case for
following reason:
For justification on scientific basis for addition of 5%
Evaluation by PEC The firm has submitted master formulation without overage.
Decision: Approved.
647. Name and address of Manufacturer / Cunnigham Pharmaceuticals (Pvt) Ltd. Plot No. 81 Sundar
Applicant Industrial Estate Raiwind Road, Lahore.
Brand Name+Dosage Form+Strength Tranmic 500mg/5ml Injection (IV/)
Tranexamic acid…. 500mg
Pharmacological Group Anti-fibrinolytics
Type of Form Form-5
Finished Product Specification BP specifications
Pack Size & Demanded Price 10’s(5ml): As per SRO
Me-too status Tranex 500mg/5ml Injection of Atco Lab. Karachi
GMP status New License (letter Issuance Date: )
Reference of intramuscular use of applied formulation is
required.
following reason:
 For justification on scientific basis for addition of
5% overage in master formulation.
 Evidence of intramuscular use of applied
formulation in reference agencies.
Evaluation by PEC The firm has submitted the following:
 Master formulation without overage.
 Withdrawal of intramuscular use of applied
formulation.
Decision: Approved.
648. Name and address of Manufacturer / Cunnigham Pharmaceuticals (Pvt) Ltd. Plot No. 81 Sundar
Applicant Industrial Estate Raiwind Road, Lahore.
Brand Name+Dosage Form+ Strength Mecol 500mcg/ml Injection (IV)
Composition Each ampoule/ml contains:
Mecobalamine…. 500mcg
Pharmacological Group Co-enzyme-type vitamin B12
Type of Form Form-5
Finished Product Specification Manufacturer’s specifications
Pack Size & Demanded Price 10’s(1ml): As per SRO
Approval status of product in Approved in PMDA
Me-too status Wycomin 500 mcg Injection of Wnsfeild Pharmaceutical
GMP status New License (letter Issuance Date:13th June, 2016 )
Certificate of cGMP is issued to the firm based on evaluation
following reason:
 For justification on scientific basis for addition of
5% overage in master formulation.
Evaluation by PEC The firm has submitted the following:
 Master formulation without overage.
Case No. 03: Registration applications for local manufacturing of (veterinary) drugs
a. New cases
Evaluator PEC-II
649. Name and address of manufacturer / M/s Selmore Pharmaceuticals Pvt Ltd. 36-Km,
Applicant Multan Road Lahore.
Brand Name +Dosage Form + Strength Vital Forte Injection
Vitamin A…….100,000IU
Vitamin D3…..40,000 IU
Vitamin E……40mg
Pharmacological Group Vitamins
Type of Form Form-5
Pack size & Demanded Price 100ml; De-controlled
Approval status of product in Reference --
Me-too status (with strength and dosage ADE-MAX Injection of M/s. Nawan laboratories, Karachi
form) (Reg.# 058990)
GMP status Last GMP inspection conducted on 23-01-2018
concluding that firm is operating at Good level of GMP
compliance and recommending the grant of GMP
certificate to the firm for export purposes.
Decision: Approved.
Brand Name +Dosage Form + Strength Amino-V Forte Injection
DL-Acetylmethionine……200mg
Cyanocobalamin….…0.2mg
L-Carnitine hydrochloride…61.3mg Eq. to L-Carnitine
………….…50mg
Alpha-Tocopherol Acetate…32.9mg Eq. to alpha-
tocopherol …….…30mg
Pharmacological Group Vitamins & amino acids
Type of Form Form-5
Me-too status (with strength and dosage METABOLASE FORTE INJECTABLE SOLUTION of
form) M/s. Prix Pharmaceuticals, Lahore (Reg.#043109)
Decision: Approved.
Brand Name +Dosage Form + Strength Cynosel Injection
Cyanocobalamin (Vitamin B12)…250mcg
Pharmacological Group Vitamins
Type of Form Form-5
Me-too status (with strength and dosage Cyanocob 250 Injection of M/s. Prix Pharmaceuticals,
form) Lahore (Reg.#072692)
Decision: Approved.
652. Name and address of manufacturer / "M/s Leads Pharma Pvt Ltd.
Applicant 81-A, Street # 6, I-10/3, Islamabad"
Brand Name +Dosage Form + Strength Vety Flor Mix Powder
Composition Each gm Contains:
Neomycin Sulphate ……150mg
Oxytetracycline HCl ……300mg
Florfenicol …… 100mg
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 2.5Kg, 5.0Kg; De-
controlled
Me-too status (with strength and dosage E-Col of M/s. Evergreen (Reg.#081733)
form)
GMP status Last GMP inspection is conducted on 04-06-2018 and the
report concludes that firm was found to be operating at
good level of GMP compliance.
Decision: Approved.
653. Name and address of manufacturer / "M/s Mylab Pvt Ltd. Khankah Sharif Bahawalpur"
Applicant
Brand Name +Dosage Form + Strength Megacam Injection 50
Meloxicam…5mg
Diary No. Date of R& I & fee Dy. No 23796 dated 12-12-2017 Rs. 20,000
Dated 08-12-2017
Type of Form Form-5
Me-too status (with strength and dosage Sanoxicam-50 injection of M/s. Sanna Laboratories
form) (Reg.#078365)
GMP status Last GMP inspection conducted on 13-09-2018 and 14-
09-2018 recommending the renewal of DML
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Diminazine Injection
Diminazine diaceturate…….35mg
Dated 08-12-2017
Pharmacological Group Antiprotozoal drug
Type of Form Form-5
Me-too status (with strength and dosage Dimenol injection of M/s. Breeze Pharma Islamabad
form) (Reg.#059138)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Megacam 7.5mg Injection
Meloxicam…7.5mg
Dated 08-12-2017
Type of Form Form-5
Me-too status (with strength and dosage Camilox injection of M/s. Selmore Pharmaceutical (PVT)
form) LTD., Lahore. (Reg.#071089)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Hi-Immune Water Soluble Powder
Lysozyme……22%
Vitamin E……0.5%
Dated 08-12-2017
Pharmacological Group Antiinfective/Vitamin
Type of Form Form-5
Pack size & Demanded Price 500gm, 1000gm, 5000gm
Me-too status (with strength and dosage Vitozyme powder of M/s. Selmore Pharmaceutical (PVT)
form) LTD., Lahore. (Reg.#049622)
Decision: Registration Board referred the case to Expert Working Group on Veterinary Drugs.
Applicant
Brand Name +Dosage Form + Strength Saralin Injection
Spiramycin Adipate…125mg
Lincomycin HCl…75mg
Dated 08-12-2017
Type of Form Form-5
Me-too status (with strength and dosage LISPIRACIN INJECTION of M/s. LEADS PHARMA
form) (PVT) LTD., ISLAMABAD (Reg.#069602)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Diarest Suspension
Sulphadiazine...36mg
Sulphadimidine (Sodium)...35mg
Streptomycin Sulphate...7.6mg
Neomycin Sulphate...1.8mg
Sodium Chloride...11.33mg
Calcium Gluconate...2.2mg
Magnesium Sulphate...0.6mg
Potassium Chloride.....3.6mg
Kaolin...103.3mg
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Pectin...7.1mg
Glycin...20.9mg
Dated 08-12-2017
Pharmacological Group Combination of antibiotics, Anti toxins, Anti spasmodic &
Minerals
Type of Form Form-5
Pack size & Demanded Price 500ml, 1.0 ltr, 5.0ltr.
Me-too status (with strength and dosage NO-SCOUR ORAL SUSPENSION of M/s. M/S. NAWAN
form) LABORATORIES, KARACHI (Reg.#072673)
Applicant
Brand Name +Dosage Form + Strength Durectic Water Soluble Powder
Composition Each kg Contains:
Frusemide…20gm
Magnesium Sulphate…35gm
Maganese Sulphate…1gm
Potassium Chloride…400mg
Sodium Chloride…35gm
Calcium Carbonate…45gm
Dated 08-12-2017
Pharmacological Group Combination of Minerals & diuretic
Type of Form Form-5
Pack size & Demanded Price 500gm, 1000gm, 5000gm
Me-too status (with strength and dosage NEYPHRALYTE POWDER of M/s. SELMORE
form) PHARMACEUTICAL (Pvt) Ltd., Lahore. (Reg.#071072)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Termisole Drench
Tetramisole HCl…30.00mg
Dated 08-12-2017
Pharmacological Group Anthelmintic
Type of Form Form-5
Pack size & Demanded Price 100ml, 500ml, 1000ml
Me-too status (with strength and dosage VERMITOL 3% SOLUTION of M/s. VITAL MARK
form) LABORATORIES TOBA TEK SINGH. (Reg.#013689)
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Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Hi-Fenac Injection
Aceclofenac as sodium…25mg/ml
Dated 08-12-2017
Type of Form Form-5
Me-too status (with strength and dosage VETAFENAC-SUPER INJECTION Of M/s. S.J. & G.
form) FAZUL ELLAHIE (PVT) Ltd, Karachi. (Reg.#046569)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Toldin Injection
Toldimfos Sodium…200mg
Dated 08-12-2017
Pharmacological Group Tonic agent
Alimentary tract & metabolism; Mineral supplement
Type of Form Form-5
Me-too status (with strength and dosage TOLDIVET INJECTION Of M/s. LEADS PHARMA
form) (PVT) LTD., ISLAMABAD. (Reg.#043557)
GMP status Last GMP inspection conducted on 13-9-2018 & 14-9-
2018 recommending the renewal of DML
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Meprax Injection
Mepyramine maleate ….. 50mg
Dated 08-12-2017
Type of Form Form-5
Me-too status (with strength and dosage MEPRAWITS INJECTION Of M/s. WIMITS
form) PHARMACEUTICALS, (Reg.#078303)
Applicant
Brand Name +Dosage Form + Strength Butavet Injection
Buparvaquone…50mg
Dated 08-12-2017
Pharmacological Group Hydroxynaphthoquinone
Type of Form Form-5
Me-too status (with strength and dosage PARVON INJECTION Of M/s. SELMORE
form) Pharmaceuticals (Pvt) Ltd., Lahore. (Reg.#034580)
Decision: Approved.
Evaluator PEC-III
665. Name and address of manufacturer / M/s Mylab Pvt Ltd. Khankah Sharif Bahawalpur
Applicant
Brand Name +Dosage Form + Strength Levamax Drench
Levamisole…15mg
Type of Form Form 5
Pack size & Demanded Price 100ml, 150ml, 500ml, 1000ml
Approval status of product in N.A
Me-too status Levamit-Drench by Wimits Pharma (Reg# 078333)
GMP status Last GMP inspection report dated 13th and 14th September,
2018 recommended renewal of DML and grant of additional
sections.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Aldavec Drench
Albendazole…10gm
Triclabendazole…12gm
Ivermectin…0.2gm
Type of Form Form 5
Me-too status Thunder Drench by Star labs (Reg# 058941)
sections.
3
Applicant
Brand Name +Dosage Form + Strength Levanol Drench
Bithinol Sulfoxide…100mg
Levamisole…15mg
Type of Form Form 5
Me-too status Irchasol Suspension by Medi-Vet (Reg# 011092)
sections.
3
Applicant
Brand Name +Dosage Form + Strength Atrovin Injection
Atropine Sulphate…1mg
Pharmacological Group Anticholinergic
Type of Form Form 5
Me-too status Atopin Injection by Symans Pharma (Reg#062122)
sections.
Remarks of the Evaluator3.  Finished product specification is available in
USP but it does not specify whether for human and
veterinary use.
Decision: Approved with USP specification.
Applicant
Brand Name +Dosage Form + Strength Aspire-C Water Soluble Powder
Acetylsalicylic Acid…67mg
Vitamin C…200mg
Pharmacological Group Analgesic and vitamin
Type of Form Form 5
Pack size & Demanded Price 500g, 1000g, 5000g
Me-too status Gesix-C Water Soluble Powder by Prix Pharma
(Reg#043286)
sections.
Remarks of the Evaluator3.  The applied formulation is previously referred to
veterinary evaluation committee by the Registration Board.
Applicant
Brand Name +Dosage Form + Strength Albamax 25 Drench
Albendazole…25mg
Type of Form Form 5
Me-too status Alvenax 2.5% Drench by Star Labs (Reg#043298)
sections.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Coxivet Water Soluble Powder
Amprolium HCL…200mg
Ethopabate…20mg
Pharmacological Group Coccidiostat
Type of Form Form 5
Me-too status Ethoprol Powder by Selmore Pharma (Reg# 049617)
sections.
Applicant
Brand Name +Dosage Form + Strength Ectoflee Solution
Cypermethrin…10%w/v
Pharmacological Group Insecticide
Type of Form Form 5
Me-too status Ectorid Solution Disinfectant by Symans Pharma
(Reg#078372)
sections.
3
Remarks of the Evaluator .  The applied formulation is topical solution for use as
disinfectant/insecticide while the firm has following
approved sections only as per DML renewal report
 Liquid injectable (General vial)
 Oral Liquid (General)
 Oral Powder (General)
 Liquid Injectable (Penicillin)
 Dry powder injectable (Penicillin)
 Oral powder (Penicillin)
 Liquid Injectable (Hormone)
 Liquid Injectable (steroid)
 Oral liquid (General)
 Aerosol Veterinary
The firm has responded that they will manufacture this drug
in aerosol veterinary section. This section do not have
packing line for topical solution.
Decision: Registration Board deferred the case for confirmation of manufacturing facility from
Licensing Division.
Applicant
Brand Name +Dosage Form + Strength Megacam 10mg Injection
Meloxicam…10mg
Type of Form Form 5
Me-too status Meloxi-10 Injection by Selmore Pharma (Reg#049643)
sections.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Clozectin Injection
Closantel as Sodium…125mg
Ivermectin…10mg
Pharmacological Group Anthelmentic
Type of Form Form 5
Me-too status Pri-Closmec Injection by Prix Pharma (Reg# 080753)
sections.
3
Applicant
Brand Name +Dosage Form + Strength Neomax Forte Water Soluble Powder
Neomycin Sulphate…720mg
Type of Form Form 5
Me-too status Neomycin-72 Water Soluble Powder by Farm Aid Group
(Reg# 029669)
sections.
676. Name and address of manufacturer / M/s Elko Organization Pvt Ltd. Plot No.27 & 28, Sector 12-
Applicant B, North Karachi, Industrial Area, Karachi
Brand Name +Dosage Form + Strength El-Tylodox-BC Oral Powder
Tylosin Tartrate…100mg
Doxycycline HCL…200mg
Bromhexine…10mg
Colistin Sulphate…30mg
Pharmacological Group Broad spectrum antibiotic, anti-inflammatory and mucolytic
agent
Type of Form Form 5
Me-too status I-BROMOCOL TD POWDER by INTERNATIONAL
PHARMA (Reg#079225)
GMP status Routine GMP inspection conducted on 13-06-2017 & 06-07-
2017 concluded that the firm is operating at good level of
GMP compliance as of today 08.11.2018
677. Name and address of manufacturer/ M/s Noble Pharma Plot No. B-1, Old Industrial Area, Mirpur
Applicant AJK, Pakistan.
Brand Name+ dosage Form+ Strength Nobimint 10% Powder
Composition Each 100g contains:
Amantadine HCl……10gm
Diary No. Date of R&I & fee Dy No. 14205: 7-09-2017 PKR 20,000/-: 6-9-2017
Pharmacological Group Antiviral
Type of Form Form 5
Pack size & Demanded price 100g, 250g, 500g, 1Kg Jar : Decontrolled
Approval status of product in NA
Me-too status Amantabak 10% powder by Attabak Pharma
GMP status Last inspection report dated 08-11-2016: Firm is GMP
compliant
Decision: Registration Board referred the case to QA & LT Division for updated GMP status of
the firm.
Brand Name+ dosage Form+ Strength Nobifenda oral suspension
Oxfendazole…….2.265%w/v
Oxyclozanide…….6.25%w/v
Cobalt sulphate…….0.167%w/v
Sodium selinate……..0.05%w/v
Pharmacological Group Anthelmintic / De wormer
Type of Form Form 5
Pack size & Demanded price 100ml, 250ml, 500ml, 1L Pack : Decontrolled
Me-too status Crefenda Oral Suspension by Delux chemicals indusrties
compliant
the firm.
Brand Name+ dosage Form+ Strength Fighter suspension
Albendazole……10g
Ivermectin………0.2g
Triclabendazole…….12g
Pharmacological Group Anthelmintic / De wormer
Type of Form Form 5
Pack size & Demanded price 100ml, 250ml, 500ml, 1L Pack : Decontrolled
Me-too status Thunder Drench by Star labs
compliant
the firm.
Evaluator PEC-VIII
680. Name and address of manufacturer / M/s. Decent Pharma plot # 30 Street St 3 National
Applicant Industrial Zone Rawat - Islamabad.
Brand Name +Dosage Form + Strength Evomec Super Injection
Composition Each 1ml contains:-
Ivermectin ....10mg
Clorsulon…..100mg
Diary No. Date of R& I & fee Dy. No.1189,02-05-2017, 20,000/-, 28-04-2017
Pharmacological Group Anti-parasitic
Type of Form Form-5
Pack size & Demanded Price 50ml(i.m, subcut); Decontrolled
Me-too status Actimec plus injection of Selmore Pharmaceuticals
(10ML.
50ML.100ML.)
GMP status Panel inspection conducted on 31-08-2018 & 05-09-2018
recommends resumption of production to M/s decent
Pharmaceuticals by the competent forum of CLB subject
to the following conditions:
 The management has agreed not to manufacture
sterile products prior to the installation of
distillation assembly during this tenure the
management has been advised to conduct BET
testing on market samples (post market
surveillance) & retained samples.
 The management shall submit monthly progress
report to the office of concerned Federal inspector
of Drugs on the updated progress on all the
undertakings submitted alongside this report.
 The management has also undertaken to purchase
FTIR within Two months.
(Report by Area FID dated 05-09-2018 verified purchase
of FTIR, So the QA Division vide letter No.F.8-6/2018-
QA dated 18th September, 2018 concluded that the firm
M/s. Decent Pharma, Rawat is allowed to resume
production in oral dosage forms. However, production in
sterile area shall remain suspended till the installation of
distillation assembly, verification by the panel of experts
and subsequent approval for resumption of production).
Remarks of the Evaluator Firm has Liquid injection Vet (general section).
Firm is not carrying out Terminal sterilization with this
justification that applied drug product is heat sensitive.
Firm is using Type II glass with this justification that as it
is recommended for acidic, aqueous, & alkaline
parenteral preparation by USP. Furthermore product does
not contain any ingredients which could react with USP
type II glass. USP article 660.
However, The USP article 660 to which the applicant is
referring for the choice of container closure system,
states following:
The following recommendations can be made as to the
suitability of the glass type for containers for
pharmaceutical products, based on the tests for hydrolytic
resistance. Type I glass containers are suitable for most
products for parenteral and nonparenteral uses. Type II
glass containers are suitable for most acidic and neutral
aqueous products for parenteral and nonparenteral uses.
Type II glass containers may be used for alkaline
parenteral products where stability data demonstrate
their suitability. Type III glass containers usually are not
used for parenteral products or for powders for
parenteral use, except where suitable stability test data
indicate that Type III glass is satisfactory.
 Justification on scientific basis for not performing terminal sterilization during
manufacturing of applied formulation.
 Justification on scientific basis for preferring Type II glass over Type I glass as a
container closure system for applied formulation or otherwise for use of Type I glass
container for the applied formulation.
 Rectification of above stated observation in the distillation plant made by Panel during
the inspection.
681. Name and address of manufacturer / M/s. Decent Pharma plot # 30Street SS 3 National
Brand Name +Dosage Form + Strength Clozamax oral suspension 110mg/ml
Closantal…. 110mg
Type of Form Form-5
Finished Product Specification B.P Specifications
Pack size & Demanded Price 100ml, 500ml, 1 Litre; Decontrolled
Me-too status Closenmall of mallard Pharmaceuticals, Multan (Reg #
046690) (not verifiable)
Remarks of the Evaluator. Firm has Liquid Vet (general section).
Evidence of Me Too provide by the firm is not verifiable.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm.
Brand Name +Dosage Form + Strength Biomectin LA injection
Ivermectin…. 20mg
Diary No. Date of R& I & fee Dy No.1193;02-05-2017 : 20,000/-, 28-04-2017
Type of Form Form-5
Pack size & Demanded Price 50ml (i.m, subcut); Decontrolled
Me-too status Elvomec D/S. Injection 2% Of Elko Organization (Pvt)
Ltd., Karachi (50ML, 100ML)
Remarks of the Evaluator. Firm has Liquid injection Vet (general section).
states following:
container closure system for applied formulation OR otherwise for use of Type I glass
the inspection.
Brand Name +Dosage Form + Strength Solofos Injection
Toldfimos sodium …. 100mg
Pharmacological Group Immune booster
Type of Form Form-5
Me-too status Fosfan Injection Of Selmone Agencies Lahore (20ml,
50ml)
states following:
the inspection.
Brand Name +Dosage Form + Strength Doramax Injection
Doramectin…. 10mg
Type of Form Form-5
Me-too status Dectomax Injectable Solution Of Ghazi Brothers,
Karachi. ( 10ml, 20ml, 25ml, 50ml, 200ml, 500ml)
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states following:
the inspection.
Brand Name +Dosage Form + Strength Evomec LA Injection
Ivermectin ....10mg
Type of Form Form-5
Me-too status Actimec injection of Selmore Pharmaceuticals
(10ML.20ml
50ML.100ML.)
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states following:
products for parenteral and non-parenteral uses. Type II
aqueous products for parenteral and non-parenteral uses.
the inspection.
Brand Name +Dosage Form + Strength Choice Oral Powder
Composition Each kg powder contains:-
Doxycycline HCl....400gm
Tylosin tartrate….200gm
Colistin Sulphate…. 500MIU
Bromhexine HCl…. 10gm
Pharmacological Group Anti-bacterial/mucolytic agent
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 01kg, 2.5kg, 5kg, 10kg, 20kg, 25kg;
Decontrolled
Me-too status Respi 100 W/S Powder of Dmaarson Pharmaceuticals
Rawat. (not verifiable)
Remarks of the Evaluator. Evidence of Me Too provide by the firm is not verifiable.
Firm has submitted letter of CLB dated 12th March, 2013
verifying manufacturing facility “Oral dry Powder
Section (vet)”.
Brand Name +Dosage Form + Strength Piprazol Oral Powder
Composition Each kg powder contains:-
Piperazine citrate……1000gm
Pharmacological Group Anti-bacterial/mucolytic agent
Type of Form Form-5
Pack size & Demanded Price 100gm, 200gm, 500gm, 01kg, 2.5kg, 5kg, 10kg, 20kg,
25kg; Decontrolled
Me-too status P.C Water Soluble Powder Of M/S. Inshal
Pharmaceutical Industries
Remarks of the Evaluator. Firm has submitted letter of CLB dated 12th March, 2013
verifying manufacturing facility “Oral dry Powder
Section (vet)”.
Decision: Approved with Innovator’s Specifications.
Evaluator PEC-XIII
688. Name and address of manufacturer / M/s Biolabs (Pvt.) Limited, Plot # 145- Industrial
Applicant Triangle, Kahutta Road, Islamabad.
Brand Name +Dosage Form + Strength Clo- Animectin Injection 10ml
Ivermectin……………………...10mg
Clorsulon……………………...100mg
Pack size & Demanded Price 1x1 vial of 10ml & As per PRC
Approval status of product in N/A
Me-too status Ivoron super injection of M/s Veti- Care
Pharmaceuticals, (Reg.# 028519)
GMP status GMP certificate granted based on inspection dated: 5th
and 6th Dec, 2017.
Remarks of the Evaluator Firm has liquid injection general (Vet) section as is
Decision: Approved.
Ivermectin……………...10mg
Clorsulon……………...100mg
Me-too status Elvomec super injection of M/s Elko (Reg.#025788)
and 6th Dec, 2017.
Remarks of the Evaluator. Firm has liquid injection general (vet) section as is
Decision: Approved.
Ivermectin….10mg
Clorsulon…..100mg
Me-too status Ivoron super injection of M/s Veti- Care
Pharmaceuticals, (Reg.# 028519)
and 6th Dec, 2017.
Remarks of the Evaluator. Firm has liquid injection general (vet) section as is
Decision: Approved.
Applicant Triangle, Kahutta Road , Islamabad
Brand Name +Dosage Form + Strength Tylomix injection 10% (100ml)
Tylosin Phosphate…………….10%
Pharmacological Group Macrolide Antibiotic
Pack size & Demanded Price 1x1 Vial of 100ml & As per PRC
Me-too status Tylosin Injection 10% of M/s B2B Pakistan
and 6th Dec, 2017.
Remarks of the Evaluator  Firm has liquid injection general (vet) section as is
 The me- too status of the applied formulation could
not be confirmed.
692. Name and address of manufacturer / M/s Inshal Pharmaceuticals, Plot # 2 Street SS-2 RCCI
Applicant Industrial Area, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Citrolyte Powder 100g
Composition Each 100gm powder contains:
Vitamin C…………..….20gm
Paracetamol……………..2gm
Magnesium Sulphate.....3.5gm
Calcium Carbonate……4.5gm
Potassium Chloride…..….4gm
Diary No. Date of R& I & fee Dy. No. 370; 25-05-2011; 8000/- (25-05-2011) &
Rs.12,000/- (05-12-2014)
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Pack size & Demanded Price 30g, 50g, 100g, 250g, 500g, 1kg, 10kg, 25kg &
Decontrolled
Me-too status Spin-C Powder of M/s Leads Pharmaceuticals,
Islamabad (Reg. # 078239)
GMP status Last GMP inspection was conducted on 11-05-18 and
the report concludes renewal of DML.
Remarks of the Evaluator Firm has Oral Powder Section (Veterinary).
Decision: Deferred for submission of correct pharmacological group.
693. Name and address of manufacturer / M/s Inshal Pharmaceuticals, Plot # 2 Street SS-2 RCCI
Applicant Industrial Area, Rawat, Islamabad.
Brand Name +Dosage Form + Strength CRD-Kill Liquid
Tylosin Tartrate………….…...50mg
Sulfamethoxypyridazine……...50mg
Trimethoprim…………………10mg
Bromhexine HCl…………..…...5mg
Colistin sulphate………..500,000 IU
Diary No. Date of R& I & fee Dy. No. 296; 07-06-2012; 8000/- (07-06-2012) &
Rs.12,000/- (05-12-2014)
Pharmacological Group Antibacterial / antiviral
Pack size & Demanded Price 100ml, 250ml, 500ml, 1 litre, 5 litre, 10 litre, 25litre &
Decontrolled
Me-too status Complimats liquid of M/s D- Maarson Pharmaceuticals,
Islamabad (Reg. # 072681)
the report concludes renewal of DML.
Remarks of the Evaluator Firm has Oral Liquid Section (Veterinary).
Evaluator PEC-XIV
694. Name and address of manufacturer / M/s. Decent Pharma Plot No. 30, Street SS 3, National
Applicant Industrial Zone, Rawat
Brand Name +Dosage Form + Strength DOTCO Water Soluble powder
Composition Each Kg contains:
Tylosin Tartrate ……………………100gm
Doxycycline HCl……………………200gm
Colistin sulphate…………………….500MIU
Bromhexine HCl………………...…..5gm
Diary No. Date of R& I & fee 14-11-2016, Dy. No.2114, Rs.20,000/-, 10-11-2016
Pharmacological Group Antibacterial/Expectorant
Type of Form Form-5
Pack size & Demanded Price 50g, 100g, 500g, 1kg, 5Kg, 10Kg,20Kg; Decontrolled
Me-too status Colidoxin WSP of M/s. Symans Pharma (Reg#063849)
GMP status QA Division vide letter No.F.8-6/2018-QA dated 18th
September, 2018 concluded that the firm M/s. Decent
Pharma, Rawat is allowed to resume production in oral
dosage forms. However, production in sterile area shall
remain suspended till the installation of distillation
assembly, verification by the panel of experts and
subsequent approval for resumption of production.
Brand Name +Dosage Form + Strength AMOXIL C Water Soluble Powder
Amoxycillin trihydrate……………….200mg
Colistin sulphate………………………600,000IU
Pharmacological Group Antibiotic/Antibacterial
Type of Form Form-5
Me-too status ALMOXIN C WSP of Breeze Pharma (Reg#075662)
Remarks of the Evaluator.  Brand name mentioned on fee challan is ALMOXIL C
while brand name mentioned on Form-5 is AMOXIL C.
Similarly, brand name mentioned under enclosure of
“Recommended clinical use” is ALMOXIL C.
Clarification is required.
 The submitted me-too reference could not be verified in
terms of quantity of Colistin sulphate.
 Clarification regarding quantity of amoxycillin base is
required to be mentioned.
Brand Name +Dosage Form + Strength DOXIN PLUS ORAL SOLUTION
Tylosin Tartrate ……………………100gm
Doxycycline HCl……………………200gm
Colistin sulphate…………………….500MIU
Bromhexine HCl………………...…..12g
Pharmacological Group Antibiotic/Mucolytic
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 150ml, 200ml, 450ml,500ml, 1L, 2.5L, 5L;
10L, 25L ;Decontrolled
Me-too status TY-Dox Plus Liquid of M/s. Breeze Pharma (Reg# 075670)
Brand Name +Dosage Form + Strength R-Flush Oral Powder
Composition Each 100gm contains:
Methanamine……….………95g
Vitamin B1…………………800mg
Vitamin B2…………………900mg
Vitamin K3…………………200mg
Vitamin C..…………………1000mg
Pharmacological Group Anti-infective/Multivitamin
Type of Form Form-5
Me-too status RENALVIT Oral Powder of M/s. Intervac Pharma (Reg #
058759)
Brand Name +Dosage Form + Strength Vital-C Oral Powder
Composition Each 100g powder contains:
Vitamin C……………….…20g
Acetyl Salicylic……………20g
Vitamin K3………………2.5g
Pharmacological Group Analgesic and Antipyretic (NSAIDs)
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1kg, 2.5Kg, 5Kg, 10Kg,20Kg, 25kg;
Decontrolled
Me-too status C-Plus Powder of M/s. Intervac Pharma (Reg#046598)
Decision: Registration Board referred the case to Expert working group on Veterinary Drugs
for review of formulation.
Brand Name +Dosage Form + Strength FENLOR PLUS ORAL SOLUTION
Florfenicol …………………100mg
Pharmacological Group Quinolone Antibiotic
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 150ml, 200ml, 450ml,500ml, 1Litre, 2.5Litre,
5Litre, 10Litre, 20Litre; Decontrolled
Me-too status Maxi-Flor Liquid of M/s.Biogen Pharma (Reg#075612)
Decision: Deferred for correction of pharmacological group.
Brand Name +Dosage Form + Strength ANFLOX C Oral liquid
Enrofloxacin……………………....10g
Colistin sulphate………………….50MIU
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 150ml, 200ml, 450ml,500ml, 1Litre, 2.5Litre,
5Litre, 10Litre, 20Litre; Decontrolled
Me-too status Eaflexin Tage Oral Liquid of M/s. Vantage pharma (Reg #
081707)
Brand Name +Dosage Form + Strength AQUAFLOR Oral Solution
Florfenicol………..…….230mg
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 150ml, 200ml, 450ml, 500ml, 1Litre,
2.5Litre, 5Litre, 10Litre, 20Litre;Decontrolled
Me-too status Neflox solution of Selmore Pharma (Reg # 049647)
Brand Name +Dosage Form + Strength RESPOWEL ORAL SOLUTION
Tylosin Tartrate…………………….100g
Doxycycline HCl………………….200g
Colistin sulphate………………….500MIU
Bromhexine HCl…………………5g
Pharmacological Group Antibiotic/Mucolytic
Type of Form Form-5
2.5Litre, 5Litre, 10Litre, 25Litre; Decontrolled
Me-too status PULMOPRO Liquid of M/s. Breeze Pharma (Reg #
063556)
Brand Name +Dosage Form + Strength AMCODOXY-T Water Soluble Powder
Composition Each Kg powder contains:
Tylosin Tartrate…………………….100gm
Doxycycline HCl………………….200gm
Colistin sulphate………………….3gm
Bromhexine HCl…………………1gm
Pharmacological Group Antibacterial/Expectorant
Type of Form Form-5
Me-too status BRONCO MARS Powder of D-Maarson Pharma
Remarks of the Evaluator.  The submitted me-too reference could not be
verified. Provide correct reference.
Brand Name +Dosage Form + Strength AMCO DOX Water Soluble Powder
Doxycycline as Hyclate…………….. 500g
Type of Form Form-5
Me-too status Riz wan-S W/S Powder of Nawal Pharma
Remarks of the Evaluator. The submitted me-too reference could not be verified.
Provide correct reference.
Brand Name +Dosage Form + Strength COLMIX 100 Water Soluble Powder
Colistin sulphate…………………..800MIU
Lincomycin HCl…………………...100g
Type of Form Form-5
Me-too status COLIN Oral powder of Biogen Pharma (Reg # 049726)
Brand Name +Dosage Form + Strength AMCO AMENTA Water Soluble Powder
Amantadine HCl……………………..100g
Type of Form Form-5
Me-too status Antamits WSP of M/s. Wimits Pharma (Reg # 078316)
Brand Name +Dosage Form + Strength AMCOCOL Water Soluble Powder
Enrofloxacin…………………….200g
Colistin sulphate………………..500MIU
Pharmacological Group Antibacterial/Growth promoter
Type of Form Form-5
Me-too status Encol oral powder of M/s. Biogen Pharma
Enromall-C of Mallard Pharma (Reg#049731) the strength
of me-too reference
Brand Name +Dosage Form + Strength NSP PLUS Water Soluble Powder
Neomycin sulphate…………………10gm
Streptomycin sulphate………………36gm
Procaine penicillin………………….12gm
Zinc Bacitracin 10%.......................... 52gm
Type of Form Form-5
Me-too status Pro SB-Plus of M/s. NoaHemis Pharma
Brand Name +Dosage Form + Strength BIOLINCOMIX Water Soluble Powder
Composition Each Kg Powder contains:
Lincomycin HCl……………200gm
Colistine Sulphate…………..800MIU
Type of Form Form-5
Me-too status COLIN WSP of M/s Biogen pharma
Remarks of the Evaluator. The submitted me-too reference is of different strength.
Brand Name +Dosage Form + Strength CTD Oral Powder
Colistin Sulphate………………500MIU
Tylosin Tartrate………………..100gm
Doxycycline HCl………………200gm
Pharmacological Group Antibacterial & Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 50g, 100g, 500g, 1kg, 5Kg, 10Kg, 20Kg, 25kg;
Decontrolled
Me-too status CT-DOX WSP of M/s Inshal Pharma (Reg#048172)
Decision: Deferred for correction of Pharmacological group.
Brand Name +Dosage Form + Strength PRIDE Oral Powder
Bromhexine HCl……………….5gm
Pharmacological Group Antibacterial and Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1kg, 5Kg, 10Kg, 20Kg, 25kg; Decontrolled
Me-too status PULMOMATS WSP of M/s. Nawal Pharma (Reg#074093)
Decision: Deferred for correction of Pharmacological group.
Brand Name +Dosage Form + Strength NEO-72 ORAL POWDER
Composition Each Kg Powder contains:
Neomycin Sulphate…………….720gm
Type of Form Form-5
Me-too status Neomycin-72 WSP of M/s Farm-Aid (Reg#029669)
Brand Name +Dosage Form + Strength KLIK Oral Powder
Colistin Sulphate………………60gm
Bromhexine HCl……………….20gm
Pharmacological Group Antibacterial and Bronchodilator
Type of Form Form-5
Me-too status NOBI TDC 680 of M/s. Noble Pharma (Reg#074093)
Brand Name +Dosage Form + Strength PCS MIX Water Soluble Powder
Procaine Penicillin……………12gm
Streptomycin Sulphate…………..36gm
Zinc Bacitracin…………………52gm
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1kg, 5Kg, 10Kg, 20Kg; Decontrolled
Me-too status PRO SB-Plus of M/s Noa Hemis (Reg#028508)
Brand Name +Dosage Form + Strength ZESEL ORAL SOLUTION
Composition Each Liter contains:
Vitamin E……………..200,000mg
Sorbitol……………….50,000 mg
Choline Chloride………50,000 mg
Vitamin C……………...20,000 mg
Selenium as sodium selenite……..150 mg
Zinc as Zinc Sulphate……………4000 mg
Pharmacological Group Multivitamin/Nutritional Supplement
Type of Form Form-5
2.5Litre, 5Litre, 10Litre, 20Litre;Decontrolled
Me-too status Vestol-Forte oral liquid of M/s Sanna (Reg#078272)
Decision: Deferred for rationale of quantities of APIs in applied formulation.
Brand Name +Dosage Form + Strength U FLOR ORAL SOLUTION
Florfenicol……………….200mg
Type of Form Form-5
Me-too status FLUROTIN LIQUID of M/s Elegance (Reg#075751)
Brand Name +Dosage Form + Strength MYCOFLOR ORAL LIQUID
Composition Each liter contains:
Florfenicol…………………110gm
Colistin Sulphate…………..500MIU
Type of Form Form-5
Me-too status F-COL Liquid of M/s D-Maarson (Reg#072679)
Brand Name +Dosage Form + Strength FLOCIN ORAL LIQUID
Florfenicol ……………….25gm
Colistin sulphate………….50 MIU
Type of Form Form-5
Me-too status FLOCOL Liquid of M/s D-Maarson (Reg#074082)
Brand Name +Dosage Form + Strength SINASET ORAL LIQUID
Enrofloxacin…………………75 mg
Sulphamethoxy pyridazine………..75 mg
Sulphamethazine………………….50 mg
Trimethoprim…………………….25 mg
Type of Form Form-5
Me-too status CINA T.S Oral Suspension of Vety-Care (Reg#031456)
Brand Name +Dosage Form + Strength FLOXIMAX ORAL SOLUTION
Enrofloxacin……………200mg
Colistin sulphate………….0.5MIU
Type of Form Form-5
Me-too status FLOXICOL Oral Liquid of M/s Biogen pharma
(Reg#058966)
Decision: Deferred for clarification regarding the quantity of colistin sulphate in applied
formulation.
Brand Name +Dosage Form + Strength LIFER ORAL SOLUTION
L-Carnitine………………….50 mg
Betain HCl…………………..20 mg
Inositol………………………7 mg
Choline chloride……………..100 mg
Sorbitol………………………200 mg
Magnesium sulphate…………10 mg
Pharmacological Group Electrolyte / Amino acid
Type of Form Form-5
Me-too status Hepabar Oral Liquid of M/s Baariq Pharma (Reg#080733)
Decision: Registration Board referred the case to Expert working group on Veterinary Drugs
for review of formulation.
722. Name and address of manufacturer / M/s Divine Pharmaceuticals, plot No. 226 –A, Sundar
Applicant industrial estate, Lahore
Brand Name +Dosage Form + Strength Ampro C 20 w/s Powder
Amprolium HCl…………….20% w/v
Colistin sulphate…………….500 MIU
Pharmacological Group Antiprotozoal
Type of Form Form-5
Pack size & Demanded Price Plastic Jar/100gm, 250gm, 500gm, 1Kg, 5Kg & 25Kg;
Decontrolled
Me-too status Amorocol WSP of Attabak Pharma
GMP status Not submitted
Remarks of the Evaluator. The firm has submitted that
“Presently no GMP inspection report is available due to
following reasons:
M/s Divine Pharma got new license in November 2016.
M/s Divine Pharma got registration of products on
September 2017.
FBR issues for import of raw materials resolved in January
2018.
Production started just in June 2018, so no GMP inspection
has been conducted yet.”
Me-too reference could not be verified
Brand Name +Dosage Form + Strength Doxy Col Hy W/S Powder
Doxycycline (as Hyclate)…………..20% w/w
Colistin sulphate……………….500MIU
Type of Form Form-5
Decontrolled
Me-too status Microdox powder of Prix Pharma
GMP status Not submitted.
following reasons:
September 2017.
2018.
Me-too reference could not be verified
Brand Name +Dosage Form + Strength DOXY-T 20 w/s Powder
Doxycycline HCl……………20%
Tylosin Tartrate………………10%
Bromhexine HCl…………….0.5%
Type of Form Form-5
Decontrolled
Me-too status TYLOXI PLUS oral powder of Westmont (Reg#053935)
following reasons:
September 2017.
2018. Production started just in June 2018, so no GMP
inspection has been conducted yet.”
Applicant industrial Estate, Lahore
Brand Name +Dosage Form + Strength AMANTA-D 10 w/s Powder
Amantadine HCl…………………10%w/w
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1Kg plastic Jar; Decontrolled
Me-too status Antamits WSP of M/s Wimits (Reg#078316)
following reasons:
September 2017.
Brand Name +Dosage Form + Strength AMANTA-D5 w/s Powder
Amantadine HCl……………5%w/w
Type of Form Form-5
Me-too status Antamits WSP of M/s Wimtis (Reg#078316)
GMP status
following reasons:
September 2017.
2018.
Brand Name +Dosage Form + Strength Doxy Hy 50 W/S Powder
Doxycycline (as hyclate)…………….50%w/w
Type of Form Form-5
Me-too status Z-Doxy 50% WSP of M/s Zoic International (Reg#080947)
following reasons:
September 2017.
2018.
Brand Name +Dosage Form + Strength G-FLOR PLUS SOLUTION
Florfenicol…………….25% w/v
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml plastic bottle;
Decontrolled
Me-too status Florfenicol oral Liquid of Attabak (Reg#075707)
following reasons:
September 2017.
2018.
Brand Name +Dosage Form + Strength BROMEXIN 2% SOLUTION
Bromexine HCl ……………2% w/v
Pharmacological Group Mucolytic
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml plastic bottle;
Decontrolled
Me-too status Bro man Liquid of M/s D-Maarson (Reg#073994)
following reasons:
September 2017.
Brand Name +Dosage Form + Strength BROMENT SUPER ORAL SOLUTION
Bromhexine HCl……………4% w/w
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml bottle;Decontrolled
Me-too status Bromhexine 5 of Guyton Pharma
GMP status
following reasons:
September 2017.
b. Deferred cases
731. Name and address of manufacturer / M/s Univet Pharmaceuticals, 14-Km, Adayala road, post
Applicant office Dahga, Rawalpindi
Brand Name +Dosage Form + Strength FLUMECOL LIQUID
Flumequine ………………….20g
Colistin sulphate……………....2g
Diary No. Date of R& I & fee Dy. No.45, R&I Dated 18-01-2016, (No evidence of fee)
Type of Form Form -5
Pack size & Demanded Price 100ml,500ml, 1000ml; De-controlled price
Me-too status Flu-Col liquid of M/s Leads Pharma
GMP status Last (panel) inspection was conducted on 02-10-2014
which concludes grant of additional section namely oral
liquid general section Veterinary (General).
Previous decision Deferred for confirmation of fee submission date (M-277).
Deferred for evidence of applied formulation/drug already
approved by DRAP (generic status) alongwith registration
number, brand name and name of firm. (M-283).
Evaluation by PEC The firm has submitted fresh fee challan of Rs. 20,000/-
(Deposit slip # 0746072) dated 27-02-2018.
Inspection conducted on 26-10-2017 showed no
observation as reported by QA.
The firm has submitted me-too reference “QUINCOL
Liquid of M/s Bio-Labs” (Reg#043172) verified from
available database.
732. Name and address of manufacturer / M/s Univet Pharmaceuticals, 14-Km, Adayala road, post
Applicant office Dahga, Rawalpindi
Brand Name +Dosage Form + Strength Zixx liquid suspension 100ml
Composition Each Litre contains:
Vitamin E acetate…………...200,000mg
Vitamin C (Ascorbic Acid)…….2000mg
Sodium Selenite………………...2200mg
Zinc as sulphate……………....10,000mg
Diary No. Date of R& I & fee Dy. No.925, R&I Dated 09-08-2016, Rs. 20,000/-
(05.08.2016)
Pharmacological Group Nutritional supplement
Type of Form Form -5
Finished Product Specification Manufacturers
Pack size & Demanded Price 1x50ml, 1x100ml, 1x250ml, 1x500ml, 1x1000ml & De-
Controlled
Approval status of product in Not Available
Me-too status Pam-E-Sel suspension of M/s Pameer Pharma
GMP status Last (panel) inspection was conducted on 02-10-2014
which concludes grant of additional section namely oral
liquid general section Veterinary (General).
Previous decision Registration Board referred the case to QA & LT Division
to conduct GMP inspection of Firm on priority.
Registration Board directed the firm to submit details of
target species for applied formulation. (M-277)
Evaluation by PEC Inspection conducted on 26-10-2017 showed no
observation as reported by QA.
Zixx suspension is intended to be used in poultry.
(generic / me-too status) along with registration number, brand name and name of firm.
Case No. 04: Registration applications of newly granted DML or New section
(Veterinary)
a. New DML /section Evaluator-PEC-VI
On the Recommendation of the panel of experts, the CLB in its 265th meeting held on 9th & 10th August
2018 has considered and approved the following 7 sections of your firm M.s Internaional Pharma labs,
Raiwind road, Lahore.
1) Liquid Repacking (Human section)
2) Powder repacking Human Section
3) Sachet General (Human section)
4) External Preparation/ Application/Aerosol (Human section)
5) Liquid Injectable (Steroid Vet section)
6) Oral Powder (Penicillin Vet Section)
7) Quality Control Lab (Amendments)
Liquid Injectable (Steroid vet Section) 11 Molecules/ 16 Products
733. Name and address of manufacturer / M/s International Pharma Labs. Raiwind Road, Bhobtian
Applicant Chowk, Defence Road, 1-KM Towards Kahna, Lahore.
Brand Name +Dosage Form + Strength I-Pred 1% Injection 20ml
Prednisolone Acetate…10mg
Diary No. Date of R& I & fee Dy.No 31030-E dated 14-09-2018 Rs.20,000/- Dated 14-
09-2018
Pharmacological Group Steroid
Type of Form Form-5
Pack size & Demanded Price 20ml, Decontrolled
Approval status of product in Reference

Me-too status KOMIPREDNISOLONE INJECTION by KOREA
MICROBIOLOGICAL LABS KOREA imported by
ATZAN PHARMACEUTICALS MULTANReg # 020080
GMP status the panel of experts, the CLB in its 265th meeting held on
9th & 10th August 2018 has considered and approved the
section.
Decision: Deferred for submission of the target specie/s for the applied product.
Brand Name +Dosage Form + Strength I-Pre-C Injection
Prednisolone…10mg
Chlorpheniramine Maleate…4mg
Diary No. Date of R& I & fee Dy.No 31030-B dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5
Me-too status SOLOMIN INJECTION Reg # 049642 by Selmore
Pharmaceuticals
section.
Brand Name +Dosage Form + Strength I-Alpha Pre Injection 10ml
9-Alpha-Fluoro Prednisolone…0.2gm
Dated 14-09-2018
Type of Form Form-5
Me-too status ABICORTEN INJECTABLE SOLUTION by FATRO
S.P.A ITALY imported by PRIX Pharma Lahore Reg #
020756
section.
Remarks of the Evaluator Provided me-too is available in 50ml pack size. Whereas
firm has applied in 10ml pack size.
Brand Name +Dosage Form + Strength I-Alpha Pre Injection 50ml
9-Alpha-Fluoro Prednisolone…0.2gm
Diary No. Date of R& I & fee Dy.No 31030-C dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5

Me-too status ABICORTEN Injectable Solution by FATRO S.P.A
ITALY imported by Prix Pharma Lahore Reg# 020756
section.
Brand Name +Dosage Form + Strength I-Pred 2.5% Injection
Prednisolone…25mg
Diary No. Date of R& I & fee Dy.No 31030-A dated 14-09-2018 Rs.20,000/- 14-9-2018
Type of Form Form-5
Me-too status PREDISON INJECTION 2.5% by MANHATTAN
PHARMA, KARACHI Reg # 035091
section.
Brand Name +Dosage Form + Strength I-Dexa Injection 100ml
Kanamycin Sulphate…50mg
Colistin Sulphate…100,000IU
Dexamethasone…0.5mg
Diary No. Date of R& I & fee Dy.No 31030-L dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Pharmacological Group Steroid + penicillin
Type of Form Form-5
Me-too status KONO DEX INJECTION by ALINA COMBINE
PHARMACEUTICA Reg # 052347
section.
739. Name and address of manufacturer / M/s International Pharma Labs.
Applicant Raiwind Road, Bhobtian Chowk, Defence Road, 1-KM
Towards Kahna, Lahore.
Brand Name +Dosage Form + Strength I-Tylocol Injection 100ml
Thiamphenicol…200mg
Tylosin…57.5mg
Prednisolone as acetate…5mg
Diary No. Date of R& I & fee Dy.No 31030-K dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Pharmacological Group Antibacterial + steroid
Type of Form Form-5
Me-too status Tylopen Injection by DAE SUNG Microbiological Labs.,
KOREA imported by Selmore Agencies Reg # 058815
section.
Brand Name +Dosage Form + Strength I-Pre-C Plus Injection 20ml
Chlorpheniramine Maleate…10mg
Diary No. Date of R& I & fee Dy.No 31030-I dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5

Me-too status PREDMINE INJECTION by CHERISHED
PHARMACEUTICALS Reg # 057084
section.
Brand Name +Dosage Form + Strength ID-Pred Injection 10ml
Prednisolone…7.50mg
Diary No. Date of R& I & fee Dy.No 31030-H dated 14-09-2018 Rs.20,000/- Dated 14-
09-2018
Type of Form Form-5
Me-too status PREDEXA INJECTION by SHINIL CHEMICAL AND
LIVESTOCK LTD KOREA Imported by TAROBINA
CORPORATION LAHORE Reg # 020762
section.
Brand Name +Dosage Form + Strength La Dexpre Injection 10ml
Prednisolone…9mg
Dexamethasone…3mg
Diary No. Date of R& I & fee Dy.No 31030-G dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5
section.
Remarks of the Evaluator Me-too status could not be confirmed.
Decision: Deferred for submission of the target specie/s and me-too status for the applied
product
Brand Name +Dosage Form + Strength I-Pred 1% Injection 50ml
Diary No. Date of R& I & fee Dy.No 31030-F dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5

Me-too status Komiprednisolone Injection by Korea Microbiological
Labs Korea Imported by Atzan Pharmaceuticals Multan
Reg # 020080 Pack size 20ml
section.
Remarks of the Evaluator Me-too pack size is 20ml, while firm has applied in 50ml
pack size.
Brand Name +Dosage Form + Strength I-Dexa Injection
Kanamycin Sulphate…50mg
Colistin Sulphate…100,000IU
Diary No. Date of R& I & fee Dy.No 26771-E dated 03-08-2018 Rs.20,000/-
Dated 03-08-2018
Pharmacological Group Steroid+ Penicillin
Type of Form Form-5

Me-too status KONO DEX INJECTION by Alina Combine
Pharmaceutical (Pvt) Ltd. Karachi Reg # 052347
section.
Remarks of the Evaluator Fee Challan Photocopy attached.
Brand Name +Dosage Form + Strength Cephra Injectable Solution
Composition Each 4gm contains:
Cephradine……..300mg
Neomycin Sulphate….200mg
Prednisolone Sulphate…..5gm
Dated 03-08-2018
Pharmacological Group Steroid+ Antibiotic
Type of Form Form-5
Pack size & Demanded Price 4gm, Decontrolled
Me-too status LACTOVET INTRAMAMMARY STERILE Injectable
Solution by Nawan Laboratories (Pvt) Ltd, Karachi (4gm
Syringe Solution)
section.
Brand Name +Dosage Form + Strength I-Multivet IMM Injection
Composition Each 5gm Contains:
Procaine Penicillin…..…100,000IU
Streptomyin Sulphate………100mg
Neomyin Sulphate………….100mg
Prednisolone……………….10mg
Diary No. Date of R& I & fee Dy.No 26771-C dated 03-08-2018 Rs.20,000/-
Dated 03-08-2018
Type of Form Form-5

Me-too status MULTIJECT IMM INJECTION Reg # 018871 by
NORBROOK LABS IRELAND Imported by NAWAN
TRADING Corp. Karachi (5gm Single doses syringe)
section.
Remarks of the Evaluator Fee challan photocopy attached
Brand Name +Dosage Form + Strength Linconepre Injection
Composition Each injection contains:
Lincomycin as HCl…..200mg
Neomycin as Sulphate….200mg
Prednisolone…..5mg
Diary No. Date of R& I & fee Dy.No 26771-D dated 03-08-2018 Rs.20,000/-
Dated 03-08-2018
Type of Form Form-5
Me-too status Mastigon Intrammary Ointment by Star Labs Reg#
016285
Each injector contains: - Lincomycin as Hcl 200mg,
Neomycin as Sulphate 200mg, Prednisolone 5mg
Pack size 10gm.
section.
Remarks of the Evaluator Fee challan photocopy attached
Provided me too is ointment.
Decision: Deferred for submission of the target specie/s and me-too status for the applied
product.
Brand Name +Dosage Form + Strength OTC Cort Spray
Oxytetracycline HCl…….750mg
Hydrocortisone…..240mg
Diary No. Date of R& I & fee Dy.No 26771-F dated 03-08-2018 Rs.20,000/-
Dated 03-08-2018
Pharmacological Group Antibacterial and Anti-Inflammatory
Type of Form Form-5
Me-too status CORTISEL SPRAY Reg # 071079
GMP status The panel of experts, the CLB in its 265th meeting held on
section.
Remarks of the Evaluator Fee challan photocopy attached.
Decision: Registration Board rejected the application as the firm do not have approved
manufacturing facility for the applied product.
CLB in its 264th meeting held on 9th July 2018 approved 2 additional sections of the firm M/s Intervac Pvt
Ltd, 18-km, Lahore Sheikhupura road, Sheikhupura.
A) Liquid Injectable (Penicillin Veterinary Section)
B) Dry Powder Injection (Penicillin Veterinary Section)
Liquid Injectable (Penicillin Veterinary Section)
8 Molecules/ 14 Products
749. Name and address of manufacturer / M/s Intervac Pvt Ltd, 18-km, Lahore Sheikhupura road,
Brand Name +Dosage Form + Strength Ampimox-10 Injection
Ampicillin trihydrate sodium eq to Ampicillin…...100mg
Pharmacological Group Penicillin
Type of Form Form-5
Me-too status AMCICOLI Injection by KOREA Microbiological Labs
Korea Imported by Atzan Pharmaceuticals Multan pack
of 20ml and 50ml
GMP status CLB in its 264th meeting held on 9th July 2018 approved 2
additional sections of the firm.
A) Liquid Injectable (Pencillin Veterinary Section)
Brand Name +Dosage Form + Strength Ampimox-15 Injection
Ampicillin trihydrate sodium eq to Ampicillin….150mg
Pharmacological Group Pencillin
Type of Form Form-5
Me-too status Novamox-La By SelmorebReg # 043135
Decision: Approved with innovator’s specification
Brand Name +Dosage Form + Strength Intercillin Injection
Ampicillin Trihydrate eq to Ampicillin…..200mg
Type of Form Form-5

Me-too status AMPICON INJECTABLE 200 by VETCON PHARMA
AZAD KASHMIR Reg # 012868
Brand Name +Dosage Form + Strength PPS-360 Injectable Suspension
Procaine Penicillin……200mg
Streptomycin Sulphate….160mg
Type of Form Form-5
Me-too status Neo-Strepen of Nawan Reg # 053997 (Not confirmed)
Remarks of Evaluator Me-too status could not be confirmed.
(generic / me-too status) alongwith registration number, brand name and name of firm
Brand Name +Dosage Form + Strength Clomox-150 Injection
Amoxicillin trihydrate eq to Amoxcillin……100mg
Cloxacillin sodium eq to Cloxacillin…..50mg
Type of Form Form-5
Me-too status Clomix Injection of Alina Combine (Reg # 049680)
Brand Name +Dosage Form + Strength Biofas-La Injection
Benzathine Pencillin G……100,000 IU
Procaine Penicillin G……150,000 IU
Dihydrostreptomycin Sulphate……200mg (as base)
Type of Form Form-5
Me-too status PPS Injection of Selmore Reg # 016291
Brand Name +Dosage Form + Strength Prostrept Injectable Suspension
Procaine Penicillin G……200mg
streptomycin Sulphate……250mg
Type of Form Form-5
Me-too status Strep-Pen Injection of Nawan Labs (Reg # 022716)
Brand Name +Dosage Form + Strength PP-225 Injection
Procaine Penicillin……20,000 IU
Dihydrostreptomycin Sulphate….25,000 IU
Type of Form Form-5
Remarks of Evaluator Me-too status could not be confirmed
Brand Name +Dosage Form + Strength Amoxi-Gent Injection
Amoxicillin Trihydrate eq to Amoxicillin……50mg
Gentamycin Sulphate eq to Gentamycin……25mg
Type of Form Form-5
Me-too status Amoxygent by Selmore Reg # 080953
Brand Name +Dosage Form + Strength Amoxitin Plus Injection
Amoxcillin trihydrate eq to Amoxcillin….120mg
Colistine Sulphate….300,000 IU
Pharmacological Group Pencillin/Anti infective
Type of Form Form-5
Me-too status Colimox Injection by Alina Combine Reg # (049675)
Brand Name +Dosage Form + Strength Intermox 5% Injection
Type of Form Form-5
Me-too status Trioxyl L.A. I.M Injection by Raja Poultry Karachi Reg #
021275
Type of Form Form-5
Me-too status Not confirmed
Type of Form Form-5
Me-too status BETAMOX.LA INJECTABLE by NAWAN TRADING
CORP. KARACHI Reg # 013716
Brand Name +Dosage Form + Strength Intermox 250 Injection
Type of Form Form-5
CLB in its 265th meeting held on 9th and 10th August, 2018 has decided and approved the following 2
additional sections of M/s. Izfaar Pharmaceuticals Pvt Ltd. 542/A-B Sunder Industrial Estate.
01) Veterinary Oral Liquid (General & General Antibiotic)
02) Veterinary Powder (General & General Antibiotic)
Veterinary Oral Liquid (General & General Antibiotic) 10 Molecules/ 10 Products
763. Name and address of manufacturer / M/s Izfaar Pharmaceutical Pvt Ltd. 542-A & B, Sundar
Applicant Industrial Estate, Lahore, Pakistan
Brand Name +Dosage Form + Strength Fendox Plus Drench (Oral Liquid)
Oxfendazole………22.65mg
Cobalt Sulphate…..1.67mg
Sodium Selenite…… 0.5mg
Pharmacological Group Antihelmintic
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1 Liter, 2.5Liter, 5 Liter,
Decontrolled
Me-too status Punch Drench by Selmore Pharmaceuticals Reg # 032206
(Not Confirmed)
GMP status New Section Veterinary Oral Liquid
Remarks of Evaluator Me-too status could not be confirmed
Brand Name +Dosage Form + Strength Four-X Drench
Sulphadiazine….35.5mg
Sulphadimidine……28.4mg
Neomycin Sulphate……1.8mg
Hyoscine MethylBromide…..0.04mg
Pectin……7.1mg
Kaolin…..103.3mg
Vitamin B1…..0.15mg
Vitamin B2……0.22mg
Pharmacological Group AntiDiarroheal
Type of Form Form-5
Pack size & Demanded Price 100ml,250ml, 500ml, 1Liter, 2.5Liter, 5Liter,
Decontrolled
Me-too status Scour-X Oral Suspension by Selmore Pharmaceuticals
Reg # 029661
Decision: Deferred for confirmation of rational of applied formulation based on compatibility of
APIs.
Brand Name +Dosage Form + Strength Florofar oral Solution
Florfenicol…….230mg
Type of Form Form-5
Pack size & Demanded Price 100ml,250ml,450ml,500ml, 1Liter, 2.5Liter, 5Liter,
Decontrolled
Me-too status Neflox Solution by Selmore Pharma Reg#049647
Brand Name +Dosage Form + Strength Nilfar Oral Liquid
Levamisole HCl……15mg
Oxyclozanide…….30mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 450ml, 500ml, 1 Liter, 2.5Liter, 5 Liter,
Decontrolled
Me-too status Nilzan Oral Solution by ICI Reg # 002105
Brand Name +Dosage Form + Strength Zolox-CS Drench
Oxyclozanide…….62.5mg
Oxfendazole…..22.65mg
Cobalt Sulphate…..1.67mg
Sodium Selenite……0.5mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 450ml, 500ml, 1 Liter, 2.5Liter, 5 Liter,
Decontrolled
Me-too status Punch Drench by Selmore Pharmaceuticals Reg # 032206
Brand Name +Dosage Form + Strength Fendox Drench (Oral Liquid)
Oxfendazole………22.65mg
Type of Form Form-5
Decontrolled
Me-too status Oxasym Drench by Syman Pharmaceuticals Reg# 022741
Brand Name +Dosage Form + Strength Deltrin Liquid
Deltamethrin……25mg
Type of Form Form-5
Decontrolled
Me-too status Delta-25 Solution by Selmore Pharmaceuticals
Reg#029608
Decision: Approved.
Brand Name +Dosage Form + Strength Albadox-10 Drench
Albendazole…..100mg
Type of Form Form-5
Decontrolled
Me-too status Albensel-10 Drench by Selmore Pharmaceuticals
Reg#043143
Decision: Approved.
Brand Name +Dosage Form + Strength Levacozol Plus Drench
Levamisole as Hcl……15mg
Oxyclozanide…….30mg
Cobalt Sulphate…….1.67mg
Sodium Selenite…….0.5mg
Type of Form Form-5
Decontrolled
Me-too status Helmex Plus Drench by Selmore Pharmaceuticals
Reg#029605
Brand Name +Dosage Form + Strength Storm Drench
Albendazole…..10gm
Ivermectin….0.2gm
Triclabendazole….12gm
Pharmacological Group Antiparasitic
Type of Form Form-5
Pack size & Demanded Price 100ml, 1000ml, Decontrolled
Me-too status Thunder Drench by Star laboratories Reg # 058941
Veterinary Powder (General & General Antibiotic) 10-Moleucles/ 10- Products
Brand Name +Dosage Form + Strength Ampro-20 Powder
Amprolium HCl……200mg
Pharmacological Group Coccidiostat
Type of Form Form-5
Pack size & Demanded Price 50gm, 100gm, 250gm, 500gm, 1000gm, 2.5kg, 5kg
Decontrolled
Me-too status Reg #023413 BIO-AMP 20% POWDER by Bio-Labs ltd
GMP status New Section Veterinary Powder (General&General
Antibiotic)
Brand Name +Dosage Form + Strength Eryprim Powder
Erythromycin……100mg
Trimethoprim….20mg
Sulphadiazine…..100mg
Type of Form Form-5
10Kg, Decontrolled
Me-too status Erythro-TS Powder by pameer Pharmaceuticals Reg #
026417
Antibiotic)
Brand Name +Dosage Form + Strength Doxysin-C Powder
Doxycycline Hyclate……500mg
Tylosin Tartarate……100mg
Colistin Sulfate……30mg
Type of Form Form-5
10Kg, Decontrolled
Me-too status Doxy-Tol Powder by Lead Pharmaceuticals (Not
Confirmed)
Antibiotic)
Brand Name +Dosage Form + Strength Sulfachlor-T Powder
Sulfachlorpyridaizine….100mg
Trimethoprim……20mg
Type of Form Form-5
10Kg, Decontrolled
Me-too status Cosumix Plus Powder by HILTON PHARMA (PVT)
LTD., KARACHI Reg # 026595
Antibiotic)
Brand Name +Dosage Form + Strength Flucofar Powder
Flumequine….500mg
Colistine Sulphate…..50mg
Type of Form Form-5
10Kg, Decontrolled
Me-too status COLIQUIN POWDER. by Selmore Pharmaceuticals Reg
# 035013
Antibiotic)
Brand Name +Dosage Form + Strength Furol Powder
Furazolidone…....950mg.
Pharmacological Group Antiprotozoal
Type of Form Form-5
Pack size & Demanded Price 20gm, 50gm, 100gm, 250gm, 500gm, 1000gm, 2.5kg, 5kg
10Kg, Decontrolled
Me-too status Furasym Powder by Syman Pharmaceuticals Reg #
023435
Antibiotic)
Decision:Registration Board referred the case to Expert working group on Veterinary Drugs.
Brand Name +Dosage Form + Strength CTC Fort Oral Powder
Chlortetracycline HCl…..200mg
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 2.5kg, 5kg 10Kg,
Decontrolled
Me-too status KAAZ-CTC-20 POWDER. by Bio-labs Reg # 028513
Antibiotic)
Brand Name +Dosage Form + Strength Tricofon Oral Powder
Trichlorfon…..980mg
Pharmacological Group Antiparasitic
Type of Form Form-5
Pack size & Demanded Price 10gm,50gm, 250gm, 500gm, 1000gm, 2.5kg, 5kg 10Kg,
Decontrolled
Me-too status TRICHLOR WATER SOLUBLE POWDER Reg #
052334
Antibiotic)
Brand Name +Dosage Form + Strength Enrotin-A Powder
Enrofloxacin as HCl……100mg
Colistin Sulfate…..35mg
Amantadine as HCl….40mg
Type of Form Form-5
Pack size & Demanded Price 50gm,100gm 250gm, 500gm, 1000gm, 2.5kg, 5kg
10Kg, Decontrolled
Me-too status Intracin Plus Powder by Leads Pharmaceutical Reg #
049652
Antibiotic)
Decision: Deferred for rationale of amantadine in applied formulation.
Brand Name +Dosage Form + Strength Doxylin Powder
Doxycyclin Hyclate…..500mg
Type of Form Form-5
Pack size & Demanded Price 50gm,100gm 250gm, 500gm, 1000gm, 2.5kg, 5kg
10Kg, Decontrolled
Me-too status Seldox Powder by Selmore Pharmaceutical Reg # 058717
Antibiotic)
Decision: Approved.
Evaluator PEC-II
On the Recommendation of the panel of experts, the CLB in its 265 meeting held on 9th & 10th August
th
2018 has considered and approved the following 7 sections of firm M/s Internaional Pharma labs,
Raiwind Road, Lahore.
1) Liquid Repacking (Human section)
2) Powder repacking Human Section
3) Sachet General (Human section)
4) External Preparation/ Application/Aerosol (Human section)
5) Liquid Injectable (Steroid Vet section)
6) Oral Powder (Penicillin Vet Section)
7) Quality Control Lab (Amendments)
Sachet Section (General) 10products/8molecules
Applicant Chowk, Defence Road, 1-km Towards Kahna, Lahore.
Brand Name +Dosage Form + Strength I-Cal C Sachet
Calcium Lactate………. 3.24gm
Calcium Carbonate………0.300gm
Diary No. Date of R& I & fee Dy. No 31029-A 14-09-2018 Rs.20,000/- 14-09-2018
Type of Form Form-5
Finished product Specification Manufacturer Specifications
Pack size & Demanded Price 10’s; Rs. 75/-
25’s; Rs. 187.5/-
50’s; Rs. 375/-
Me-too status Calc-M-Forte Sachet of M/s Medimarker's, Hyderabad
(Reg.#048612)
GMP status Inspection conducted on 19th Dec., 2017 & 2nd March,
2018
Renewal of DML and grant of additional sections. Panel
recommends renewal of DML and grant of additional
sections.
Remarks of the Evaluator Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting.
authorities/agencies which were adopted by the Registration Board in its 275th meetin
Brand Name +Dosage Form + Strength I-Cal C 1000 Sachet
Calcium Lactate…….578gm
Calcium Carbonate…….327gm
Calcium Gluconate…….422mg"
Dated 14-09-2018
Type of Form Form-5
25’s; Rs. 187.5/-
50’s; Rs. 375/-
Me-too status N/A
2018
Renewal of DML and grant of additional sections.
Panel recommends renewal of DML and grant of
additional sections.
Remarks of the Evaluator  Evidence of approval of applied formulation in
adopted by the Registration Board in its 275th meeting.
by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm
which were adopted by the Registration Board in its 275th meeting.
alongwith registration number, brand name and name of firm
Brand Name +Dosage Form + Strength I-Cal Vit Sachet
Calcium Lactate……..1000mg
Calcium Carbonate……..327mg
Vitamin C……….500mg
Diary No. Date of R& I & fee Dy.No 31029-C dated 14-09-2018 Rs.20,000/- Dated 14-
09-2018
Type of Form Form-5
Pack size & Demanded Price 10’s; Rs. 75/- 25’s; Rs. 187.5/-
50’s; Rs. 375/-
Me-too status Calwell Sachet of M/s Well & Well Pharma (Pvt) Ltd.
(Reg.#068899)
2018
adopted by the Registration Board in its 275th
meeting.
Brand Name +Dosage Form + Strength I-Cal Vit Plus Sachet
Calcium Lactate………1gm
Calcium Carbonate………600mg
Vitamin C……….1000mg"
Diary No. Date of R& I & fee Dy.No 31029-D dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5
25’s; Rs. 187.5/-
50’s; Rs. 375/-
Me-too status CXT-3 2.6 g Sachet of M/s Wnsfeild Pharmaceutical
(Reg.#075591)
2018
Remarks of the Evaluator Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the
Brand Name +Dosage Form + Strength I-Vitacal Plus Sachet
Calcium Carbonate…….0.327gm
Calcium Lactate……..1gm
Ascorbic Acid……..100mg
Dated 14-09-2018
Type of Form Form-5
Pack size & Demanded Price Pack size not submitted, Rs.134.2/-;
Pack size not submitted, Rs.335.5/-;
Pack size not submitted, Rs.671/-.
Me-too status Max-V Sachet by M/s Alliance Pharmaceuticals
(Reg#043770)
2018
meeting.
 Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name
of firm as submitted reference is of different
composition.
Brand Name +Dosage Form + Strength Carbo Soda Sachet
Sodium Bicarbonate…….. 1.716gm
Sodium Citrate……. 0.613gm
Citric Acid……. 0.702gm
Tartaric Acid…….. 0.858gm
Diary No. Date of R& I & fee Dy. No 31029-G dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5
Pack size & Demanded Price Pack size not submitted, Rs.275/-;
Pack size not submitted, Rs.687.5/-;
Pack size not submitted, Rs.1375/-.
Me-too status Wapocit Sachet of M/s. Libra Pharmaceuticals (Pvt) Ltd
(Reg.# 073287)
2018
Remarks of the Evaluator Evidence of applied formulation/drug already approved
number, brand name and name of firm as submitted
reference is of different composition.
Decision: Deferred for Evidence of approval of applied formulation in reference regulatory
Brand Name +Dosage Form + Strength I-Husk Sachet
Psyllium Husk …600mg
Diary No. Date of R& I & fee Dy. No 31029-H dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5
Pack size & Demanded Price Rs. 110/-, 10’s;
Rs. 375, 30’s.
Me-too status Not confirmed.
2018
adopted by the Registration Board in its 275th meeting.
of firm as submitted reference is of different
composition.
Brand Name +Dosage Form + Strength Proteclyte (O.R.S) Sachet
Sodium Chloride……. 2.6gm
Trisodium Citrate Dihydrate…….. 2.9gm
Potassium Chloride……. 1.5gm
Glucose Anhydrous……. 13.5gm
Diary No. Date of R& I & fee Dy.No 31029-I dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Pharmacological Group Nutrients and vitamins
Type of Form Form-5
Pack size & Demanded Price Rs 123.74/-, 10’s;
Rs 309.37/-, 25’s;
Rs618.7/-, 50’s.
Approval status of product in Reference Reduced osmolarity ORS formulation (WHO approved)
Me-too status Pliva-ORS Powder by M/s Pliva Pakistan (Pvt) Ltd
(Reg#073620)
2018
Remarks of the Evaluator  Pharmacological Group is incorrect.
Decision: Deferred for clarification of Pharmacological group.
Brand Name +Dosage Form + Strength I-Spaghul Sachet
Mebeverine hydrochloride……135gm
Ispaghula Husk….… 3.5gm
Diary No. Date of R& I & fee Dy.No 31029-J dated 14-09-2018 Rs.20,000/- Dated 14-
09-2018
Type of Form Form-5
Pack size & Demanded Price 10’s, Rs.80/-;
30’s, Rs.240/-
Approval status of product in Reference Fybogel Mebeverine effervescent granules by M/s Reckitt
Regulatory Authorities. Benckiser Healthcare (UK) Ltd. (MHRA approved)
Contains mebeverine hydrochloride 135mg
Me-too status MEVULAK Sachet of M/s Sami (Reg.#076311)
Contains mebeverine hydrochloride 135mg
2018
Remarks of the Evaluator  Pharmacological Group is not correct.
 Approval status of product in Reference Regulatory
Authorities not confirmed.
 Me-too status not confirmed from available database.
 Clarification of Pharmacological group.
Brand Name +Dosage Form + Strength Ieurofen Sachet
Ibuprofen……..600mg
Diary No. Date of R& I & fee Dy.No 31029-K dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Type of Form Form-5
Pack size & Demanded Price Pack size not submitted, Rs.220/-;
Approval status of product in Reference Brufen Granules 600mg by M/s BGP Products Ltd.
Me-too status Hibufen 600mg Sachet by M/s Hirani (Reg#081554)
2018
Remarks of the Evaluator  Approved formulation in MHRA contains Ibuprofen

effervescent granules but formulation submitted by
the firm is not of effervescent granules.
Decision: Deferred for clarification of applied dosage form since reference product contains
efferevescent granules whereas no such details are submitted in the dossier.
Case No. 05: Registration applications of categories to be considered on priority
Evaluator PEC-III
Following two cases were received from section R-V vide letter No. F.8-6/2013-Reg-V dated 6th
November 2018. According to the contents of the letter the firm has claimed one molecule to be
considered on priority against export worth USD 100290.16 which is duly verified from submitted
documents (Form E GD and shipment invoices) as per the decision of Registration Board.
793. Name and address of manufacturer / M/s Neutro Pharma (Pvt) Ltd., 9.5 Km, Sheikhupura Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Coxib 100mg Capsule
Celecoxib…..100mg
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 50’s, 100’s: As per SRO
Approval status of product in Celebrex Capsule by GD Searle
Me-too status Celetab capsule by Indus Pharma
report concludes that firm has fair level of GMP
compliance
3
794. Name and address of manufacturer / M/s Neutro Pharma (Pvt) Ltd., 9.5 Km, Sheikhupura Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Coxib 200mg Capsule
Celecoxib…..200mg
Diary No. Date of R& I & fee Dy No. 35387: 24-10-2018
PKR 20,000/-: 24-10-2018
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 50’s, 100’s: As per SRO
Approval status of product in Celebrex Capsule by GD Searle
Me-too status Celetab capsule by Indus Pharma
report concludes that firm has fair level of GMP
compliance
Evaluator PEC-XIV
Export Facilitation: Applications were received through letter No.F.7-7/2017-Reg-II, The firm claimed 4
molecules to be considered on priority”. Out of which 2 molecules are presented here.
795. Name and address of manufacturer / M/s Atco Laboratories Limited , B-18, S.I.T.E., Karachi
Applicant
Brand Name +Dosage Form + Strength BISOP TABLETS 2.5mg
Bisoprolol Fumarate…………..2.5mg
Pharmacological Group Selective Beta blocking agents
Type of Form Form-5
Pack size & Demanded Price 7’s, Rs.70/-,
10’s, Rs.100/-,
14’s, Rs.140/-,
20’s, Rs.200/-,
28’s Rs.280/-,
30’s; Rs.300/-
Approval status of product in Cardicor 2.5mg tablet Of ( MHRA Approved)
Me-too status Biscot 2.5mg Tablet Of M/S Scotmann Pharmaceuticals
GMP status The panel inspection dated 28-02-2018 recommended the
grant of renewal of DML of the firm.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength BISOP TABLETS 5mg
Type of Form Form-5
10’s, Rs.200/-,
14’s, Rs.280/-,
20’s, Rs.400/-,
28’s Rs.560/-,
30’s; Rs.600/-
Approval status of product in Cardicor 5mg tablet Of ( MHRA Approved)
Me-too status Biscot 5mg Tablet Of M/S Scotmann Pharmaceuticals,
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength BISOP TABLETS 10mg
Type of Form Form-5
10’s, Rs.300/-,
14’s, Rs.420/-,
20’s, Rs.600/-,
28’s Rs.840/-,
30’s; Rs.900/-
Approval status of product in Bisoprolol 10mg film-coated tablet of M/s Accord
Reference Regulatory Authorities. Healthcare Limited, (MHRA Approved)
Me-too status Monitor 10mg tablet of M/s Werrick Pharma
(Reg. # 026802)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength TIOCARDIS 20MG TABLET
Telmisartan ……………20mg
Pharmacological Group Angiotensin II receptor antagonist
Type of Form Form-5
10’s, Rs.1000/-,
14’s, Rs.1400/-,
20’s, Rs.2000/-,
28’s Rs.2800/-,
30’s; Rs.3000/-
Me-too status Tasmi 20mg tablet of M/s Getz Pharma (Reg. # 047481)
Decision: Approved.
Applicant
Type of Form Form-5
10’s, Rs.2000/-,
14’s, Rs.2800/-,
20’s, Rs.4000/-,
28’s Rs.5600/-,
30’s; Rs.6000/-
Decision: Approved.
Applicant
Type of Form Form-5
10’s, Rs.4000/-,
14’s, Rs.5600/-,
20’s, Rs.8000/-,
28’s Rs.11200/-,
30’s; Rs.12000/-
Decision: Approved.
b. Local manufacturing applications of priority categories defined by Registration

Board in its 257th meeting
Evaluator PEC-III
801. Name and address of manufacturer / M/s Pharmedic Laboratories Pvt Ltd. 16-km, Multan Road
Applicant Lahore, Pakistan
Brand Name +Dosage Form + Strength Evolar 2.5mg Tablet
Everolimus…2.5mg
Pharmacological Group Antineoplastic agent
Type of Form Form 5
Pack size & Demanded Price 30’s, Rs. 10000/- per tablet
Approval status of product in Everolimus 2.5mg Tablets by Synthon Hispania
Me-too status Afinitor tablets by Novartis
GMP status Last GMP inspection report dated 31-8-2016 confirms
 Justify the formulation of film coated tablet
since the reference product is uncoated tablet, in case of
revision of formulation as per the reference product
requisite fee needs to be submitted.
Decision: Deferred for following submissions:
 Revision of formulation to uncoated tablet as per the reference product along with
submission of fee.
 Updated GMP status of the firm from QA&LT Division
Brand Name +Dosage Form + Strength Lenide 2.5mg Capsule
Lenalidomide…2.5mg
Pharmacological Group Other immunosuppressant
Type of Form Form 5
th
| 354
Pack size & Demanded Price Rs. 15000/capsule, 7’s, 21’s
Approval status of product in Linalidomide capsules (MHRA Approved)
Me-too status Not available
3
Remarks of the Evaluator Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) along with registration
number, brand name and name of firm is required.
Decision: Decision: Deferred for following submissions:
alongwith registration number, brand name and name of firm or else application on form
5-D along with submission of differential fee and stability study data as per the
requirements of 278th meeting of Registration Board.
 Updated GMP status of the firm from QA&LT Division.
Brand Name +Dosage Form + Strength Lenide 5mg Capsule
Lenalidomide…5mg
Type of Form Form 5
3
Remarks of the Evaluator Evidence of applied formulation/drug already approved by
Brand Name +Dosage Form + Strength Lenide 7.5mg Capsule
Lenalidomide…7.5mg
Type of Form Form 5
Remarks of the Evaluator3 Evidence of applied formulation/drug already approved by
Lenalidomide…10mg
Type of Form Form 5
Lenalidomide…25mg
Type of Form Form 5
Brand Name +Dosage Form + Strength Nilo 150mg Capsule
Nilotinib as hydrochloride…150mg
Pharmacological Group Protein kinase inhibitor
Type of Form Form 5
Pack size & Demanded Price 28’s: As per brand leader
Approval status of product in Tasigna Capsule by Novartis
Me-too status Tasigna Capsule by Novartis
 The me-too of the drug has been registered in
Import, while as per S.R.O 1117(I)/2012 the fee for
drugs which are not manufactured locally is 50,000/-
Decision: Deferred for updated GMP status of the firm from QA&LT Division.
Brand Name +Dosage Form + Strength Nilo 200mg Capsule
Nilotinib as HCL…200mg
Pharmacological Group Protein kinase inhibitor
Type of Form Form 5
Approval status of product in Tasigna Capsule by Novartis
Me-too status Tasigna Capsule by Novartis
Brand Name +Dosage Form + Strength Nexanib 200mg Tablet
Sorafenib (as tosylate)…200mg
Pharmacological Group Protein Kinase Inhibitor
Type of Form Form 5
Pack size & Demanded Price 6x10’s: As per brand leader
Approval status of product in Nexavar 200 mg film coated tablet by Bayer Australia Ltd
Reference Regulatory Authorities. (TGA Approved)
Me-too status Nexavar 200mg Tablets By M/s Bayer Pakistan
Brand Name +Dosage Form + Strength Satin 50mg Capsule
Sunitinib maleate eq. to sunitinib…50mg
Pharmacological Group Protein Kinase Inhibitor
Type of Form Form 5
Approval status of product in Sutent Capsule by CPPI CV
Me-too status Sutent 50mg Capsule by Pfizer
Remarks of the Evaluator3 The me-too of the drug has been registered in Import,
while as per S.R.O 1117(I)/2012 the fee for drugs which
are not manufactured locally is 50,000/-
Evaluator PEC-XIV
811. Name and address of manufacturer / M/s Werrick Pharmaceuticals, Plot # 216, 217, I-10/3,
Applicant Industrial Area, Islamabad.
Brand Name +Dosage Form + Strength OLARIB CAPSULES 50mg
OLAPARIB…………………….50mg
Pharmacological Group Inhibitor of polyadenosine 5’-diphosphoribose
polymerase (PARP) enzyme
Type of Form Form-5
Finished product Specification In-house specs
Pack size & Demanded Price 10’s, 20’s, & 70’s ; As per SRO
Approval status of product in Reference LYNPARZA Capsules 50mg of Astra Zeneca, USFDA
GMP status Routine GMP inspection conducted on 07-12-2017
concluded that the firm is operating at a very good level
of GMP compliance.
Remarks of the Evaluator. Evidence of applied formulation already approved by
DRAP/DCO (generic/me-too) is required to be
submitted.
Brand Name +Dosage Form + Strength NERIB TABLETS 40mg
Neratinib Maleate……………..40mg
Pharmacological Group Protein Kinase inhibitor
Type of Form Form-5
Approval status of product in Reference NERLYNX TABLETS 40mg of Puma Biotechnology,
Regulatory Authorities. USFDA
of GMP compliance.
submitted.
Brand Name +Dosage Form + Strength PONIB TABLETS 45mg
Ponatinib hydrochloride……………45mg
Pharmacological Group Kinase inhibitor
Type of Form Form-5
Approval status of product in Reference ICLUSIG TABLETS 45mg of ARIAD Pharma, USFDA
of GMP compliance.
submitted.
Brand Name +Dosage Form + Strength BOSNIB TABLETS 500mg
Bosutinib monohydrate……………500 mg
Pharmacological Group Kinase inhibitor
Type of Form Form-5
Approval status of product in Reference BOSULIF TABLETS 500mg of Pfizer, USFDA
of GMP compliance.
submitted.
Evaluator-PEC-VI
815. Name and address of manufacturer / M/s DeMont Research Laboratories Pvt Ltd, 20km,
Applicant Sharqpur road, Lahore
Brand Name +Dosage Form + Strength Lezra 2.5mg tablet
Letrozole……2.5mg
Pharmacological Group Non-Steroidal aromatase inhibitor
Type of Form Form-5
Approval status of product in Reference FEMARA 2.5 mg Tablet by M/s Novartis

Regulatory Authorities. Pharmaceuticals (USFDA approved)
Me-too status Aromek 2.5mg Tablet by M/s Glaxy Pharmaceuticals
(Reg#052258)
GMP status Last GMP inspection is conducted on 26- 02- 2018 and
the report concludes that overall firm has satisfactory
compliance of GMP
with condition that manufacturer shall provide safety and protective measures for workers
and personnel which remain in direct contact or are involved in close handling of these drugs
c. Import Applications of Priority Categories Defined by Registration Board in its

257th meeting.
i. Human
Evaluator PEC-I
816. Name and address of Applicant M/s Servier Research and Pharmaceuticals [Pakistan](pvt).
Ltd, Country Head Office: 65- Main Boulevard, Gulberg,
Lahore, Pakistan.
Detail of Drug Sale License Renewed upto 28-04-2019
Name and address of manufacturer M/s Servier (Ireland) Industries ltd., Gorey Road, Arklow Co
Wicklow, Ireland.
Name and address of marketing M/s Les laboratories Servier, 50 rue Carnot, 92284, Suresnes
authorization holder Cedex, France.
Name of exporting country Ireland
Type of Form Form 5-A
Diary No. & Date of R& I Dy No. 12544: 05-4-2018
Fee including differential fee PKR 50,000/-: 05-04-2018
Brand Name+Dosage Form+ Strength COVERSAM 5/10 tablet
Perindopril Arginine ………………………………5mg
Amlodipine besylate eq. to Amlodipine…………. 10mg
Finished Product Specification Innovator’s Specs.
Pharmacological Group Anti- Hypertensive
Shelf life 03-Years (demanded)
Demanded Price As per SRO
Pack size 30’s
International availability Perindopril/Amlodipine. 5mg/10mg. Tablets IC0041-013-
002. Approved in HPRA, Ireland.
Me-too status NA.
Detail of certificates attached  Original and Legalized Certificate of Pharmaceutical
Product (COPP).
 Sole Agency agreement (Expired).
 Copy of Valid Drug Sale License.
 Credentials of the manufacturer.
 GMP inspection report of the manufacturer conducted on
31st March 2017 wherein stated that the firm comply
with the requirements of the EU Guide to GMP.
 Copy of Sole Agency agreement submitted notarized from Lahore, wherein it is stated that,
“This agreement shall thereafter remain en-forced until September 30, 2016. It shall thereafter be
automatically renewed for subsequent one (1) year period.”
 Undertaking that the applied brand name is not similar or has no resemblance (look alike- sound
alike) with already registered drugs to justify the fee submitted.
Decision: Deferred for submission of original, valid and notarized sole agency agrrement.
Lahore, Pakistan.
Wicklow, Ireland.
Brand Name +Dosage Form + COVERSAM 10/10 tablet
Strength
Perindopril Arginine ……………………….…10mg
Amlodipine besylate eq. to Amlodipine…………...10mg
Pack size 30’s
Me-too status NA.
Product (COPP).
Lahore, Pakistan.
Wicklow, Ireland.
Strength
Amlodipine besylate eq. to Amlodipine…………. .5mg
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Pack size 30’s
International availability Perindopril/Amlodipine. 5mg/5mg. Tablets IC0041-012-002.
Approved in HPRA, Ireland.
Me-too status NA.
Product (COPP).
Lahore, Pakistan.
Wicklow, Ireland.
Strength
Amlodipine besylate eq. to Amlodipine…………. …5mg
Pack size 30’s
Me-too status NA.
Product (COPP).
Evaluator PEC-VII
820. Name and address of Applicant M/s. Pfizer Pakistan Limited 12 Dockyard road, west Wharf,
Karachi
Detail of Drug Sale License Address: M/s. Pfizer Pakistan Limited 12 Dockyard road, west
Wharf, Karachi
Validity: 6-7-18
Status: Drug License by Way of distributor
Name and address of M/S GlaxoSmithKline manufacturing s.P.A via. A. Fleming
manufacturer 2,37135 Verona Italy.
Name and address of marketing M/s. Pfizer irland pharmaceuticals, operation support group,
authorization holder Ringaskiddy, country Cork Ireland
Name of exporting country Italy
Diary No. & Date of R& I Dy. No.27548 Dated 16-08-2018
Fee including differential fee Rs. 100,000/- Dated 10-Aug-2018
Brand Name +Dosage Form + Zavicefta injection 2 g/0.5 g
Strength
Composition Each vial contain
Ceftazidime pentahydrate eq Ceftazidime……… 2gm
Avibactam Sodium Eq to Avibactam Ceftazidime…0.5 g
Finished Product Specification in-house
Shelf life 24 months
Demanded Price 240 rupees per box
Pack size 8 tablets/box
International availability AVYCAZ (avibactam sodium; ceftazidime eq 0.5gm
base;2gm/vial) USFDA
Me-too status NA
Detail of certificates attached GMP certificate
(Translated Copy, Embassy attested)
Certificate No: UK API 4 insp GMP 4/15697-0019
Certifying Authority: MHRA
Issue date: 7- 7-2017
COPP (Original, Notary Attested from EMA)
Certificate No:01/18/116234
Certifying Authority: European medicine agency
Issue Date: 24-6-2016
Manufacturing license DP manufacturer :
Certificate No: aM-43//2017
Certifying Authority: Agenzia italiana del farmaco
Letter of Authorization (Copy)
Date of Agreement:25-April-2018 (Valid for 5 year)
Remarks of the Evaluator.  Submitted Label specimen is without the Urdu version
which is required as per The Drugs (Labelling and
Packaging) Rules, 1986
Label with Urdu version is submitted
 Complete protocols of stability studies are needed.
Submitted
The name of actives on form 5A are without salt form
Form 5 is revised by the firm with proper salt form of
active.
Decision: Deferred for submission of fee for revision of form 5-A
821. Name and address of Applicant Huaxing Pharmaceuticals (Pvt) Ltd. 207,D1, Nespak society
district Lahore
Detail of Drug Sale License Address: Huaxing Pharmaceuticals (Pvt) Ltd.
Address: 207,D1, Nespak society district Lahore
Validity: 28-june 2018
Name and address of M/S Shandong Luoxin pharmaceutical group stock co. limited
manufacturer Road Luo 7, High & New technology industries development
zone, Linyi city, Shandong province china.
Name and address of marketing Huaxing Pharmaceuticals (Pvt) Ltd.
authorization holder Address: 207,D1, Nespak society district Lahore
Name of exporting country People’s republic of China
Fee including differential fee Rs. 100,000/- Dated 6-july-2018
Brand Name +Dosage Form + Aciclovir tablet 0.1 g tablet
Strength
Composition Each tablet contain
Acyclovir…. 100 mg
Pharmacological Group Anti-viral
Shelf life 24 month
Pack size
International availability NA
Me-too status NA
(Translated Copy, attested)
Certificate No:SD20160446
Certifying Authority: China food and drug administration
Issue date: 25-1-2016
Valid date: 24-1-2021
COPP (Copy, Embassy Attested)
Certificate No:LY2018-013
Certifying Authority: Shandong Linyi food and drug
administration
Issue Date:1-01-2016
Valid: 18-3-2019
Date of Agreement:12-march-2018 (Valid for 5 year)
Remarks of the Evaluator.  Submitted Label specimen is without the Urdu version which
is required as per The Drugs (Labelling and Packaging)
Rules, 1986
Submitted
meeting.
Not found in any reference regulatory authority in this strength
 Evidence of approval of applied formulation in DRAP (me
too status).
Not approved in this strength
 Stability data is not submitted. Submit stability studies (long
term & accelerated) conducted under the conditions of zone
IV-A of 03 batches duly signed shall be submitted.
Provided
Previously due to the location of the manufacturer and the
applicant initial stability study was carried out under the
condition of zone-II (25°C ± 2°C / 60% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) Stability data for 3
batches is submitted . however on query new stability
specific to zone IV A (30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) firm commit to
complete the stability study of 3 commercial batches up to
shelf life.
 Detailed method of manufacturing of tablet is missing
Submitted
Submitted
authorities/agencies which were adopted by the Registration Board
 Stability study data as per zone IV A.
district Lahore
Address: 207, D1, Nespak society district Lahore
Brand Name +Dosage Form + Aniracetam capsule 0.2 g
Strength
Composition Each Capsule contain
aniracetam…. 0.2 g
Pharmacological Group Antidepressant, Mental performance enhancer
Shelf life 24 month
Demanded Price 600 rupees per bottle
Pack size 18 capsules per bottle
Me-too status NA
Issue date: 10- July 2002
administration
Issue Date:9-12-2005
Valid: 18-3-2019/
Submitted
Not approved in any reference regulatory authority
 Evidence of approval of applied formulation in DRAP (me
too status).
Not approved in DRAP
 Stability data is not submitted. Submit stability studies
(long term & accelerated) conducted under the conditions of
zone IV-A of 03 batches duly signed shall be submitted.
Provided
Previously due to the location of the manufacturer and the
applicant initial stability study was carried out under the
condition of zone-II (25°C ± 2°C / 60% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) Stability data for
3 batches is submitted . however on query new stability
specific to zone IV A (30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) firm commit to
complete the stability study of 3 commercial batches up to
shelf life.
 Detailed method of manufacturing of tablet is missing
Submitted
Submitted
authorities/agencies which were declared/approved by the Registration Board
 Stability study data as per zone IV A.
district Lahore
th
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Brand Name +Dosage Form + Calcium Folinate injection
Strength
Composition Each vial contain
Calcium folinate….100 mg
Demanded Price 1800 per vial
Pack size 1’s vial
International availability Leucovorin Calcium 100 mg/vial (USFDA)
Me-too status NA
administration
Issue Date:31-March-2005
Valid: 18-3-2019
Submitted
(long term & accelerated) conducted under the
conditions of zone IV-A of 03 batches duly signed shall
be submitted.
Provided
Previously due to the location of the manufacturer and
the applicant initial stability study was carried out under
the condition of zone-II (25°C ± 2°C / 60% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) Stability data
for 3 batches is submitted . however on query new
stability specific to zone IV A (30°C ± 2°C / 65% ± 5%
RH Accelerated: 40°C ± 2°C / 75% ± 5% RH) firm
commit to complete the stability study of 3 commercial
batches up to shelf life.
Submitted
Decision: Deferred for submission of stability study data as per zone IV A.
district Lahore
Brand Name +Dosage Form + Cefprozil tablet 0.25g
Strength
Composition Each Film coated tablet contain
Cefprozil…..0.2g
Pharmacological Group Cephalosporin
International availability CEFPROZIL (CEFPROZIL) tablet LUPIN
Me-too status NA
administration
Valid: 18-3-2019
Free Sale certificate:
Certificate No:LYFSC2018-003
Certifying Authority: Shandong food and drug administration of
the people’s republic of china
Submitted
 Evidence of approval of applied formulation in DRAP
(me too status) not available.
Evidence of cefprozil capsule is provided not of tablet
be submitted.
Provided
Submitted
district Lahore
Brand Name +Dosage Form + Oxaliplatin injection
Strength
Composition Each Vial Contains:
Oxaliplatin….. 100mg
lyophilized powder for IV injections
Pharmacological Group Antineoplastic Drug
Demanded Price 10,000 rupies per vial
International availability ELOXATIN for injection (50mg 100mg) by M/s
SANOFI AVENTIS US, USFDA approved
Me-too status Me-too status Celdach 50 injection by Hakimsons (Reg # 72564)
administration
Issue Date: 11-Dec-2012
Valid: 18-3-2019
Submitted
be submitted.
Provided
 Finished product specifications (along with the official
monograph if the product is pharmacopoeial).
The firm has claimed In House manufacturing
specifications while the product is available in USP. As
per USP the product contains Oxaliplatin and Lactose
monohydrate while according to formulation provided
by the firm the product also contain Oxaliplatin and
lactose.
Submitted
district Lahore
Brand Name +Dosage Form + Ambroxol HCL tablets
Strength
Composition Each tablet contain
ambroxol hydrochloride…. 30 mg
Finished Product Specification in-house
Pharmacological Group Respiratory system
International availability AMBROXOL ARROW 30 mg tablet (ANSM)
Me-too status FLUIBRON of CHIESI PHARMACEUTICALS
administration
Issue Date: 11-Dec-2012
Valid: 2020-2-7
Label with Urdu version is submitted
meeting.
Approved in France
be submitted.
Provided
Submitted
Decision: Deferred for consideration on its turn with respect to the queue.
Evaluator PEC-V
827. Name and address of Applicant M/s Pharmatec Pakistan (PVT) Limited,
D-86/A, Mangophir Road, SITE, Karachi.
Detail of Drug Sale License Address: D-86/A, Mangophir Road, SITE, Karachi.
Validity: 22/06/2019
Status: Drug sale license by the way of wholesale
Name and address of M/s Samyang Biopharmaceuticals Corporation, 55 Munpyeongseo-
manufacturer ro,18beon-gil, Daedeok-gu Daejeon, Rpublic of Korea
Name and address of marketing M/s Samyang Biopharmaceuticals Corporation, 55
authorization holder Munpyeongseo-ro, 18beon-gil, Daedeok-gu Daejeon, Rpublic of
Korea
Diary No. & Date of R& I Dy. No.16386 Dated 28/09/2017
Fee including differential fee Rs. 50,000/- Dated 28/09/2017
Brand Name +Dosage Form + RHEUMASTOP Plaster
Strength
Composition Each plaster contains:
Diclofenac diethylammonium……… 120 mg
Finished Product Specification In House
Pharmacological Group Plaster/NSAIDS
Demanded Price Rs. 1750/- for pack of 5 patches
Pack size 5’s
International availability Voltarol Medicated Plaster 140mg
Incorrect
Me-too status Could not be confirmed.
Detail of certificates attached  Original legalized CoPP (certificate No. 2017-GI-0660)
certified by Daejeon Regional Food & Drug Administration,
Korea issued on 16/03/2017 confirms the free sale of the
product in exporting country. The facilities and operations
conform to WHO-GMP.
 GMP certificate issued by Daejeon Regional Food and Drug
Administration on 10/04/2017.
Remarks of the Evaluator:
 The firm has claimed In House specifications and the product is not present in USP/BP.
Followings are the short comings:
 Stability studies (long term & accelerated) conducted under the conditions of zone IV-A of 03
batches till shelf life. Provided data 30C/60%RH.
Firm has submitted it was a typographical error. Firm has submitted supporting documents from
where humidity could not be verified.
 Significant change i.e. 5 % has been observed in the assay values at 12 months and Out of
specifications at 24 month studies. Justify.
Batch No. Initial 12 month 18 month 24 month
RS10A3P 101.86% 92.3% 93.2% 88.6%

OOS
RS10A2P 102.32% 96.7% 92.4% 83.8%
OOS
RS10A1P 102.86% 97.4% 93.4% 83.8%
The decrease in assay at 12 month is not critical as the product is under its shelf life limits as well as
same trend is found in the accelerated data, hence we claim shelf life 18 months.
 International availability and Me-too could not be confirmed.
Decision: Registration Board referred the case to MDMC division for opinion whether it falls
under medical devices or not.
828. Name and address of Applicant M/s Hoffmann Human Health Pakistan, ltd.
32-Babar Block, New Garden town,Lahore
Detail of Drug Sale License Address: 32-Babar Block, New garden town, Lahore.
Validity: 29, Nov, 2019
Status: License to sell drugs as a Distributor
Name and address of Head Office:
manufacturer B-1,Extn./A-27, MCIE, Malthura Road, New Dehli 110044, India
Factory:
M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel Pradesh-173
205, India
Form 5-A + Sole
Name and address of marketing M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel Pradesh-173
authorization holder 205, India
Name of exporting country India
Brand Name +Dosage Form + MYCEPT 250mg Capsule
Strength
Mycophenolate mofetil…..250mg
Demanded Price Rs. 4000/- per box of 30 capsule
Pack size 3x10’s Blister strip.
International availability Cellcept 250mg Capsules
Me-too status N/A
Detail of certificates attached  Original legalized CoPP (certificate No.
MB/05/203/WHO/GMP/18-116) certified by State Drugs
Controller, Licensing Authority cum Controlling Authority,
Himachel Pradesh, India valid till 11/02/2020 confirms the
free sale of the product in exporting country. The facilities
and operation conform to WHO-GMP. (does not contains
the name of Pakistan)
 Free sale certificate (Legalized) confirming free sale of the
applied product is attached.
 Letter of Authorization valid up to 30, April 2020.
Remarks of the Evaluator. Product is present in USP not in BP.
Decision: Deferred for confirmation whether applied formulation can be imported from India or
otherwise as per prevailing Import Policy Order.
829. Name and address of Applicant M/s Hoffmann Human Health Pakistan, ltd.
32-Babar Block, New Garden town,Lahore
Detail of Drug Sale License Address: 32-Babar Block, New garden town, Lahore.
Validity: 29, Nov, 2019
Name and address of Head Office:
manufacturer B-1,Extn./A-27, MCIE, Malthura Road, New Dehli 110044, India
Factory:
M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel Pradesh-173
205, India
Form 5-A + Sole
Name and address of marketing M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel Pradesh-173
authorization holder 205, India
Brand Name +Dosage Form + MYCEPT 500 tablet
Strength (film coated tablet)
Mycophenolate mofetil…..500mg
Demanded Price Rs. 8000/- per box of 30 capsule
Pack size 3x10’s Blister strip.
International availability Cellcept 500mg Film-Coated Tablets
Me-too status N/A
Detail of certificates attached  Original legalized CoPP (certificate No.
MB/05/203/WHO/GMP/18/117) certified by State Drugs
Controller, Licensing Authority cum Controlling Authority,
Himachel Pradesh, India valid till 11/02/2020 confirms the
free sale of the product in exporting country. The facilities
and operation conform to WHO-GMP. (does not contains
the name of Pakistan)
 Free sale certificate (Legalized) confirming free sale of the
applied product is attached.
 Letter of Authorization valid upto 30, April 2020.
Remarks of the Evaluator. Product is present in USP.
Decision: Deferred for confirmation whether applied formulation can be imported from India or
otherwise as per prevailing Import Policy Order.
ii. Veterinary
830. Name and address of Applicant M/s Al-|Habib Agencies, Suit 11, 2nd floor Kala Khan Shopping
Center Shamasabad, Murree Road , Rawalpindi
Detail of Drug Sale License Address: Suit 11, 2nd floor Kala Khan Shopping Center
Shamasabad, Murree Road , Rawalpindi
Validity: 04-05-2020
Status: License to sell drugs as a distributor
Name and address of Baoding Sunlight Herb Medicament Co. Ltd, No 76, North
manufacturer Tuanjie Road, Qingyuan, Baoding City, Hebei, Province China
Name and address of marketing Free sale does not mention the Marketing Authorization holder.
authorization holder
Name of exporting country China
Diary No. & Date of R& I Dy. No. 1574 Dated 11/01/2018
Brand Name +Dosage Form + A-|Mast Intramammary Infusion
Strength
Procaine Benzyl Penicillin 100mg
Streptomycin Sulphate…100mg
Neomycin Sulphate..100mg
Prednisolone…10mg
Shelf life 2 years
Demanded Price As per approval from DRAP.
Pack size LDPE barrel 10ml
International availability Multiject IMM Intramammary Suspension(Ireland)
Each 5g syringe contains:
Active Substances:
Procaine Benzylpenicillin 100,000 IU
Streptomycin Sulphate 100 mg
Neomycin Sulphate 100 mg
Prednisolone 10 mg
Incorrect
Me-too status Mastigon (Ointment)Incorrect.
Detail of certificates attached Original and Legalized Free Sale Certificate
Certificate No.: 20180727
Certifying Authority: Bureau of Agriculture of Baoding City
Legalized GMP Certificate
Certificate No. 2014GMP95
Certifying Authority: Ministry of Agriculture
Validity date: 11-05-2019
Legalized Agreement
Baoding Sunlight Herb Medicament Co. LTD
No 76, North Tuanjie Road, Qingyuan, Baoding City, Hebei,
Province China
&
M/s Al-|Habib Agencies
Suit 11, 2nd floor Kala Khan Shopping Center S|hamasabad,
Murree Road , Rawalpindi
Dated: 13-04-2015
Validity : 5 years
Declaration: Termination with Bless Pharmaceuticals from 13-
04-2015
Remarks of the Evaluator. Target Specie: Cattle
meeting.
by DRAP (generic / me-too status) along with
registration number, brand name and name of firm.
 Certifying Authority for free sale: Bureau of
Agriculture of Baoding City.
 Free sale certificate does not mention the Marketing
Authorization holder.
status) along with registration number, brand name and name of firm.
 Submission of free sale certificate issued by Concerned Regulatory Authority clearly
stating the Marketing Authorization Holder of the applied formulation.
831. Name and address of Applicant M/s Al-|Habib Agencies, Suit 11, 2nd floor Kala Khan Shopping
Center Shamasabad, Murree Road , Rawalpindi
Detail of Drug Sale License Address: Suit 11, 2nd floor Kala Khan Shopping Center
Shamasabad, Murree Road , Rawalpindi
Name and address of Baoding Sunlight Herb Medicament Co. Ltd, No 76, North
manufacturer Tuanjie Road, Qingyuan, Baoding City, Hebei, Province China
Name and address of marketing Free sale does not mention the Marketing Authorization holder
Brand Name +Dosage Form + A-Pen Plus Injection Suspension
Strength
Composition 50ml, 100ml
"Each ml Contains: -
Procaine Penicillin G 200,000 IU
Dihydrostreptomycin Sulfate 200mg
Dexamethasone Acetate…10mg"
Finished Product Specification Inhouse
Shelf life 2 years
Demanded Price As per approval from DRAP.
Pack size 50ml, 100ml glass bottle
International availability
DEXA-SP INJECTION
"Each ml Contains: -
Procaine Penicillin G 200,000 IU
Dihydrostreptomycin Sulfate 250mg (Potency).
Dexamethasone…1mg"
Incorrect
Detail of certificates attached Original and Legalized Free Sale Certificate
Certificate No.: 20180727
Certifying Authority: Bureau of Agriculture of Baoding City
Legalized GMP Certificate
Certificate No. 2014GMP95
Certifying Authority: Ministry of Agriculture
Validity date: 11-05-2019
Legalized Agreement
Baoding Sunlight Herb Medicament Co. LTD
No 76, North Tuanjie Road, Qingyuan, Baoding City, Hebei,
Province China
&
M/s Al-|Habib Agencies
Suit 11, 2nd floor Kala Khan Shopping Center S|hamasabad,
Murree Road , Rawalpindi
Dated: 13-04-2015
Validity : 5 years
Declaration: Termination with Bless Pharmaceuticals from 13-
04-2015
Remarks of the Evaluator. Target Specie: Cow, Sheep
declared/approved by the Registration Board in its
275th meeting.
by DRAP (generic / me-too status) along with
registration number, brand name and name of firm.
 Certifying Authority for free sale: Bureau of
Agriculture of Baoding City.
 Free sale does not mention the Marketing Authorization
holder.
 Formulation mentioned on free sale is
Procain Penicillin G, Dihydrostreptomycin sulphate,
Dexamethasone 0.08% (as per free sale)
along with registration number, brand name and name of firm.
 Submission of free sale certificate issued by Concerned Regulatory Authority clearly
stating the Marketing Authorization Holder of the applied formulation.
Case No. 06: Registration applications of import cases
a. New Cases (Human)

Evaluator PEC-V
832. Name and address of Applicant M/s Highnoon Laboratories Limited, 17.5 Kilometer, Multan Road,
Lahore.
Detail of Drug Sale License Firm has applied for Renewal. Token dated: 27-12-2017.
Name and address of M/s Cipla ltd., Plot no. 9 7 10, Pharma Zone, Phase II, Indore SEZ,
manufacturer Pithampur (MP)-454775
Name and address of marketing M/s Cipla ltd., Plot no. 9 7 10, Pharma Zone, Phase II, Indore SEZ,
authorization holder Pithampur (MP)-454775
Brand Name +Dosage Form + NASEHALER 50mcg Nasal Spray suspension
Strength
Composition Each Spray Delivers:
Mometasone Furoate Monohydrate Eq. to Mometasone
Furoate…… 50mcg (0.05% w/w)
Benzalkonium chloride….. 0.02% w/w
Demanded Price Rs. 700/- per 140 metered dose (MD)
Pack size 1×1’s (140 Metered Doses).
International availability NASONEX® 50 micrograms/actuation Nasal Spray, Suspension by
Ms. MSD, MHRA approved
Me-too status Rinelon aqueous nasal spray 50mcg by M/s Schering plough
Pakistan (IMPORTED from Belgium) (Reg # 063937)
Detail of certificates attached  Original legalized CoPP
Certificate No.03/2010
Certified by: Food and Drug Administration, Madhya, Pradesh
India valid till 15/06/2019
Confirms the free sale of the product in exporting country.
The facilities and operations conform to GMP as recommended by
WHO.
Remarks of the Evaluator.  The firm has claimed for In House manufacturing
specifications while the product is present in BP.
 Firm has applied for Renewal of DSL Token dated: 27-12-
2017.
 The assay value of long term stability studies for
Benzalkonium chloride shows a significant change for
batch number FC3306 (10.2%) and for batch number
FC3341 (6.9%). However, the results are in the specified
limit.
 The corticosteroid hormones are present in negative list as
per Import Policy Order.
Decision: Deferred for the following reasons:
 Submission of valid drug sale license.
 Justification for significant changes in assay values of long term stability studies for
Benzalkonium chloride for batch number FC3306 (10.2%) and for batch number
FC3341 (6.9%).
 Confirmation whether applied formulation can be imported from India or otherwise as
per prevailing Import Policy Order.
b. New Cases (Veterinary)
Evaluator PEC-I
833. Name and address of Applicant M/S Huzaifa International,
Commercial Area, Aziz Bhatti Town, Sargodha.
Detail of Drug Sale License Valid upto 2019.
Name and address of manufacturer M/s Super’s DIANA S.L CTRA C.17,Km17, 08150 Parets
Del Valles, Barcellona, Spain.
Name and address of marketing M/s Super’s DIANA S.L CTRA C.17,Km17, 08150 Parets
authorization holder Del Valles, Barcellona, Spain.
Name of exporting country SPAIN.
Diary No. & Date of R& I Dy. No. 19410: 30-10-2017
Fee including differential fee PKR 100,000/- 30-10-2017
Brand Name +Dosage Form + DIACEF Injection
Strength
Ceftiofur Hydrochloride…………………………50mg/ml
Finished Product Specification USP-40-NF-35
Pharmacological Group Anti- Biotic
Shelf life 24 months.
Demanded Price De-controlled.
Pack size 100ml
International availability SPAIN.
Me-too status Could not be confirmed as per available DRAP Database.
Detail of certificates attached  Original Free Sale Certificate of Spain.
 Sole Agency agreement.
 GMP inspection report of the manufacturer conducted
on 16th Feb. 2017.
Decision: Approved as per Policy for inspection of Manufacturer abroad.
834. Name and address of Applicant M/S Huzaifa International,
Commercial Area, Aziz Bhatti Town, Sargodha.
Detail of Drug Sale License Valid upto 2019.
Name and address of M/s Super’s DIANA S.L CTRA C.17,Km17, 08150 Parets Del
manufacturer Valles, Barcellona, Spain.
Name and address of marketing M/s Super’s DIANA S.L CTRA C.17,Km17, 08150 Parets Del
authorization holder Valles, Barcellona, Spain.
Name of exporting country SPAIN.
Diary No. & Date of R& I Dy. No. 19408: 30-10-2017
Fee including differential fee PKR 100,000/- 30-10-2017
Brand Name +Dosage Form + SUPER’S SPRAY
Strength
Chlortetracycline Hydrochloride……………………17.8mg/ml
Pharmacological Group Anti- Biotic
Shelf life 36-months.
Demanded Price De-controlled.
Pack size 200ml.
International availability SPAIN.
Me-too status N/A
Detail of certificates attached  Original Free Sale Certificate of Spain.
 Sole Agency agreement.
16th Feb. 2017.
Evaluator PEC-II
835. Name and address of Applicant M/s Tarobina Corporation, 226-Ahmed Block, New Garden Town,
Lahore
Detail of Drug Sale License Address: Tarobina Corporation 226-Ahmed Block, New Garden
Town, Lahore
Name and address of M/s Handong Co., Ltd.,
manufacturer Head Office: Handong Bldg., 535, Ogeumro, Songpa-gu, Seoul,
Korea.
Factroy: 235-26, Chusaro, Sinam-myeon, Yesan-gun,
Chungcheongnam-do, Korea
Name and address of marketing M/s Handong Co., Ltd.,
authorization holder Head Office: Handong Bldg., 535, Ogeumro, Songpa-gu, Seoul,
Korea.
Name of exporting country The Republic of Korea
Fee including differential fee Rs. 100,000/- Dated 12/10//2015
Brand Name +Dosage Form + AMITOP-S injection IM/ IV/Sc
Strength Solution for injection
L-Isoleucine……………………..85mg
L-leucine………………………...187mg
L-Phenylalanine………………....119mg
L-Valine…………………………136mg
L-Tryptophan……………………34mg
L-Threonine……………………..78.2mg
L-Methionine……………………51mg
L-Lysine hydrochloride………...170mg
Glycine………………………….375mg
Sodium L-Glutamat hydrate……375mg
L-Arginine………………………142.5mg
Thiamine hydrochloride…………10mg
Pyridoxine hydrochloride………..10mg
Calcium pantothenate……………10mg
Nicotinamide…………………….300mg
Riboflavim Sodium phosphate….5mg
Calcium chloride, dihydrate……200mg
Sodium acetate trihydrate……. 750mg
Potassium chloride dehydrate.... 200mg
Magnesium chloride hexahydrate……200mg
Finished Product Specification In house
Pharmacological Group Nutrients
th
| 379
Shelf life 24months
Demanded Price Rs. 789.44/-
Pack size 1’s (50ml, 100ml) Glass vial
International availability --
Me-too status Aminovital (Reg.# 08486)
Detail of certificates attached  Original legalized CoPP (certificate No. 25-98) for
applied formulation issued by Animal and Plant Quarantine
Agency of the Ministry for Agriculture food and Rural affairs,
Korea on 14/07/2015 which confirms the free sale of the product
in exporting country and GMP status of the manufacturer.
 Original legalized Certificate of Free Sales for applied
formulation issued by Animal and Plant Quarantine Agency of
the Ministry for Agriculture food and Rural affairs, Korea on 04-
02-2015.
 Scanned copy of Certificate of Good manufacturing
Practice issued by Animal and Plant Quarantine Agency of the
Ministry for Agriculture food and Rural affairs, Korea on 27-07-
2015, for M/s HAN DONG Co., LTD. 235-26, Chusaro, Sinam-
myeon, Yesan-gun, Chungcheongnam-do, Korea, declaring that
manufacturer conforms to Korean Veterinary Good
manufacturing Practice.
Remarks of the Evaluator.  The firm has claimed In House specifications and the product
is not present in USP/BP.
 Firm has submitted letter of Certification letter declaring as
under:
“M/s Tarobina Corporation, 226-Ahmed Block, New Garden
Town, Lahore hereby certifies that Amitop-S injection is
manufactured only in South Republic of Korea, by “M/s HAN
DONG Co., LTD.” Korea and will be import only from Korea and
will distribute by Tarobina Corporation Lahore.
 Firm has submitted 6months accelerated and 24 months long
term stability data for three batches of applied formulation as
per Zone IV-A conditions.
Decision: Approved as per policy for inspections of manufacturer abroad.
836. Name and address of Applicant M/s Tarobina Corporation,
226-Ahmed Block, New Garden Town, Lahore
Detail of Drug Sale License Address: Tarobina Corporation 226-Ahmed Block, New Garden
Town, Lahore
Name and address of M/s Handong Co., Ltd.,
manufacturer Head Office: Handong Bldg., 535, Ogeumro, Songpa-gu, Seoul,
Korea.
Name and address of marketing M/s Handong Co., Ltd.,
authorization holder Head Office: Handong Bldg., 535, Ogeumro, Songpa-gu, Seoul,
Korea.
Name of exporting country
Fee including differential fee Rs. 100,000/- Dated 12/10//2015
Brand Name +Dosage Form + CEFTIFUR Injection
Strength (Chick: Sc, Cattle: IM)
Powder for solution for injection
Composition Each vial of 4gram (titer) Contains:
Ceftiofur sodium………. 4000mg (titer)
Target species Cattle, Chick
Pack size 1’s vial of 4g
International availability
Me-too status LG Accent 4g powder by M/s Ghazi Brothers (Reg # 026548)
Detail of certificates attached  Original legalized CoPP (certificate No. 25-242) for
applied formulation issued by Animal and Plant Quarantine
Agency of the Ministry for Agriculture food and Rural affairs,
Korea on 14/07/2015 which confirms the free sale of the product
in exporting country and GMP status of the manufacturer.
 Original legalized Certificate of Free Sales for applied
formulation issued by Animal and Plant Quarantine Agency of
the Ministry for Agriculture food and Rural affairs, Korea on 04-
02-2015.
 Scanned copy of Certificate of Good manufacturing
Practice issued by Animal and Plant Quarantine Agency of the
Ministry for Agriculture food and Rural affairs, Korea on 27-07-
2015, for M/s HAN DONG Co., LTD. 235-26, Chusaro, Sinam-
myeon, Yesan-gun, Chungcheongnam-do, Korea, declaring that
manufacturer conforms to Korean Veterinary Good
manufacturing Practice.
Remarks of the Evaluator.  Firm has submitted letter of Certification letter declaring as
under:
“M/s Tarobina Corporation, 226-Ahmed Block, New Garden
Town, Lahore hereby certifies that Ceftiofur injection is
manufactured only in South Republic of Korea, by “M/s HAN
DONG Co., LTD.” Korea and will be import only from Korea and
will distribute by Tarobina Corporation Lahore.
 Firm has submitted 6months accelerated and 24 months long
term stability data for three batches of applied formulation as
per Zone IV-A conditions.
 Firm has submitted Sole Agency Agreement for applied
formulation.
Decision: Approved as per policy for inspections of manufacturer abroad.
Evaluator PEC-VII
837. Name and address of Applicant M/s. Ghazi Brothers, Gazi house
d-35, KDA Scheme No.1. Miran Muhammad Shah Road
Karachi
Detail of Drug Sale License Copy of DSL
Address: M/s. Ghazi Brothers, Gazi house
d-35, KDA Scheme No.1. Miran Muhammad Shah Road Karachi
Validity: 25 may 2020
Name and address of M/s Jiangsu Sel Biochem Co., Ltd. No 98 Yuejiang road,
manufacturer Natong city Jiangsu, China.
marketing authorization holder Natong city Jiangsu, China.
Rs. 50,000/- Dated 31/May/2018 (Duplicate)
Brand Name +Dosage Form + TiaMax 45
Strength
Composition Each kg contain
Tiamulin Hydrogen fumarate…………450 g
Shelf life 2 years
Demanded Price Decontrolled
Pack size 2 layered polyethylene bag in well closed paperboard carton
International availability Vetmulin (Denmark Approved)
HPRA Approved
Me-too status TIAMUTIN 45% HILTON KARACHI, Hilton Pharma
(006846)
Detail of certificates attached Legalized Free sale certified by Jiangsu province agricultural
commission people republic of china confirms the free sale of
the product in exporting country is attached.
The legalized GMP certificate issued by people’s republic of
china, issued in 2015 valid till 2020 is provided.
Remarks of the Evaluator. Short Coming:
 Real time Stability Studies have been performed at
25C/60%RH for up to 36 months instead of zone IVA.
Firm has submitted the data according to Zone IVa
 On Free sale certificate, both Tiamulin Hydrogen
fumarate and Tiamulin fumarate is mentioned.
According to firm both the tiamulin fumarate and
tiamulin hydrogen fumarate mentioned on free sale
certificate firm provided the reference of pub chem in
which both the names are mentioned as synonym. In
different countries it is marketed from both the name so
that’s why both name are mentioned on free sale.
 DSL was missing
Provided by the Firm
 Me too of Hilton pharma was available justify the fee of
50,000/-
Additional fee of 50,000/- was payed
Decision: Approved as per policy of inspection of manufacturers abroad.
838. Name and address of Applicant M/s. Ghazi Brothers, Gazi house
d-35, KDA Scheme No.1. Miran Muhammad Shah Road
Karachi
Detail of Drug Sale License Copy of DSL attached
Address: M/s. Ghazi Brothers, Gazi house
d-35, KDA Scheme No.1. Miran Muhammad Shah Road Karachi
Validity: 25 may 2020
manufacturer Natong city Jiangsu, China.
marketing authorization holder Natong city Jiangsu, China.
Rs. 50,000/- Dated 31/May/2018
Brand Name +Dosage Form + TiaMax 10
Strength
Composition Each kg contain
Tiamulin Hydrogen fumarate…………100 g
Shelf life 2 years
Pack size 2 layered polyethylene bag in well closed paperboard carton
Me-too status Tiamutin 10% Each Kg Contains: - Tiamulin Hydrogen
Fumarate 100gm, Hilton Pharma
Detail of certificates attached Legalized Free sale certified by Jiangsu province agricultural
commission people republic of china confirms the free sale of
the product in exporting country is attached.
The original legalized GMP certificate issued by people’s
republic of china, issued in 2015 valid till 2020 is provided.
Legalized
The original legalized power of attorney issued by s Jiangsu Sel
Biochem Co., Ltd. No 98 Yuejiang road, Natong city Jiangsu,
China was provided
Remarks of the Evaluator. Shortcomings:
 Real time Stability Studies have been performed at
25C/60%RH for up to 36 months instead of zone IVA.
Firm has submitted the data according to Zone IVa
 On Free sale certificate, both Tiamulin Hydrogen
fumarate and Tiamulin fumarate is mentioned.
According to firm both the tiamulin fumarate and
tiamulin hydrogen fumarate mentioned on free sale
certificate firm provided the reference of pub chem in
which both the names are mentioned as synonym. In
different countries it is marketed from both the name so
that’s why both name are mentioned on free sale.
 DSL was missing
Provided by the Firm
 Me too of Hilton pharma was available justify the fee of
50,000/-
Additional fee of 50,000/- was payed
Decision: Approved as per policy of inspection of manufacturers abroad.
c. Deferred cases
i. Human
Evaluator PEC-III
839. Name and address of Applicant M/s SiTech Pharmaceuticals (Pvt) Ltd., SF-07 and 09, 4th
Floor Shahnaz Arcade 158- Main Shaheed e Millat Road,
BYJCHS Karachi
Detail of Drug Sale License Address: SF-07, 4th Floor Shahnaz Arcade 158- Main
Shaheed e Millat Road, BYJCHS Karachi
Status: drug sale license by the way of wholesale
Name and address of manufacturer Laboratorio Farmaceutico CT Srl-Via Dante Alighieri, 71-
18038 Sanremo (IM) Italy (All stages of production)
 Fresenius Kabi Anti Infectives S.R.L: Via A. Boito, 13-
20053 Taccona Muggio (MB) Italy (salification and
mixture of the two active ingredients)
 Fresenius Kabi Anti Infectives S.R.L: Localita Masserie
Armieri-86077 Pozzilli (IS)-Italy (salification and
mixture of the two active ingredients)
 Fresenius Kabi Anti Infectives S.R.L: Via San Leonardo,
23-45010 Villadose (RO) (salification and mixture of the
two active ingredients)
Name and address of marketing M/s Laboratorio Farmaceutico C.T. S.R.L. Strada Solaro,
authorization holder 75/77 18038-Sanremo (IM) Italy
Exported by: MedExport Italia Via Alcide De Gasperi, 35-00165 Roma,
Italy
Brand Name +Dosage Form + Limerik
Strength
Piperacillin sodium eq to piperacillin…….4g
Tazobactam sodium eq to tazobactam……500mg
Finished Product Specification Firm has claimed inhouse specifications derived from
European pharmacopoeia specifications for API.
Shelf life 24 Months
Pack size Vial
International availability Available in Italy
Me-too status Talzon injection by Getz Pharma
Detail of certificates attached Firm has claimed inhouse specifications derived from
European pharmacopoeia specifications for API, while the
finished product monograph is available in USP. The
specifications provided by the firm have strict limits for all
the tests than USP.
 Firm has submitted original, legalized certificate of
Factory Authorization’s office Italian Medicine Agency
which authorizes
M/s Laboratorio Farmaceutico C.T. S.R.L. Strada Solaro,
75/77 18038-Sanremo (IM) to produce medicinal products
in the factory
“Laboratorio Farmaceutico C.T. S.R.L. Via Dante
Alighieri, 71 18038-Sanremo (IM.
 Original, legalized sole agency agreement is provided
between M/s Laboratorio Farmaceutico CT Srl-Via Dante
Alighieri, 71-18038 Sanremo (IM) Italy and applicant in
Pakistan dated 09-05-2017.
 Original, legalized Certificate of Medicinal Product (No.
No CPP/2017/1690) issued by AIFA Italy dated 12-July
2017 confirms free sale status of the product in Italy. The
certificate further states that “the medicinal products
authorized to be marketed in Italy are manufactured in
national plants which are inspected periodically by Italian
Medicine Agency, following actual laws, in order to verify
the compliance with principles and guidelines of GMP and
quality control recommended by WHO and commission
directives No 2003/94/EC. The certificate also clarifies
roles of all manufacturers. The roles are mentioned in
Italian Language for which google translator was used to
translate the roles from Italian to English language The
CoPP format is not as per WHO approved format.
 Firm has also submitted copy of GMP certificate of M/s
Laboratorio Farmaceutico CT Srl-Via Dante Alighieri, 71-
18038 Sanremo (IM) Italy based on inspection dated 27-
02-2015 issued by AIFA Italy.
 The manufacturing process also describes as 2 step
process including First step which is to be performed by
Fresenius Kabi which involves manufacturing of co-
lyophilized piperacillin / tazobactam (8:1) intermediate
products packed in aluminium tins. The second step
involves aseptic filling which is performed by Laboratorio
Farmaceutico.
Remarks of the Evaluator.  Firm has submitted complete 2 years real time stability
study data as per zone IV-B for only 1 batch
manufactured in 06-2014. The firm has as submitted
only 1 year real-time stability study data for 2 batches.
Decision of previous meeting of Deferred for submission of stability study data of 3 batches
RB conducted as per the requirements of zone IV-A for
complete shelf life (M-285)
Evaluation by PEC Firm has now submitted real time stability study data sheets
of 3 batches conducted at the conditions of Zone IV-A
Decision: Approved with Innovator’s specifications as per Policy for inspection of
Manufacturer abroad.
Evaluator PEC-II
840. Name and address of Applicant M/s Novartis Pharma (Pakistan) Ltd.
Detail of Drug Sale License Notarized copy of Drug Licence by way of Wholesale (License
number 0488) of M/s Novartis Pharma (Pakistan) Ltd. issued by
EDO Health Services Karachi valid upto 26-11-2019
Name and address of manufacturer M/s Ebewe Pharma Ges.m.b.H. Nfg. KG MondseestraeBe 11 A-
4866 Unterach am Attersee, Austria
Name and address of marketing M/s Hexal AG Industriestraße 25, 83607 Holzkirchen, Germany
authorization holder MA. No: 82615.00.00 dated 07-09-2012
Name of exporting country Germany
Diary No. & Date of R& I Dy. No. 13986 Dated 13-04-2018
Fee including differential fee Rs. 100,000/- Dated 11-04-2018
Brand Name +Dosage Form + Idarubicin Sandoz 20mg/20ml Injection
Strength
Composition Each Vial contains:
Idarubicin hydrochloride ……. 1mg/1ml
Finished Product Specification Manufacturer specifications
Pharmacological Group Anti-cancer
Shelf life 2 years
Demanded Price As per approved DPC/ Pricing Policy
Pack size 20ml
International availability Germany
Me-too status Not verifiable
Certificate No: 2678 Ph_12-20-678
Certifying Authority: BFARM, Germany
Free sale in exporting country: Yes
 GMP Certificate
Certificate no. INS-480020-0095-005 valid upto November,
2019
Manufacturer Address: M/s Ebewe Pharma Ges.m.b.H. Nfg. KG
MondseestraeBe 11 A-4866 Unterach am Attersee, Austria
Copy of GMP certificate issued by Austrian Medicines and
Medical Devices Agency.
The submitted GMP certificate has been verified on-line from
following weblink as accessed on 20-07-2018
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPC
ompliance.do?ctrl=searchGMPCResultControlList&action=Drill
down&param=42680
Sole Agency Agreement: Notarized copy of Sole agency

agreement issued by M/s Hexal AG Industriestraße 25, 83607
Holzkirchen, Germany declaring “M/s Novartis Pharma
(Pakistan) Ltd.” as sole distributor in Pakistan for applied
formulation.
 Recommended storage conditions are “Store in a refrigerator (2oC – 8o C)”
 USP monograph is available for applied formulation while manufacturer has performed
stability studies as per in-house specifications.
 Manufacturer has claimed in-house specifications whereas USP monograph is available for
Strength
Shelf life 2 years
Pack size 10ml
 GMP Certificate
2019
down&param=42680

formulation.
Strength
Shelf life 2 years
Pack size 5ml
 GMP Certificate
2019
down&param=42680

formulation.
Previous Decision: All above cases were deferred in 285th meeting of Registration Board wherein
Board deferred for justification for stability studies performed on in-house specifications when USP
monograph is available for applied formulation.
Evaluation by PEC:
Comparison of Specifications:
Sr.# Specifications In-House Limits USP limits
i. pH 3 – 4.5 5 -7.0
ii. Identity of Idarubicin Must correspond to reference Must correspond to reference
iii. Content of Idarubicin 95 – 105% 90-110%
iv. Bacterial Endotoxins NMT 8.9IU/ml NMT 8.9IU/ML
Comparison of Chromatographic conditions:

Sr.# Chromatographic In-House method USP monograph
parameter
i. Detector 254nm 254nm
ii. Mobile phase Buffer: Tetrahydrofuran: Prepare a mixture of water, acetonitrile, methanol,
Methanol (60:25:15 v/v/v) and phosphoric acid (540:290:170:2). Dissolve
Buffer= 0.01M sodium 1gm of sodium lauryl sulphate in 1 000 ml of this
dodecylsulfate in 0.02M solution, adjust with 2 N sodium hydroxide to a
phosphoric acid pH of 3.6 ± 0.1
iii. Column Octyl silica, 3 x 100 mm, 4.6-mm x 25-cm column that contains packing L
3.0µm 13 (Trimethylsilane chemically bonded to porous
silica particles,3 to 10µm in diameter)
iv. Flow rate 0.7ml/min 2ml/min
v. Injection volume 5µl 20 µl
Firm has submitted that applied limits for various tests performed during stability studies are within
the limits specified by USP monograph. However the chromatographic conditions applied in In-house
method varies from the USP monograph. Firm has further submitted that “We undertake that we have
no objection if DRAp shall give us approval with USP specifcications. USP finished product
specification would be acceptable for us.”
Decision: Registration Board approved the following applications with USP
specifications.
i. Idarubicin Sandoz 5mg/5ml Injection.
ii. Idarubicin Sandoz 10mg/10ml Injection.
iii. Idarubicin Sandoz 20mg/20ml Injection.
Evaluator PEC-V
843. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited,
15 West Wharf, Karachi.
Detail of Drug Sale License Address: Novartis Pharma Pakistan Ltd. 15, West Wharf,
Karachi.
Status: By the way of wholesale
Name and address of M/s Catalemt Germany Eberbach GmbH, Gammelsbacher Str. 2,
manufacturer 69412 Eberbach, Baden wuerttemberg, Germany
Name and address of marketing M/s Novartis Europharm Limited, Frimley Business Park,
authorization holder Camerley GU16 7SR, United Kingdom
Brand Name +Dosage Form + RYDAPT soft capsule 25mg
Strength
Composition Each Soft Capsule contains:
Midostaurin…….. 25mg
Demanded Price Rs. 450,000/- per pack of 28’s (Rs. 16,071/- per capsule)
Rs. 800,000/- per pack of 56’s (Rs. 14,285/- per Capsule)
Rs. 1,600,000/- per pack of 112’s (Rs. 14,285/- per Capsule)
Pack size 28’s, 56’s, 112’s
International availability EMA approved as per COPP
Me-too status N/A
Detail of certificates attached Original legalized CoPP
Certificate No. 12/17/115066)
Issued by EMA on 01/12/2017
Confirms the free sale of the product in exporting region.
The facilities and operation conform to GMP as recommended
by WHO.
Remarks of the Evaluator.  The firm has claimed In House specifications and the
product is not present in USP/BP.
 Chemical tests (Assay of active ingredient and degradation
products) of long term stability are performed till 18 months
while the firm has claimed a life of 36 months.
Previous Decision  Deferred for submission of stability data of long term till
M-278 claimed shelf life of 36 months.
Fresh Evaluation Firm has submitted long term stability data up to shelf life i.e.
36 months at 30 °C & 75%RH.
844. Name and address of Applicant M/s Mukhtar Enterprises, 55 Block B, Faisal town Lahore
Detail of Drug Sale License Address: M/s Mukhtar Enterprises, 1st floor 55B, Faisal town
Lahore
Name and address of M/s Xellia Pharmaceuticals APS Dalslandsgade11, 2300
manufacturer Copenhagen S Denmark
Name and address of marketing M/s Xellia Pharmaceuticals APS Dalslandsgade11, 2300
authorization holder Copenhagen S Denmark
Name of exporting country Denmark
Brand Name +Dosage Form + COLISTIMETHATE SODIUM powder for solution for IV
Strength injection/infusion
Composition Each vial (10ml) contains:
Colistimethate Sodium…….. 1MIU
Finished Product Specification Mfg. Specs
Pharmacological Group Antibacterial.
Demanded Price Rs. 1295/- per vial
Pack size 1’s
International availability Available in Denmark as per CoPP
Me-too status Colistat injection 1MIU by M/s Medisure (reg # 076160)
Certificate No. 2017073239
Certified by Danish Medicines Agency
Issued on 21/07/2017
Confirms the free sale of the product in exporting country.
The facilities and operations conform to WHO-GMP.
Remarks of the Evaluator.  Submit differential fee.
 Present in BP and USP.
Previous Decision(M-284):
Deferred for submission of differential fee Rs. 50,000/-.
Fresh Evaluation:
 Firm has submitted differential fee Rs. 50.000/- dated: 30-07-2017 with demanded price Rs.
1675/- per vial.
 Validity of DML: 24/10/2018.
Decision: Registration Board approved the applied formulations as per Policy for inspection
of Manufacturer abroad.
ii. Veterinary
Evaluator PEC-XIV
845. Name and address of Applicant M/s Mustafa Brothers, 186-D, People Colony No. 1, Faisalabad
Detail of Drug Sale License Address: Mustafa Brothers, P-186-D, Peoples Colony No.1
Faisalabad.
Name and address of manufacturer M/s Delos Impex 96 SRL, 81, Horia, Closca si Crisan street,
Otopeni, Ilfov county, Romania.
Name and address of marketing M/s Delos Impex 96 SRL, 81, Horia, Closca si Crisan street,
authorization holder Otopeni, Jud.Ilfov county, Romania.
Name of exporting country Romania
Brand Name +Dosage Form + BROMEX-ORAL Solution
Strength (for poultry use)
Enrofloxacin…………....200mg
Bromhexine HCL……...15mg
Pharmacological Group Flouroquinolone, Mucolytics
Finished Product Specification Romanian Pharmacopoeial specifications
Shelf life 2years
Pack size Bottle of 100ml, 250ml, 500ml, 1000ml and 5 litre
Demanded price 15.9 US dollers per litre
International availability Cannot be confirmed
Me-too status Cannot be confirmed
Detail of certificates attached 1. Original legalized free sale certificate (certificate No.
200/1/DPMVNA/25.03.2014) of Romania issued on
01/01/2014 confirms the free sale of the product in exporting
country.
2. Original legalized GMP certificate of manufacturer is
attached.
Remarks of the Evaluator. 1. The firm has claimed for Romanian Pharmacopoeial
specifications but the product is not present in available
pharmacopoeia (B.P & USP)
2. The evidence of me-too status provided by the firm cannot
be verified as the provided reference is of different strength.
Bromoflox by Mylab (pvt) ltd
Each ml contains:-
Enrofloxacin…………200mg
Bromhexine HCl……10mg
While the applied formulation contains 15mg of Bromhexine
HCl per ml.
3. Withdrawal period: 10 days after cessation of Oral
medication.
Previous Decision Registration Board deferred the case as the concerned member
of
Board (veterinary expert) was not available. (M-270)
Deferred for confirmation of approval status by reference
regulatory authorities and me too status. (M-271)
Evaluation by PEC The firm has submitted Registration letters where Bromex
Oral Solution is registered and available in local markets in
addition to country of origin:
Albania Europe
Maldova Europe
Vietnam Asia
The firm has submitted that formulation is not available in
local (Pakistan) market but the same formulation is available
in different countries of the world, like Maldova Albania,
Vietnam, Argentina and Romania.
Case No. 07: Registration applications of drugs for which stability study data is
submitted.
a. New cases
Evaluator PEC-VII
Sr. No. Name & Address Brand Name Type of Form, International
of Manufacturer / (Proprietary Name Initial Diary & Date, Availability / Local
Applicant + Dosage Form + Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / Pack GMP Inspection Report
Pharmacological size Date & Remarks
Group,
Finished Product
Specification
846. M/s Innvotek Olotek forte 0.7% Form-5-D Pazeo (Olopatadine
Pharmaceuticals, Ophthalmic Dy. No: 25901 Hydrochloride)
Plot No. 35, Solution 5ml Dated.26-12-2012 Solution/Drops Of
Industrial Each ml contains: Rs.20,000/- (4-4-2016) Novartis Pharms Corp
Triangle, Kahuta Olopatadine as Rs.30,000/- (26-12- USFDA Approved.
Road, Islamabad. hydrochloride 2017) According to last
17.76 mg eq. to 5ml; inspection report dated
Olopatadine As per SRO 09-03-2017 the
(base)……7mg company is complying
Anti-allergic with the GMP
Mfg specs guidelines
STABILITY STUDY DATA
Drug Olotek forte 0.7% Ophthalmic Solution 5ml
Name of Manufacturer M/s Innvotek Pharmaceuticals, Plot No. 35, Industrial Triangle,
Kahuta Road, Islamabad.
Manufacturer of API MSN Laboratories Pvt.Ltd
API Lot No. Olopatadine hydrochloride: POPL0021017
Description of Pack 5 ml, HD non irritating and leachable polyethylene bottles with
(Container closure system) integral nozzles and pilfer proof caps.
Stability Storage Condition Real time : 25°C ± 2°C / 75% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Time Period Real time: 6 months
Accelerated:6 months
Frequency Accelerated: 0,1, 3,6 (month)
Real Time: 0,3,6 (month)
Batch No. Trial 1 Trial 2 Trial 3
Batch Size 1 liter 1 liter 1 liter
Manufacturing Date 20-1-2017 20-2-2017 20-3-2017

Date of Initiation 20-1-2017 20-2-2017 20-3-2017
No. of Batches 03
Date of Submission 26-12-2017 (Dy. No. 25901)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. No. Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory Olopatadine hydrochloride: Copy of GMP
authority of country of origin or GMP certificate issued to MSN Laboratories Pvt.Ltd.
certificate of API manufacturer issued Sy.No 317 & 323, Rudraram (village),
by regulatory authority of country of Patancheru (Mandal), Sangareddy District,
origin. Telangana India., valid upto sep 2022. The said
certificate has been verified from following
website link when accessed on 16-4-2018:
http://dca.telangana.gov.in/content.php?U=7
Address on the website was:
MSN Labs Pvt Ltd, Sy.No. 317 & 223,
Rudraram Village, Patancheru Mandal, Medak
District
3. Protocols followed for conduction of
Yes
stability study and details of tests.
4. Data of 03 batches will be supported
by attested respective documents like
Yes
chromatograms, laboratory reports,
data sheets etc.
5. Documents confirming import of API Copy of commercial invoice has been submitted
etc. issued by ADC, Karachi DRAP.
6. All provided documents will be
attested (name, sign and stamp) for
Yes
ensuring authenticity of data /
documents.
7. Commitment to continue real time
stability study till assigned shelf life Yes
of the product.
8. Commitment to follow Drug
Yes
Specification Rules, 1978.
REMARKS OF EVALUATOR
Sr.# Deficiency/Observation Response by Pharma

i. • GMP certificate(s) of API Submitted
manufacturers issued by regulatory
authority of the country of origin is
required.
ii. Clarification is required since With reference to letter with subject registration of drugs
applied product is pharmacopeial under drug act 1976, Firm submitted the following reply:
where the assay is with HPLC We are submitting the HPLC method as testing method of
method instead of UV and you have Olotch is already developed on double beam spectrometer
performed assay with UV instead of and internal validation as per specification dully submitted
HPLC. Clarification regarding why for your kind consideration. Now we applied for olotek fort
your results of assay of stability and as the official testing procedure is based on HPLC so we
batches are not performed on HPLC have also developed the method on HPLC and submitted.
is required. Both methods are validated as per specification and
requirements and meet full testing protocols.
iii. Detailed method of testing has not Provided
been provided along with the
stability protocols and
specifications.
iv. Raw data sheets for calculation of Provided
results at all time points are
required for all the three batches
v. Date of manufacturing along with Provided
date of initiation of stability studies
of all the three batches is required.
vi. Clarification regarding the batch
size for all the three batches.
vii. Clarification is required, since the Pack sized mentioned in submitted reply is 5 ml
pack size mentioned in Form 5-D is
5 ml and previously multiple
volumes were mentioned in the
dossier.
viii. Unsigned/unstamped Provided chromatograms are now signed and stamped
chromatograms have been
submitted in the data.
ix. Description of Packaging material 5 ml, HD non irritating and leachable polyethylene bottles
(Container closure system) is not with integral nozzles and pilfer proof caps.
submitted.
x. Complete and detailed composition Provided
of the product is required as per
instructions.
Response of 2nd Letter
xi. GMP certificate(s) of API Submitted
manufacturers issued by regulatory
authority of the country of origin is
required. The attached document is
form 25 licenses of manufacturer
not GMP.
xii. Clarification is required regarding Regarding real time stability study that is performed on 25C
the conditions of stability (real instead of 30 C it is claimed by the firm that as per ICH
time) which is performed on 25ºC stability guidelines Q1AR2 storage conditions for long term
instead of 30ºC. stability study is 25°C ± 2°C / 60% ± 5% RH or 30°C ± 2°C
/ 65% ± 5% RH so these studies could be performed on any
condition
Remarks of evaluator:
 Regarding real time stability study that is performed on 25C instead of 30 C it is claimed
by the firm that as per ICH stability guidelines Q1AR2 storage conditions for long term
stability study is 25°C ± 2°C / 60% ± 5% RH or 30°C ± 2°C / 65% ± 5% RH so these
studies could be performed on any condition
 On query that clarification is required since applied product is pharmacopeial where the
assay is with HPLC method instead of UV and you have performed assay with UV
instead of HPLC. Clarification regarding why your results of assay of stability batches are
not performed on HPLC is required. Following reply was submitted:
We are submitting the HPLC method as testing method of Olotch is already developed on
double beam spectrometer and internal validation as per specification dully submitted for
your kind consideration. Now we applied for olotek fort and as the official testing
procedure is based on HPLC so we have also developed the method on HPLC and
submitted. Both methods are validated as per specification and requirements and meet full
testing protocols.
Decision: Deferred for stability study data as per zone IV-A.
Evaluator PEC-V
Sr. Name & Address of Brand Name Type of Form, International Previous DRB
No. Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision /
Applicant Dosage Form + Date, Fee Local Remarks
Strength), Composition, (including Availability (if any)
Pharmacological differential fee),
Group, Demanded Price GMP
Finished Product / Pack size Inspection
Specification Report Date &
Remarks
847. M/s Searle IV Sovalrain Tablets Form 5 Harvoni Fee is 20,000
Solutions Limited Each film coated tablet DUPLICATE (FDA Diary number
1.5 Km Manga contains:- Diary No. 1 Approved). not provided.
Raiwind Road, Manga Sofosbuvir…….400mg dated 03-8-
Mandi, Lahore Anti-viral 2016. Date of
Rs. 20,000/- inspection
28’s in blister. 27-02-2018
One pack: GMP
9999.0 complaint
One Tablet:
357.11/-
As per SRO.
Drug Sovalrain Film coated Tablets 400mg (Sofosbuvir)
Name of Manufacturer M/s Searle IV Solutions Limited
1.5 Km Manga Raiwind Road, Manga Mandi, Lahore
Manufacturer of API Suli Pharmaceutical Technolo gy Jiangyin, Jiangsu Province, China
API Lot No. SLZY059-Form6-16060101
Description of Pack
Blister
(Container closure system)
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 26 Weeks Real Time: 26 Weeks
Frequency Accelerated: 0,1,2,3,4,6,8,12,16,20,24,26 (Weeks)
Real Time: 0,1,2,3,4,6,8,12,16,20,24,26 (Weeks), 9 months
Batch No. RD-17008 RD-17009 RD-17010
Batch Size 1000 Tablets 1000 Tablets 1000 Tablets
Manufacturing Date 09-2017 09-2017 09-2017
No. of Batches 03
Sr. Documents To Be Provided Status
1. COA of API Batch No. SLZY059-Form6-16060101
2. Approval of API by regulatory authority of Suli Pharmaceutical Technology Jiangyin
country of origin or GMP certificate of API Jiangsu Province, China
manufacturer issued by regulatory authority of Scope: Bulk Drug
country of origin. Certified by: Jiangsu Food and Drug
Administration
3. Protocols followed for conduction of stability
Yes
study and details of tests.
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, Yes
laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Invoice No. 16SLZY039
3 KG; 12-08-2016
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of Yes
data / documents.
7. Commitment to continue real time stability
Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification
Yes
Rules, 1978.
PREVIOUS REMARKS OF EVALUATOR1
i. Dissolution method is as per USFDA.
Sr. Reply
Deficiencies/Shortcomings
No.
Firm first submitted that their manufacturing method is direct
compression. Then upon communication of innovator method
of manufacturing i.e. dry granulation the firm submitted that
their method of manufacturing is also dry granulation, no
compaction or wet granulation is involved. So both methods
are same. However, their manufacturing procedure consisted
of following steps:
a. Initial Mixing b. final mixing.
Load all the ingredients in Double Cone Mixer after sieving
through 40 ss mesh, mix for 30 minutes. Sieve Magnesium
stearate through 40 ss mesh and add to the mixer for final
mixing.
Mention the method of
 Upon clarification of this dry granulation method firm
manufacturing whether dry
1. added the process of slugging after initial mixing.
granulation or direct
Innovator manufacturing method
compression.
• The manufacturing process of innovator consists of 4
main steps:
(i) Sofosbuvir is blended, milled, and then dry-granulated
with intra-granular excipients (mannitol, microcrystalline
cellulose, croscarmellose sodium, colloidal anhydrous silica
and magnesium stearate);
(ii) the granules are blended with extra-granular excipients
(microcrystalline cellulose, croscarmellose sodium, colloidal
anhydrous silica and magnesium stearate) and compressed to
form the tablet cores;
(iii) the tablet cores are film-coated.
(iv)the finished product is packaged.
The source of API is Suli Pharmaceutical Technology,
Jiangyin.
Documents confirming
2. GMP certificate of API manufacturer does not mention the
import of API etc.
bulk drug that is sofosbuvir and GMP certificate could not be
verified.
Protocols followed for The stability batches mentioned in Protocol are different.
3. conduction of stability 17008, 17009, 17010 instead of RD-17008, RD-17009, RD-
study and details of tests. 17010.
Decision: Registration Board after thorough deliberation and keeping in view previous cases of
same nature decided to confirm the API manufacturer from import documents from DRAP I&E
office Lahore for further processing the case.
Evaluator PEC-XIV
No Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision /
Applicant Dosage Form + Date, Fee Local Availability Remarks
Strength), (including (if any)
Composition, differential fee), GMP Inspection
Pharmacological Demanded Price / Report Date &
Group, Pack size Remarks
Finished Product
Specification
848. M/s Highnoon Nebvax 5/80 mg Form 5D Byvalson of M/s The firm has
Laboratories Tablet Dy. No.21689 Allergan sales, claimed
limited. 17.5 Each film coated 21-06-2018 USFDA Manufacturer’s
Kilometer, Multan tablet contains: Rs.50,000/-, N/A Specifications.
Road, Lahore Nebivolol as Last GMP
HCl………...5mg (Duplicate inspection dated
Valsartan Dossier) 06-07-2017; firm
……80mg is considered to
Anti-Hypertensive 14’s, 30’s, 60’s; be operating at
As per SRO Good level of
(Manufacturers compliance of
specifications) GMP
requirements at
the time of
inspection.
Drug Nebvax 5/80 mg Tablet
Name of Manufacturer M/S Highnoon Laboratories limited
Manufacturer of API Valsartan: M/s. Zhejiang Tianyu Pharmaceuticals Co. Ltd. China
Nebivolol HCl: M/s. Cadila Pharmaceuticals Ltd, 294, G.I.D.C, Estate
Ankleshawar- 3293002, Gujrat India
API Lot No. Valsartan: 10230-161204
Valsartan: 10230-161117
Valsartan: 10230-161116
Nebivolol HCl: 17NV011
Description of Pack Alu/Alu Blister in outer unit carton
Stability Storage Accelerated: 40°C ± 2°C & 75±5%RH
Condition Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months
Real Time: 09 Months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6,9 (Months)
Batch No. RD 17091 RD 17092 RD 17093
Manufacturing Date August-2017 August-2017 August-2017
Date of Initiation September-2017 September-2017 September-2017
No. of Batches 3
1. COA of API Valsartan: Copy of COA from M/s Zhejiang Tiianyu
Pharmaceuticals, China is submitted
Nebivolol HCl: Copy of COA from M/s Cadila
Pharmaceuticals Ltd, India is submitted.
2. Approval of API by regulatory authority of Valsartan: Copy of GMP of M/s Zhejiang Tianyu
country of origin or GMP certificate of Pharmaceuticals, China (Certificate No. ZJ20130111)
API manufacturer issued by regulatory issued by State Food and Drug Administration has
authority of country of origin. been submitted.
Nebivolol HCl: Copy of GMP of M/s Cadila
Pharmaceuticals Certificate No.16061158 6078745
issued by Food & Drug control Adminstration,
Gujarat Estate. India is submitted
3. Protocols followed for conduction of Yes
4. Data of 03 batches will be supported by Yes
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc. Valsartan: Copy of ADC (Lahore) attested dated:
27-04-2017 Commercial Invoice No TY117257
Dated: 17-05-2017 issued by M/s Zhejiang Tianyu
Pharmaceuticals is submitted.
Nebivolol HCl: Copy of ADC (Lahore) attested
dated: 16-06-2017 Commercial Invoice No
CPL/BD/123/17-18 Dated: 14-06-2017 issued by M/s
Cadila Pharmaceuticals Ltd is submitted.
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
authenticity of data / documents.
7. Commitment to continue real time stability Yes
8. Commitment to follow Drug Specification Yes
Rules, 1978.
REMARKS OF EVALUATOR(VI)
● The firm has provided 06 Months Accelerated and 09 Months Real Time Stability Data for 03
Batches.
● The firm has procured Valsartan from M/s Zhejiang Tianyu Pharmaceuticals, China.
● EMA has updated on medicines containing valsartan from Zhejiang Tianyu, China.
“Company no longer authorised to manufacture valsartan active substance for EU medicines due to
presence of NDMA”.
https://www.ema.europa.eu/documents/press-release/update-medicines-containing-valsartan-
zhejiang-tianyu_en.pdf
Previous Decision: Registration Board deferred the case for impurity profiling for identification of
NDMA levels in the procured valsartan from Zhejiang Tianyu, China. (M-285)
● The firm has submitted calculation comparison for maximum level of NDMA in finished product
Nebvax 5/80mg tablet as well as FDA acceptable intake limit by consuming finished products as
shown in table below;
Calculations for Maximum Level of NDMA in finished product Nebvax 5/80mg Tablet
NDMA in Valsartan (API)
Provisional Acceptable Limit of NDMA in 0.3ppm or 0.3 µg/g or 0.3 nanogram/mg
API (Valsartan) 1ppm = 1 µg/g = 1 nanogram /mg
Max NDMA in Valsartan from API NMT 0.3 ppm
Manufacturer Zhejiang Tianyu Pharmaceutical (NMT 0.3 ppm or 0.3 µg/ g or 0.3
Co. Ltd., China nanogram/mg)
FDA acceptable intake Limit of NDMA by 0.096 µg/Day or 96 nanogram/day
consuming Finished products
Qty of Valsartan in Nebvax 5/80mg Tablet 80mg /Tablet
Maximum daily dose of Nebvax 5/80mg 1 Tablet / Day
Tablet
Daily intake of Valsartan by consuming 80mg / Day
maximum dose of Nebvax 5/80mg Tablet
Maximum Qty of NDMA in Valsartan as 1 Tablet / Day
confirmed by API manufacturer
Maximum daily intake of NDMA by 80 mg × 0.3 nanogram/mg = 24 nanogram
consuming Nebvax 5/80mg Tablets
Conclusion Per day quantity of NDMA in Nebvax tablet is
1/4th of FDA acceptable limit.
● In view of the above, we request you to please approve registration of Nebvax 5/80mg tablet and
exempt inspection for stability data in the light of above submitted document.
Decision: Registration Board decided to consider the case after onsite inspection by the panel to
be constituted by Chairman Registration Baord for verification of authenticity of submitted
stability data and associated documents, import of API, quality, specification, test analysis,
facilities etc
b. Deferred cases
Verification of stability study data
Evaluator PEC-III
Sr. Name & Address of Brand Name Type of Form, International Availability / Local
No. Manufacturer / (Proprietary Name + Initial Diary & Availability
Applicant Dosage Form + Date, Fee
Strength), (including GMP Inspection Report Date &
Composition, differential fee), Remarks
Pharmacological Demanded Price
Group, / Pack size
Finished Product
Specification
849. M/s Scilife Pharma Dexlanz Capsule 30 Form 5 USFDA approved capsule
(Private) Limited mg Rs. 20,000/- Dexilant 30 mg manufactured by
Plot # FD-57/58- Each gastro resistant Rs.80,000 Takeda Pharma
A2, Korangi Creek Capsule contains: Dy. No.1205
Industrial park Dexlansoprazole 08-06-2016 Last GMP inspection conducted
(KCIP) Karachi Enteric Coated 14’s / As Per on 05-12-2017, the report
Pellets…… 30 mg SRO concludes that firm is showing
Proton pump Inhibitor Good level of compliance.
(Scilife Spec)
Source of pellets M/s
Spansules
Formulation, India
Decision of Previous meetings of Registration Board:
Deferred for submission of application on Form 5D, requisite fee and stability data as per
guidelines approved by registration Board in 251st meeting (M-260)
Remarks of Evaluator:
Firm has NOT submitted application on Form 5-D along with requisite fee, now this formulation is
a me-too product.
Firm has also changed the source of API from M/s Spansules formulations India to M/s Murli
Krishna India.
The firm has submitted stability study data along with required documents as per checklist
approved in 251st meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 28689 dated 27-8-2018)
Drug Dexlanz Capsule 30 mg
Name of Manufacturer M/s Scilife Pharma (Private) Limited
Plot # FD-57/58-A2, Korangi Creek Industrial park (KCIP) Karachi
Manufacturer of API M/s Murli Krishna Pharma (Pvt) Ltd., D-98, Ranjangaon MIDC,
Ranjangaon, Taluka-Shirur, Pune Mahrashtra State, India
API Lot No. PDL/DEF-1-240617
Description of Pack
Alu-Alu blister with unit carton
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Real Time: 0, 3, 6 (Months) Accelerated: 0, 3, 6 (Months)
Batch No. 093B17 094B17 095B17
Batch Size 1000 capsules 1000 capsules 1000 capsules
Manufacturing Date June 2017 June 2017 June 2017
No. of Batches 03
Date of Submission Dy.# 28689 dated 27-8-2018
Sr# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of
Firm has submitted GMP certificate of M/s Murli
country of origin or GMP certificate of API
Krishna issued by FDA Mahrashtra on 11-09-
manufacturer issued by regulatory authority of
2017
country of origin.
Yes
5. Documents confirming import of API etc. Firm has initially submitted copy of ADC
attested invoice dated 25-10-2017 confirming
import of 1kg dexlansoprazole 23% pellets from
M/s Murli Krishna Pharma
Firm has later submitted copy of DHL envelope
containing pasted receipts
sign and stamp) for ensuring authenticity of data Yes
/ documents.
Yes
Yes
Rules, 1978.
 Firm has initially submitted ADC attested invoice dated 25-10-2017 while the batches were
manufactured in June 2017, upon clarification firm submitted copy of DHL receipt showing
import of dexlansoprazole pellets. Panel may verify the date of receiving of pellets in the firm
along with manufacturer of the pellets.
Group, / Pack size
Finished Product
Specification
850. M/s Scilife Pharma Dexlanz Capsule 60 Form 5 USFDA approved capsule
(Private) Limited mg Rs. 20,000/- Dexilant 60 mg manufactured by
Plot # FD-57/58- Each gastro resistant Rs.80,000 Takeda Pharma
A2, Korangi Creek Capsule contains: Dy. No.1204
Industrial park Dexlansoprazole 08-06-2016 Last GMP inspection conducted
(KCIP) Karachi Enteric Coated Pellets 14’s / As Per on 05-12-2017, the report
…… 60 mg SRO concludes that firm is showing
Proton pump Inhibitor Good level of compliance.
(Scilife Spec)
Source of pellets M/s
Spansules
Formulation, India
Decision of Previous meetings of Registration Board:
Deferred for submission of application on Form 5D, requisite fee and stability data as per
guidelines approved by registration Board in 251st meeting (M-260)
Firm has NOT submitted application on Form 5-D along with requisite fee, now this formulation is
a me-too product.
Firm has also changed the source of API from M/s Spansules formulations India to M/s Murli
Krishna India.
(Dy.# 28690 dated 27-8-2018)
Drug Dexlanz Capsule 60 mg
Name of Manufacturer M/s Scilife Pharma (Private) Limited
Plot # FD-57/58-A2, Korangi Creek Industrial park (KCIP) Karachi
Manufacturer of API M/s Murli Krishna Pharma (Pvt) Ltd., D-98, Ranjangaon MIDC,
Ranjangaon, Taluka-Shirur, Pune Mahrashtra State, India
API Lot No. PDL/DEF-1-240617
Description of Pack
Alu-Alu blister with unit carton
Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 096B17 097B17 098B17

Manufacturing Date June 2017 June 2017 June 2017
No. of Batches 03
# Documents To Be Provided Status
1. COA of API Yes
Firm has submitted GMP certificate of M/s Murli
Krishna issued by FDA Mahrashtra on 11-09-
2017
country of origin.
Yes
Yes
respective documents like chromatograms,
5. Documents confirming import of API etc. Firm has submitted copy of ADC attested
invoice dated 25-10-2017 confirming import of
1kg dexlansoprazole 23% pellets from M/s Murli
Krishna Pharma
sign and stamp) for ensuring authenticity of data Yes
/ documents.
Yes
Yes
Rules, 1978.
 Firm has initially submitted ADC attested invoice dated 25-10-2017 while the batches were
manufactured in June 2017, upon clarification firm submitted copy of DHL receipt showing
import of dexlansoprazole pellets. Panel may verify the date of receiving of pellets in the firm
along with manufacturer of the pellets.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of
Dexlanz (Dexlansoprazole) 30mg & 60mg Capsules by M/s Scilife Pharma Pvt. Limited, Plot # FD-
57/58-A2, KCIP, Karachi.
Reference No: F.13-11/2017-PEC (Pt) dated 29th October, 2018.

Investigation Date and Time: 9th November, 2018. (Afterrnoon)
Investigation Site: Factory premises of M/s Scilife Pharma Pvt. Ltd. Plot # FD-
57/58-A2, KCIP, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Scilife Pharma Pvt. Ltd. Plot #
FD-57/58-A2, KCIP, Karachi for registration of Dexlanz (Dexlansoprazole) 30mg & 60mg Capsules and
constituted a three member panel to investigate the authenticity / genuineness of data (import of raw
material and stability data). Panel was advised to conduct inspection of the firm and to submit report for
further consideration. It was also advised to verify:
“Firm has initially submitted ADC attested invoice dated 25-10-17 while the batches were
manufactured in June 2017. Upon clarification, firm submitted copy of DHL receipt showing import of
dexlansoprazole pellets. Panel may verify the date of receiving of pellets in the firm along with
manufacturer of pellets.”
Composition of Panel:
1. Dr. Ghulam Sarwar, Dean Faculty of Pharmacy, Jinnah University for Women, Karachi.
(Member Registration Board).
2. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
3. Dr. Saif ur Rehman Khattak, Director/FGA, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective
evidence physical inspection of the facilities for manufacturing and quality control, material used and
retained, personnel involved, ongoing studies, printed data and integrity and security of data in
respective databases were also audited. The details of investigation may be summarized as under:
Details of Inspection
S.No. Description Observation by panel
The firm has procured 1.0 Kg Dexlansoprazole pellets
Do you have documents confirming from M/s Murli Krishna Pharma Pvt. Ltd.. by DHL.
1 the import of API including There was no approval was obtained from DRAP at that
approval from DRAP? time. However, the firm obtained retrospective approval
from DRAP
The firm has proper vendor qualification program and
they select vendors as per their SOP which comprises of:
Do you have any rationale behind
2 GMP Certificate
selecting the particular manufacturer
DMF
Desktop Audit
Do you have documents confirming The firm has procured 200mg working standard and
3 the Import of Reference standard 50mg each of two impurities through Murli Krishna
and Impurities standards? Pharma Pvt. Ltd.
4 The firm has Certificate of Analysis for API, working
Do you have certificate of analysis
standards and impurities standard.
of the API reference standard and
impurities standards?
Do you have any approval of API or The firm has provided copy of GMP certificate issued by
GMP certificate of manufacturer Food & Drug Administration M.S. Bandra, Mumbai,
5
issued by regulatory authority of having product list containing Dexlansoprazole Pellets
country of origin? 23% w/w.
Do you use API manufacturer The firm has used API Manufacturer’s method of testing
6 method of Testing for testing of
API?
Do you have stability Studies The firm has stability studies report of API
7
Report on API? Dexlansoprazole conducted by API manufacturer.
If Yes, whether the stability testing The manufacturer of API has performed the stability
has been performed as per SIM studies of API as per SIM Method and the Related
8
method and degradation products Substance have been quantified by the API manufacturer
have been quantified.?
Do you have method for quantifying The firm has methods for quantifying the impurities in
9 API.
the impurities in the API?
Do you have some remaining The firm has remaining quantity of API Dexlansoprazole
10 quantities of the API, Its reference its working standard and impurities standards.
standard and impurities standard?
Have you used pharmaceutical Empty HGC Shell size no 3 for 30mg.
11 Empty HPMC Shell size no 2 for 60mg
grade excipients?
Empty HGC Shell were procured locally from M/s
Do you have documents confirming
12 Capsugel and Empty HPMC shell were procured from
the import of the used excipients?
M/s Jiangsu Lefan Capsule.
Do you have test reports and other The firm has test reports on empty shell size no 3 and 2.
13
records on the excipients?
Do you have written and authorized The firm has written and authorized protocol for the
14 protocols for the development of development of Dexlanz Capsuless 30mg/60mg
Dexlanz Capsules 30mg/60mg?
Have you performed Drug- Not Applicable
15
Excipient compatibility studies?
Firm has performed comparative studies with innovator
Have you performed comparative DEXILANT CAPSULES 30mg/60mg manufactured by
16
studies? Takeda Pharmaceutical company 17-85 Jusohomarchi, 2-
chome Osaka 532-8686, Japan.
Do you have Product Development / The firm has product development (R&D) Section with
17 R&D Section? the facility of manufacturing only whereas analysis part
was performed in routine Analytical Laboratory
Do you have necessary equipment’s The firm has necessary equipment available in product
available in product development development section for development of Dexlanz
18
section for development of Dexlanz Capsules 30mg/60mg.
Capsules 30mg/60mg?
Are the equipment’s in product The available equipment in Product Development are
19 qualified.
development qualified?
Do you have proper maintenance / There is proper maintenance / calibration program for the
calibration / re-qualification equipment used in PD
20
program for the equipment used in
PD?
Do you have qualified staff in The firm has proper qualified staff for Product
product development section with Development.
21
proper knowledge and training in 02 Pharmacists and 04 Chemists.
product development?
The firm has manufactured three stability batches 1000
Capsules of Dexlanz 30mg and 500 capsules of Dexlanz
60mg.
Dexlanz Capsules 30mg
Have you manufactured three Batch No Expiry Date
stability batches for the stability Batch No. 093B17 MAY-2019
studies of Dexlanz Capsules
Batch No. 094B17 MAY-2019
30mg/60mg as required?
22 Batch No. 095B17 MAY-2019
Dexlanz Capsules 60mg

Batch No Expiry Date
Do you have any criteria for fixing The criteria for fixing the batch size of stability batches
23 the batch size of stability of is the number of samples required per testing
batches? frequencies.
Do you have complete record of The firm has detailed record of the stability batches of
24 Dexlanz Capsules 30mg/60mg.
production of stability batches?
Do you have protocols for stability The firm has protocols for testing of stability batches.
25
testing of stability batches?
Do you have developed and The firm has developed and validated method of testing
26 validated the method for testing of of finish product Dexlanz Capsules 30mg/60mg, based
stability batches? on method of testing of API.
Do you have method transfer studies Method transfer studies is not applicable as the firm
in case when the method of testing developed their own method and validated.
27
being used by your firm is by any
other lab?
Do you have documents confirming The firm has proper documents confirming the
the qualification of equipment / qualification of equipment / instruments being used in
instruments being used in the test the test and analysis of the Dexlanz Capsules
28
and analysis of the product’s API 30mg/60mg.
and product Dexlanz Capsules
30mg/60mg?
The firm has performed force degradation study on their
Do your method of analysis
29 product for conformance of its stability indicating
Stability indicating?
method.
Do your HPLC software 21CFR The HPLC software is 21CFR compliant and having
30
compliant? certificates of Compliance by USFDA
Can you show audit trail reports on The firm has audit trail Reports on their testing.
31
Dexlanz Capsules testing?
Do you have some remaining The firm has some remaining quantities of stability
32 quantities of degradation products batches.
and stability batches?
The firm has three stability batches kept on stability for
Do you have batches kept on
33 Real time stability testing. 12 Months Real Time and 6
stability testing?
months Accelerated stability studies has been conducted.
Do you have valid calibration status The firm has valid calibration status for the equipment
for the equipment’s used in Dexlanz used in Dexlanz Capsules 30mg/60mg production and
34
Capsules 30mg/60mg production analysis.
and analysis?
Do Proper and Continuous Adequate monitoring and control are available for
35 monitoring and control are available stability chamber. Chambers are controlled and
for stability chamber? monitored through software 21CFR compliance.
Do related manufacturing area, Related manufacturing area, equipment, personnel and
36 equipment, personnel and utilities utilities can be rated as compliant.
be rated as GMP compliant?
Any specific observation / As per record available with the firm The firm has
recommendation by the PE&R: imported dexlansoprazole pellets through DHL, the
Firm has initially submitted ADC consignment was received on 26-07-2017. However, the
attested invoice dated 25-10-17 firm has used the pellet manufacturing date as date of
while the batches were manufacturing which is June 2017.
manufactured in June 2017. Upon
37
clarification, firm submitted copy of
DHL receipt showing import of
dexlansoprazole pellets. Panel may
verify the date of receiving of
pellets in the firm along with
manufacturer of pellets.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by
the firm for registration of Dexlanz (Dexlansoprazole) 30mg & 60mg Capsules is verifiable to
satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are compliant to GMP
standards and are suited for the manufacturing of Dexlanz (Dexlansoprazole) 30mg & 60mg
Capsules
Recommendation:
The panel unanimously recommends the grant of registration of Dexlanz (Dexlansoprazole) 30mg &
60mg Capsules in the name of the firm.
Decision: Registration Board decided to approve registration of “Dexlanz (Dexlansoprazole) 30mg
& 60mg Capsules with Innovator’s specifications by M/s Scilife Pharma Pvt. Ltd. Plot # FD-57/58-
A2, KCIP, Karachi. Manufacturer will place first three production batches of both products on
long term stability studies throughout proposed shelf life and on accelerated studies for six
months.
Evaluator PEC-V
Sr. Name & Address of Brand Name Type of Form, International REMARKS
No. Manufacturer / (Proprietary Name Initial Diary & Date, Availability / (IF ANY)
Applicant + Dosage Form + Fee (including Local
Strength), differential fee), Availability
Composition, Demanded Price /
Pharmacological Pack size GMP
Group, Inspection
Finished Product Report Date &
Specification Remarks
851. M/s Bosch Soval Tablets 400 Form 5 D USFDA Brand name
Pharmaceuticals mg + 100 mg 15-12-2016 07-06-2018; resemblance
Bosch House 221, Each film coated 2849 GMP and with Sovel of
Sector 23, Korangi tablet contains: Rs. 50,000/- follow up Searle.
Industrial Area, Sofosbuvir Pack size :28 Tablets inspection
Karachi …400mg in HDPE Bottle Firm is
Velpatasvir 100mg As per PRC operating at
(Anti-viral) acceptable level
of GMP
compliance.
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug Sovel Tablets 400 mg + 100 mg
Name of Manufacturer M/s The Searle Company Limited, F-319, SITE, Karachi
Manufacturer Sofosbuvir Nantong Chanyoo Pharmatec Co. LTD (DOM-Jun 2017)
of API
Velpatasvir & Co-
povidone solid Nantong Chanyoo Pharmatec Co. LTD (DOM-Jun 2017)
dispersion
API Lot No. Sofosbuvir 201706151(150kg)
Velpatasvir & 201706001(500 g)
Co-povidone
solid dispersion
Description of Pack HDPE bottle with cap pilfer proof.
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Real Time: 6 months
Frequency Real Time: 0,3,& 6th month
Accelerated: 0,3,& 6th month
Batch No. TR-SV-02 TR-SV-03 TR-SV-04
Batch Size 600 Tablet 600 Tablet 600 Tablet
No. of Batches 3
Date of Submission 11-07-2018
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP Yes
certificate of API manufacturer issued by regulatory authority of country of Copy of GMP certificate.
origin. No. 2017006
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
Yes
chromatograms, laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign and stamp) for ensuring
Yes
7. Commitment to continue real time stability study till assigned shelf life of
Yes
the product.
8. Commitment to follow Drug Specification Rules, 1978. Yes
REMARKS OF EVALUATOR2
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Soval

400mg/100mg Tablets (Sofosbuvir/Velpatasvir) Tablets by M/s. Bosch Pharmaceuticals, Korangi
Industrial Area, Karachi.
Reference No: F.13-11/2017-PEC dated 28th, September, 2018.
Investigation Date and Time: 17th October, 2018 (Afternoon).
Investigation Site: Factory premises of M/s. Bosch Pharmaceuticals, Korangi Industrial Area, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Bosch Pharmaceutical, Bosch House 221,
Sector 23, Korangi Industrial Area, Karachi for registration of Soval 400mg/100mg (Sofosbuvir/Velpatasvir)
Tablets and constituted a three-member panel to investigate the authenticity / genuineness of data (import of
raw material and stability data). Panel was advised to conduct inspection of the firm and to submit report for
further consideration.
4. Dr. Rafeeq Alam Khan, Meritorious Professor, Department of Pharmacology, University of Karachi.
(Member Registration Board)
5. Mr. Sajjad Abbasi, Federal Inspector of Drugs, DRAP, Karachi.
6. Dr. Saif ur Rehman Khattak, Director, CDL, DRAP, Karachi.

The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained,
personnel involved, ongoing studies, printed data and integrity and security of data in respective databases
were also audited. The details of investigation may be summarized as under:
SOVAL 400MG/100MG TABLETS
S.No. Question Observation by panel
1 Do you have documents confirming the The firm has imported 150kg Sofosbuvir Batch no.
import of API ? RD-SFB (Form IV)-201706151 and Velpatasvir batch
no. 201706001 from M/s Nantong Chanyoo China and
has taken approval from DRAP-Karachi for import..
2 What was the rationale behind selecting There is proper vendor qualification being
the particular manufacturer of API? implemented by the firm which includes GMP Status,
provision of DMF, reference standard, impurity
standards etc.
The firms is already importing sofosbuvir from the
same source for their already registered product.
3 Do you have documents confirming the The firm has documents confirming the import of both
import of API reference standard and APIs of said batches working standards and their
impurity standards? impurities standards.
4 Do you have certificate of Analysis of the The firm has certificates of analysis for both APIs,
API, reference standards and impurity working standards and their impurities.
standards?
5 Do you have any approval of API or The firm has GMP certificate of the manufacturer
GMP certificate of API manufacturer issued by Nantong Food & Drug Administration,
issued by regulatory authority of country China
of origin?
6 Do you use API manufacturer method of The firm has used API manufacturer method of testing
testing? for both APIs.
7 Do you have stability studies reports on The firm has stability studies reports on both APIs.
API?
8 If yes, whether the stability testing has The stability testing has been performed as per SIM
been performed as per SIM method and method and degradation products have been quantified.
degradation products have been
quantified?
9 Do you have method for quantifying the The firm has method for quantifying the impurities in
impurities in the API? the API.
10 Do you have some remaining quantities The firm has remaining quantities of API, reference
of the API, its reference standard and standard and impurity standards.
11 Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excipients?
12 Do you have documents confirming the The firm has documents confirming the import of all
import of the used excipients? excipients used.
13 Do you have test reports and other The firm has test reports and other records on the
records on the excipients used? excipients used.
14 Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of API development of Soval (Sofosbuvir 400mg+Velpatasvir
tablets? 100mg) tablets.
15 Have you performed Drug-excipient Drug-excipients compatibility studies were not
compatibility studies? performed as the firm has used the same excipients as
of innovator.
16 Have you performed comparative The firm has performed comparative dissolution
dissolution studies? studies and their product has shown comparable
dissolution profile.
17 Do you have product development The firm has product development (R&D) section with
(R&D) section equipment for manufacturing of tablet dosage form and
analytical lab for test/ analysis of R&D and stability
batches.
18 Do you have necessary equipment The firm has necessary equipment for product
available in product development section development of Soval tablets.
for development of API tablets?
19 Are the equipment in product The available equipment in product development
development section qualified? section are qualified.
20 Do you have proper maintenance / The firm has SOP for the
calibration / re-qualification program for maintenance/calibration/requalification of equipment
the equipment used in PD section? used on PD section.
21 Do you have qualified staff in product The firm has qualified staff in product development
development section with proper section with relevant work experience.
knowledge and training in product
development?
22 Have you manufactured three stability The firm has manufactured three consecutive stability
batches for the stability studies of API batches for the accelerated and real time stability
tablets as required? studies of Soval tablet TR-SV-02,TR-SV-03 and TR-
SV-04.
23 What was the criteria for fixing the batch The criteria for fixing the batch size of stability batches
size of stability batches? is the number of tablets per testing and the number of
tablets required for whole stability testing.
24 Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. Necessary log books of equipment used has
been available with the firm.
25 Do you have protocols for stability testing The firm has detailed protocol for stability testing of
of stability batches? stability batches.
26 Do you have developed and validated the The firm has developed and validated their own
method for testing of stability batches? method for testing of stability batches. The method is
supported by impurities standards spiking studies and
forced degradation, hence capable of quantifying the
degradation products in their tablets kept on stability
testing.
27 Do you have method transfer studies in Not Applicable
case when the method of testing being
used by your firm is given by any other
lab?
28 Do you have documents confirming the The firm has proper documents confirming the
qualification of equipment / instruments qualification of equipment / instruments being used in
being used in the test and analysis of API the test and analysis of API and finished drug.
and the finished drug?
29 Do your method of analysis stability The firm’s method of analytical testing has stability
indicating? indicating parameters.
30 Do your HPLC software is 21CFR The HPLC software is 21CFR Compliant as per record
compliant? available with the firm.
31 Can you show Audit Trail reports on API The firm showed the audit trail reports on API testing.
testing?
32 Do you have some remaining quantities The firm has remaining quantities of stability batches.
of degradation products and stability
batches?
33 Do you have commitment batches kept on The firm has completed accelerated stability testing on
stability testing? the three stability batches. The real time stability
testing is in progress on all the three stability batches.
34 Do you have valid calibration status for The firm has valid calibration status for the equipment
the equipment used in API tablets used in Soval tablets production and analysis.
production in analysis?
35 Do proper and continuous monitoring Continuous power supply and monitoring are available
and control are available for stability for stability chambers.
chamber?
36 Do related manufacturing area, The related manufacturing area, equipment, personnel
equipment, personnel and utilities be and utilities be rated as GMP compliant.
rated as GMP compliant?
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data
submitted by the firm for registration of Soval 400mg/100mg (Sofosbuvir/Velpatasvir)
Tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant
and well suited for the manufacturing of Soval 400mg/100mg Tablets.
Recommendations:
1. The firm may kindly be granted necessary registration of Soval 400mg / 100mg tablets.
2. Since Velpatasvir falls in BCS Class IV (Low solubility and low permeability), therefore, its
combination with Sofosbuvir will also fall in BCS Class IV hence will require Bioequivalence
Studies. Therefore, post-registration bioequivalence studies are also recommended.
Note:
The firm has submitted written commitment vide letter No. Nil dated 31-10-2018 for bioequivalence studies
on Soval tablets
Soval Tablets 400 mg + 100 mg
Decision: Registration Board decided to approve registration of “Soval Tablets 400 mg + 100 mg with
Innovator’s specifications by M/s Bosch Pharmaceuticals Bosch House 221, Sector 23, Korangi
Industrial Area, Karachi. Manufacturer will place first three production batches of both products on
long term stability studies throughout proposed shelf life and on accelerated studies for six months.
Evaluator PEC-VIII
VERIFICATOIN OF GENUINENESS/ AUTHENTICITY OF STABILITY DATA AND ASSOCIATED
DOCUMENTS.
The Firm Getz Pharma has submitted a letter stating as under :
Registration Board in its 271st meeting has directed us to submit stability studies data of our product
Arcox (Etoricoxib 90mg and 120mg). Our subject products are pending since 2009.
We have now manufactured 3 batches of our products and submitted the required stability data along with all
relevant documents as per decision of 251st RB meeting.
The firm also quoted the 214th RB meeting minutes decision, “The Registration board took a policy
decision that once a drug is registered under Drug Act, 1976, then applications for the same drug with similar
dosage form but different strengths will be considered as Me Too instead of New Drug. Hence such application
will be applied on Form-5 rather than on Form-5D and Rs.8,000/- will be deposited on account of registration
board”
Firm further added that Registration Board is requested to treat our product as line extension of already
registered product “Etoricoxib 60mg tablet” as we already has registration of Etoricoxib 60mg since May
2013, and we are marketing it as well.”
Now the case has been placed before the Board for consideration of Board.
852. Name and address of manufacturer / M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi Industrial
Applicant Area, Karachi.
Brand Name +Dosage Form + Strength Arcox Tablets 90mg
Etoricoxib…90mg
Diary No. Date of R& I & fee Duplicate Dossier; Rs. 15,000/-, 28-07-2009, Rs. 35,000/-,
30-07-2013,
Type of Form Form-5D
Pack size & Demanded Price 14’s: Rs. 870.00/- per pack, Rs. 62.14/- per tablet
Me-too status (with strength and N/A
dosage form)
GMP status
Drug Arcox Tablets 90mg (Etoricoxib 90mg)
Name of Manufacturer M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi Industrial
Area, Karachi.
Manufacturer of API Glenmark Pharmaceutical Ltd, India
API Lot No. 84170074
Description of Pack
Alu-Alu blister
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months
Accelerated: 06 Months
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,3,6 Months
Batch No. 412DS01 412DS02 412DS03
Batch Size 25000 tablets 25000 tablets 25000 tablets
No. of Batches 03
Date of Submission Dy No.3457, 26-01-18
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Copy of GMP certificate having a number
of origin or GMP certificate of API manufacturer 6076982 issued for Export Registration by
issued by regulatory authority of country of origin. Licensing Authority Food & Drug administration
Pune Division, Maharashtra State valid for a
period from 01-08-2017 to 31-07-2018.
3. Protocols followed for conduction of stability study Yes
and details of tests.
4. Data of 03 batches will be supported by attested Yes
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Yes
documents.
7. Commitment to continue real time stability study till Yes
assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules, Yes
1978.
● The firm has claimed In House specifications and the product is not present in USP/BP.
Decision: Board decided as follows:

Onsite inspection by following panel to confirm genuineness/ authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc:
i. Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
ii. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
iii. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
OR
Firm can submit requisite documents as decided in 278th meeting of Registration Board to claim
exemption form on site investigation of submitted stability data
853. Name and address of manufacturer / M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi Industrial
Applicant Area, Karachi.
Brand Name +Dosage Form + Strength Arcox Tablets 120mg
Etoricoxib…120mg
Diary No. Date of R& I & fee Duplicate Dossier; Rs. 15,000/-, 28-07-2009, Rs. 35,000/-,
30-07-2013, (Photocopies)
Type of Form Form-5D
Pack size & Demanded Price 7’s: Rs. 585.00/- per pack, Rs. 83.57/- per tablet
Me-too status (with strength and N/A
dosage form)
GMP status
Drug Arcox Tablets 120mg (Etoricoxib 120mg)
Name of Manufacturer M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi Industrial
Area, Karachi.
Manufacturer of API Glenmark Pharmaceutical Ltd, India
Description of Pack
Alu-Alu blister
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months Accelerated: 06 Months
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,3,6 Months
Batch No. 412DS01 412DS02 412DS03
No. of Batches 03
Date of Submission Dy No.3458, 26-01-18
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Copy of GMP certificate having a number
of origin or GMP certificate of API manufacturer 6076982 issued for Export Registration by
issued by regulatory authority of country of origin. Licensing Authority Food & Drug administration
Pune Division, Maharashtra State valid for a
period from 01-08-2017 to 31-07-2018.
documents.
1978.
● The firm has claimed In House specifications and the product is not present in USP/BP.
Decision: Board decided as follows:

Onsite inspection by following panel to confirm genuineness/ authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc:
i. Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
ii. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
iii. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
OR
Firm can submit requisite documents as decided in 278th meeting of Registration Board to claim
exemption form on site investigation of submitted stability data
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Arcox
(Etoricoxib) 90mg & 120mg Tablets by M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi Industrial
Area , Karachi.
Reference No: F.13-11/2017-PEC dated 26th September, 2018.

Investigation Date and Time: 17th September, 2018. (Forenoon)
Investigation Site: Factory premises of M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi
Industrial Area, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Getz Pharma Pvt. Limited, 29-30/27,
Korangi Industrial Area, Karachi for registration of Arcox (Etoricoxib) 90mg & 120mg Tablets and constituted
a three member panel to investigate the authenticity / genuineness of data (import of raw material and stability
data). Panel was advised to conduct inspection of the firm and to submit report for further consideration.
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Department of Pharmacology, University of Karachi.
(Member Registration Board)
3. Dr. Saif ur Rehman Khattak, Director, CDL, DRAP, Karachi.

physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also
audited. The details of investigation may be summarized as under:
Details of Investigation:
Arcox (Etoricoxib) Tablets 90mg & 120mg
Q. Question Observation by panel
No.
1. Do you have documents confirming the The firm has imported “Etoricoxib” from M/s
import of Etoricoxib API including Glenmark Pharmaceuticals Ltd, India and has approval
approval from DRAP? from DRAP for import vide License No.1733/15-DRAP
(K) dated 13.07.2015.
2. What was the rationale behind selecting There is proper vendor evaluation process being
the particular manufacturer of API? implemented by the firm and the rationale behind vendor
selection is controlled through Postal Audit checklist /
Physical Site Inspection and availability of valid GMP
approval by competent authority.
Etoricoxib is the approved API of the firm and regularly
procuring it for the manufacture of their registered and
marketed product ‘Starcox Tablets 60mg’.
3. Do you have documents confirming the Firm has imported Etoricoxib reference standard from M/s
import of Etoricoxib reference standard Glenmark Pharmaceuticals Ltd, India vide invoice No.
and impurity standards? F20016000257 dated 04.03.2016. Firm has imported
impurity standards; Impurity A, Impurity B & Impurity C
from M/s Glenmark Pharmaceuticals Ltd, India vide
invoice No. F20018000987 dated 11.07.2018.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API, reference
API, reference standards and impurity standard and impurity standards.
standards?
5. Do you have GMP certificate of API Firm has provided copy of valid GMP certificate of M/s
manufacturer issued by regulatory Glenmark Pharmaceuticals Ltd, India valid till 24-05-
authority of country of origin? 2021.
6. Do you use API manufacturer method of The firm has used API manufacturer’s method of testing.
testing for testing API?
7. Do you have stability studies reports on The firm has stability studies reports on API.
API?
8. If yes, whether the stability testing has The stability testing has been performed as per SIM
been performed as per SIM method and method and degradation products have been quantified.
quantified?
9. Do you have method for quantifying the The firm has gradient method for quantifying the
impurities in the API? impurities
10. Do you have some remaining quantities of The firm has some remaining quantities of the API,
the API, its reference standard and working standard and impurity standards.
11. Have you used pharmaceutical grade The firm have used pharmaceutical grade excipients
excipients? which include Microcrystalline Cellulose (Avicel PH-
102), Dibasic Calcium Phosphate Anhydrous,
Croscarmellose Sodium and Magnesium Stearate. Film
coating materials include Instacoat Aqua III Pink (for
Etoricoxib Tablets 90mg) and Opadry II Green (for
Etoricoxib Tablets 120mg).
12. Do you have documents confirming the The firm has necessary documents confirming the import
import of the used excipients? of the used excipients.
13. Do you have test reports and other records The firm has test reports and other records on the
on the excipients used? excipients used.
14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of Etoricoxib Tablets 90mg & 120mg.
Etoricoxib tablets?
15. Have you performed Drug-excipient Since firm has used same excipients as used by the
compatibility studies? innovator. Therefore, compatibility studies were not
performed.
16. Have you performed comparative The firm has performed Comparative Studies with
dissolution studies? Arcoxia Tablets 120mg Batch no. R003511
Manufactured for M/s Merck Sharp & Dohme BV, The
Netherlands
The firm’s products (Etoricoxib Tablets 90mg & 120mg)
show comparable dissolution profile with innovator
product Arcoxia Tablets 120mg.
17. Do you have product development (R&D) The firm has dedicated product development (R&D)
section section with requisite manufacturing and analysis
facilities.
18. Do you have necessary equipment The firm has necessary equipment available in product
available in product development section development section for development of Etoricoxib
for development of Etoricoxib tablets? Tablets 90mg & 120mg.
19. Are the equipment in product The available equipment in product development section
development section qualified? are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration with re-
calibration / re-qualification program for qualification program for the equipment used in PD
the equipment used in PD section? section.
21. Do you have qualified staff in product The firm has qualified staff in product development
development section with proper section with proper knowledge and training in product
knowledge and training in product development. There are 50 Scientists (Pharmacist &
development? Chemist) working only in R&D Section.
22. Have you manufactured three stability The firm has manufactured three stability batches of
batches for the stability studies of Etoricoxib Tablets 90mg & 120mg. Packed in Alu-Alu
Etoricoxib tablets as required? blisters:
Etoricoxib Tablets 90mg
Batch No. Date of Mfg. Batch Size
412DS01 May 2017 2500 Tablets

Batch No. Date of Mfg. Batch Size
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is
batch size of stability batches? the capacity of their R&D equipment where probable
simulation of manufacturing procedure of production
batches is expected as well as quantity of tablets required
per testing frequencies.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. All the Log Books are properly maintained.
25. Do you have protocols for stability testing The firm has detailed protocols for stability testing of
of stability batches? stability batches having protocol number:
Batch No. Protocol No.
412DS01 FS-086-17
412DS02 FS-087-17
412DS03 FS-088-17

Batch No. Protocol No.
413DS01 FS-089-17
413DS02 FS-090-17
413DS03 FS-091-17
26. Do you have developed and validated the The firm has developed and validated the method for
method for testing of stability batches? testing of stability batches.
27. Do you have method transfer studies in The firm has developed and validated method of testing
case when the method of testing being for finished product and complete Method Validation
used by your firm is given by any other Report is available. Therefore, method transfer studies are
lab? not applicable.
28. Do you have documents confirming the The firm has proper documents confirming the
qualification of equipments / instruments qualification of equipment / instruments being used in the
being used in the test and analysis of test and analysis of Etoricoxib API and the finished drug.
Etoricoxib API and the finished drug?
29. Do your method of analysis stability The firm has performed forced degradation (FD) study on
indicating? their product Etoricoxib Tablets 90mg & 120mg for the
conformance of its stability indicating nature. Further,
degradation products are also analysed during stability
studies.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per record
Compliant? available with the firm.
31. Can you show Audit trail reports on Audit trail on the testing reports is available.
Etoricoxib testing?
32. Do you have some remaining quantities of The firm has remaining quantities of stability batches
degradation products and stability only.
batches?
33. Do you have stability batches kept on The firm has three stability batches kept on real time
stability testing? stability testing.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment
the equipments used in Etoricoxib tablets used in production and analysis of Etoricoxib Tablets
production and analysis? 90mg & 120mg.
35. Do proper and continuous monitoring and Adequate monitoring and control are available for
control are available for stability stability chamber. Chambers are controlled and monitored
chamber? through software having alarm system for alerts as well.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be rated utilities are GMP compliant.
as GMP compliant?
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Arcox (Etoricoxib) 90mg & 120mg Tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited
for the manufacturing of Arcox 90mg & 120mg Tablets.
Recommendations:
3. The firm may kindly be granted necessary registration of Arcox 90mg & 120mg tablets.
Decision: Registration Board decided to approve registration of “Arcox 90mg & 120mg Tablets
(Etoricoxib 90mg & 120mg)” by M/s Getz Pharma (Pvt) Ltd. Manufacturer will place first three
production batches of both products on long term stability studies throughout proposed shelf life and on
accelerated studies for six months.
Evaluator PEC-II
Sr. Name & Address of Brand Name Type of Form, International
No. Manufacturer / Applicant (Proprietary Name + Dosage Form Initial Diary & Date, Availability / Local
+ Strength), Composition, Fee (including Availability
Pharmacological Group, differential fee), GMP Inspection
Finished Product Specification Demanded Price / Pack Report Date &
size Remarks
854. M/s Carveda XR 20mg Capsule Form-5 Coreg CR 20 mg
Ferozsons Each capsule contains:- 21-06-2011 capsules of M/s
Laboratories limited, P.O Carvedilol Phosphate SR pellets Diary No 222. Smithkline
Ferozsons, Amangarh, (20% w/w) eq. to Carvedilol Beecham approved
Nowshera, …….20mg. Form-5D (20-6-2016) by USFDA
KPK Beta-adrenergic Copy of challan of
blocking drug Rs. 15000/-
Source of pellets:- M/s Alphamed dated 21-06-2011
formulations (Pvt.) Ltd. India Copy of challan of
Rs. 85000/-
dated 27-2-2014
Laboratories limited, P.O Carvedilol Phosphate SR pellets diary No 220. Smithkline
Ferozsons, Amangarh, (20% w/w ) eq. to Carvedilol Form 5D (20-6-2016) Beecham approved
Nowshera, ….40mg. Copy of challan of by USFDA
KPK Beta-adrenergic blocking drug Rs. 15000/- dated 21-
Source of pellets:- M/s Alphamed 06-2011
formulations (Pvt.) Ltd. India. Copy of challan of
Rs. 85000/-
dated 26-2-2014
Rs.40 per capsule
856. M/s Carveda XR Form-5 Coreg CR 80 mg
Ferozsons 80mg Capsule 21-06-2011 capsules of M/s
Laboratories limited, P.O Each capsule contains:- diary No 219. Smithkline
Ferozsons, Amangarh, Carvedilol Phosphate SR pellets Form 5D (20-6-2016) Beecham approved
Nowshera, (20% w/w) eq. to Carvedilol Copy of challan of by USFDA
KPK …………..80mg. Rs. 15000/-
Beta-adrenergic blocking drug dated 21-06-2011
Copy of challan of
Source of pellets:- M/s Alphamed Rs. 85000/-
formulations (Pvt.) Ltd. India. dated 27-2-2014
Rs.79 per capsule
Laboratories limited, P.O Carvedilol Phosphate SR pellets diary No 221. Smithkline
Ferozsons, Amangarh, (20% w/w) eq. to Carvedilol Form 5D (20-6-2016) Beecham approved
Nowshera, …10mg. Copy of challan of by USFDA
KPK Beta-adrenergic Rs. 15000/-
blocking drug dated 21-06-2011
Copy of challan of
Source of Rs. 85000/-
pellets:- M/s Alphamed dated 27-2-2014
formulations (Pvt.) Ltd. India Rs.79 per capsule
Previous DRB Decision / Remarks (if any):
All above cases were presented in 278th meeting of Registration Board meeting along with stability studies data,
wherein Board decided to constitute the following panel for onsite investigation of all the above cited strengths
of Craved XR capsules, to confirm genuineness/ authenticity of stability data and associated documents, import
of API, quality, specification, test analysis, facilities etc. Moreover Registration Board also directed the panel to
confirm that whether the firm has verified the claim of supplier regaring different types of pellets in final boend,
through any analysis or not.
 Director DTL Peshawar (Member Registration Board)
 Mr. Syed Adnan Ali Shah (Assistant Director, PE&R Islamabad)
 Mr. Farhadullah (Assistant Director E&M, DRAP Peshawar)
Report on Verification of Authenticity of Stability Data submitted for Registration of Carveda XR 10mg,
20mg, 40mg and 80mg Capsules (Carvedilol Phosphate SR Pellets) by M/s Ferozsons Laboratories Ltd,
Nowshera KPK
Reference No.F.13-11/2017-PEC
Inspection date: 31st August 2018 (Morning)
Inspection site: Factory Premises of M/s Ferozsons Laboratories Nowshera KPK
Panel Members:
1. Dr. Jamshed Ali Khan (Member Central Licensing Board)
2. Syed Adnan Ali Shah (Assistant Director, PE & R, DRAP, Islamabad)
3. Farhad Ullah (Assistant Director, DRAP Peshawar)
The constituted panel conducted detailed inspection of M/s Ferozsons Laboratories Ltd, Nowshera, Khyber
Pakhtunkhwa as per following details:
S. No Question Observation by panel
Firm has documents confirming the import of Carvedilol
Do you have documents confirming the Phosphate Extended Release Pellets 20% w/w vide
Q.No.1 import of API including approval from license # 00987/2015-DRAP(P)/3968 dated 31/12/2015
DRAP? from M/s. Alphamed Formulations Pvt. Ltd India along
with approval by DRAP Peshawar for import.
The firm has informed that they have selected the said
What was the rationale behind selecting manufacturer (i.e M/s. Alphamed Formulations Pvt. Ltd
Q.No.2
the particular manufacturer of API? India) because of its GMP certification and provision of
stability data.
Firm has documents showing the import of Carvedilol
Phosphate working standard from M/s. Alphamed
Formulations Pvt. Ltd India (having no DRAP Peshawar
Do you have documents confirming the
approval/ADC attestation). Whereas impu ities standard
Q.No.3 import of reference standard and impurity
are imported from M/s. LGC Standards GmnH
standards?
Mecratorstra βe 51 464 5 Wesel G rman vid NOC#
F-11-1/ 01 -Ferozsons-DRAP(P)2217 dated
27/07/201 with approval from DRAP Pe hawar.
Do you have certificate of Anal sis of
Fi m has c rtificate of analysis of API, working
Q.No.4 the API, refere c tandards and
sta dard and impurity standards.
impurity standards?
Do you have GMP certificate of API Firm has provided copy of GMP certificate of API
Q.No.5 manufacturer issued by regulatory manufacturer issued by Drugs Control Administration
authority of country of origin? (Govt. of Telangana), India
Do you use API manufacturer method of The firm has informed that they used API manufacturer’s
Q.No.6
testing for testing API? method of testing.
Do you have stability studies reports on The firm has provided real time and accelerated stability
Q.No.7
API? study data sheets from API manufacturer.
Q.No.8 If yes, whether the stability testing has The stability studies have been performed as per SIM
been performed as per SIM method and method.
quantified?
Q.No.9 Do you have method for quantifying the The firm has used the method provided by API
impurities in the API? manufacturer for quantification of impurities.
Do you have some remaining quantities The firm doesn’t has remaining quantities of the API.
Q.No.1
of the API, its reference standard and However some remaining quantities of working standard
0
impurities standards? and impurity standards were present.
Q.No.1 Have you used pharmaceutical grade
Not applicable.
1 excipients?
Q.No.1 Do you have documents confirming the
Not applicable.
2 import of the used excipients?
Q.No.1 Do you have test reports and other
Not applicable.
3 records on the excipients used?
Do you have written and authorized
Q.No.1 The firm has written and authorized protocols for the
protocols for the development of applied
4 development of applied product.
product?
Q.No.1 Have you performed Drug-excipients
Not applicable.
5 compatibility studies?
Firm has performed comparative dissolution studies of the
Q.No.1 Have you performed comparative
applied product against Coreg CR capsule of M/s. GSK
6 dissolution studies?
Canada.
The firm has product development (R&D) section with
Q.No.1 Do you have product development requisite manufacturing facilities. However, production of
7 (R&D) section trial batches of Carveda XR capsules were performed in
production area as R&D section is established recently.
Do you have necessary equipments The firm has all the necessary equipment in product
Q.No.1
available in product development section development section. However, production of Carveda
8
for development of applied product? XR capsules were performed in production area.
Q.No.1 Are the equipments in product The equipments used in the product development section
9 development section qualified? were qualified.
Do you have proper maintenance /

Q.No.2 The firm has proper maintenance and calibration program
calibration / re-qualification program for
0 for the equipment used in product development.
the equipment used in PD section?
Q.No.2 Do you have qualified staff in product Firm has qualified staff with proper knowledge and
1 development section with proper training in product development.
development?
The firm has manufactured three stability batches for the
stability studies of Carveda XR capsules with the
following batch No’s.
Have you manufactured three stability 1. PD16-72A 7. PD16-74A
Q.No.2
batches for the stability studies of applied 2. PD16-72B 8. PD16-74B
2
product as required? 3. PD16-72C 9. PD16-74C
4. PD16-73A 10. PD16-75A
5. PD16-73B 11. PD16-75B
6. PD16-73C 12. PD16-75C
Firm has informed that criteria approved in 251st meeting
Q.No.2 Do you have any criteria for fixing the
of DRB was followed for fixation of batch size of the
3 batch size of stability batches?
stability batches.
Q.No.2 Do you have complete record of The firm has complete batch manufacturing record of all
4 production of stability batches? the stability batches.
Q.No.2 Do you have protocols for stability Firm has protocols for stability testing of the stability
5 testing of stability batches? batches.
Q.No.2 Do you have developed and validated the The firm has informed that they used API method of
6 method for testing of stability batches? testing for testing of stability batches.
Q.No.2 Do you have method transfer studies in Not Applicable
7 case when the method of testing being
lab?
Q.No.2 Do you have documents confirming the Firm has complete record/documents confirming the
8 qualification of equipments / instruments qualification of equipments/instruments used in the test
being used in the test and analysis of API and analysis of API and the finished drug.
and the finished drug?
Q.No.2 Is your method of analysis stability The method of analysis used for analysis of stability
9 indicating? batches was stability indicating.
Q.No.3 Is your HPLC software is 21CFR
The HPLC software of the firm is 21CFR compliant.
0 compliant?
Q.No.3 Can you show Audit Trail reports on Firm has demonstrated audit trail reports of testing.
1 stability studies testing?
Q.No.3 Do you have some remaining quantities The firm has some remaining quantities of stability
2 of degradation products and stability batches.
batches?
Q.No.3 Do you have stability batches kept on The firm has remaining quantities of stability batches kept
3 stability testing? on stability testing.
Do you have valid calibration status for

Q.No.3 The firm has valid calibration status of the equipment
the equipments used in production and
4 used in production and analysis of Carveda XR capsule.
analysis?
Do proper and continuous monitoring and The firm has stability chambers for carrying out
Q.No.3
control are available for stability accelerated and real time stability studies provided with
5
chamber? uninterrupted power supply and data loggers.
Do related manufacturing area,
Q.No.3 Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be
6 utilities are as per GMP compliance.
Conclusion:
As per direction of the Registration Board the panel verified that the firm has performed dissolution studies to
confirm the claim of supplier regarding different types of pellets in final blend.
On risk-based approach the genuineness / authenticity of stability data submitted by the firm for registration of
Carveda XR 10mg, 20mg, 40mg and 80mg capsules (Carvedilol Phosphate SR Pellets) is verifiable to
satisfactory level.
Decision: Registration Board decided to approve registration of “Carveda XR 20mg Capsule, Carveda XR
40mg Capsule, Carveda XR 80mg Capsule, Carveda XR 10mg Capsule by M/s Ferozsons Laboratories
limited, P.O Ferozsons, Amangarh, Nowshera, KPK. Manufacturer will place first three production
batches of all four products on long term stability studies throughout proposed shelf life and on
No. Manufacturer / (Proprietary Name + Initial Diary & Availability / Local (IF ANY)
Applicant Dosage Form + Date, Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / GMP Inspection
Pharmacological Pack size Report Date &
Group, Remarks
Finished Product
Specification
858. M/s Werrick Werdex capsules Form 5- Approved by USFDA The firm has
Pharmaceuticals, 216- 30mg Diary No. 21041 Dolgina DR capsules claimed
217, I-10/3, Industrial Each dual delayed dated 21-06-2018 of M/s Hilton Pharma Manufacturer’
Area, Islamabad. release capsule Rs.20,000/- dated s
contains: 11-05-2018 Last GMP inspection Specifications
Dexlansoprazole (as Rs. 80,000/- dated conducted on 7-12-
22.5% w/w dual 12-06-2018 2017 ,and the
delayed release report concludes that
pellets) ….. 30mg 14’s & 28’s ; As firm is operating at
per SRO good level of
(Proton pump compliance of GMP.
inhibitor)
Drug Werdex capsules 30mg
Name of Manufacturer M/s Werrick Pharmaceuticals, 216-217, I-10/3, Industrial Area, Islamabad.
Manufacturer of API M/S Alphamed Formulations Pvt. Ltd., Telangana , India
API Lot No. RD0050-006
Description of Pack Alu/Alu-PVC packed in card box unit carton blister foil packed in unit carton
Time Period Real Time: 26 weeks
Accelerated: 26 weeks
Frequency Real Time: 0,1,2,3,4,6,8,12,16,20,24 & 26 weeks
Accelerated: 0,1,2,3,4,6,8,12,16,20,24 & 26 weeks
Batch No. Trial No.-01 Trial No.-02 Trial No.-03
No. of Batches 03
No.
1. COA of API Yes
country of origin or GMP certificate of API Copy Of GMP Certificate Issued By DCA, Government Of
manufacturer issued by regulatory authority Telangana, valid upto 12-2018
of country of origin.
Yes
4. Data of 03 batches will be supported by
Raw data sheets & lab reports have not been submitted
sheets etc.
5. Documents confirming import of API etc. Copy of clearance certificate dated 21-06-2017 issued by
ADC, DRAP Islamabad, in the name of M/s Werrick
Pharmaceuticals for import of Dexlansoprazole pellets
from M/s Alphamed Formulations, India vide invoice no.
024/2017-18.
6. All provided documents will be attested
(name, sign and stamp) for ensuring Yes
Yes
Yes
Rules, 1978.
No. Manufacturer / (Proprietary Name Initial Diary & Availability / Local (IF ANY)
Applicant + Dosage Form + Date, Fee Availability
Strength), (including
Pharmacological Demanded Price / Report Date &
Group, Pack size Remarks
Finished Product
Specification
859. M/s Werrick Werdex capsules Form 5- Approved by USFDA The firm has
Pharmaceuticals, 216- 60mg Diary No. 21040 Dolgina DR capsules claimed
217, I-10/3, Industrial Each dual delayed dated 21-06-2018 of M/s Hilton Pharma Manufacturer’
Area, Islamabad. release capsule Rs.20,000/- dated s
contains: 11-05-2018 Last GMP inspection Specifications
Dexlansoprazole (as Rs. 80,000/- dated conducted on 07-12-
22.5% w/w dual 12-06-2018 2017,and the
delayed release report concludes that
pellets) ….. 60mg 14’s & 28’s ; As firm is operating at
per SRO good level of
(Proton pump compliance of GMP.
inhibitor)
Drug Werdex capsules 60mg
Name of Manufacturer M/s Werrick Pharmaceuticals, 216-217, I-10/3, Industrial Area, Islamabad.
Manufacturer of API M/S Alphamed Formulations Pvt. Ltd., Telangana , India
API Lot No. RD0050-006
Description of Pack Alu/Alu-PVC packed in card box unit carton blister foil packed in unit carton
Time Period Real Time: 26 weeks
Frequency Real Time: 0,1,2,3,4,6,8,12,16,20,24 & 26 weeks
Accelerated: 0,1,2,3,4,6,8,12,16,20,24 & 26 weeks
Batch No. Trial No.-01 Trial No.-02 Trial No.-03
No. of Batches 03
No.
1. COA of API Yes
country of origin or GMP certificate of API Copy Of GMP Certificate Issued By DCA, Government Of
manufacturer issued by regulatory authority Telangana, valid upto 12-2018
Yes
Raw data sheets & lab reports have not been submitted
sheets etc.
5. Documents confirming import of API etc. Copy of clearance certificate dated 21-06-2017 issued by
ADC, DRAP Islamabad, in the name of M/s Werrick
Pharmaceuticals for import of Dexlansoprazole pellets
from M/s Alphamed Formulations, India vide invoice no.
024/2017-18.
Yes
Yes
Rules, 1978.
Report on investigation of genuineness / authenticity of data submitted for registration of Werdex 30mg
capsule and Werdex 60mg capsule of M/s Werrick Pharmaceuticals 216-217, I-10/3, industrial area,
Islamabad.
Reference No: F.13-11/2017-PEC dated 31st July, 2018.
Investigation Date and Time: 19th October, 2018 (Evening)
Investigation Site: Factory premises of M/s Werrick Pharmaceuticals, Islamabad
Background:
M/s Werrick Pharmaceuticals Islamabad have applied for registration of Werdex 30mg capsule and
Werdex 60mg capsule (Dexlansoprazole). PEC considered scientifically rational laboratory scale data submitted
by the firm as pre-requisite of registration, So the chairman Registration Board has constituted a three member
panel for on-site investigation to confirm genuineness / authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
1. Mr. Abdullah, Additional Director (PE&R), DRAP, Islamabad
2. Mr. Muhammad Amin, Deputy Director (PE&R), DRAP, Islamabad
3. Mst Sana Kanwal Assistant Director, (PE& R), DRAP, Islamabad
Investigation to confirm genuineness / authenticity of stability data and associated documents, import of
API, quality, specification, test analysis, facilities etc.
audited. The details of investigation may be summarized as under:
Focus of Inspection:
The inspection was focused on a thorough evaluation of data for stability studies of following products namely:
Sr. Name of Firm Name of Drug and Composition
1. M/s Werrick Pharmaceuticals Werdex 30mg capsule
216-217, I-10/3, industrial Each dual delayed release apsule contains:
area, Islamabad. Dexlansoprazole (as 22,5% w/w dual release pellets)... 30 mg
Werdex 60mg capsule
Each dual delayed release apsule contains:
Dexlansoprazole (as 22,5% w/w dual release pellets)......60 mg
Panel visited the R&D Laboratory and Quality Control Laboratory of the firm. Panel also visits the
whole Premises of factory including palletization and capsule filling section. Documents were evaluated
according to the check list provided as given below:
Detail of investigation:
1. Werdex 30 mg capsule
2. Werdex 60 mg capsule
No.
1. Do you have documents confirming The firm used pellets made by “M/s Alphamed formulations
the import of API including approval Pvt. Ltd., Telangana, India” purchased through invoice
from DRAP? #024/2017-18. The quantity of dexlansoprazole raw material
obtained was 3Kg from M/s Alphamed formulations.
2. What was the rationale behind Firm performed vendor evaluation and qualification for
selecting the particular manufacturer selection of API manufacturer/supplier. The criteria includes
of API? GMP certification of API manufacturer from the country of
origin, CoA of API, Reference Standard and impurities (if
any), supply of Reference Standards and Impurity Standards,
stability study report on API, method of quantifying impurities,
physical and chemical method of testing and material safety
data sheet.
3. Do you have documents confirming Firm imported Dexlansoprazole working standard i.e
the import of API reference standard Lansoprazole (10 gm), Batch #LSI000916 Impurity standard
and impurity standards? i.e Lansoprazole Sulfone (25 mg) Batch # SPL-021/117/014
from Sympure Labs India Pvt. Ltd. Firm informed that
working standard and impurity standard were imported
alongwith pellets.
4. Do you have certificate of Analysis of The firm had certificates of analysis for
the API, reference standards and API pellets:
impurity standards? Batch # RD0050-006,
Quantity: 3 kg
Working standard:
Batch # LSI000916
10gm
Impurity standards:
Batch # SPL-021/117/014
25mg
5. Do you have GMP certificate of API Firm had provided valid GMP certificate (No.
manufacturer issued by regulatory 12359/E(M)/TS/2016) issued by DCA, Government of
authority of country of origin? Telangana Valid up to December,2018.
6. Do you use API manufacturer method The firm used API manufacturer’s method of testing
of testing for testing API? Document # STP/FAJIA00-1-04 dated 03/03/2017.
7. Do you have stability studies reports The firm had stability studies reports on API from M/s
on API? Alphamed formulations.
8. If yes, whether the stability testing has The stability testing had been performed as per SIM method
been performed as per SIM method and degradation products had been quantified (Protocol
and degradation products have been no.STFAJIA00-16-010).
quantified?
9. Do you have method for quantifying Firm had testing method (STP/FAJIA00-1-04 dated
the impurities in the API? 03/03/2017) to quantify the impurities as per raw material
manufacturer.
10. Do you have some remaining The firm had some remaining quantities of the API (1.1970
quantities of the API, its reference kg).But working standard and impurity standard was all
standard and impurities standards? consumed.
11. Have you used pharmaceutical grade The firm had used ready to fill pellets therefore no other
excipients? excipient has been used. While documents confirming
purchase of gel cap was available.
12. Do you have documents confirming The firm had used ready to fill pellets therefore no other
the import of the used excipients? excipient has been used.
13. Do you have test reports and other The firm had used ready to fill pellets therefore no other
records on the excipients used? excipient has been used.
14. Do you have written and authorized The firm had written and authorized protocols for the
protocols for the development of development of Werdex 30mg capsule and Werdex 60mg
applied formulation? capsule.
15. Have you performed Drug-excipient The firm had used ready to fill pellets therefore no other
compatibility studies? excipient has been used.
16. Have you performed comparative ● Firm had presented Comparative dissolution study report.
dissolution studies? The details of reference product & Sample product are as
follows:
Feature Reference product Product of
Werrick pharma
Brand name Dexilant 30 mg Werdex 30mg
Capsule capsule
Batch No. A25349 Trial no. 01
Brand name Dexilant 60 mg Werdex 60mg
Capsule capsule
Batch No. A25220 Trial no. 01
●
Comparative dissolution studies have been performed in
following mediums:
1. Acidic Stage
 0.1N HCl buffer, 500 ml for 120 min
2. Basic Phase
 pH 7 buffer (with SLS) for 120 min
17. Do you have product development The firm had product development (R&D) section
(R&D) section
18. Do you have necessary equipment Product development section had necessary equipment to
available in product development develop products however Dexlansoprazole capsules were
section for development of applied filled in production area.
formulation?
19. Are the equipment in product The available equipment in product development section were
development section qualified? qualified. Documents for installation and operation
qualification was provided.
20. Do you have proper maintenance / The firm has SOP for maintenance / calibration / re-
calibration / re-qualification program qualification program for the equipment used in production
for the equipment used in PD section? and QC, used for product development section.
21. Do you have qualified staff in product The firm had 09 qualified personnel in product development
development section with proper section with suitable knowledge and training in product
knowledge and training in product development.
development?
22. Have you manufactured three stability The firm had manufactured three stability batches for the
batches for the stability studies of stability studies of
applied formulation as required? Dexlansoprazole capsules (30 mg,60 mg) with batch numbers
i.e.
Product Batch 1 Batch 2 Batch 3
Werdex 30 mg Trial No. 01 Trial No. 02 Trial No. 03
capsules
Werdex 60 mg Trial No. 01 Trial No. 02 Trial No. 03
capsules
The Batch size for these batches is 1500 capsules
23. Do you have any criteria for fixing the As per statement of the firm the criteria for fixing the batch
batch size of stability batches? size of stability batches is the number of capsule per testing
frequency and number of testing frequencies.
24. Do you have complete record of The firm had complete record of production of stability
production of stability batches? batches. Necessary log books of equipment used has been
available with the firm, assuring the traceability of
manufacturing and analysis of stability batches.
25. Do you have protocols for stability The firm had detailed protocols for stability testing of stability
testing of stability batches? batches.
26. Do you have developed and validated The firm had developed and validated method of testing for
the method for testing of stability finished product based on method of testing of API
batches? manufacturer.The method is stability indicating while using the
working standard of API and impurities
27. Do you have method transfer studies The firm has not conducted method transfer studies, however,
in case when the method of testing they have validated their method.
being used by your firm is given by
any other lab?
28. Do you have documents confirming The firm had document (Ref no. TL/Cal/werrick-HPLC/2017-
the qualification of equipment’s / 2018 dated 23.01.2018) confirming the qualification of
instruments being used in the test and equipment / instruments being used in the test and analysis of
analysis of API and the finished drug? API and the finished drug.
29. Do your method of analysis stability Firm had validated testing method which was stability
indicating? indicating.
30. Do your HPLC software 21CFR Firm had HPLC which was 21CFR complaint. HPLC system
Compliant? was used for stability studies of Werdex capsules. The record
from logbooks, analytical test reports was verifiable onsite. A
complete trail of validation studies is available and verifiable.
31. Can you show Audit trail reports on Firm had demonstrated audit trail reports (assay & dissolution
applied formulation testing? analysis on HPLC) for the submitted stability batches.
32. Do you have some remaining The firm had remaining quantities of stability batches.
quantities of degradation products and Werdex 30mg capsule
stability batches? T-01: 18 packs
T-02: 18 packs
T-03: 19 packs
Werdex 60mg capsule
T-01: 22 packs
T-02: 22 packs
T-03: 22 packs
33. Do you have stability batches kept on The firm had stability batches on stability testing.
stability testing?
34. Do you have valid calibration status The firm had valid calibration status for the equipment used in
for the equipment used in production werdex capsule production and analysis.
and analysis?
35. Do proper and continuous monitoring Adequate monitoring and control (humidity and temperature)
and control are available for stability
was available for stability chamber (Data logger serial no.
chamber? S320EX7405 and S320EX7391 for longterm and accerlerated
studies).Continuous power supply and monitoring with back
up from generator are available for stability chamber.
36. Do related manufacturing area, Requisite facilities were satisfactory and GMP compliant.
equipment, personnel and utilities be
Conclusion /Recommendations:
Based on the facility inspected, documents reviewed and technical staff availability, the panel is of the
opinion that data provided by the firm M/s Werrick Pharmaceuticals, Islamabad regarding stability studies of
Werdex products 30 and 60mg was conducted by the firm. Firm had demonstrated audit trail reports (assay &
dissolution analysis on HPLC) for the submitted stability batches which were verifiable onsite from logbooks,
analytical test reports.
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Werdex 30 mg and 60 mg capsule is verifiable to satisfactory level.
The related manufacturing area, equipment and facility was GMP compliant at the time of inspection and
found appropriate for the manufacturing of Werdex 30 mg and 60 mg capsule.
Decision: Registration Board decided to approve registration of “Werdex products 30 and 60mg by M/s
Werrick Pharmaceuticals, Islamabad” Manufacturer will place first three production batches of both
products on long term stability studies throughout proposed shelf life and on accelerated studies for six
months
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability
Applicant Dosage Form + Fee (including
Strength), differential fee), GMP Inspection Report Date &
Composition, Demanded Price / Remarks
Pharmacological Pack size
Group,
Finished Product
Specification
860. M/s Vision Sofovir-V Form 5-D Epclusa Tablet by Gilead Sciences
Pharmaceuticals, Plot 400mg/100mg Tablet Dy No. 2469 (USFDA Approved)
No. 22-23, Industrial Each film coated 23-2-2017
Triangle, Kahuta tablet contains: PKR 50,000/- Inspection dated 26-1-2018, overall
Road, Islamabad. Sofosbuvir…..400mg (23-02-2017) GMP was Good.
Velpatasvir…100mg 28’s: As per SRO
(In house
specification)
The firm has submitted stability study data along with required documents as per checklist approved in
251st meeting of Registration Board. Details of submitted data are as under:
(Dy.# 21788 dated 22-06-2018)
Drug Sofovir-V 400mg/100mg Tablet
Name of Manufacturer M/s Vision Pharmaceuticals, Islamabad.
Manufacturer of API Sofosbuvir Ruyuan HEC Pharm Co. Ltd China
Velpatasvir Ruyuan HEC Pharm Co. Ltd China
API Lot No. Sofosbuvir S104B-201706201
Velpatasvir VEP11-201704001
Description of Pack
Child resistant HDPE bottle of 28 tablets
Time Period Real time: 0, 1, 2, 3, 4, 6, 8 (weeks), 3, 4, 5, 6 (months)
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. NPD 701 (T-01) NPD 701 (T-02) NPD 701 (T-03)
No. of Batches 03
1. COA of API Firm has provided COA of both sofosbuvir and
velpatasvir from Ruyuan HEC
2. Approval of API by regulatory authority of Copy of GMP certificate issued by Shaoguan food and
country of origin or GMP certificate of API Drug Administration has been submitted for M/s
manufacturer issued by regulatory authority of Ruyuan HEC Pharm Co., Ltd. The certificate is valid
country of origin. upto 12-12-2018.
GMP Inspection of M/s Ruyuan HEC Pharm. Co., Ltd.
Shaoguan City, China dated 09/11/15 by CDER (US
FDA) classified as NAI (No Action Indicated).
Yes
5. Documents confirming import of API etc. Sofosbuvir: Firm has submitted copy of ADC attested
invoice dated 09-08-2017 confirms import of 3 Kg
sofosbuvir from WIS Pharmatech Co. Ltd., China,
Manufactured by M/s Ruyuan HEC Pharm Co. Ltd,
China.
Velpatasvir: Firm has submitted copy of ADC attested
invoice dated 21-07-2017 confirms import of 1.5 Kg
Velpatasvir and co povidone solid dispersion from WIS
Pharmatech Co. Ltd., China, Manufactured by M/s
Ruyuan HEC Pharm Co. Ltd, China.
sign and stamp) for ensuring authenticity of data / Yes
documents.
7. Commitment to continue real time stability study
Yes
till assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules,
Yes
1978.
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Sofovir-V
400mg/100mg Tablets by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate,
Kahuta road, Model Town, Islamabad.
Inspection Date and Time: 5th & 15th October, 2018 (Afternoon)
Inspection Site: Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta
road, Model Town, Islamabad.
Background:
M/s. Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23, Industrial Estate, Kahuta road, Model Town,
Islamabad applied for registration of Sofovir-V 400mg/100mg Tablet. Each film coated tablet contains:
Sofosbuvir…..400mg and Velpatasvir…100mg. Chairman Registration Board constituted a three member panel
to verify the authenticity / genuineness of data (import of raw material and stability data). Panel was advised to
conduct inspection of the firm to verify the data submitted by the firm and to submit report for further
consideration of case by the Registration Board.
1. Dr. Qurban Ali, Member Registration Board.
2. Area FID, Islamabad.
3. Ms. Iqra Aftab, Assistant Director, PEC
Scope of Inspection:
Inspection for the authenticity/genuineness of data (including import of raw material and stability data),
Tools for Inspection:
The Inspection was conducted by using a structured questionnaire of DRAP. For objective evidence
audited. The details of Inspection may be summarized as under:
Detail of Inspection:
Q.
Question Observation by panel
No
1. Do you have documents Sofosbuvir (ADC Attested Invoice )
confirming the import of API Number: WIS170091
including approval from DRAP? ADC attestation date: 09-08-2017
Exporter: WIS Pharmatech Co .Ltd. Shanghai, China
Manufacturer: M/s Ruyuan HEC Pharm Co. LTD, Xiaba Development
Zone , Shaoguan City, Guangdong Province, China
Batch No. S104B-201706201
Mfg. Date:13.06.2017
Exp. Date:12.06.2019
Quantity: 3kg
Velpatasvir and Copovidone Solid Dispersion (ADC Attested
Invoice )
Number: WIS170067
ADC attestation date: 21-07-2017
Exporter:WIS Pharmatech Co .Ltd. Shanghai, China
Manufacturer: Manufacturer: M/s Ruyuan HEC Pharm Co. LTD,
Xiaba Development Zone , Shaoguan City, Guangdong Province,
China
Batch No. VEPII-20174001
Mfg. Date:18.04.2017
Exp. Date:17.04.2019
Quantity: 1.5 kg
The testing of the API is on 12-07-2017. However, the ADC
attestation date of API is 21-07-2017.
2. What was the rationale behind The firm has provided vendor qualification SOP Effective date: 22-01-
selecting the particular 2018.
manufacturer of API? Sofosbuvir
 According to SOP. the firm acquired Product Development
samples from 3 sources:
 Ruyuan HEC Pharm, China
 Pharmagen Pakistan
 Nantong Chanyoo
 A comparative analysis was performed for above sources to
compare for different attributes including availability of
reference and impurity standards, stability studies data, DMF
and results of QC.
 Firm concluded that stability data as well GMP status of
Ruyuan HEC Pharm, China was more authenticated as
compared to other sources. Moreover, prompt response and
good documentation was additional factor for selection of this
source for sofosbuvir.
Velpatasvir and Co-povidone Solid Dispersion
According to SOP, the firm acquired Product Development samples
from 2 sources:
 Ruyuan HEC Pharm, China
 Reyphon Pharma, China
 The comparative analysis was performed for above sources to
compare for different attributes including availability of
reference and impurity standards, stability studies data, DMF
and results of QC.
 Firm concluded that due to better documentation and robust
stability testing data of API from M/s Ruyuan HEC Pharm,
China they have selected M/s Ruyuan HEC Pharm, China.
Moreover, less number of impurities was also a considerable
factor in selection of this particular source.
The API materials was imported before effective date of SOP.
3. Do you have documents The firm imported following reference and impurity standards:
confirming the import of  Sofosbuvir Reference Standard
Velpatasvir and Sofosbuvir  Velpatasvir Reference Standard.
reference standard and impurity  Sofosbuvir Impurity B and F
standards?  Velpatasvir Impurity A Reference Standard.
4. Do you have certificate of The firm has submitted COAs of following drugs (APIs)/materials of
Analysis of the API, reference source as mentioned below:
standards and impurity standards? Sofosbuvir
 Sofosbuvir Reference Standard
 Reference standard for Sofosbuvir Impurity A
 Reference standard for Sofosbuvir Impurity B
 Reference standard for Sofosbuvir Impurity C
 Reference standard for Sofosbuvir Impurity D
 Reference standard for Sofosbuvir Impurity F
 Reference standard for Sofosbuvir Impurity G
Velpatasvir
 Velpatasvir Reference Standard
 Velpatasvir Impurity A Reference Standard.
5. Do you have any approval of API Sofosbuvir
or GMP certificate of API The firm has submitted copy of GMP certificate in the name of
manufacturer issued by regulatory Manufacturer that is “M/s Ruyuan HEC Pharm Co. LTD, Xiaba
authority of country of origin? Development Zone, Ruyuan County, Shaoguan City, 512721,
Guangdong Province, China” of Sofosbuvir by the Certifying
Authority of “Shaoguan Food and Drug Administration.”
Validity:12-12-2018
Shaoguan city is prefecture-level city. However, the firm has been
found approved (NAI) by the USFDA mentioning the date of
inspection 09/11/15.
Velpatasvir (Co-povidone)
The firm has submitted copy of GMP certificate in the name of
Manufacturer that is “M/s Ruyuan HEC Pharm Co. LTD, Xiaba
Development Zone, Ruyuan County, Shaoguan City, 512721,
Guangdong Province, China” of Velpatasvir (Copovidone) by the
Certifying Authority of “Shaoguan Food and Drug Administration.”
Validity:20-03-2018
Shaoguan city is prefecture-level city. However, the firm has been
found approved (NAI) by the USFDA mentioning the date of
inspection 09/11/15.
6. Do you use API manufacturer The firm has submitted testing methods of APIs namely Sofosbuvir
method of testing? and Velpatasvir (Copovidone) as provided by manufacturer/source
and has used the same.
7. Do you have stability studies Firm has submitted data of long term stability studies of three batches
reports on API? up to 12 months and accelerated data up to 6 months conducted by the
API manufacturer M/s Ruyuan HEC Pharm under conditions of Zone-
IV A that is 30 Co + 2 Co & 65 % RH + 5 % and 40 Co + 2 Co & 75 %
RH + 5 % for both APIs namely Sofosbuvir and Velpatasvir and
Copovidone Solid.
8. If yes, whether the stability The stability testing has been performed as per SIM (Stability
testing has been performed as per Indicating Method) with capability of calculating API quantitatively in
SIM method and degradation a precise manner free from impurities, excipients and degradation
products have been quantified? products (as per definition of SIM). No degradation products have
been quantified.
9. Do you have method for The firm has submitted manufacturer’s method for quantifying the
quantifying the impurities in the impurities in the both APIs for Sofosbuvir and Velpatasvir Co-
API? povidone.
10. Do you have some remaining The firm has submitted remaining quantities of the API, reference
quantities of the API, its standard and impurities standards as per details below:
reference standard and impurities Sofosbuvir (API) T-01-335.673 gm
standards? T-02-335.673 gm
T-03-335.673 gm
Velpatasvir Copovidone(API) T-01-163.33 gm
T-02-163.33 gm
T-03-163.33 gm
Sofosbuvir reference standard 0.4 gm
Velpatasvir reference standard 0.3 gm
Reference standard for Sofosbuvir Impurity B Nil
Reference standard for Sofosbuvir Impurity F Nil
Reference standard for Impurity A of Nil
Velpatasvir
11. Have you used pharmaceutical The firm has used pharmaceutical grade excipients as indicated from
grade excipients? the COAs submitted by firm.
12. Do you have documents The firm has necessary documents confirming the import of the used
confirming the import of the used excipients.
excipients? Excipients Company / Origin B. No. Invoice Supplier Date
Name Manufacturer No.
Croscarmellos Accent Indi D20150038 1606- Multi 08-01-
e sodium Microcell a 000108 Chem 2016
(Pvt) Ltd. -D
Magnesium Coin Power Tai MGS-R MGSR Kanny 10-01-
stearate internationa wan 0127 0127 chemi 2016
l Co., Ltd cals
Microcrystalli NB India 160108w2 E/12 NB 04-02-
ne cellulose Intrepreneu Intrepre 2016
Sancel–102 rs, Nagpur neurs,
Nagpur
Tab Coat Pink Colorcon Englan SH586520 551710 Bank 26-06-
Limited d Al 2016
Habib
Limited
Tab Coat Colorcon Englan SH586518 551710 Bank 26-06-
White Limited d Al 2016
Habib
Limited
13. Do you have test reports and The firm has performed tests on excipients and hence has test reports
other records on the excipients and other records on the excipients used.
used?
14. Do you have written and The firm has written and authorized protocols for the development of
authorized protocols for the Sofovir-V 400mg/100mg Tablets. But submitted documented was not
development of Sofovir tablets? in accordance with ICH Q-8 which pertains to Pharmaceutical
Development. The firm was advised to improve the submitted protocol
in the light of said document.
15. Have you performed Drug- The firm has not performed Drug-Excipients compatibility studies as
excipients compatibility studies? their formulation (API & pharmaceutical grade Ecipients) is
similar/comparable to that of the Epclusa Tablets by Gilead Sciences.
16. Have you performed comparative The firm has performed comparative dissolution studies with
dissolution studies? innovator product Epclusa Tablets of Gilead Sciences, USA. The
dissolution test was carried out on 14 baskets Electrolab dissolution
apparatus on one pH 5.0. The analytical tests were carried out using 21
CFR II compliant.
The said studies have not been performed on three (3) pH considering
the body fluid pH pattern. The firm was advised to improve their
protocols/SOPs for conducting comparative dissolution studies in the
light of scientific based internationally accepted guidelines.
17. Do you have product The firm has product development section. However, the
development (R&D) section manufacturing and testing of trial batches has been carried out in
qualified equipment’s used for commercial production.
18. Do you have necessary Yes, the firm has following necessary equipments in R & D section
equipment’s available in product though for the development of Sofovir-V 400mg/100mg Tablet. They
development section for have used the equipments qualified for manufacturing of commercial
development of Sofovir tablets? scale batches:
S. Descriptio Qualifica Preventive Model Equipment Origen Qty
No. n tion and No. No.
Machinery maintenance
schedule
1 Multifunctio 20-07- January, U&M- VP-RD- China 1
n-functional 2016 2018 II 001
pharmaceuti
cal R&D
Machine.
2 Single 13-07- October, U&M- VP-RD- China 1
Tablet press 2016 2018 25 002
Machine
3 Mechanic 09-02- June, 2018 HY- VP-RD- China 1
al Test 2016 200 003
Sieve
4 Drying 08-02- April, 2018 DHG- VP-RD- China 1

Oven 2016 9030A 004
19. Are the equipments in product The equipment used in production and analysis of trial batches are
development section qualified? qualified as per details mentioned in reply of question # 18.
20. Do you have proper The firm has preventive maintenance program for the equipment used
maintenance/calibration/re- in production and QC as per details mentioned in reply of question 18.
qualification program for the
equipment used in PD section?
21. Do you have qualified staff in The firm has appointed a team of following technical personnels:
product development section with S. Name Designation Qualification Experience
proper knowledge and training in No.
product development? a. Dr. Zia Ud Chief operating B. Pharm (Pak), 26 years
Din officer & PGD (UK), MS
Technical Director (UK)
b. Aatikah Deputy Manager R Pharm-D 08 years
Younis &D
c. Humera Manager QC M.Sc. Chemistry 21 years
Iqbal
d. Saima Iqbal Assistant Manager Pharm-D 08 years
QC
e. Muhammad R & D officer Pharm-D 04 Years
Mudssar Ali
f. Laila tul R & D officer Pharm-D 02 Years
Qadar
22. Have you manufactured three The firm has manufactured following three stability batches for the
stability batches for the stability stability studies of Sofovir-V tablets:
studies of Sofovir tablets as S. No. Stability Batchs Batch Sizes
required? a. NPD701(T-01) 833 Tablets
b. NPD701(T-02) 833 Tablets
c. NPD701(T-03) 833 Tablets
23. Do you have any criteria for The firm has set the criteria for fixing the batch size of stability
fixing the batch size of stability batches as/& derived the quantity sufficient for the studies both in
batches? accelerated and real time studies to cover all testing time points as per
details below.
S. Tablets /Packs for Packs for Total packs per
No. real time studies accelerated studies batch required
a. 420 tablet = 308 tablets = 15 + 11= 26 packs
15 packs 11 packs
No. of minimum tablets: 728 tablets
No. of minimum packs per batch: 26
Per tablet weight = 1200mg
Tablets/batch size = 29 packs x 28 tablet = 833 tablets
Batch size = 1 kg = 10,00,000 = 833 tablets
1200
24. Do you have complete record of The firm has complete record of production of stability batches.
production of stability batches? Starting from Raw Material manufacturing order sheet, line clearance,
necessary log books of equipment used has been available with the
firm, assuring the traceability of manufacturing and analysis of all the
three stability batches.
25. Do you have protocols for The firm has controlled protocol and records/reports of testing of
stability testing of stability stability batches at 30 Co + 2 Co & 65 % RH + 5 % with them for real
batches? time studies and at 40 Co + 2 Co & 75 % RH + 5 % for accelerated
studies.
26. Do you have developed and The firm has used manufacturer’s method of testing of API in their
validated the method for testing stability studies of their finished product (Tablets). The firm has also
of stability batches? submitted a report verifying the validation studies of the analytical
method derived from the method provided by the API manufacturer.
The validation studies covers following parameters of validation:
i. Specificity
ii. Linearity and Range
iii. Accuracy and Recovery
iv. Precision
a. Repeatability
v. Ruggedness
vi. Robustness
27. Do you have method transfer The firm has not conducted method transfer studies. According to the
studies in case when the method firm since no method transfer studies have been received from the API
of testing being used by your firm manufacturer, hence method transfer studies are not required. This
is given by any other lab? statement of firm indicates that they do not have concept of Method
Transfer Studies.
28. Do you have documents The firm has documents confirming the qualification of equipment /
confirming the qualification of instruments being used in the test and analysis of APIs and the
equipments / instruments being finished drug.
used in the test and analysis of
APIs and the finished drug
29. Do your method of analysis The firm method of testing is stability indicating for stability testing of
stability indicating? their finished product, as supported by forced degradation studies
submitted by the firm.
30. Do your HPLC software is Firm has 1 HPLC dedicated for R&D testing and is 21 CFR II
21CFR compliant? compliant. This HPLC system is used for stability studies of Sofovir-
V 400mg/100mg Tablets. The HPLC used for the stability studies is
21CFR compliant. However, the record from logbooks, analytical test
reports was randomly found verifiable onsite. A complete trail of such
testing was available and verifiable.
31. Can you show Audit Trail reports Audit trail on the testing reports are available.
on Sofovir-V Tablet testing?
32. Do you have some remaining The firm has remaining quantities of stability batches as per following
quantities of degradation products details:
and stability batches? NPD701 (T-01) 2 packs
NPD701 (T-02) 3 Packs
NPD701 (T-03) 3 Packs
However, there is no degradation product left.
33. Do you have stability batches The firm has completed the accelerated stability testing on the three
kept on stability testing? stability batches of Sofovir 400/100mg tablets. Also the firm has
completed the real time stability testing up to 12 months on all three
batches with satisfactory results.
34. Do you have valid calibration The firm has valid calibration status for the equipments used in
status for the equipment’s used in Sofovir 400/100mg tablets production and analysis as per record
production in analysis? available during onsite visit.
35. Do proper and continuous Continuous power supply and monitoring with back up from generator
monitoring and control are are available for stability chamber to address the problem of
available for stability chamber? interrupted power supply or load shedding. Digital data loggers are
available for continuous monitoring for stability chamber.
36. Do related manufacturing area, The related manufacturing area, equipment, personnel and utilities are
equipment, personnel and utilities rated as GMP compliant.
be rated as GMP compliant?
Conclusions & Recommendations:

1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Sofovir-V 400mg/100mg Tablets is verifiable to a satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and suitable for the
manufacturing of Sofovir-V 400mg/100mg Tablets, therefore, the panel recommends the registration of
Sofovir-V 400mg/100mg Tablets in the name of the manufacturer.
Decision: Registration Board decided to approve registration of “Sofovir-V by M/s Vision
Pharmaceuticals, Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad.. Manufacturer will place
first three production batches of product on long term stability studies throughout proposed shelf life
and on accelerated studies for six months.
861. Assessment and confirmation of manufacturing capacity of M/s Bio Labs (Pvt.)
Ltd, Islamabad
Following report on assessment and confirmation of manufacturing capacity of M/s Bio Labs
(Pvt.) Ltd, Islamabad was presented in 284th meeting of Registration Board:
Reference No: No. F.13-11/2017-PEC dated 23rd May, 2018.

Inspection Date: 12th July, 2018
Background:
Registration Board in its different meeting considered registration application of drugs
applied by various firms to be manufactured on contact by M/s Bio- Labs (Pvt) Ltd, Plot #
145, Industrial Triangle, Kahuta Road, Islamabad. The Board deferred the applications for
assessment and confirmation of manufacturing capacity of M/s Bio-labs by panel to be
constituted by Chairman Registration Board for further granting contract manufacturing
permission as the firm has already been granted approval for contract manufacturing of
numerous products.
The Chairman Registration Board approved the following panel for aforesaid purpose.
1. Mr. Abdullah, Additional Director, PE&R Division, DRAP Islamabad.
2. Mrs. Tehreem Sara, Deputy Director RRR, PE&R Division, DRAP Islamabad
3. Mr. Asif Jalil, In-charge PEC, P.E. & R Division, DRAP, Islamabad
The scope of inspection was assessment and confirmation of manufacturing capacity of M/s
Bio-labs for following 3 sections:
1. Dry vial (Cephalosporin)
2. Ampoule (General)
3. Infusion (non-antibiotic and antibiotic)
For Lyophilized Vial (General) section, the firm has informed in writing that section is
not ready for inspection due to ongoing upgradation activities as per approved layout. The
firm further requested to hold the toll products which are under registration for this section
till section is ready. Therefore inspection for capacity determination for this section was not
conducted. As per GMP Certificate issued to the firm on 04-01-2018, in addition to aforesaid
sections, firm also has section of Tablet (Non-antibiotic, Antibiotic and Psychotropic),
Capsule (Non-antibiotic, Antibiotic and Cephalosporin), Dry Powder Suspension (Non-
antibiotic, Antibiotic and Cephalosporin), Syrup (non-antibiotic), cream ointment (Non-
antibiotic, Antibiotic and Steroidal), oral powder veterinary (Non-antibiotic and Antibiotic),
oral liquid veterinary (Non-antibiotic and Antibiotic) and oral powder Penicillin (B-Lactum
antibiotic).
Data of manufacturing including Data from SAP software (Systems Applications and
Products in Data Processing) was evaluated from July-2017 to June-2018 (1 year) for the said
purpose. The details of capacity calculations are as under:
Registered Products
Biolabs products registered (human) 448

Biolabs Products registered (Veterinary) 140
Products on Contract from Biolabs 174
SECTION WISE CAPACITY CALCULATION
A. CAPACITY OF DRY VIAL (CEPHALOSPORIN) INJECTION SECTION
BIO -Labs BIO -Labs Pending Contract Products Contract products Pending
Registrations applications Registrations applications
16 1 84 38
STEP WISE CAPACITY OF EACH PROCESS

Capacity Capacity - Capacity Capacity - Capacit Capacity - Capacity – Capacity -
- Washing – Dry heat Dry heat y- Filling per Blistering/ Blistering per
Washing per month sterilizatio sterilizatio Filling Month with packing Month with
of vials with single n - Single n per (per single shift per hour Single shift of
(per shift of 8 shift month hour) of 8 hours 8 hours (23
hour) hours (23 (Load per Single (23 working working Days)
working Day) Shift (23 Days)
Days) working
Days)
6,000 1,104,000 40,000 920,000 7,000 1,288,000 9,000 1,656,000
Capacity calculated with respect to the Dry heat sterilization being capacity limiting step
QUARTER WISE CAPACITY UTILIZED (2017/2018)

Quarter Actual Production Capacity Capacity utilized in %
3rd-2017 1,314,630 2,760,000 47.63
4th-2017 1,504,252 2,760,000 54.50
1st-2018 1,327,878 2,760,000 48.11
2nd-2018 1,286,389 2,760,000 46.60
Average Capacity Utilized for 2017-2018 in % 49.21
Manufacturing Capacity Utilized (average) : 49.21%

Manufacturing Capacity Available (average) : 50.78%
However the Cephalosporin production facility is dedicated and it has 3 sections (Dry
vial, Dry suspension and capsule) with one common de-dusting area, quarantine area, Raw
material store and in-process store. The panel observed that space of de-dusting area,
quarantine area, Raw material store and in-process store was fully occupied and already
congested. Temperature and humidity were not controlled and Good Manufacturing Practices
/Good Storage Practices were not upto satisfactory level.
B. CAPACITY OF AMPOULE (GENERAL)) SECTION
BIO -Labs BIO -Labs Pending Contract products Contract products Pending
26 2 29 49

Capacity Capacity - Capacity – Capacity - Capacity Capacity - Capacity – Capacity -
- Washing per Dry heat Dry heat - Filling Filling per Blistering/ Blistering per
Washing month with sterilization - sterilization (per Month with packing Month with Single
(per hour)single shift of Single shift per month hour) single shift of per hour shift of 8 hours (23
8 hours (23 (Load per (23 working 8 hours working Days)
working Day) Days) (23 working
Days) Days)
7,000 1,288,000 45,000 1,035,000 7,000 1,288,000 7,000 1,288,000
QUARTER WISE CAPACITY UTILIZED (2017-2018)

3rd-2017 140,611 3,105,000 4.52
4th-2017 167,579 3,105,000 5.39
1st-2018 261,400 3,105,000 8.41
2nd-2018 290,457 3,105,000 9.35

C. CAPACITY OF INFUSION (NON-ANTIBIOTIC AND ANTIBIOTIC)

SECTION
BIO -Labs BIO -Labs Pending Contract products Contract products Pending
10 0 8 21

Capacity - Capacity - Capacity – Capacity - Dry Capacity - Capacity - Filling per
Washing Washing per Dry heat heat sterilization Filling Month with single shift
(per hour) month with sterilization per month (per hour) of 8 hours (23
single shift of 8 - Single shift Single Shift (23 working Days)
hours (23 (Load per working Days)
working Days) Day)
1,000 184,000 2,400 55,200 1,000 184,000
QUARTER WISE CAPACITY UTILIZED (2017-2018)
3-2017 11,305 165,600 6.82
4-2017 21,454 165,600 12.95
1-2018 56,110 165,600 33.88
2-2018 38,578 165,600 23.29

CAPACITY OF QUALITY CONTROL DEPARTMENT
Quality Control Equipment Details
S.No Equipment Quantity Capacity per day

1 HPLC 3 6
2 Spectrophotometer 1 20
3 pH Meter 1 50
4 FTIR 1 50
5 Polarimeter 1 15
6 Karl Ficsher 1 20
7 Dissolution 2 10
8 Balance 1 50
9 Moisture Analyzer 1 20
10 Melting Point Apparatus 1 20
11 Viscometer 1 20
12 Incubator 2 100
13 Filtration assembly 2 6
HPLC Capacity Calculation Quarter Wise

(Average 2 tests/day/HPLC)
TOTAL 3 HPLC
Capacity Capacity
QUARTER Average Capacity of 3 HPLCs Performed Utilized % Available %
III/2017 414 142 34.29% 65.71%
IV/2017 414 99 23.91% 76.09%
I/2018 414 111 26.81% 73.19%
II/2018 414 107 25.84% 74.16%
Average capacity Available: 72.29%
UV Spectrophotometer Capacity Calculation Quarter Wise

(Average 20 tests/day)
Capacity Utilized Capacity

Descritpion Capacity Performed % Available %
III/2017 1380 592 42.89% 57.11%
IV/2017 1380 752 54.49% 45.51%
I/2018 1380 800 57.97% 42.03%
II/2018 1380 741 53.69% 46.31%
Average capacity Available: 47.74%
Capacity Calculation for sterility testing Quarter Wise

Description Capacity Test Capacity Utilized % Capacity Available %

Performed
III/2017 414 254 61.35% 38.65%
IV/2017 414 234 56.52% 43.48%
I/2018 414 305 73.67% 26.32%
II/2018 414 251 60.62% 39.38%
Average capacity available: 36.96%
Capacity Calculation for Bacterial Endotoxin Test Quarter Wise
Description Capacity Test Performed Capacity Utilized % Capacity Available %
III/2017 690 314 45.50% 54.49%
IV/2017 690 330 47.82% 52.17%
I/2018 690 439 63.62% 36.37%
I/2018 690 403 58.40% 41.59%
Average capacity available: 46.15%
CONCLUSION:
Manufacturing capacity utilized and available for following 3 sections and QC capacity
utilized and available of the firm is summarized as follow:
1. Dry vial (Cephalosporin):
BIO -Labs BIO -Labs Pending Contract Products Contract products
Registrations applications Registrations Pending applications
16 1 84 38

However, the Cephalosporin production facility is dedicated and it has 3 sections (Dry
vial, Dry suspension and capsule) with one common de-dusting area, quarantine area, Raw
material store and in-process store. The panel observed that space of de-dusting area,
quarantine area, Raw material store and in-process store was fully occupied and already
congested. Temperature and humidity were not controlled and Good Manufacturing Practices
/Good Storage Practices were not upto satisfactory level.
2. Ampoule (General):
BIO -Labs BIO -Labs Pending Contract products Contract products
26 2 29 49
3. Infusion (non-antibiotic and antibiotic):
BIO -Labs BIO -Labs Pending Contract products Contract products

10 0 8 21

4. QC Department:
HPLC Average capacity Available: 72.29%

UV SPECTROPHOTOMETER Average capacity Available:
47.74%
STERILITY TESTING Average capacity Available: 36.96%
BACTERIAL ENDOTOXIN TESTING Average capacity Available: 46.15%
Decision:
Registration Board discussed the inspection report in details. Deliberations were made
on used and available capacity keeping in view registered product, currently applied
products and future products. After thorough deliberation, the Board decided to defer
all applied products of Cephalosporin facility, Ampoule general section and infusion
(Non-Antibiotic and Antibiotic) section. The board further directed the firm to
enhance its manufacturing capacity especially of cephalosporin facility and Quality
Control & microbiology.
Firm’s Response: Firm has submitted as under:

“We have purchased additional incubators (both hot and cool incubators). The incubators
have been delivered in the lab. By the purchase of these incubators, the incubation capacity of
batches has been increased. This will suffix our future requirements.”
Three head filtration assembly as per capacity enhancement requirement. By the purchase of
the assembly, the filtration capacity has been increased. This will suffix our future
requirements
Firm has submitted following documents in support:
i. Copy of invoice from M/s Western Instruments, Lahore” in the name of M/s Bio-labs,
Islamabad” dated 28-08-2018, mentioning the description and price of a Hot incubator
(Capacity 108 Ltr.) & a Cooled Incubator (Capacity 126 Ltr.).
ii. Copy of inward gate pass of M/s Bio-Labs, Islamabad dated 30-08-2018, for the Cool
& Hot incubators.
iii. Pictures of Incubators titled as “New Cool Incubator” & “Hot Incubator (New)”.
iv. Product specification for Hot incubator from M/s Memmert & Instruction manual for
Cool incubator form M/s Sanyo.
v. Copy of invoice from M/s Western Instruments, Lahore” in the name of M/s Bio-labs,
Islamabad” dated 10-09-2018, mentioning the description and price of Filtration
Assembly 3 station.
Decision: Keeping in view above status, Registration Board did not allow the
contract manufacturing in Dry Vial (General) section till capacity
assessment and Dry vial (Cephalosporin) till capacity enhancement
however the Board allowed contract manufacturing for Infusion (non-
antibiotic and antibiotic) and Ampoule (General) section.
d. Exemption from onsite verification of stability data
Evaluator PEC-III
Sr. Name & Brand Name Type of Form, International Availability / Local
No. Address of (Proprietary Name + Initial Diary & Availability
Manufacturer / Dosage Form + Date, Fee
Applicant Strength), Composition, (including GMP Inspection Report Date &
Pharmacological Group, differential fee), Remarks
Finished Product Demanded Price /
Specification Pack size
862. M/s Saffron Viraldi Tablet Form 5-D Harvoni, FDA
Pharmaceutical Each tablet contains:- Dairy No.185
(Pvt) Ltd. 19 Sofosbuvir……400mg dated 07-12-2015 Last inspection report 13-10-2017:
Km Ledipasvir…….90mg Rs.50,000/- Panel recommends renewal of DML
Sheikhupura (HCV NS5A Inhibitor 30’s
Road, and Nucleotide analog Rs.60,000/-
Faisalabad. inhibitor of Hcv NS5B
Polymerase.)
Decision of previous meeting (M-260):
The case was deferred in 260th meeting of Registration Board for submission of stability study data
and rectification of shortcoming.
The firm has submitted stability study data along with required documents as per checklist approved
in 251st meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 24716 dated 17-7-2018)
Drug Viraldi Tablet
Name of Manufacturer M/s Saffron Pharmaceutical Faisalabad.
Manufacturer of API Sofosbuvir: Ruyuan HEC Pharm Co. Ltd, Xiaba Development Zone, Ruyuan
country, Shaoguan City, Guandong Province, China
Ledipasvir: Ruyuan HEC Pharm Co. Ltd, Xiaba Development Zone, Ruyuan
country, Shaoguan City, Guandong Province, China
API Lot No. Sofosbuvir: YAK-201603002 (2Kg), YAK-RD201608202 (5Kg)
Ledipasvir: YAXII-201612002 (1Kg), HCS16254-28 (0.6Kg)
Description of Pack
(Container closure
system)
Stability Storage Real time : 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0, 1, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. T-004 T-005 T-006

No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate of M/s
country of origin or GMP certificate of Ruyuan HEC Pharm Co Ltd. Issued by Shaoguan Food
API manufacturer issued by regulatory and Drug Administration China dated 15-01-2016.
authority of country of origin. This GMP certificate is not issued by relevant
regulatory authority.
The GMP inspection of the firm was conducted by
USFDA on 09/11/15 and overall conclusion was NAI
(No action Indicated). The inspection report is
available online at the FDA database
(https://www.accessdata.fda.gov/scripts/inspsearch/)
accesed on: 12-10-2018
Yes
Yes
sheets etc.
5. Documents confirming import of API etc. Sofosbuvir:
 Firm has submitted copy of ADC attested invoice
confirming import of 2 Kg Sofosbuvir from WIS
Pharmatech. The invoice was cleared on 08-04-
2016. The invoice do not contain details of the
manufacturer of API, batch number, mfg date and
expiry date of API. Firm has submitted unattested
copy of Form 3 and Form 7 which contains batch
number, mfg and expiry date.
 Firm has also submitted copy of ADC attested
invoice confirming import of 5 Kg Sofosbuvir from
WIS Pharmatech. The invoice was cleared on 15-
01-2017. The invoice do not contain details of the
manufacturer of API, batch number, mfg date and
expiry date of API. Firm has submitted unattested
copy of Form 3 and Form 7 which contains batch
number, mfg and expiry date.
Ledipasvir:
 Firm has submitted copy of ADC attested invoice
confirming import of 0.6 Kg Ledipasvir and
copovidone solid dispersion from WIS Pharmatech.
The invoice was cleared on 08-04-2016. The
invoice do not contain details of the manufacturer of
API, batch number, mfg date and expiry date of
API. Firm has submitted unattested copy of Form 3
and Form 7 which contains batch number, mfg and
expiry date.
 Firm has also submitted copy of ADC attested
invoice confirming import of 1 Kg Ledipasvir and
copovidone solid dispersion from WIS Pharmatech.
The invoice was cleared on 06-03-2017. The
invoice do not contain details of the manufacturer of
API, batch number, mfg date and expiry date of
API. Firm has submitted unattested copy of Form 3
and Form 7 which contains batch number, mfg and
expiry date.
Yes
Yes
Rules, 1978.
DATA FOR EXEMPTION FROM ONSITE INVESTIGATION OF SUBMITTED STABILITY
DATA
ADMINISTRATIVE PORTION
1. Reference of last Firm has referred to onsite inspection report of their product Saffaldi Tablet
onsite panel inspection 400mg (Sofosbuvir), which was conducted on 8th January, 2018 and was
for instant dosage form presented in 279th meeting of Registration Board held on 28th
conducted during last February-2nd March, 2018.
two years. Following two observations were reported in the report:
i. The HPLC software is 21CFR Compliant.
ii. Firm has shown all Audit trail reports.
iii. Adequate monitoring and control are available for stability chambers.
Data Loggers are also placed in stability chambers for monitoring
2. Documents for the Sofosbuvir:
procurement of API  Firm has submitted copy of ADC attested invoice confirming import of 2
with approval from Kg Sofosbuvir from WIS Pharmatech. The invoice was cleared on 08-04-
DRAP (in case of 2016. The invoice do not contain details of the manufacturer of API,
import). batch number, mfg date and expiry date of API. Firm has submitted
unattested copy of Form 3 and Form 7 which contains batch number, mfg
and expiry date.
 Firm has also submitted copy of ADC attested invoice confirming import
of 5 Kg Sofosbuvir from WIS Pharmatech. The invoice was cleared on
15-01-2017. The invoice do not contain details of the manufacturer of
API, batch number, mfg date and expiry date of API. Firm has submitted
unattested copy of Form 3 and Form 7 which contains batch number, mfg
and expiry date.
Ledipasvir:
 Firm has submitted copy of ADC attested invoice confirming import of
0.6 Kg Ledipasvir and copovidone solid dispersion from WIS
Pharmatech. The invoice was cleared on 08-04-2016. The invoice do not
contain details of the manufacturer of API, batch number, mfg date and
expiry date of API. Firm has submitted unattested copy of Form 3 and
Form 7 which contains batch number, mfg and expiry date.
 Firm has also submitted copy of ADC attested invoice confirming import
of 1 Kg Ledipasvir and copovidone solid dispersion from WIS
Pharmatech. The invoice was cleared on 06-03-2017. The invoice do not
contain details of the manufacturer of API, batch number, mfg date and
expiry date of API. Firm has submitted unattested copy of Form 3 and
Form 7 which contains batch number, mfg and expiry date.
3. Documents for the Firm has submitted airway bill and fedex invoice for procurement of
procurement of reference and impurity standard.
reference standard and
impurity standards.
4. Approval of API/ Firm has submitted copy of GMP certificate of M/s Ruyuan HEC Pharm Co
DML/GMP certificate Ltd. Issued by Shaoguan Food and Drug Administration China dated 15-01-
of API manufacturer 2016. This GMP certificate is not issued by relevant regulatory authority.
issued by regulatory The GMP inspection of the firm was conducted by USFDA on 09/11/15 and
authority of country of overall conclusion was NAI (No action Indicated). The inspection report is
origin. available online at the FDA database
(https://www.accessdata.fda.gov/scripts/inspsearch/) accesed on: 12-10-
2018.
5. Mechanism for Firm has submitted copy of SOPs for vendor qualification
Vendor pre-
qualification
6. Certificate of analysis Firm has submitted COA of API and reference standard. COA of impurity
of the API, reference standards are not provided.
standards and impurity
standards
7. Documents for the Firm has submitted documents for procurement of excipients.
procurement of
excipients used in
product development?
8. List of qualified staff Firm has provided list of technical staff of product development section.
involved in product
development with
relevant experience.
PRODUCTION DATA
9. Authorized Protocols/SOP Firm has submitted authorized general protocols/SOPs for the
for the development & development & testing of trial batches.
stability testing of trial
batches.
10. Complete batch Firm has provided Batch Manufacturing Record for all the three
manufacturing record of batches
three stability batches.
11. Record of remaining Firm has provided following remaining quantities for each batch
quantities of stability  T-004: 320 Tablets
batches.  T-005: 360 Tablets
 T-006: 364 Tablets
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of Digital data logger for temperature
temperature and humidity and humidity monitoring of stability chambers.
monitoring of stability chambers
(real time and accelerated)
13. Method used for analysis of API Firm has submitted COA and method of analysis of API.
along with COA.
14. Method used for analysis of FPP Firm has submitted method of analysis of FPP and complete
& complete record of testing of record of testing of stability batches along with chromatograms
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
15. Reports of stability studies of API Firm has submitted both accelerated (40°C ± 2°C & 75±5%RH)
from manufacturer. stability studies & long term (30°C ± 2°C & 65±5%RH) stability
studies reports of three batches.
16. Analysis reports for excipients Firm has submitted analysis reports for all excipients used.
used.
17. Drug-excipients compatibility Firm has submitted drug excipient compatibility studies by
studies. mixing both API with all excipients and then determination of %
content by HPLC.
18. Record of comparative  Firm has submitted data of comparative dissolution profile at
dissolution data. pH 1.2, 4.5 and 6.8.and calculated values of f2 which were
within accepted range
19. Compliance Record of HPLC Firm has submitted audit trail reports for HPLC analysis for all
software 21CFR & audit trail the three batches.
reports on product testing.
Evaluation by PEC:
Shortcomings communicated Response by the firm
Justify the use of primojel and sodium lauryl Disintegration and dissolution of our initial trial
sulphate since the reference product approved by was not satisfactory therefore primojel and SLS
USFDA has not used any of these excipient. were used in the product. Also compatibility
Further the use of primojel as specified in studies has been performed with these excipients
“Handbook of Pharmaceutical Excipient” is and the data has been provided showing there is
disintegrant in tablets prepared by either direct no incompatibility between these excipients and
compression or wet granulation, while the applied API
formulation has been prepared by dry granulation
/ slugging method.
Justify the time gap between final mixing after
R&D development activity are dependent on
slugging (performed on 28-07-2018) and finalproduction department for the use of equipments
compression (performed on 22-8-2017) for Batch
which in case cause delay in availability of
T-006. compression machine, hence there is a gap
between final mixing and final compression.
Justify the time gap between initial mixing R&D development activity are dependent on
(performed on 13-06-2017) and slugging production department for the use of equipments
(performed on 04-07-2017) for Batch T-005. which in case cause delay in availability of
compression machine, hence there is a gap
between initial mixing and slugging.
Decision: Registration Board decided to approve registration of “Viraldi Tablet (Sofosbuvir
400mg, Ledipasvir 90mg)” with Innovator’s specifications by M/s Saffron Pharmaceutical (Pvt)
Ltd. 19 Km Sheikhupura Road, Faisalabad. Manufacturer will place first three production batches
of both products on long term stability studies throughout proposed shelf life and on accelerated
studies for six months.
863. M/s Helix Nesrina Tablets Form 5-D Nesina Tablets by Takeda Pharma
Pharma (Pvt) 6.25mg (DUPLICATE (USFDA Approved)
Ltd., A-56 Each film coated tablet DOSSIER) Last inspection dated 24-9-2018
S.I.T.E., contains: PKR 15,000/- confirms that the firm is found
Manghopir Alogliptin benzoate eq (07-09-2011) satisfactory and compliant as per
Road, Karachi to Alogliptin….6.25mg (DUPLICATE) GMP guidelines
+ PKR 35,000/-
(09-11-2018)
(Dy.# 32253 dated 27-9-2018)
Drug Nesrina Tablets 6.25mg
Name of Manufacturer M/s Helix Pharma (Pvt) Ltd., A-56 S.I.T.E., Manghopir Road, Karachi
Manufacturer of API Wisdom Pharmaceutical Co. Ltd. No. 18 Qinghua Road, Sanchang, Haimen,
Jiangsu, China.
API Lot No. PAGLT160601A
Description of Pack
(Container closure 1x10’s: Alu-Alu blister pack
system)
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. TF 001 TF 002 TF 003

No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate issued by
country of origin or GMP certificate of CFDA China which was valid till 28-01-2018.
API manufacturer issued by regulatory The submitted GMP certificate is verifiable from sfda
authority of country of origin. website but with different name of manufacturer i.e.
Haimen Huiju Pharmaceutical Co., Ltd.
Yes
Yes
sheets etc.
5. Documents confirming import of API etc.  Firm has submitted copy of Form 6 (License to
import drugs for clinical trial examination) dated 05-
12-2017 for import of 250g alogliptin.
 Firm has also submitted ADC attested copy of
invoice confirming import of 250g alogliptin
benzoate dated 05-12-2017.
Yes
Yes
Rules, 1978.
DATA
1. Reference of last onsite panel inspection for Firm has referred to last onsite inspection of their
instant dosage form conducted during last product RAMELTON Tablets 8mg (Ramelteon)
two years. which was considered and approved by Registration
Board in its 273rd Meeting with following details:
 Date of Inspection: 18-08-2017.
 The HPLC is 21CFR Compliant.
 Audit trail on the testing reports of ―Ramelton
(Ramelteon) Tablets 8mg were available.
2. Documents for the procurement of API with  Firm has submitted copy of Form 6 (License to
approval from DRAP (in case of import). import drugs for clinical trial examination) dated
05-12-2017 for import of 250g alogliptin.
3. Documents for the procurement of reference Firm has submitted analytical reports and COA of
standard and impurity standards. reference standard and impurity standards.
The analytical reports generated by Helix Pharma are
based on tests conducted on 01-11-2017 while the
API was cleared on 05-12-2017
4. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate issued by
API manufacturer issued by regulatory CFDA China which was valid till 28-01-2018.
authority of country of origin. The submitted GMP certificate is verifiable from sfda
website but with different name of manufacturer i.e.
5. Mechanism for Vendor pre-qualification Firm has submitted blank copy of vendor evaluation
questionnaire.
6. Certificate of analysis of the API, reference Firm has submitted COA of API and reference
standards and impurity standards standard. COA of impurity standards are not
provided.
7. Documents for the procurement of excipients Firm has submitted documents for procurement of
used in product development? excipients.
8. List of qualified staff involved in product Firm has provided list of technical staff of product
development with relevant experience. development section.
PRODUCTION DATA
9. Authorized Protocols/SOP for the Firm has submitted authorized general
development & stability testing of trial protocols/SOPs for the development & testing of trial
batches. batches.
10. Complete batch manufacturing record of Firm has provided Batch Manufacturing Record for
three stability batches. all the three batches
11. Record of remaining quantities of stability Firm has provided following remaining quantities for
batches. each batch
 TF 001: 190 Tablets
QA/QC DATA
12. Record of Digital data logger for temperature Firm has submitted record of Digital data logger for
and humidity monitoring of stability temperature and humidity monitoring of stability
chambers (real time and accelerated) chambers.
13. Method used for analysis of API along with Firm has submitted COA and method of analysis of
COA. API.
14. Method used for analysis of FPP & complete Firm has submitted method of analysis of FPP and
record of testing of stability batches (i.e. complete record of testing of stability batches along
chromatograms, lab reports, raw data sheets with chromatograms
etc.)
15. Reports of stability studies of API from Firm has submitted both accelerated (40°C ± 2°C &
manufacturer. 75±5%RH) stability studies & long term (25°C ± 2°C
& 60±5%RH) stability studies reports of three
batches.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients
used.
17. Drug-excipients compatibility studies. Firm has submitted that their formulation is as per
reference product so they do not require drug
excipient compatibility studies.
18. Record of comparative dissolution data.  Firm has submitted data of comparative dissolution
profile at pH 1.2 HCl solution, 4.5 acetate buffer,
6.8.phosphate buffer and 0.01N HCl and calculated
difference of % release with innovator product but
did not calculated values of f2.
19. Compliance Record of HPLC software Firm has submitted audit trail reports for HPLC
21CFR & audit trail reports on product analysis for all the three batches.
testing.
Evaluation by PEC:
 The submitted GMP certificate by the firm could not be verified from the sfda website. The same
certificate number contains different name of manufacturer i.e. Haimen Huiju Pharmaceutical Co.,
Ltd. Upon verification from the website of Wisdom Pharmaceuticals corporate history
(http://www.wisdompharma.com/milestone.html accessed on 06-11-2018) it was determined that the
name of the firm was changed to Haimen Huiju Pharmaceutical Co., Ltd. in October 2002. The
documents including GMP certificate, COA, ADC attested invoice all are issued on latest dates with
the name of Wisdom Pharmaceuticals.
 The analytical reports generated by Helix Pharma are based on tests conducted on 01-11-2017 while
the API was cleared on 05-12-2017. The firm informed that they have procured small quantity of the
API for vendor prequalification and that quantity was used for testing and development of working
standard. The quantity of API tested on 01-11-2017 is 250gm which is the exact quantity imported on
05-12-2017.
 Firm has submitted comparative dissolution profile data at 1.2 pH HCl solution, 4.5 pH acetate
buffer, 6.8pH phosphate buffer and 0.01 N HCl solution, while as per FDA guidance for industry
“Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral
Dosage Forms Based on a Biopharmaceutics Classification System” the Dissolution testing should be
carried out in following dissolution media: (1) 0.1 N HCl or Simulated Gastric Fluid USP without
enzymes; (2) a pH 4.5 buffer; and (3) a pH 6.8 buffer or Simulated Intestinal Fluid USP without
enzymes.
 Stability study data of API is not as per the requirements of Zone IV-A.
Decision: Deferred for following submission:
 Stability study data of 3 batches of the API as per the requirements of Zone IV-A.
 Clarification is required since the GMP certificate of M/s Wisdom Pharmaceuticals was
submitted while as per the sfda database the same GMP certificate was issued to M/s
864. M/s Helix Nesrina Tablets Form 5-D Nesina Tablets by Takeda Pharma
Pharma (Pvt) 12.5mg (DUPLICATE (USFDA Approved)
Ltd., A-56 Each film coated tablet DOSSIER) Last inspection dated 24-9-2018
S.I.T.E., contains: PKR 15,000/- confirms that the firm is found
Manghopir Alogliptin benzoate eq (07-09-2011) satisfactory and compliant as per
Road, Karachi to Alogliptin….12.5mg (DUPLICATE) GMP guidelines
+ PKR 35,000/-
(09-11-2018)
(Dy.# 32254 dated 27-9-2018)
Drug Nesrina Tablets 12.5mg
Jiangsu, China.
Description of Pack
system)
Frequency Accelerated: 0, 3, 6 (Months)
No. of Batches 03
1. COA of API Yes
Yes
Yes
sheets etc.
Yes
Yes
Rules, 1978.
DATA
questionnaire.
provided.
PRODUCTION DATA
batches. batches.
batches. each batch
QA/QC DATA
COA. API.
etc.)
batches.
used.
 Firm has submitted data of comparative dissolution
18. Record of comparative dissolution data.
testing.
Evaluation by PEC:
05-12-2017.
enzymes.
865. M/s Helix Nesrina Tablets 25mg Form 5-D Nesina Tablets by Takeda Pharma
Pharma (Pvt) Each film coated tablet (DUPLICATE (USFDA Approved)
Ltd., A-56 contains: DOSSIER) Last inspection dated 24-9-2018
S.I.T.E., Alogliptin benzoate eq PKR 15,000/- confirms that the firm is found
Manghopir to Alogliptin….25mg (07-09-2011) satisfactory and compliant as per
Road, Karachi (DUPLICATE) GMP guidelines
+
PKR 35,000/-
(09-11-2018)
(Dy.# 32255 dated 27-9-2018)
Drug Nesrina Tablets 25mg
Jiangsu, China.
Description of Pack
system)
No. of Batches 03
1. COA of API Yes
Yes
Yes
sheets etc.
Yes
Yes
Rules, 1978.
DATA
questionnaire.
provided.
PRODUCTION DATA
batches. batches.
batches. each batch
QA/QC DATA
COA. API.
etc.)
batches.
used.
18. Record of comparative dissolution data.  Firm has submitted data of comparative dissolution
testing.
Evaluation by PEC:
05-12-2017.
enzymes.
Group, / Pack size
Finished Product
Specification
866. M/s Hilton Pharma Obehil Tablet 5mg Form 5-D Ocaliva Tablets by Intercept
(Pvt) Ltd., Plot 13 Dy No. 1278 Pharms INC (USFDA Approved)
& 14, Sector 15, Each film coated 22-9-2016
Korangi Industrial tablet contains: PKR 50,000/- Product specific inspection for
Area, Karachi Obeticholic 21-9-2016 Sofosbuvir/velpatasvir tablet
acid…5mg 10’s, 20’s, 30’s: conducted on 14-12-2017
As per SRO
(Dy.# 35263 dated 24-10-2018)
Drug Obehil Tablet 5mg
Name of Manufacturer M/s Hilton Pharma (Pvt) Ltd., Plot 13 & 14, Sector 15, Korangi
Industrial Area, Karachi
Manufacturer of API Virupaksha Organics Limited, Unit 1 Sy No. 10 Gaddapotharam Vi
Jinnaram, Medak District, Telangana India.
API Lot No. AOBTC0217003
Description of Pack
Tablet blistered in alu-alu foil
Batch No. OBE-252310-6 OBE-252510-7 OBE-252610-8
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate
country of origin or GMP certificate of API issued dated 07-08-2018of M/s Virupaksha
manufacturer issued by regulatory authority of Organics Ltd., Telangana state, India issued by
country of origin. Drugs Control Administration Government of
Telangana.
Yes
Yes
chromatograms, laboratory reports, data sheets
etc.
5. Documents confirming import of API etc. Firm has submitted copy of ADC attested invoice
dated 05-09-2017 confirming import of 250g
obeticholic acid from M/s Virupaksha Organics
Limited, Telangana India.
Yes
Rules, 1978.
DATA
20. Reference of last onsite panel Firm has referred to last onsite inspection of their product
inspection for instant dosage form HILVEL Tablets (Sofosbuvir / Velpatasvir) which was
conducted during last two years. considered and approved by Registration Board in its 277th
Meeting with following details:
 Audit trail on the testing reports were available.
1. Documents for the procurement of Firm has submitted copy of ADC attested invoice dated 05-
API with approval from DRAP (in 09-2017 confirming import of 250g obeticholic acid from
case of import). M/s Virupaksha Organics Limited, Telangana India.
2. Documents for the procurement of Firm has submitted copy of invoice of purchase of
reference standard and impurity impurities standard from Morgan Chemicals.
standards.
3. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate issued dated
certificate of API manufacturer issued 07-08-2018of M/s Virupaksha Organics Ltd., Telangana
by regulatory authority of country of state, India issued by Drugs Control Administration
origin. Government of Telangana.
4. Mechanism for Vendor pre- Firm has submitted copy of vendor’s audit form and SOPs
qualification for selection of vendor.
5. Certificate of analysis of the API, Firm has submitted COA of API, reference standard and
reference standards and impurity impurity standards.
standards
6. Documents for the procurement of Firm has submitted documents for procurement of
excipients used in product excipients.
development?
7. List of qualified staff involved in Firm has provided list of technical staff of product
product development with relevant development section.
experience.
PRODUCTION DATA
8. Authorized Protocols/SOP for the Firm has submitted authorized general protocols/SOPs for
development & stability testing of trial the development & testing of trial batches.
batches.
9. Complete batch manufacturing record Firm has provided Batch Manufacturing Record for all the
of three stability batches. three batches
10. Record of remaining quantities of Firm has provided following remaining quantities for each
stability batches. batch
 OBE-252310-6: 110 Tablets
 OBE-252510-7: 110 Tablets
 OBE-252610-8: 110 Tablets
QA/QC DATA
11. Record of Digital data logger for Firm has submitted record of Digital data logger for
temperature and humidity monitoring temperature and humidity monitoring of stability
of stability chambers (real time and chambers.
accelerated)
12. Method used for analysis of API along Firm has submitted COA and method of analysis of API.
with COA.
13. Method used for analysis of FPP & Firm has submitted method of analysis of FPP and
complete record of testing of stability complete record of testing of stability batches along with
batches (i.e. chromatograms, lab chromatograms
reports, raw data sheets etc.)
14. Reports of stability studies of API Firm has submitted both accelerated (40°C ± 2°C &
from manufacturer. 75±5%RH) stability studies & long term (30°C ± 2°C &
65±5%RH) stability studies reports of three batches. The
real time stability data of all the three batches are of 6
months only.
15. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used.
reference product so they do not require drug excipient
compatibility studies.
17. Record of comparative dissolution  Firm has submitted data of comparative dissolution
data. profile at pH 1.2 buffer, 4.5 buffer, 6.8.phosphate buffer
and calculated difference of % release with innovator
product and also calculated f2 factor at pH 4.5 buffer
while in other mediums the dissolution release was above
85%.
18. Compliance Record of HPLC software Firm has submitted audit trail reports for HPLC analysis
21CFR & audit trail reports on product for all the three batches.
testing.
Evaluation by PEC:
 The submitted dissolution parameters are different from those recommended in the review of
innovator product of USFDA.
Parameter Submitted by the firm Recommended by USFDA

Acceptance criteria NLT 85% in 45 minutes NLT 85% in 15 minutes
Volume of dissolution medium 500ml 900ml
 The submitted real time stability study data of API is only for 6 months.
Decision: Registration Board deferred the case and advised the firm to perform
dissolution testing using FDA recommended dissolution parameters using 900ml
dissolution medium and acceptance criteria “NLT 85% in 15 minutes”.
Group, / Pack size
Finished Product
Specification
867. M/s Hilton Pharma Obehil Tablet 10mg Form 5-D Ocaliva Tablets by Intercept
(Pvt) Ltd., Plot 13 Dy No. 1280 Pharms INC
& 14, Sector 15, Each film coated 22-9-2016 (USFDA Approved)
Korangi Industrial tablet contains: PKR 50,000/-
Area, Karachi Obeticholic 21-9-2016 Product specific inspection for
acid...10mg 10’s, 20’s, 30’s: Sofosbuvir/velpatasvir tablet
As per SRO conducted on 14-12-2017
(Dy.# 35263 dated 24-10-2018)
Drug Obehil Tablet 10mg
Name of Manufacturer M/s Hilton Pharma (Pvt) Ltd., Plot 13 & 14, Sector 15, Korangi
Industrial Area, Karachi
Manufacturer of API Virupaksha Organics Limited, Unit 1 Sy No. 10 Gaddapotharam Vi
Jinnaram, Medak District, Telangana India.
API Lot No. AOBTC0217003
Description of Pack
Tablet blistered in alu-alu foil
Batch No. OBE-252410-9 OBE-252710-10 OBE-252810-11
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate
country of origin or GMP certificate of API issued dated 07-08-2018of M/s Virupaksha
manufacturer issued by regulatory authority of Organics Ltd., Telangana state, India issued by
country of origin. Drugs Control Administration Government of
Telangana.
Yes
Yes
etc.
5. Documents confirming import of API etc. Firm has submitted copy of ADC attested invoice
dated 05-09-2017 confirming import of 250g
obeticholic acid from M/s Virupaksha Organics
Limited, Telangana India.
Yes
Yes
Rules, 1978.
DATA
1. Reference of last onsite panel Firm has referred to last onsite inspection of their product
inspection for instant dosage form HILVEL Tablets (Sofosbuvir / Velpatasvir) which was
conducted during last two years. considered and approved by Registration Board in its 277th
Meeting with following details:
 Audit trail on the testing reports were available.
2. Documents for the procurement of Firm has submitted copy of ADC attested invoice dated 05-
API with approval from DRAP (in 09-2017 confirming import of 250g obeticholic acid from
case of import). M/s Virupaksha Organics Limited, Telangana India.
3. Documents for the procurement of Firm has submitted copy of invoice of purchase of
reference standard and impurity impurities standard from Morgan Chemicals.
standards.
4. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate issued dated
certificate of API manufacturer issued 07-08-2018of M/s Virupaksha Organics Ltd., Telangana
by regulatory authority of country of state, India issued by Drugs Control Administration
origin. Government of Telangana.
5. Mechanism for Vendor pre- Firm has submitted copy of vendor’s audit form and SOPs
qualification for selection of vendor.
6. Certificate of analysis of the API, Firm has submitted COA of API, reference standard and
reference standards and impurity impurity standards.
standards
7. Documents for the procurement of Firm has submitted documents for procurement of
excipients used in product excipients.
development?
8. List of qualified staff involved in Firm has provided list of technical staff of product
experience.
PRODUCTION DATA
9. Authorized Protocols/SOP for the Firm has submitted authorized general protocols/SOPs for
development & stability testing of trial the development & testing of trial batches.
batches.
10. Complete batch manufacturing record Firm has provided Batch Manufacturing Record for all the
of three stability batches. three batches
11. Record of remaining quantities of Firm has provided following remaining quantities for each
stability batches. batch
 OBE-252410-9: 110 Tablets
 OBE-252710-10: 110 Tablets
 OBE-252810-11: 110 Tablets
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of Digital data logger for
temperature and humidity monitoring temperature and humidity monitoring of stability
of stability chambers (real time and chambers.
accelerated)
13. Method used for analysis of API along Firm has submitted COA and method of analysis of API.
with COA.
14. Method used for analysis of FPP & Firm has submitted method of analysis of FPP and
complete record of testing of stability complete record of testing of stability batches along with
batches (i.e. chromatograms, lab chromatograms
15. Reports of stability studies of API Firm has submitted both accelerated (40°C ± 2°C &
from manufacturer. 75±5%RH) stability studies & long term (30°C ± 2°C &
65±5%RH) stability studies reports of three batches. The
real time stability data of all the three batches are of 6
months only.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used.
reference product so they do not require drug excipient
18. Record of comparative dissolution  Firm has submitted data of comparative dissolution
data. profile at pH 1.2 buffer, 4.5 buffer, 6.8.phosphate buffer
and calculated difference of % release with innovator
product and also calculated f2 factor at pH 4.5 buffer
while in other mediums the dissolution release was above
85%.
19. Compliance Record of HPLC software Firm has submitted audit trail reports for HPLC analysis
21CFR & audit trail reports on product for all the three batches.
testing.
Evaluation by PEC:
 The submitted dissolution parameters are different from those recommended in the review of
innovator product of USFDA.
Parameter Submitted by the firm Recommended by USFDA
Acceptance criteria NLT 85% in 45 minutes NLT 85% in 15 minutes
Volume of dissolution medium 500ml 900ml
 The submitted real time stability study data of API is only for 6 months.
Decision: Registration Board deferred the case and advised the firm to perform dissolution testing
using FDA recommended dissolution parameters using 900ml dissolution medium and acceptance
criteria “NLT 85% in 15 minutes”.
Evaluator PEC-XII
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Fee Availability / Local
Applicant Dosage Form + (including differential Availability
Strength), fee),
Group,
Finished Product
Specification
868. M/s Genix Pharma EMPAG 10mg Form 5-D Jardiance tablet 10mg
(Pvt) Ltd. 44 45-B Tablets (Duplicate) by M/s Boehringer
Korangi Creek Road, Each film coated Dairy No. Ingelheim (USFDA
Karachi. tablet contain: dated 18-1-2016. Approved)
Empagliflozin…10mg Rs.50,000/- dated 12-
(Sodium-glucose co- 01-2016. Last inspection report
transporter 2 (SGLT2) (Challan#0548816) 8-8-2017 firm was
inhibitors) (Duplicate) considered to be
Manufacturer’s 7’s.., As per SRO operating at a
Specifications. 14’s.. As per SRO satisfactory level of
28’s. As per SRO compliance with GMP
276th meeting of Registration Board for exemption from “On site investigation of submitted stability
data”
Drug Empag 10mg Tablet
Name of Manufacturer M/s Genix Pharma (Pvt) Ltd.
44 45-B Korangi Creek Road, Karachi.
Manufacturer of API M/s Ruyuan HEC Pharm Co. Ltd, China.
API Lot No. EGLZ-RD20171101A
Description of Pack Alu/alu blister.
Real Time: 25°C ± 2°C & 60±5%RH
Time Period Accelerated: 6 months
Real Time: 6 months
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (months)
Real Time: 0, 3, 6 (months)
Batch No. 18SB-063-01 18SB-064-02 18SB-065-03
Manufacturing Date Feb 2018 Feb 2018 Feb 2018
No. of Batches 03
Sr. Documents to Be Provided Status
No.
1. COA of API  Certificate of analysis of the API and
working standard submitted by the firm.
2. Approval of API by regulatory authority of  Photocopy of GMP Certificate No. 2017029
country of origin or GMP certificate of API issued by Shaoguan Food and Drug
manufacturer issued by regulatory authority of Administration is submitted.
country of origin. Issued on: 22-01-2018
Valid till: 21-01-2019
Yes
5. Documents confirming import of API etc.  Firm has submitted commercial invoice for
the procurement of API detailed as under:
ADC attested copy dated 07-12-2017
confirming import of 0.75kg of
Empagliflozin.
Batch# Not mentioned in invoice.
Invoice no.WIS170152 (14-11-2017)
Manufactured by: Ruyuan Hec Pharm Co,.
Ltd.
Exporter: Wis Pharmtech Co,. Ltd.
Sample for research, development and trial
purpose only.
 Firm has submitted copy of declaration from
Wis Pharmtech Co,. Ltd. Dated 27-09-2018
stating that the API is manufactured by
Ruyuan Hec Pharm Co,. Ltd. With
batch#EGLZ-RD20171101A.
data / documents.
Yes
Rules, 1978. Yes
Data for exemption from On-site investigation of submitted stability data

Administrative Portion
1. Reference of last onsite panel inspection Firm has referred to onsite inspection report of their
for instant dosage form conducted during product “Wymly Tablets 25mg (Tenofovir
last two years. alafenamide)”, which was conducted on 9th April,
2018 and was presented in 281st meeting of
Registration board. Registration Board decided to
approve registration of Wymly Tablets 25mg
(Tenofovir alafenamide) by M/s. Genix
Pharmaceuticals (Pvt.) Ltd., Karachi.
 According to the report generated on 9th April,
2018 following points were confirmed
a) The firm has necessary equipment available in
product development section for development of
Wymly Tablets 25mg.
b) The HPLC software is 21CFR compliant and
having certificates of Compliance by USFDA
c) The firm has audit trail Reports on testing.
d) Adequate monitoring and control are available
for stability chamber. Chambers are controlled
and monitored through software 21CFR
compliance.
e) Related manufacturing area, equipment,
personnel and utilities can be rated as compliant
to minimum GMP standards.
2. Documents for the procurement of API  Firm has submitted commercial invoice for the
with approval from DRAP (in case of procurement of API detailed as under:
import). ADC attested copy dated 07-12-2017
confirming import of 0.75kg of Empagliflozin.
Invoice no.WIS170152 (14-11-2017)
Manufactured by: Ruyuan Hec Pharm Co,. Ltd.
purpose only.
stating that the API is manufactured by Ruyuan
Hec Pharm Co,. Ltd. With batch#EGLZ-
RD20171101A.
3. Documents for the procurement of  Firm has submitted copy of declaration from
reference standard and impurity manufacturer i.e. Ruyuan Hec Pharm Co,. Ltd.
standards. stating:
Ruyuan Hec Pharm Co,. Ltd herewith confirms
that we have submitted 2g Empagliflozin
working standard batch# EGLZ-WS201612101
to Genix Pharma (Pvt)Ltd.
4. Approval of API/ DML/GMP certificate  Photocopy of GMP Certificate No. 2017029
of API manufacturer issued by regulatory issued by Shaoguan Food and Drug
authority of country of origin. Administration is submitted.
Issued on: 22-01-2018
5. Mechanism for Vendor pre-qualification  Firm has submitted vendor evaluation form
which is filled by API manufacturer.
6. Certificate of analysis of the API,  Certificate of analysis of the API and working
reference standards and impurity standard e standards submitted by the firm.
standards  COA of impurity standard not submitted by the
firm.
7. Documents for the procurement of  Firm has submitted documents for procurement
excipients used in product development? of excipients used in product development.
8. List of qualified staff involved in product  The firm has 04 Pharmacists and 01 Chemist
development with relevant experience. involved in product development.
Production Data
9. Authorized Protocols/SOP for the  Firm has submitted SOP for stability testing of
development & stability testing of trial trial batches (document # STB/107/18) of
batches. Empag Tablet 10mg.
 Firm has submitted SOP for product
development of trial batches (document # PD-
RFT-014) of Empag Tablet 10mg
10. Complete batch manufacturing record of  Firm has provided complete batch
three stability batches. manufacturing record of all the three batches
11. Record of remaining quantities of stability  Firm has submitted following remaining
batches. quantities in the real time stability study
chamber:
1. 18SB-063-01: 252 Tablets
2. 18SB-064-02: 252 Tablets
3. 18SB-065-03: 252 Tablets
QA/QC DATA
12. Record of Digital data logger for  Firm has submitted record of data logger for
temperature and humidity monitoring of temperature and humidity monitoring control for
stability chambers (real time and the complete stability period.
accelerated)  The record submitted is filled manually.
 For accelerated stability study the time period
was from 01-02-2018 to 06-08-2018.
 For real time stability study the time period was
from 01-02-2018 to 06-08-2018.
13. Method used for analysis of API along  Firm has submitted COA of API Method used
with COA. for analysis of API by the manufacturer
 Firm has submitted method used for analysis of
API along with copy of COA generated by
itself.
14. Method used for analysis of FPP & Firm has submitted method used for analysis of FPP
complete record of testing of stability (Document# QC-FPNS-129). & complete record of
batches (i.e. chromatograms, lab reports, testing of stability batches
raw data sheets etc.)
15. Reports of stability studies of API from  Firm has submitted summary sheet of 3 batches
manufacturer. of API conducted at 30°C ± 2°C / 65% ± 5%RH
for long term for 24 months and 40°C ± 2°C /
75% ± 5%RH for accelerated studies for 6
months.
16. Analysis reports for excipients used.  Firm has submitted analysis reports of all
excipients used in the study.
17. Drug-excipients compatibility studies.  Not submitted by the firm.
 Firm has stated that composition of developed
product is similar to innovator’s product
formulation. Therefore it is presumed that used
inactive ingredients are compatible with active
& also with each other and this is ensured by
satisfactory results from formal stability studies.
18. Record of comparative dissolution data.  Firm has submitted summary sheets for
comparative dissolution study and also
submitted relevant analytical record i.e.
chromatograms and raw data sheets for the
comparative dissolution study conducted
19. Compliance Record of HPLC software  Firm has submitted compliance record of HPLC
21CFR & audit trail reports on product software 21 CFR & copy of audit trail reports,
testing. from 09-02-2018 till 09-08-2018.
Evaluation by PEC:
Decision: Registration Board decided to approve registration of “EMPAG 10mg Tablets

(Empagliflozin) by M/s Genix Pharma (Pvt) Ltd., Karachi. Manufacturer will place first three
production batches of the product on long term stability studies throughout proposed shelf life and
on accelerated studies for six months.
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Fee Availability / Local
Applicant Dosage Form + (including differential Availability
Strength), fee),
Group,
Finished Product
Specification
869. M/s Genix Pharma EMPAG 25mg Form 5-D Jardiance tablet 25 mg
(Pvt) Ltd. Tablets by M/s Boehringer
44 45-B Korangi Creek Each film coated (Duplicate) Ingelheim (USFDA
Road, Karachi. tablet contain: Dairy No. dated 18-01- Approved)
Empagliflozin…25mg 2016.
Rs.50,000/- dated 12- Last inspection report
(Sodium-glucose co- 01-2016.(Duplicate) 8-8-2017 firm was
transporter 2 (SGLT2) (Challan#0548817) considered to be
inhibitors) 7’s.., As per SRO operating at a
Manufacturer’s 14’s.. As per SRO satisfactory level of
Specifications. 28’s. As per SRO compliance with GMP
276th meeting of Registration Board for exemption from “On site investigation of submitted stability
data”
Drug Empag 25mg Tablet
Name of Manufacturer M/s Genix Pharma (Pvt) Ltd.
44 45-B Korangi Creek Road, Karachi.
Manufacturer of API M/s Ruyuan HEC Pharm Co. Ltd, China.
API Lot No. EGLZ-RD20171101A
Description of Pack Alu/alu blister.
Real Time: 25°C ± 2°C & 60±5%RH
Real Time: 6 months
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (months)
Real Time: 0, 3, 6 (months)
Batch No. 18SB-066-01 18SB-067-02 18SB-068-03
Manufacturing Date Feb 2018 Feb 2018 Feb 2018
No. of Batches 03
th
| 463
No.
1. COA of API  Certificate of analysis of the API and
working standard submitted by the firm.
2. Approval of API by regulatory authority of  Photocopy of GMP Certificate No. 2017029
country of origin or GMP certificate of API issued by Shaoguan Food and Drug
manufacturer issued by regulatory authority of Administration is submitted.
country of origin. Issued on: 22-01-2018
Yes
5. Documents confirming import of API etc.  Firm has submitted commercial invoice for
the procurement of API detailed as under:
ADC attested copy dated 07-12-2017
confirming import of 0.75kg of
Empagliflozin.
Invoice no.WIS170152 (14-11-2017)
Manufactured by: Ruyuan Hec Pharm Co,.
Ltd.
purpose only.
stating that the API is manufactured by
Ruyuan Hec Pharm Co,. Ltd. With
batch#EGLZ-RD20171101A.
data / documents.
Yes
Rules, 1978.
Yes

for instant dosage form conducted during product “Wymly Tablets 25mg (Tenofovir
last two years. alafenamide)”, which was conducted on 9th April,
2018 and was presented in 281st meeting of
Registration board. Registration Board decided to
approve registration of Wymly Tablets 25mg
(Tenofovir alafenamide) by M/s. Genix
Pharmaceuticals (Pvt.) Ltd., Karachi.
 According to the report generated on 9th April,
2018 following points were confirmed
a) The firm has necessary equipment available in
product development section for development of
Wymly Tablets 25mg.
b) The HPLC software is 21CFR compliant and
having certificates of Compliance by USFDA
c) The firm has audit trail Reports on testing.
d) Adequate monitoring and control are available
for stability chamber. Chambers are controlled
and monitored through software 21CFR
compliance.
e) Related manufacturing area, equipment,
personnel and utilities can be rated as compliant
to minimum GMP standards.
2. Documents for the procurement of API  Firm has submitted commercial invoice for the
with approval from DRAP (in case of procurement of API detailed as under:
import). ADC attested copy dated 07-12-2017
confirming import of 0.75kg of Empagliflozin.
Invoice no.WIS170152 (14-11-2017)
Manufactured by: Ruyuan Hec Pharm Co,. Ltd.
purpose only.
stating that the API is manufactured by Ruyuan
Hec Pharm Co,. Ltd. With batch#EGLZ-
RD20171101A.
3. Documents for the procurement of Firm has submitted copy of declaration from
reference standard and impurity manufacturer i.e. Ruyuan Hec Pharm Co,. Ltd.
standards. stating:
Ruyuan Hec Pharm Co,. Ltd herewith confirms
that we have submitted 2g Empagliflozin
working standard batch# EGLZ-WS201612101
to Genix Pharma (Pvt)Ltd.
4. Approval of API/ DML/GMP certificate Photocopy of GMP Certificate No. 2017029 issued
of API manufacturer issued by regulatory by Shaoguan Food and Drug Administration is
authority of country of origin. submitted.
Issued on: 22-01-2018
5. Mechanism for Vendor pre-qualification  Firm has submitted vendor evaluation form
which is filled by API manufacturer.
6. Certificate of analysis of the API,  Certificate of analysis of the API and working
reference standards and impurity standard submitted by the firm.
standards  COA of impurity standard not submitted by the
firm.
7. Documents for the procurement of  Firm has submitted documents for procurement
excipients used in product development? of excipients used in product development.
8. List of qualified staff involved in product  The firm has 04 Pharmacists and 01 Chemist
development with relevant experience. involved in product development.
Production Data
9. Authorized Protocols/SOP for the  Firm has submitted SOP for stability testing of
development & stability testing of trial trial batches (document # STB/107/18) of
batches. Empag Tablet 25mg.
 Firm has submitted SOP for product
development of trial batches (document # PD-
RFT-014) of Empag Tablet 25mg
10. Complete batch manufacturing record of  Firm has provided complete batch
three stability batches. manufacturing record of all the three batches
11. Record of remaining quantities of stability  Firm has submitted following remaining
batches. quantities in the real time stability study
chamber:
1. 18SB-066-01: 252 Tablets
2. 18SB-067-02: 252 Tablets
3. 18SB-068-03: 252 Tablets
QA/QC DATA
12. Record of Digital data logger for  Firm has submitted record of data logger for
temperature and humidity monitoring of temperature and humidity monitoring control for
stability chambers (real time and the complete stability period.
accelerated)  The record submitted is filled manually.
 For accelerated stability study the time period
was from 01-02-2018 to 06-08-2018.
 For real time stability study the time period was
from 01-02-2018 to 06-08-2018.
13. Method used for analysis of API along  Firm has submitted COA of API Method used
with COA. for analysis of API by the manufacturer
 Firm has submitted method used for analysis of
API along with copy of COA generated by
itself.
14. Method used for analysis of FPP & Firm has submitted method used for analysis of FPP
complete record of testing of stability (Document# QC-FPNS-130). & complete record of
batches (i.e. chromatograms, lab reports, testing of stability batches
15. Reports of stability studies of API from  Firm has submitted summary sheet of 3 batches
manufacturer. of API conducted at 30°C ± 2°C / 65% ± 5%RH
for long term for 24 months and 40°C ± 2°C /
75% ± 5%RH for accelerated studies for 6
months.
16. Analysis reports for excipients used.  Firm has submitted analysis reports of all
excipients used in the study.
17. Drug-excipients compatibility studies.  Not submitted by the firm.
 Firm has stated that composition of developed
product is similar to innovator’s product
formulation. Therefore it is presumed that used
inactive ingredients are compatible with active
& also with each other and this is ensured by
satisfactory results from formal stability studies.
18. Record of comparative dissolution data. Firm has submitted summary sheets for comparative
dissolution study and also submitted relevant
analytical record i.e. chromatograms and raw data
sheets for the comparative dissolution study
conducted
19. Compliance Record of HPLC software  Firm has submitted compliance record of HPLC
21CFR & audit trail reports on product software 21 CFR & copy of audit trail reports,
testing. from 09-02-2018 till 09-08-2018.
Evaluation by PEC:
Decision: Registration Board decided to approve registration of “EMPAG 25mg Tablets
(Empagliflozin) by M/s Genix Pharma (Pvt) Ltd., Karachi.. Manufacturer will place first three
production batches of the product on long term stability studies throughout proposed shelf life and
Evaluator PEC-VII
No. Manufacturer / Applicant (Proprietary Name + Dosage Initial Diary & Date, Availability / Local
Form + Strength), Fee (including Availability
Composition, differential fee),
Pharmacological Group, Demanded Price / GMP Inspection
Finished Product Pack size Report Date &
870. M/s Helix Pharma (Pvt) Ltd., Valsar-S tablets 49/51 Form-5D USFDA.
A-56, S.I.T.E., Manghopir Each film coated tablet Dy. No: 22841 ENTRESTO by M/s
Road, Karachi contains Dated.15-8-2018 Novartist
Sacubitril….49 mg Rs.50,000/- Not applicable
Valsartan…..51 mg (22-May-2017)
(Angiotensin II Receptor Duplicate The firm was
Antagonists, Neprilysin As per SRO granted GMP
Inhibitor ) certificate based on
Firm has claimed Mfg. inspection
Specs. conducted on
5/1/2018.

Drug Valsar – S Tablets 24/26mg (Sacubitril / Valsartan)
Name of Manufacturer M/s Helix Pharma (Pvt) Ltd., A-56, S.I.T.E., Manghopir Road, Karachi
Manufacturer of API Sacubitril/Valsartan: M/s Zhuhai Rundu Pharmaceutical Co. Ltd China
No.6, North Airport Road, Sanzao Town, Jinwan District, Guangdong,
China
API Lot No. Sacubitril/Valsartan 57317060103
Description of Pack
Alu/Alu blister packed in unit cartoon (1x10’s)
Frequency Accelerated: 0, 3,6 (month) Real Time: 0, 3,6 (month)
Batch No. TF001 TF002 TF003
Batch Size 500 500 500
Date of Initiation 15-12- 2017 15-12- 2017 15-12- 2017
No. of Batches 03
Date of Submission 23-5-2018 (Dy. No.18779)
No.
1. COA of API Copy of COA from M/s Zhuhai Rundu
Pharmaceutical Co. Ltd China is submitted
2. Approval of API by regulatory authority of country of Copy of GMP Certificate issued on
origin or GMP certificate of API manufacturer issued by December 22, 2016 by Food and Drug
regulatory authority of country of origin. Administration People’s Republic of China
is submitted.
3. Protocols followed for conduction of stability study and
Yes
details of tests.
4. Data of 03 batches will be supported by attested respective Yes
documents like chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc. Sacubitril/Valsartan:
Copy of commercial invoice has been
submitted issued by ADC, Karachi DRAP.
Import quantity: 600 g
Reference standard Sacubitril: 50 mg
Batch #: 160403
Working standard:
Batch #: C5271-17-075
Working standard Valsartan: Label text is
provided
Impurities: Provided
Address of Exporter (Head office): M/s
Zhuhai Rundu Pharmaceutical Co. Ltd
China No.6, North Airport Road,Sanzao
Town, Jinwan District, Guangdong, China
Address of Consignee: M/s Helix Pharma
(Pvt) Ltd., A-56, S.I.T.E., Manghopir
Road, Karachi
6. All provided documents will be attested (name, sign and
Yes
stamp) for ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till
Yes
ii. USFDA, dissolution: Sacubitril/Valsartan , Tablet II (Paddle), 50 Phosphate Buffer, pH 6.8[degassed],
volume: 900 Interval: 10, 15, 20, 30 and 45. (same as Firm)
iii. Comparative Dissolution in: pH 1.2 HCl solution, pH 4.5 acetate buffer and pH 6.8 phosphate buffer
solution
iv. Calculations of F2 Value is missing in comparative dissolution
v. Impurities details provided ( valsartan B C, COA provided)
vi. Batch size is 500 tablets, for each month stability 32 tablets are needed.
vii. Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-VII), to
which firm has responded as under:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product
inspection for instant dosage form “Ramelteon” (Paracetamol+ Phenylephrine), which was
conducted during last two years. conducted on 9-August 2017 and was presented in 273th
meeting of Registration board. Registration Board decided to
approve registration of “Ramelteon” by M/s.Helix Pharma
Karachi. According to the report following points were
confirmed
 HPLC is 21 CFR compliant
 Audit trails of the test reports were available.
 Related manufacturing area equipment’s personals
and utilities were found GMP compliant.
2. Documents for the procurement of The firm has submitted photocopies of ADC (Karachi)
API with approval from DRAP (in attested Form 6 dated 15/11/2017, Commercial Invoice for
case of import). 600gm via Invoice # RIS17086 dated: 27/09/2017 lot No.
57317060103 from M/s. Zhuhai Rundu Pharmaceutical Co.
Ltd China No.6, North Airport Road, Sanzao Town, Jinwan
District, Guangdong, China vide proper approval from DRAP
Office, Karachi
3. Documents for the procurement of The reference and impurity standards were received free of
reference standard and impurity cost with API secubitril/valsartan. Therefore no procuring
standards. documents available. The procurement documents of
valsartan is provided
4. Approval of API/ DML/GMP Copy of GMP Certificate issued on December 22, 2016 by
certificate of API manufacturer Zhuhai Food and Drug Administration People’s Republic of
issued by regulatory authority of China is submitted
country of origin.
5. Mechanism for Vendor pre- Firm has submitted SOPs for vendor evaluation and
qualification performance monitoring
6. Certificate of analysis of the API,  Sacubitril/Valsartan API:
reference standards and impurity Photocopy of COA of Batch No. 57317060103 issued by
standards M/s Zhuhai Rundu Pharmaceutical Co., Ltd., China is
submitted.
 Reference standards and impurity standards:
The firm has submitted the copy of Working Standards
(Sacubitril & Valsartan), Reference Standard and
impurity standards of both APIs provided by the API
Manufacturer - M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd., China
7. Documents for the procurement of Firm has submitted documents for procurement of excipients
excipients used in product used in product development.
development?
8. List of qualified staff involved in Firm has submitted list of 2 qualified person working in R&D
product development with relevant section
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of generalized SOP with the title
development & stability testing of ‘Protocol For Development Of New Product’.
trial batches. Effective date 12-08-2017.
10. Complete batch manufacturing record Firm has provided complete batch manufacturing record of all
of three stability batches. the three batches
VALSAR- S Tablets 49/51mg
Batch Bach size Mfg. Mfg.
No. Started Completed
TF001 500 Tabs 05-12-2017 05-12-2017
TF002 500 Tabs 05-12-2017 05-12-2017
TF003 500 Tabs 05-12-2017 05-12-2017
11. Record of remaining quantities of Firm has submitted following remaining quantities:
stability batches. Valsar - S Tablet 49/51mg ; Stability Pack Size : 1 x
10’s)
 TF001: Batch Size : 500 Tablets
Yield 491 Tablets (49 Packs), 03 Packs used for testing
method validation. 02 Packs used for Comparative
Dissolution Profile,03 packs used for Initial Testing. 41
Packs placed on stability (Accelerated : 10 Packs , Real
Time : 31 Packs) out of which 29 packs are remaining
(Accelerated : 04 Packs , Real Time : 25 Packs).
Yield 490 Tablets (49 Packs), 03 packs used for Initial
Testing. 46 Packs placed on stability (Accelerated : 10
Packs , Real Time : 36 Packs) out of which 34 packs are
remaining (Accelerated : 04 Packs , Real Time : 30
Packs).
Yield 494 Tablets (49 Packs).
03 packs used for Initial Testing. 46 Packs placed on
stability (Accelerated : 10 Packs , Real Time : 36 Packs)
out of which 34 packs are remaining (Accelerated : 04
Packs , Real Time : 30 Packs).
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of digital data logger for
temperature and humidity monitoring temperature and humidity monitoring control for the complete
of stability chambers (real time and stability period.
accelerated)  Previously Reported in panel inspection:
The firm has installed software for recording the
temperature/Humidity of the chamber (for real time stability
software V5.7T Thermo, India & for Accelerated Stability
studies, software is Logit Chrt; Technoman; Pakistan) & the
data can been verified for 01 year.
Now the firm has submitted copy of record of digital data
logger (Logit Chart, Technoman) for temperature and
humidity monitoring of stability chambers from 15-12-2017
to 14-06-2018.
13. Method used for analysis of API Firm has provided the method used for analysis of API along
along with COA. with its certificate of analysis
14. Method used for analysis of FPP & Firm has provided method used for analysis of FPP and
complete record of testing of stability complete record of testing of stability batches including
batches (i.e. chromatograms, lab chromatograms, lab reports and raw data sheets are submitted
reports, raw data sheets etc.) with 06 months stability data (Accelerated & Real Time).
15. Reports of stability studies of API SACUBITRIL/VALSARTAN : The firm has submitted
from manufacturer. copy of accelerated, 06 Months (40°C ± 2°C & 75±5%RH) ,
long term, 18 Months 18 Months (30°C ± 2°C &
75±5%RH) ,& stability study reports of 03 batches of
Sacubitril/Valsartan from M/s Zhuhai Rundu Pharmaceutical
Co., Ltd., China
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients used
in the applied formulation.
17. Drug-excipients compatibility The firm has not submitted Drug-excipients compatibility
studies. studies and has referred to the Innovator Product
(ENTRESTO Tablets).
18. Record of comparative dissolution Firm has submitted comparative dissolution profile with the
data. reference product Entresto Novertis europharma UK
Feature Reference Product of HELIX
Product Pharma
Brand name Entresto Tablets VALSAR – S
49mg/51mg 49/51mg
Batch No. TJ432 TF001
Mfg. date Exp. 03-2020 Mfg;
12 - 2017
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21
software 21CFR & audit trail reports CFR & audit trail reports
on product testing.
Evaluation by PEC:
Sr.# Deficiency/Observation Response by Pharma.
i. Firm has not submitted documents The reference and impurity standards were received free
for procurement of reference and of cost with API secubitril/valsartan. Therefore no
impurity standards procuring documents available. The procurement
documents of valsartan is provided
ii. Firm has not submitted SOPs for Submitted.
vendor evaluation and performance
monitoring
iii. Firm has not submitted documents Provided for Glycrine, cross carmilose,
for procurement of excipients used HPMC,Magnesium stearate, Fumed Silica, Cross
in product development. povidone, Talcum powder, opa dry etc.
iv. List of qualified staff involved in In R& D they have 2 pharmacist and one assistant.
product development with relevant
experience.
v. Record of remaining quantities of Received quantity= 600 gm
stability batches missing In 3 Trial batches of valsartan-s 24/26 mg=81 gm
In 3 Trial batches of valsartan-s 49/51 mg=162 gm
QC sample for testing= 5 gm
Total consumption of API=572
Remaining Quantity in RM stores=28 gm
vi. Firm has not submitted COA and Provided
analysis reports of all excipients
used in the study
vii. Evidence of fee of 50,000/- DRAP receiving copy of product dossier application
along with fee of Rs. 50,000/-is provided
Decision: Registration Board decided to approve registration of “Valsar-S tablets 49/51” by M/s Helix
Pharma (Pvt) Ltd., A-56, S.I.T.E., Manghopir Road, Karachi. Manufacturer will place first three
Sr. Name & Address of Brand Name Type of Form, International Availability
No. Manufacturer / Applicant (Proprietary Name + Dosage Initial Diary & / Local Availability
Form + Strength), Composition, Date, Fee
Pharmacological Group, (including GMP Inspection Report
Finished Product Specification differential fee), Date & Remarks
Demanded Price /
Pack size
871. M/s Helix Pharma (Pvt) Valsar-S tablets 24/26 Form-5D USFDA. ENTRESTO
Ltd., A-56, S.I.T.E., Each film coated tablet Dy. No: 27842 by M/s Novartist
Manghopir Road, Karachi contains Dated.15-8-2018 Not applicable
Sacubitril….24 mg Rs.20,000/- The firm was granted
Valsartan…..26 mg (22-May-2017) GMP certificate based
(Angiotensin II Receptor As per SRO on inspection conducted
Antagonists, Neprilysin Inhibitor ) on 07-08-2017 and 17-
Firm has claimed Mfg. Specs. 10-2017.
Drug Valsar-S tablets
Manufacturer of API Sacubitril/Valsartan: M/s Zhuhai Rundu Pharmaceutical Co. Ltd China No.6,
North Airport Road,Sanzao Town, Jinwan District, Guangdong, China
Description of Pack
1x10’s Alu Alu blister packed in unit cartoon
Frequency Accelerated: 0,3,6 (month) Real Time: 0,3,6 (month)
Minutes for 286 Meeting of Registration Board , DRAP (14 – 16 November, 2018)
th th
| 471
No. of Batches 03
1. COA of API Copy of COA from M/s Zhuhai Rundu Pharmaceutical
Co. Ltd China is submitted
Copy of GMP Certificate issued on December 22, 2016
country of origin or GMP certificate of
by Zhuhai Food and Drug Administration People’s
API manufacturer issued by regulatory
Republic of China is submitted.
authority of country of origin.
Yes
Yes
sheets etc.
Copy of commercial invoice has been submitted issued
by ADC, Karachi DRAP.
Batch #: 160403
Working standard:
Batch #: C5271-17-075
Working standard Valsartan: Label text is provided
Address of Exporter (Head office): M/s Zhuhai Rundu
Pharmaceutical Co. Ltd China No.6, North Airport
Road,Sanzao Town, Jinwan District, Guangdong, China
Address of Consignee: M/s Helix Pharma (Pvt) Ltd., A-
56, S.I.T.E., Manghopir Road, Karachi
Yes
Yes
Rules, 1978.
i. USFDA, dissolution: Sacubitril/Valsartan , Tablet II (Paddle), 50 Phosphate Buffer, pH 6.8[degassed],
ii. Comparative Dissolution in: pH 1.2 HCl solution, pH 4.5 acetate buffer and pH 6.8 phosphate buffer solution
iii. Calculations of F2 Value is missing in comparative dissolution
iv. Impurities details provided ( valsartan B C, COA provided)
v. Batch size is 500 tablets, for each month stability 32 tablets are needed.
vi. Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-VII), to
inspection for instant dosage “Ramelteon” (Paracetamol+ Phenylephrine), which was conducted on
form conducted during last 9-August 2017 and was presented in 273th meeting of Registration
two years. board. Registration Board decided to approve registration of
“Ramelteon” by M/s.Helix Pharma Karachi. According to the report
following points were confirmed
 Related manufacturing area equipment’s personals and utilities
were found GMP compliant.
2. Documents for the The firm has submitted photocopies of ADC (Karachi) attested Form 6
procurement of API with dated 15/11/2017, Commercial Invoice for 600gm via Invoice #
approval from DRAP (in case RIS17086 dated: 27/09/2017 lot No. 57317060103 from M/s. Zhuhai
of import). Rundu Pharmaceutical Co. Ltd China No.6, North Airport Road,
Sanzao Town, Jinwan District, Guangdong, China vide proper approval
from DRAP Office, Karachi
3. Documents for the The reference and impurity standards were received free of cost with
procurement of reference API secubitril/valsartan. Therefore no procuring documents available.
standard and impurity The procurement documents of valsartan is provided
standards.
4. Approval of API/ DML/GMP Copy of GMP Certificate issued on December 22, 2016 by Zhuhai
certificate of API Food and Drug Administration People’s Republic of China is submitted
manufacturer issued by
regulatory authority of
country of origin.
5. Mechanism for Vendor pre- Firm has submitted SOPs for vendor evaluation and performance
qualification monitoring
6. Certificate of analysis of the  Sacubitril/Valsartan API:
API, reference standards and Photocopy of COA of Batch No. 57317060103 issued by M/s
impurity standards Zhuhai Rundu Pharmaceutical Co., Ltd., China is submitted.
The firm has submitted the copy of Working Standards (Sacubitril
& Valsartan), Reference Standard and impurity standards of both
APIs provided by the API Manufacturer - M/s Zhuhai Rundu
Pharmaceutical Co., Ltd., China
7. Documents for the Firm has submitted documents for procurement of excipients used in
procurement of excipients product development.
used in product
development?
8. List of qualified staff Firm has submitted list of 2 qualified person working in R&D section
involved in product
development with relevant
experience.
Production Data
9. Authorized Protocols/SOP The firm has submitted copy of generalized SOP with the title
for the development & ‘Protocol For Development Of New Product’.
stability testing of trial Effective date 12-08-2017.
batches.
10. Complete batch Firm has provided complete batch manufacturing record of all the three
manufacturing record of three batches
stability batches. VALSAR- S Tablets 24/26mg
Batch No. Bach size Mfg. Started Mfg. Completed
TF001 500 Tabs 05-12-2017 05-12-2017
TF002 500 Tabs 05-12-2017 05-12-2017
TF003 500 Tabs 05-12-2017 05-12-2017
11. Record of remaining Firm has submitted following remaining quantities:
quantities of stability batches. VALSAR- S Tablets 24/26mg ;
Stability Pack Size : 1 x 10’s)
Yield 490 Tablets (49 Packs), 03 Packs used for testing method
validation. 02 Packs used for Comparative Dissolution Profile, 03
packs used for Initial Testing. 41 Packs placed on stability
(Accelerated : 10 Packs , Real Time : 31 Packs) out of which 29
packs are remaining (Accelerated : 04 Packs , Real Time : 25
Packs).
Yield 493 Tablets (49 Packs), 03 packs used for Initial Testing. 46
Packs placed on stability (Accelerated : 10 Packs , Real Time : 36
Packs) out of which 34 packs are remaining (Accelerated : 04
Packs , Real Time : 30 Packs).
03 packs used for Initial Testing. 45 Packs placed on stability
Packs).
QA/QC DATA
12. Record of Digital data logger Firm has submitted record of digital data logger for temperature and
for temperature and humidity humidity monitoring control for the complete stability period.
monitoring of stability  Previously Reported in panel inspection:
chambers (real time and The firm has installed software for recording the temperature/Humidity
accelerated) of the chamber (for real time stability software V5.7T Thermo, India &
for Accelerated Stability studies, software is Logit Chrt; Technoman;
Pakistan) & the data can been verified for 01 year.
Now the firm has submitted copy of record of digital data logger (Logit
Chart, Technoman) for temperature and humidity monitoring of
stability chambers from 15-12-2017 to 14-06-2018.
13. Method used for analysis of Firm has provided the method used for analysis of API along with its
API along with COA. certificate of analysis
14. Method used for analysis of Firm has provided method used for analysis of FPP and complete
FPP & complete record of record of testing of stability batches including chromatograms, lab
testing of stability batches reports and raw data sheets are submitted with 06 months stability data
(i.e. chromatograms, lab (Accelerated & Real Time).
15. Reports of stability studies of SACUBITRIL/VALSARTAN : The firm has submitted copy of
API from manufacturer. accelerated, 06 Months (40°C ± 2°C & 75±5%RH) , long term, 18
Months 18 Months (30°C ± 2°C & 75±5%RH) ,& stability study
reports of 03 batches of Sacubitril/Valsartan from M/s Zhuhai Rundu
Pharmaceutical Co., Ltd., China
16. Analysis reports for The firm has submitted copy of COAs for the excipients used in the
excipients used. applied formulation.
17. Drug-excipients The firm has not submitted Drug-excipients compatibility studies and
compatibility studies. has referred to the Innovator Product (ENTRESTO Tablets).
18. Record of comparative Firm has submitted comparative dissolution profile with the reference
dissolution data. product Entresto Novertis europharma UK
Product Pharma
Brand name Entresto Tablets VALSAR – S 24/26mg
24mg/26mg
Batch/Lot No. TJ474 TF001
Mfg. date Not mentioned 12 - 2017
Exp. 03-2020
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21 CFR &
software 21CFR & audit trail audit trail reports
Evaluation by PEC:
i. Firm has not submitted documents for The reference and impurity standards were received free of
procurement of reference and cost with API secubitril/valsartan. Therefore no procuring
impurity standards documents available. The procurement documents of
valsartan is provided
monitoring
iii. Firm has not submitted documents for Provided for Glycrine, cross carmilose, HPMC,Magnesium
procurement of excipients used in stearate, Fumed Silica, Cross povidone, Talcum powder,
product development. opa dry etc.
experience.
analysis reports of all excipients used
in the study
vii. Evidence of fee of 50,000/- DRAP receiving copy of product dossier application along
with fee of Rs. 50,000/-is provided

No. Manufacturer / Applicant (Proprietary Name + Dosage Initial Diary & Date, Availability / Local
Form + Strength), Fee (including Availability
Pharmacological Group, Demanded Price / Pack GMP Inspection Report
Finished Product size Date & Remarks
Specification
872. M/s Helix Pharma (Pvt) Valsar-S tablets 97/103 Form-5 USFDA. ENTRESTO
Ltd., A-56, S.I.T.E., Each film coated tablet Dy. No: 27840 by M/s Novartist
Manghopir Road, contains Dated.15-8-2018
Karachi Sacubitril….97 mg Rs.50,000/- Not applicable
Valsartan…..103 mg (22-May-2017) The firm was granted
(Angiotensin II Receptor As per SRO GMP certificate based
Antagonists, Neprilysin on inspection
Inhibitor ) conducted on 07-08-
Firm has claimed Mfg. 2017 and 17-10-2017.
Specs.

Drug Valsar – S Tablet 97/103mg
Manufacturer of API Sacubitril/Valsartan: M/s Zhuhai Rundu Pharmaceutical Co.
Ltd China No.6, North Airport Road,Sanzao Town, Jinwan District,
Guangdong, China
Description of Pack
1x10’s Alu Alu blister packed in unit cartoon
Frequency Accelerated: 0,3,6 (month)
No. of Batches 03
1. COA of API Copy of COA from M/s Zhuhai Rundu
Pharmaceutical Co. Ltd China is submitted
2. Approval of API by regulatory authority of Copy of GMP Certificate issued on December
country of origin or GMP certificate of API 22, 2016 by Zhuhai Food and Drug
manufacturer issued by regulatory authority of Administration People’s Republic of China is
country of origin. submitted.
Yes
Copy of commercial invoice has been submitted
issued by ADC, Karachi DRAP.
Batch #: 160403
Working standard:
Batch #: C5271-17-075
Working standard Valsartan: Label text is
provided
Address of Exporter (Head office): M/s Zhuhai
Rundu Pharmaceutical Co. Ltd China No.6,
North Airport Road,Sanzao Town, Jinwan
District, Guangdong, China
Address of Consignee: M/s Helix Pharma (Pvt)
Ltd., A-56, S.I.T.E., Manghopir Road, Karachi
Yes
sign and stamp) for ensuring authenticity of data /
documents.
Yes
Yes
1978.
vii. USFDA, dissolution: Sacubitril/Valsartan , Tablet II (Paddle), 50 Phosphate Buffer, pH 6.8[degassed],
viii. Comparative Dissolution in: pH 1.2 HCl solution, pH 4.5 acetate buffer and pH 6.8 phosphate buffer
solution
ix. Calculations of F2 Value is missing in comparative dissolution
x. Impurities details provided ( valsartan B C, COA provided)
xi. Batch size is 500 tablets, for each month stability 32 tablets are needed.
xii. Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-VII), to
inspection for instant dosage form “Ramelteon” (Paracetamol+ Phenylephrine), which was conducted
conducted during last two years. on 9-August 2017 and was presented in 273th meeting of
Registration board. Registration Board decided to approve
registration of “Ramelteon” by M/s.Helix Pharma Karachi.
According to the report following points were confirmed
 Related manufacturing area equipment’s personals and
utilities were found GMP compliant.
2. Documents for the procurement of The firm has submitted photocopies of ADC (Karachi) attested
API with approval from DRAP (in Form 6 dated 15/11/2017, Commercial Invoice for 600gm via
case of import). Invoice # RIS17086 dated: 27/09/2017 lot No. 57317060103 from
M/s. Zhuhai Rundu Pharmaceutical Co. Ltd China No.6, North
Airport Road, Sanzao Town, Jinwan District, Guangdong, China
vide proper approval from DRAP Office, Karachi
3. Documents for the procurement of The reference and impurity standards were received free of cost with
reference standard and impurity API secubitril/valsartan. Therefore no procuring documents
standards. available. The procurement documents of valsartan is provided
4. Approval of API/ DML/GMP Copy of GMP Certificate issued on December 22, 2016 by Zhuhai
certificate of API manufacturer Food and Drug Administration People’s Republic of China is
issued by regulatory authority of submitted
country of origin.
5. Mechanism for Vendor pre- Firm has submitted SOPs for vendor evaluation and performance
qualification monitoring
6. Certificate of analysis of the API, 
Sacubitril/Valsartan API:
reference standards and impurity Photocopy of COA of Batch No. 57317060103 issued by M/s
standards Zhuhai Rundu Pharmaceutical Co., Ltd., China is submitted.
The firm has submitted the copy of Working Standards
(Sacubitril & Valsartan), Reference Standard and impurity
standards of both APIs provided by the API Manufacturer - M/s
Zhuhai Rundu Pharmaceutical Co., Ltd., China
7. Documents for the procurement of Firm has submitted documents for procurement of excipients used in
excipients used in product product development.
development?
8. List of qualified staff involved in Firm has submitted list of 2 qualified person working in R&D
product development with relevant section
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of generalized SOP with the title
development & stability testing of ‘Protocol For Development Of New Product’.
trial batches. Effective date 12-08-2017.
10. Complete batch manufacturing Firm has provided complete batch manufacturing record of all the
record of three stability batches. three batches
VALSAR- S Tablets 97/103mg
Batch Bach size Mfg. Mfg.
No. Started Completed
TF001 500 Tabs 05-12-2017 05-12-2017
TF002 500 Tabs 05-12-2017 05-12-2017
TF003 500 Tabs 05-12-2017 05-12-2017
11. Record of remaining quantities of Firm has submitted following remaining quantities:
stability batches. VALSAR - S Tablet 97/103mg ;
Stability Pack Size : 1 x 10’s)
Yield 493 Tablets (49 Packs), 03 Packs used for testing method
validation. 02 Packs used for Comparative Dissolution Profile,
(Accelerated: 10 Packs , Real Time : 31 Packs) out of which 29
Packs).
Yield 492 Tablets (49 Packs), 03 packs used for Initial Testing.
46 Packs placed on stability (Accelerated: 10 Packs , Real Time
: 36 Packs) out of which 34 packs are remaining (Accelerated :
04 Packs , Real Time : 30 Packs).
packs are remaining (Accelerated : 04 Packs , Real Time : 30 Packs).
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of digital data logger for temperature and
temperature and humidity humidity monitoring control for the complete stability period.
monitoring of stability chambers  Previously Reported in panel inspection:
(real time and accelerated) The firm has installed software for recording the
temperature/Humidity of the chamber (for real time stability
software V5.7T Thermo, India & for Accelerated Stability studies,
software is Logit Chrt; Technoman; Pakistan) & the data can been
verified for 01 year.
Now the firm has submitted copy of record of digital data logger
(Logit Chart, Technoman) for temperature and humidity monitoring
of stability chambers from 15-12-2017 to 14-06-2018.
13. Method used for analysis of API Firm has provided the method used for analysis of API along with
along with COA. its certificate of analysis
14. Method used for analysis of FPP Firm has provided method used for analysis of FPP and complete
& complete record of testing of record of testing of stability batches including chromatograms, lab
stability batches (i.e. reports and raw data sheets are submitted with 06 months stability
chromatograms, lab reports, raw data (Accelerated & Real Time).
data sheets etc.)
15. Reports of stability studies of API SACUBITRIL/VALSARTAN : The firm has submitted copy of
from manufacturer. accelerated, 06 Months (40°C ± 2°C & 75±5%RH) , long term, 18
Months 18 Months (30°C ± 2°C & 75±5%RH) ,& stability study
reports of 03 batches of Sacubitril/Valsartan from M/s Zhuhai
Rundu Pharmaceutical Co., Ltd., China
16. Analysis reports for excipients The firm has submitted copy of COAs for the excipients used in the
used. applied formulation.
17. Drug-excipients compatibility The firm has not submitted Drug-excipients compatibility studies
studies. and has referred to the Innovator Product (ENTRESTO Tablets).
18. Record of comparative dissolution Firm has submitted comparative dissolution profile with the
data. reference product Entresto Novertis europharma UK
Product Pharma
Brand name Entresto Tablets VALSAR – S 97/103mg
97mg/103mg
Batch No. TM770 TF001
Mfg. date Not mentioned 12 - 2017
Exp. 09-2020
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21 CFR &
software 21CFR & audit trail audit trail reports
Evaluation by PEC:
i. Firm has not submitted documents for The reference and impurity standards were received free
procurement of reference and impurity of cost with API secubitril/valsartan. Therefore no
standards procuring documents available. The procurement
documents of valsartan is provided
monitoring
iii. Firm has not submitted documents for Provided for Glycrine, cross carmilose,
procurement of excipients used in HPMC,Magnesium stearate, Fumed Silica, Cross
product development. povidone, Talcum powder, opa dry etc.
experience.

analysis reports of all excipients used in
the study
vii. Evidence of fee of 50,000/- DRAP receiving copy of product dossier application
along with fee of Rs. 50,000/-is provided
Evaluator PEC-IV
Sr. Name & Address Brand Name Type of Form, International Remarks
No. of Manufacturer (Proprietary Name + Initial Diary & Availability / Local
/ Applicant Dosage Form + Date, Fee Availability
Strength), (including
Pharmacological Demanded Price / Report Date
Group, Pack size
Finished Product
Specification
873. M/s. Scotmann Dapaglu Tablets 5mg Form 5 Farxiga tablet-
Pharmaceuticals, Each film coated tablet Dairy No.30033 USFDA approved
5D, I-10/3, contains: dated 06-09-2018 GMP Inspection
Industrial Area, Dapagliflozin conducted on 14-
Islamabad. propanediol Rs.20,000/- dated 09-2017 & 21-09-
monohydrate eq. to 06-09-2018 2017 concluded that
Dapagliflozin…....5mg 2×7’s, 2×14’s; As the panel
Sodium Glucose Co- per SRO unanimously
transporter 2 Inhibitors Alu-Alu/Alu- recommended for
Manufacturer’s PVC/ Jar the grant of GMP
specification certificate.
Drug Dapaglu Tablets 5mg
Name of Manufacturer M/s. Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.
Manufacturer of API M/s Virupaksha Organics Ltd, Telangana, India
API Lot No. ADAPC1116001
Description of Pack Alu Alu Blister Pack in Unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (Months) Real Time: 6 (Months)
Frequency Accelerated: 0,1,2,3,4,6 (Months) Real Time: 0,3,6 (Months) Ongoing
Batch No. Trial #01 Trial #02 Trial #03
No. of Batches 03
Date of Submission 30033 (06-09-2018)
No.
1. COA of API. Copy of COA (Batch # ADAPC1116001)
from M/s Virupaksha Organics Ltd,
Telangana, India is submitted.
2. Approval of API by regulatory authority of country Copy of GMP certificate for M/s
of origin or GMP certificate of API manufacturer Virupaksha Organics Ltd, Telangana State,
issued by regulatory authority of country of origin. India issued by Drug Control
Administration, Government of Telangana,
India has been provided. It is valid until
07-08-2019.
respective documents like chromatograms, laboratory
reports, data sheets etc.
5. Documents confirming import of API etc. The firm has submitted copy of
commercial invoice attested by ADC,
DRAP, Islamabad dated 05-07-2017.
6. All provided documents will be attested (name, sign Yes
and stamp) for ensuring authenticity of data /
documents.
1978.
● As per submitted stability study data, only one injection of Standard solution for both Assay test and
Dissolution test has been recorded.
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and
provided the following documents in conjunction with the checklist approved by the Registration Board in
its 278th Meeting:
Date of submission: 06-09-2018 vide diary no. 30034
1. Reference of last onsite panel inspection Registration Board decided to approve registration of
for instant dosage form conducted during “DASCOT 30 mg Tablets (Daclatasvir 30 mg)” &
last two years. “DASCOT 60 mg Tablets (Daclatasvir 60 mg)” as
well as VELSCOT 400mg/100mg Tablet by M/s
Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial
Area, Islamabad. Manufacturer will place first three
production batches on long term stability studies
throughout proposed shelf life and on accelerated
Date of Inspection: 26-01-2018.
 The HPLC software is 21 CFR compliant.
 The firm has demonstrated all audit trail reports
for DASCOT 30 & 60mg tablet.
 The firm has demonstrated audit trail reports for
the data submitted subsequently dated 21-12-2017
for VELSCOT 400mg/100mg tablet.
2. Documents for the procurement of API Copy of commercial invoice has been submitted
with approval from DRAP (in case of attested by ADC, DRAP Islamabad dated 05-07-2017.
import).
3. Documents for the procurement of The firm has submitted copy of invoice of working
reference standard and impurity standards. standard of Dapagliflozin Propanediol Monohydrate.
4. Approval of API/ DML/GMP certificate Copy of GMP certificate for M/s Virupaksha Organics
of API manufacturer issued by regulatory Ltd, Telangana State, India issued by Drug Control
authority of country of origin. Administration, Government of Telangana, India has
been provided. It is valid until 07-08-2019
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for Evaluation of
Vendors.
6. Certificate of analysis of the API,  Copy of COA of API (Batch # ADAPC1116001)
reference standards and impurity standards from M/s Virupaksha Organics Ltd, Telangana,
India has been submitted.
 Copy of COA of reference standard has been
submitted
However, COAs of impurity standard has not been
submitted.
7. Documents for the procurement of The firm has submitted photocopy of Commercial
excipients used in product development? invoices/COAs of all the excipients used in the
formulation of applied product.
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved
development with relevant experience. in R&D department.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of “Protocols/SOP
development & stability testing of trial for the Development of Dapagliflozin Tablet 10mg”.
batches.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch
three stability batches. Manufacturing Records of following 03 Batches:
Batch No. Batch Size Mfg. Date
Trial # 01 1500 tablets 27-11-2017
Trial # 02 1500 tablets 27-11-2017
Trial # 03 1500 tablets 29-11-2017
11. Record of remaining quantities of stability
batches. Trial No Total no. Tablets Remaining
of Tablets used for Quantities
placed in testing of tablets
stability
chamber
Trial # 01 450 224 226
Trial # 02 450 224 226
Trial # 03 450 224 226
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record
temperature and humidity monitoring of for Accelerated stability chamber from 01-12-2017 to
stability chambers (real time and 10-06-2018 and for Real Time stability chamber
accelerated) starting from 01-12-2017 to 10-06-2018
13. Method used for analysis of API along The firm has submitted photocopy of Raw Material
with COA. Specifications, Raw Material Testing Procedures along
with COAs for Dapagliflozin Propanediol
Monohydrate.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability Testing Procedure for Dapagliflozin Tablets 5mg
batches (i.e. chromatograms, lab reports, along with Stability Study Reports.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months
manufacturer. Accelerated and 18 Months Real Time Stability Study
Data of 03 Batches of Dapagliflozin Propanediol
Monohydrate from M/s Virupaksha Organics Ltd,
India.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical
reports of excipients used.
17. Drug-excipients compatibility studies. The firm has used the excipients of innovator.
18. Record of comparative dissolution data. The firm has performed comparative dissolution
studies in three media including pH 1.2, pH 4.5 and
pH 6.8 buffers with Farxiga Tablet 5mg manufactured
by M/s. Astrazeneca with Batch No.KF0463 The
firm‘s product results are comparable to that of the
comparator product. (Performed from 29-08-2018 till
02-09-2018)
19. Compliance Record of HPLC software Audit trail on testing reports of Dapagliflozin Tablet
21CFR & audit trail reports on product 5mg from 27-11-2017 to 06-09-2018 was submitted by
testing. the firm.
Remarks of Evaluator: 
On stability sheets initial testing is at 09-12-
2017 while in raw data and chromatograms for
batch No: Trial-01 initial testing date was 27-
11-2017 and for batch No: Trial-02 & for
batch No: Trial-03 initial testing date is 29-11-
2017.
Decision: Registration Board decided to approve registration of “Dapaglu 5 mg” by M/s. Scotmann
Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad. Manufacturer will place first three
production batches of both products on long term stability studies throughout proposed shelf life and
Evaluator PEC-XIV
Sr. Name & Address of Brand Name Type of Form, International Remarks
No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Availability /
Dosage Form + Date, Fee Local Availability
Strength), (including GMP Inspection
Composition, differential fee), Report Date
Pharmacological Demanded Price /
Group, Pack size
Finished Product
Specification
874. M/s. Wilson WILTRIL TABLETS Form 5 Entresto Tablet
Pharmaceuticals,387- 24/26mg of Novartis
388, I-9, Industrial Area, Dairy No.27961 pharms, USFDA
Islamabad. Each film coated dated 16-08-2018
tablet contains: Sacuvan tablets
Sacubitril……24mg Rs.20,000/- 24/26mg of
Valsartan....…26mg dated 19-07-2018 GETZ pharma
Neprilysin inhibitor/ Sovel Tablets of
Angiotensin II 14’s, 28’s ; As 24/26mg of
receptor blocker per SRO pharmEvo
Manufacturer’s Alu-Alu Blister GMP Inspection
specification conducted on 24-
01-2018
concluded that
the firm was
operating at a
very good level
of GMP
compliance at the
time of
inspection.
Drug WILTRIL TABLETS 24/26mg
Name of Manufacturer M/s. Wilson Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad.
Manufacturer of API M/s Zhuhai Rundu Pharmaceutical Co., Ltd, China
Stability Storage Accelerated: 40°C ± 2°C/75%±5% RH
Condition Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 months Real Time: 6 months
Frequency Accelerated: 0,1,2,3,4,6 (months)
Real Time: 0,3,6 (months)
No. of Batches 03
No.
1. COA of API. Copy of COA (batch #20170203) from M/s
Zhuhai Rundu Pharmaceutical Co., Ltd, China is
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate (certificate No.
country of origin or GMP certificate of API GD20170777) issued by China Food & Drugs
manufacturer issued by regulatory authority of Administration, China. It is valid until 24-12-
country of origin. 2022.
3. Protocols followed for conduction of stability Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial
invoice dated 14-06-2017 attested by ADC-
DRAP, Islamabad
6. All provided documents will be attested (name, Yes
sign and stamp) for ensuring authenticity of data
/ documents.
7. Commitment to continue real time stability study Yes
Rules, 1978.
● The firm has submitted 06 months Accelerated and 06 months Real Time Stability Data for 03
Batches.
provided the following documents in conjunction with the checklist approved by the Registration Board
in its 278th Meeting:
1. Reference of last onsite panel Registration Board decided to approve registration of “Saferon
inspection for instant dosage (Sofosbuvir 400mg) tablets by M/s Wilson Pharmaceuticals, I-9
form conducted during last two Industrial Area, Islamabad. Manufacturer will place first three
years. production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
 Audit trail on the testing reports was available and confirmed
for Saferon (Sofosbuvir 400mg) Tablet.
2. Documents for the procurement Copy of commercial invoice has been submitted attested by ADC,
of API with approval from DRAP Islamabad.
DRAP (in case of import).
3. Documents for the procurement The firm has submitted copies of invoices for the procurement of
of reference standard and following working standard substances:
impurity standards. Sacubitril sodium: 99.4 %
Valsartan Related compound B: 99.5 %
Valsartan Related compound C: 91.1 %
Valsartan: 100 %
4. Approval of API/ DML/GMP The firm has submitted copy of GMP certificate (Certificate
certificate of API manufacturer No.GD20170777) for M/s Zhuhai Rundu Pharmaceutical Co., Ltd,
issued by regulatory authority of China issued by China Food & Drug Administration, China valid
5. Mechanism for Vendor pre- The firm has submitted SOP for Evaluation of Vendors.
qualification
6. Certificate of analysis of the  Copy of COA of API (Batch # 20170203) from M/s Zhuhai
API, reference standards and Rundu Pharmaceutical Co., Ltd, China has been submitted.
impurity standards  Copy of COA of reference standard has been submitted
 However, COAs of impurity standards have not been
submitted.
7. Documents for the procurement The firm has submitted photocopy of Commercial invoices/COAs
of excipients used in product of all the excipients used in the formulation of applied product
development?
8. List of qualified staff involved The firm has submitted List of qualified staff involved in R&D
in product development with department.
Production Data
9. Authorized Protocols/SOP for The firm has submitted photocopy of “Protocols/SOP for the
the development & stability Development of WILTRIL TABLETS 24/26mg”.
testing of trial batches.
10. Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing
record of three stability batches. Records of following 03 Batches:
Trial # 01 1500 tablets 11-2017
Trial # 02 1500 tablets 11-2017
Trial # 03 1500 tablets 11-2017
11. Record of remaining quantities Trial No Total no. of Tablets Tablets Remaining
of stability batches. For stability testing used for Quantities
testing of tablets
Trial # 01 1260 394 866
Trial # 02 1316 376 940
Trial # 03 1288 376 912
QA / QC DATA
12. Record of Digital data logger Firm has submitted photocopies of data logger record for
for temperature and humidity Accelerated stability chamber from 10-10-2017 to 31-07-2018 and
monitoring of stability
for Real Time stability chamber starting from 01-11-2017 to 31-07-
chambers (real time and 2018
accelerated)
13. Method used for analysis of API The firm has submitted photocopy of Raw Material Specifications,
along with COA. Raw Material Testing Procedures along with COAs for
Sacubitril/Valsartan Complex.
14. Method used for analysis of The firm has submitted photocopy of Finished Product Testing
FPP & complete record of Procedure for “Wiltril Tablets 24/26mg” along with Stability Study
testing of stability batches (i.e. Reports.
data sheets etc.)
15. Reports of stability studies of The firm has submitted photocopy of 06 Months Accelerated and
API from manufacturer. 24 Months Real Time Stability Study Data of 03 Batches of
Sacubitril/Valsartan from M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd, China.
16. Analysis reports for excipients The firm has submitted photocopy of Analytical reports of
used. excipients used.
17. Drug-excipients compatibility The firm has used the excipients of innovator.
studies.
18. Record of comparative The firm has performed comparative dissolution studies in three
dissolution data. media including pH 1.2, pH 4.5 and pH 6.8 buffers with Entresto
Tablets 24/26mg manufactured by M/S. Novartis Pharmaceuticals,
Canada with Batch No.TP010. The firm‘s product results are
comparable to that of the innovator product.
19. Compliance Record of HPLC Audit trail on testing reports of Sacubitril/Valsartan from 07-11-
software 21CFR & audit trail 2017 to 16-06-2018 was submitted by the firm.
Decision: Registration Board decided to approve registration of “WILTRIL TABLETS 24/26mg by

M/s. Wilson Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad.” Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life and on
No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Availability / Local
Applicant Form + Strength), Date, Fee Availability
Composition, (including
Finished Product Demanded Price Report Date
Specification / Pack size
875. M/s. Wilson WILTRIL TABLETS Form 5 Entresto Tablet of
Pharmaceuticals,387- 49/51mg Novartis pharms,
388, I-9, Industrial Dairy No.27962 USFDA
Area, Islamabad. Each film coated tablet dated 16-08- Sacuvan tablets
contains: 2018 49/51mg of GETZ
Sacubitril……..49mg pharma
Valsartan…..…51mg Rs.20,000/- Sovel Tablets of
Neprilysin inhibitor/ dated 19-07- 49/51mg of
Angiotensin II receptor 2018 pharmEvo
blocker GMP Inspection
Manufacturer’s 14’s, 28’s ; As conducted on 24-
specification per SRO 01-2018
Alu-Alu Blister concluded that the
firm was operating
at a very good
level of GMP
compliance at the
time of inspection.
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 6 months
No. of Batches 03
No.
1. COA of API. Copy of COA (batch #20170203) from M/s Zhuhai
Rundu Pharmaceutical Co., Ltd, China is submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate (certificate No.
country of origin or GMP certificate of API GD20170777) issued by China Food & Drugs
manufacturer issued by regulatory authority of Administration, China. It is valid until 24-12-2022.
country of origin.
3. Protocols followed for conduction of stability Yes

etc.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice
dated 14-06-2017 attested by ADC, DRAP,
Islamabad
6. All provided documents will be attested (name, Yes
sign and stamp) for ensuring authenticity of
data / documents.
Rules, 1978.
● The firm has submitted 06 months Accelerated and 06 months Real Time Stability Data for 03 Batches.
its 278th Meeting:
form conducted during last two Industrial Area, Islamabad. Manufacturer will place first three
years. production batches on long term stability studies throughout
2. Documents for the procurement Copy of commercial invoice has been submitted attested by ADC,
of API with approval from DRAP Islamabad.
DRAP (in case of import).
3. Documents for the procurement The firm has submitted copies of invoices for the procurement of
of reference standard and following working standard substances:
impurity standards. Sacubitril sodium: 99.4 %
Valsartan : 100 %
issued by regulatory authority of China issued by China Food & Drug Administration, China valid
qualification
6. Certificate of analysis of the API,  Copy of COA of API (Batch # 20170203) from M/s Zhuhai
reference standards and impurity Rundu Pharmaceutical Co., Ltd, China has been submitted.
standards  Copy of COA of reference standard has been submitted
submitted.
7. Documents for the procurement The firm has submitted photocopy of Commercial invoices/COAs
of excipients used in product of all the excipients used in the formulation of applied product
development?
8. List of qualified staff involved in The firm has submitted List of qualified staff involved in R&D
product development with department.
Production Data
the development & stability Development of WILTRIL TABLETS 49/51mg”.
Trial # 01 1500 tablets 11-2017
Trial # 02 1500 tablets 11-2017
Trial # 03 1500 tablets 11-2017
11. Record of remaining quantities of Trial No Total no. of Tablets Tablets Remaining
stability batches. For stability testing used for Quantities
testing of tablets
Trial # 01 1288 394 894
Trial # 02 1216 332 884
Trial # 03 1288 376 912
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for
temperature and humidity Accelerated stability chamber from 10-10-2017 to 31-07-2018 and
monitoring of stability chambers for Real Time stability chamber starting from 01-11-2017 to 31-
(real time and accelerated) 07-2018.
14. Method used for analysis of FPP The firm has submitted photocopy of Finished Product Testing
& complete record of testing of Procedure for “WILTRIL TABLETS 49/51mg” along with
stability batches (i.e. Stability Study Reports.
data sheets etc.)
15. Reports of stability studies of The firm has submitted photocopy of 06 Months Accelerated and
API from manufacturer. 24 Months Real Time Stability Study Data of 03 Batches of
Ltd, China.
studies.
dissolution data. media including pH 1.2, pH 4.5 and pH 6.8 buffers with Entresto
Tablets 49/51mg manufactured by M/S. Novartis Pharmaceuticals,
Canada with Batch No.FX000105. The firm‘s product results are
comparable to that of the innovator product.
19. Compliance Record of HPLC Audit trail on testing reports of Wiltril Tablet 49/51mg from 14-
software 21CFR & audit trail 11-2017 to 21-06-2018 was submitted by the firm.

No. Manufacturer / (Proprietary Name + Initial Diary & Availability / Local
Applicant Dosage Form + Strength), Date, Fee Availability
Pharmacological Group, differential GMP Inspection
Finished Product fee), Report Date
Specification Demanded
Price / Pack
size
876. M/s. Wilson WILTRIL TABLETS Form 5 Entresto Tablet of
Pharmaceuticals,387- 97/103mg Novartis pharms,
388, I-9, Industrial Dairy USFDA
Area, Islamabad. Each film coated tablet No.27963 Sacuvan tablets
contains: dated 16-08- 97/103mg of
Sacubitril……..97mg 2018 GETZ pharma
Valsartan….…103mg
Neprilysin inhibitor/ Rs.20,000/- Sovel Tablets of
Angiotensin II receptor dated 19-07- 97/103mg of
blocker 2018 pharmEvo
Manufacturer’s GMP Inspection
specification 14’s, 28’s ; As conducted on 24-
per SRO 01-2018
Alu-Alu concluded that the
Blister firm was
operating at a
very good level of
GMP compliance
at the time of
inspection.
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 6 months
No. of Batches 03
No.
1. COA of API. Copy of COA (batch #20170203) from M/s
Zhuhai Rundu Pharmaceutical Co., Ltd, China
is submitted.
2. Approval of API by regulatory authority of country Copy of GMP certificate (certificate No.
of origin or GMP certificate of API manufacturer GD20170777) issued by China Food & Drugs
issued by regulatory authority of country of origin. Administration, China. It is valid until 24-12-
2022.

invoice dated 14-06-2017 attested by ADC,
DRAP, Islamabad
documents.
1978.
its 278th Meeting:
inspection for instant dosage form (Sofosbuvir 400mg) tablets by M/s Wilson Pharmaceuticals, I-
conducted during last two years. 9 Industrial Area, Islamabad. Manufacturer will place first
three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for
six months.
 Audit trail on the testing reports was available and
confirmed for Saferon (Sofosbuvir 400mg) Tablet.
2. Documents for the procurement of Copy of commercial invoice has been submitted attested by
API with approval from DRAP (in ADC, DRAP Islamabad.
case of import).
3. Documents for the procurement of The firm has submitted copies of invoices for the procurement
reference standard and impurity of following working standard substances:
standards. Sacubitril sodium: 99.4 %
Valsartan : 100 %
certificate of API manufacturer No.GD20170777) for M/s Zhuhai Rundu Pharmaceutical Co.,
issued by regulatory authority of Ltd, China issued by China Food & Drug Administration,
country of origin. China valid upto 24-12-2022.
qualification
6. Certificate of analysis of the API,  Copy of COA of API (Batch # 20170203) from M/s
reference standards and impurity Zhuhai Rundu Pharmaceutical Co., Ltd, China has been
standards submitted.
 Copy of COA of reference standard has been submitted
submitted.
excipients used in product invoices/COAs of all the excipients used in the formulation of
development? applied product
product development with relevant department.
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of “Protocols/SOP for the
development & stability testing of Development of WILTRIL TABLETS 97/103mg”.
trial batches.
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing
of three stability batches. Records of following 03 Batches:
Trial # 01 1500 tablets 11-2017
Trial # 02 1500 tablets 11-2017
Trial # 03 1500 tablets 11-2017
testing of tablets
Trial # 01 1260 394 866
Trial # 02 1288 376 912
Trial # 03 1260 376 884
QA / QC DATA
temperature and humidity monitoring Accelerated stability chamber from 10-10-2017 to 31-07-2018
of stability chambers (real time and and for Real Time stability chamber starting from 01-11-2017
accelerated) to 31-07-2018.
13. Method used for analysis of API The firm has submitted photocopy of Raw Material
along with COA. Specifications, Raw Material Testing Procedures along with
COAs for Sacubitril/Valsartan Complex.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product Testing
complete record of testing of stability Procedure for “WILTRIL TABLETS 97/103mg” along with
batches (i.e. chromatograms, lab Stability Study Reports.
15. Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated
from manufacturer. and 24 Months Real Time Stability Study Data of 03 Batches
of Sacubitril/Valsartan from M/s Zhuhai Rundu Pharmaceutical
Co., Ltd, China.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports of
excipients used.
studies.
18. Record of comparative dissolution The firm has performed comparative dissolution studies in
data. three media including pH 1.2, pH 4.5 and pH 6.8 buffers with
Entresto Tablets 49/51mg manufactured by M/S. Novartis
Pharmaceuticals, Canada with Batch No.FX00075. The firm‘s
product results are comparable to that of the innovator product.
19. Compliance Record of HPLC Audit trail on testing reports of Wiltril Tablet 49/51mg from
software 21CFR & audit trail reports 22-11-2017 to 21-06-2018 was submitted by the firm.
on product testing.

Sr. Name & Address Brand Name Type of Form, International Availability Remarks
No. of Manufacturer / (Proprietary Name + Initial Diary & / Local Availability
Strength), Composition, (including GMP Inspection Report
Pharmacological Group, differential fee), Date
877. M/s. Scotmann Sacuval Tablets Form 5 Entresto Tablet of
Pharmaceuticals, 97/103mg Novartis pharms,
5D, I-10/3, Dairy No.31418 USFDA
Industrial Area, Each film coated tablet dated 18-09-2018
Sacuvan tablets
Islamabad. contains:
97/103mg of GETZ
Sacubitril……..97mg Rs.20,000/-
pharma
Valsartan……103mg dated 17-09-2018
Sovel Tablets of
Angiotensin II receptor
97/103mg of pharmEvo
blocker 4×5’s, 4×7’s; As
The firm was granted
Manufacturer’s per SRO
GMP certificate based
specification Alu-Alu/Alu-
on inspection conducted
PVC/ Jar Bottles
on 17-10-2018.
Drug Sacuval Tablets 97/103mg
Name of Manufacturer M/s. Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 26 (weeks)
Real Time: 26 (weeks)
Frequency Accelerated: 0,1,3,4,6,8,12,16,20,24,26 (weeks)
Real Time: 0,1,3,4,6,8,12,16,20,24,26 (weeks)
No. of Batches 03
No.
1. COA of API. Copy of COA (batch #20170203) from
M/s Zhuhai Rundu Pharmaceutical Co.,
Ltd, China is submitted.
2. Approval of API by regulatory authority of country of origin Copy of GMP certificate (certificate
or GMP certificate of API manufacturer issued by regulatory No. GD20170777) issued by China
authority of country of origin. Food & Drugs Administration, China is
submitted. It is valid until 24-12-2022.
3. Protocols followed for conduction of stability study and Yes
details of tests.
documents like chromatograms, laboratory reports, data
sheets etc.
commercial invoice dated 14-06-2017
attested by ADC, DRAP, Islamabad
6. All provided documents will be attested (name, sign and Yes
● The firm has submitted 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 Batches.
its 278th Meeting:
Date of submission: 18-09-2018 vide diary no. 31419.
1. Reference of last onsite panel Registration Board decided to approve registration of “DASCOT
inspection for instant dosage form 30 mg Tablets (Daclatasvir 30 mg)” & “DASCOT 60 mg Tablets
conducted during last two years. (Daclatasvir 60 mg)” as well as VELSCOT 400mg/100mg Tablet
by M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area,
Islamabad. Manufacturer will place first three production batches
on long term stability studies throughout proposed shelf life and on
 The firm has demonstrated all audit trail reports for DASCOT
30 & 60mg tablet.
2. Documents for the procurement of Copy of commercial invoice has been submitted attested by ADC,
API with approval from DRAP (in DRAP Islamabad.
case of import).
3. Documents for the procurement of The firm has submitted copies of invoices for the procurement of
reference standard and impurity following working standards:
standards. Sacubitril sodium: 99.4 %
Valsartan Related compound C: 92 %
Valsartan : 100 %
issued by regulatory authority of China issued by Zhuhai Food & Drug Administration, Guangdong
country of origin. Province, China valid upto 24-12-2022.
qualification
6. Certificate of analysis of the API,  Copy of COA of API (Batch # 20170203) from M/s Zhuhai
reference standards and impurity Rundu Pharmaceutical Co., Ltd, China has been submitted.
submitted.
7. Documents for the procurement of The firm has submitted photocopy of Commercial invoices/COAs
excipients used in product of all the excipients used in the formulation of applied product
development?
product development with department.
Production Data
development & stability testing of Development of Sacuval Tablets 97/103mg”.
trial batches.
Trial # 01 1500 tablets 08-2017
Trial # 02 1500 tablets 08-2017
Trial # 03 1500 tablets 08-2017
testing of tablets
Trial # 01 920 736 184
Trial # 02 920 736 184
Trial # 03 920 736 184
QA / QC DATA
monitoring of stability chambers for Real Time stability chamber starting from 05-09-2017 to 08-
(real time and accelerated) 06-2018
14. Method used for analysis of FPP The firm has submitted photocopy of Finished Product Testing
& complete record of testing of Procedure for Sacuval Tablets 97/103mg along with Stability
stability batches (i.e.Study Reports.
data sheets etc.)
15. Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated and
from manufacturer. 18 Months Real Time Stability Study Data of 03 Batches of
Ltd, China.
17. Drug-excipients compatibility The firm has reported “not found” results under the heading of
studies. physical and chemical incompatibilities referring to the handbook
of pharmaceutical excipients. Moreover, the qualitative
composition of applied formulation is different from that of
innovator.
18. Record of comparative dissolution The firm has performed comparative dissolution studies in three
data. media including pH 1.2, pH 4.5 and pH 6.8 buffers with Entresto
Tablets 97/103mg manufactured by M/S. Novartis Europharn
Limited with Batch No.FX000075. The firm‘s product results are
comparable to that of the comparator product.
19. Compliance Record of HPLC Audit trail on testing reports of Sacubitril/Valsartan from 14-09-
software 21CFR & audit trail 2017 to 08-06-2018 was submitted by the firm.
Decision: Registration Board decided to approve registration of “Sacuval Tablet 97/103mg by M/s.
Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.” Manufacturer will place first
three production batches on long term stability studies throughout proposed shelf life and on
Sr. No. Name & Address of Brand Name Type of Form, International Availability /
Manufacturer / (Proprietary Name + Initial Diary & Date, Local Availability
Strength), Composition, differential fee), GMP Inspection Report Date
Pharmacological Group, Demanded Price / Remarks
Finished Product Pack size
Specification
878. M/s. Wilson Dap-Tab 5mg Tablets Form 5 Farxiga tablet-USFDA
Pharmaceuticals,387- approved
388, I-9, Industrial Each film coated tablet Dairy No.32161
Area, Islamabad. contains: dated 26-09-2018 Diyacon tablet of CCL
Dapagliflozin as Pharma
propanediol Rs.20,000/- dated Dapa Tablets of Hilton
monohydrate 07-09-2018 Pharma
……………....5mg
Sodium Glucose Co- As per SRO GMP Inspection conducted
transporter 2 Inhibitors on 24-01-2018 concluded
Manufacturer’s that overall, the firm was
specification found to be operating at a
very good level of GMP
compliance at the time of
inspection.
Drug Dap-Tab 5mg Tablets
Name of Manufacturer M/s. Wilson Pharmaceuticals,387-388, I-9, Industrial Area, Islamabad.
Manufacturer of API M/s Zhejiang Huayi Pharmaceutical Co., Ltd, China
API Lot No. C017-51703001
Description of Pack Film Coated tablets blistered in Alu Alu strip, packed in card box unit
(Container closure system) carton of 14’s & 28’s Tablets
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 06 (months)
Real Time: 06 (months)
Frequency Accelerated: 0,1,2,3,4,6 (Months)
Real Time: 0,3,6 (Months)
Batch No. Trial #02 Trial #03 Trial
#04
Batch Size 1500 tablets 1500 tablets 1500
tablets
Date of Initiation January-2018 January-2018 January-
2018
No. of Batches 03
No.
1. COA of API. Copy of COA (Batch # C017-51703001) from
M/s Zhejiang Huayi Pharmaceutical Co., Ltd,
China is submitted.
2. Approval of API by regulatory authority of country Copy of GMP certificate for M/s Zhejiang
of origin or GMP certificate of API manufacturer Huayi Pharmaceutical Co., Ltd, China issued
issued by regulatory authority of country of origin. by State Food and Drug Administration has
been provided. It is valid until 30-12-2018.

invoice attested by ADC, DRAP, Islamabad
dated 16-08-2017.
documents.
1978.
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by the Registration Board in its 278 th
Meeting:
form conducted during last Industrial Area, Islamabad. Manufacturer will place first three
two years. production batches on long term stability studies throughout
2. Documents for the
procurement of API with The firm has submitted copy of commercial invoice attested by
approval from DRAP (in case ADC, DRAP, Islamabad dated 16-08-2017.
of import).
3. Documents for the The firm has submitted copy of receipt from Morgan Chemicals,
procurement of reference Karachi which shows that Dapagliflozin Propanediol Monohydrate
standard and impurity working standard has been procured from Zheijiang Huayi
standards. Pharmaceutical Co., Ltd, China.
4. Approval of API/ DML/GMP Copy of GMP certificate for M/s Zhejiang Huayi Pharmaceutical
certificate of API Co., Ltd, China issued by Zheijiang provincial Food and Drug
manufacturer issued by Administration has been provided. It is valid until 30-12-2018.
regulatory authority of
country of origin.
qualification
6. Certificate of analysis of the  Copy of COA (Batch # C017-51703001) from M/s Zhejiang
API, reference standards and Huayi Pharmaceutical Co., Ltd, China is submitted.
impurity standards  Copy of COA of reference standard has been submitted
 However, COAs of impurity standard has not been submitted.
7. Documents for the The firm has submitted photocopies of invoices/COAs of the
procurement of excipients excipients used in the formulation of applied product.
used in product development?
8. List of qualified staff involved The firm has submitted List of qualified staff involved in product
in product development with development section.
Production Data
the development & stability Development of Dapagliflozin Tablet 5mg”.
10. Complete batch The firm has submitted photocopy of Batch Manufacturing Records
manufacturing record of three of following 03 Batches:
stability batches. Batch No. Batch Size Mfg. Date
Trial # 02 1500 tablets 12-2017
Trial # 03 1500 tablets 01-2018
Trial # 04 1500 tablets 01-2018
11. Record of remaining
quantities of stability batches. Trial No Total no. of Tablets Remaining
Tablets placed in used for Quantities
stability chamber testing of tablets
Trial # 02 808 224 584
Trial # 03 808 224 584
Trial # 04 808 224 584
QA / QC DATA
12. Record of Digital data logger Firm has submitted photocopies of data logger record for
for temperature and humidity Accelerated stability chamber from 12-02-2018 to 31-08-2018 and
monitoring of stability for Real Time stability chamber from 31-01-2018 to 31-08-2018.
chambers (real time and
accelerated)
13. Method used for analysis of The firm has submitted photocopy of Raw Material Specifications,
API along with COA. Raw Material Testing Procedures along with COAs for
Dapagliflozin Propanediol Monohydrate.
14. Method used for analysis of The firm has submitted photocopy of Finished Product Testing
FPP & complete record of Procedure for Dap Tab Tablets 5mg along with Stability Study
testing of stability batches (i.e. Reports.
chromatograms, lab reports,
15. Reports of stability studies of The firm has submitted photocopy of 06 Months Accelerated and 24
API from manufacturer. Months Real Time Stability Study Data of 03 Batches of
Dapagliflozin Propanediol Monohydrate from M/s Zhejiang Huayi
Pharmaceutical Co., Ltd, China.
17. Drug-excipients compatibility The firm has stated that the ingredients used in the formulation are
studies. similar to innovator brand.
dissolution data. media including pH 1.2, pH 4.5 and pH 6.8 buffers with Farxiga
Tablets 5mg manufactured by Astrazeneca Pharmaceuticals LP,
Ireland. The firm‘s product results are comparable to that of the
comparator product.
19. Compliance Record of HPLC Audit trail on testing reports of Dapagliflozin Tablet 5mg from 04-
software 21CFR & audit trail 12-2017 to 27-07-2018 was submitted by the firm.
Decision: Registration Board decided to approve registration of “Dap-Tab 5mg Tablet by M/s. Wilson
Pharmaceuticals,387-388, I-9, Industrial Area, Islamabad”. Manufacturer will place first three
production batches on long term stability studies throughout proposed shelf life and on accelerated
Sr. Name & Address of Brand Name Type of Form, International Availability /
No Manufacturer / (Proprietary Name + Initial Diary & Date, Fee Local Availability
. Applicant Dosage Form + Strength), (including differential
Composition, fee), GMP Inspection Report Date
Pharmacological Group, Demanded Price / Pack Remarks
Finished Product size
Specification
879. M/s. Wilson Dap-Tab 10mg Tablets Form 5 Farxiga tablet-USFDA
Pharmaceuticals,387- approved
388, I-9, Industrial Each film coated tablet Dairy No.32162 dated Diyacon 10mg tablet of
Area, Islamabad. contains: 26-09-2018 CCL Pharma
Dapagliflozin as Dapa 10mg Tablets of
propanediol monohydrate Rs.20,000/- dated 07- Hilton Pharma
……………....10mg 09-2018
Sodium Glucose Co- GMP Inspection conducted
transporter 2 Inhibitors As per SRO on 24-01-2018 concluded
Manufacturer’s that overall, the firm was
specification found to be operating at a
very good level of GMP
compliance at the time of
inspection.
Drug Dap-Tab 10mg Tablets
Manufacturer of API M/s Zhejiang Huayi Pharmaceutical Co., Ltd, China.
API Lot No. C017-51703001
Description of Pack Film Coated tablets blistered in Alu Alu strip, packed in card box unit
(Container closure system) carton of 14’s & 28’s Tablets
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 06 (months) Real Time: 06 (months)
Frequency Accelerated: 0,1,2,3,4,6 (Months) Real Time: 0,3,6 (Months)
Date of Initiation February-2018 February-2018 February-2018
No. of Batches 03
1. COA of API. Copy of COA (Batch # C017-
51703001) from M/s Zhejiang Huayi
Pharmaceutical Co., Ltd, China is
submitted.
2. Approval of API by regulatory authority of country of origin or Copy of GMP certificate for M/s
GMP certificate of API manufacturer issued by regulatory Zhejiang Huayi Pharmaceutical Co.,
authority of country of origin. Ltd, China issued by Zheijiang
provincial Food and Drug
Administration has been provided. It
is valid until 30-12-2018.
3. Protocols followed for conduction of stability study and details of Yes
tests.
documents like chromatograms, laboratory reports, data sheets
etc.
commercial invoice attested by ADC,
DRAP, Islamabad dated 16-08-2017.
6. All provided documents will be attested (name, sign and stamp) Yes
for ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till assigned Yes
shelf life of the product.
● The firm has submitted 06 months Accelerated and 06 months Real Time Stability Data of 03 Batches.
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by Registration Board in 278th Meeting:
inspection for instant dosage form (Sofosbuvir 400mg) tablets by M/s Wilson Pharmaceuticals, I-9
conducted during last two years. Industrial Area, Islamabad. Manufacturer will place first three
production batches on long term stability studies throughout
2. Documents for the procurement of
The firm has submitted copy of commercial invoice attested by
API with approval from DRAP (in
ADC, DRAP, Islamabad dated 16-08-2017.
case of import).
3. Documents for the procurement of The firm has submitted copy of receipt from Morgan Chemicals,
reference standard and impurity Karachi which shows that Dapagliflozin Propanediol Monohydrate
standards. working standard has been procured from Zheijiang Huayi
4. Approval of API/ DML/GMP Copy of GMP certificate for M/s Zhejiang Huayi Pharmaceutical
certificate of API manufacturer Co., Ltd, China issued by Zheijiang Provincial Food and Drug
issued by regulatory authority of Administration has been provided. It is valid until 30-12-2018.
country of origin.
qualification
6. Certificate of analysis of the API,  Copy of COA (Batch # C017-51703001) from M/s Zhejiang
reference standards and impurity Huayi Pharmaceutical Co., Ltd, China is submitted.
 However, COAs of impurity standard has not been submitted.
7. Documents for the procurement of The firm has submitted photocopies of invoices/COAs of the
excipients used in product excipients used in the formulation of applied product.
development?
8. List of qualified staff involved in The firm has submitted List of qualified staff involved in product
experience.
Production Data
development & stability testing of Development of Dap-Tab Tablet 10mg”.
trial batches.
Trial # 01 1500 tablets 01-2018
Trial # 02 1500 tablets 02-2018
Trial # 03 1500 tablets 02-2018
stability batches. placed in stability used for Quantities
chamber testing of tablets
Trial # 01 808 224 584
Trial # 02 808 224 584
Trial # 03 808 224 584
QA / QC DATA
monitoring of stability chambers for Real Time stability chamber from 01-01-2018 to 30-06-2018.
(real time & accelerated)
Dapagliflozin Propanediol Monohydrate.
complete record of testing of Procedure for Dap Tab Tablets 10mg along with Stability Study
stability batches (i.e. Reports.
chromatograms, lab reports, raw data
sheets etc.)
15. Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated and
from manufacturer. 24 Months Real Time Stability Study Data of 03 Batches of
Dapagliflozin Propanediol Monohydrate from M/s Zhejiang Huayi
excipients used.
17. Drug-excipients compatibility The firm has stated that the ingredients used in the formulation are
studies. similar to innovator brand.
18. Record of comparative dissolution The firm has performed comparative dissolution studies in three
data. media including pH 1.2, pH 4.5 and pH 6.8 buffers with Farxiga
Tablets 10mg (NX490) manufactured by Astrazeneca
Pharmaceuticals LP, Iirndianam‘s product results are comparable to
that of the comparator product.
19. Compliance Record of HPLC Audit trail on testing reports of Dapagliflozin Tablet 5mg from 30-
software 21CFR & audit trail reports 01-2018 to 16-08-2018 was submitted by the firm.
on product testing.
Decision: Registration Board decided to approve registration of “Dap-Tab 10mg Tablet by M/s. Wilson
Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad”. Manufacturer will place first three
production batches on long term stability studies throughout proposed shelf life and on accelerated
No Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision / Remarks
Applicant Dosage Form + Strength), Date, Fee Local Availability (if any)
Finished Product Demanded Price Report Date &
Specification / Pack size Remarks
880. M/s. Scotmann ADDRESS PLUS Form 5D Byvalson of M/s The firm has
Pharmaceuticals, TABLETS 5mg/80mg Allergan sales, claimed
5D, I-10/3, Each film coated tablet Dairy No.31416 USFDA Manufacturer’s
Industrial Area, contains: 18-09-2018 Specifications.
Islamabad. Nebivolol HCl eq. to The firm was
Nebivolol……..5mg Rs.50,000/- granted GMP
Valsartan…………...80mg 17-08-2018 certificate based
Beta-adrenoceptor on inspection
blocker, Angiotensin 2 3×10’s, 4×7’s, conducted on 17-
receptor blocker & 8×15’s ; As 10-2018.
Manufacturer’s specs per SRO
Drug ADDRESS PLUS TABLETS 5mg/80mg
Name of Manufacturer M/s. Scotmann Pharmaceuticals,5D,I-10/3,Industrial Area, Islamabad.
Manufacturer of API Valsartan: M/s. Zhejiang Tianyu Pharmaceuticals Co. Ltd. China
Nebivolol HCl: M/s. Cadila Pharmaceuticals Ltd, 294, G.I.D.C,
Estate Ankleshawar- 3293002, Gujarat India.
API Lot No. Valsartan: 10230-161105
Nebivolol HCl: 17NV007
Description of Pack Alu/Alu Blister packed in unit carton
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months Real Time: 06 Months
Frequency Accelerated: 0,1,2,3,4,6 (Months) Real Time: 0,3,6 (Months)
Batch No. Trial#01 Trial#02` Trial#03
No. of Batches 3
1. COA of API Valsartan: Copy of COA from M/s Zhejiang Tiianyu
Pharmaceuticals, China is submitted
Nebivolol HCl: Copy of COA from M/s Cadila Pharmaceuticals
Ltd, India is submitted.
2. Approval of API by regulatory authority Valsartan: Copy of GMP of M/s Zhejiang Tianyu
of country of origin or GMP certificate Pharmaceuticals, China (Certificate No. ZJ20130111) issued by
of API manufacturer issued by State Food and Drug Administration, China has been submitted. It
regulatory authority of country of is valid until 09-12-2018.
origin. Nebivolol HCl: Copy of GMP of M/s Cadila Pharmaceuticals
Certificate No.1806867 issued by Food & Drug control
Administration, Gujarat state. India is submitted. The certificate
was valid until 20-06-2018. Now the validity is further extended
until 20-12-2018.
sheets etc.
5. Documents confirming import of API Valsartan: Copy of ADC DRAP Islamabad attested dated: 19-04-
etc. 2017 Commercial Invoice No TYI17234 Dated: 05-04-2017 issued
by M/s Zhejiang Tianyu Pharmaceuticals Ltd, China is submitted.
Nebivolol HCl: Copy of ADC DRAP, Islamabad attested dated:
23-06-2017 Commercial Invoice No CPL/BD/120/17-18 Dated:
12-06-2017 issued by M/s Cadila Pharmaceuticals Ltd, India is
submitted.
7. Commitment to continue real time Yes
stability study till assigned shelf life of
the product.
8. Commitment to follow Drug Yes
● The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Batches.
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
1. Reference of last onsite panel inspection for Registration Board decided to approve registration of
instant dosage form conducted during last “DASCOT 30 mg Tablets (Daclatasvir 30 mg)” & “DASCOT
two years. 60 mg Tablets (Daclatasvir 60 mg)” as well as VELSCOT
400mg/100mg Tablet by M/s Scotmann Pharmaceuticals, 5-D,
I-10/3, Industrial Area, Islamabad. Manufacturer will place first
three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six
months.
 The firm has demonstrated all audit trail reports for
DASCOT 30 & 60mg tablet as well as for VELSCOT
tablet.
2. Documents for the procurement of API with Valsartan: Copy of ADC DRAP Islamabad attested dated: 19-
approval from DRAP (in case of import). 04-2017 Commercial Invoice No TYI17234 Dated: 05-04-2017
issued by M/s Zhejiang Tianyu Pharmaceuticals Ltd, China is
submitted.
Nebivolol HCl: Copy of ADC DRAP, Islamabad attested
dated: 23-06-2017 Commercial Invoice No CPL/BD/120/17-18
Dated: 12-06-2017 issued by M/s Cadila Pharmaceuticals Ltd,
India is submitted.
3. Documents for the procurement of Nebivolol HCl: The firm has submitted invoice of working
reference standard and impurity standards. standard (10gm; Invoice No: CPL/BD/227/17-17) from M/s.
Cadila Pharmaceuticals Ltd, India.
Valsartan: The firm has submitted invoice of working standard
(10gm; Invoice No. CPL/BD/227/17-17) from M/s. Zhejiang
Tianyu Pharmaceutical Co., Ltd. China.
4. Approval of API/ DML/GMP certificate of Valsartan: Copy of GMP of M/s Zhejiang Tianyu
API manufacturer issued by regulatory Pharmaceuticals, China (Certificate No. ZJ20130111) issued by
authority of country of origin. State Food and Drug Administration, China has been submitted.
It is valid until 09-12-2018.
Nebivolol HCl: Copy of GMP of M/s Cadila Pharmaceuticals
Certificate No.1806867 issued by Food & Drug control
Administration, Gujarat state. India is submitted. The certificate
was valid until 20-06-2018. Now the validity is further
extended until 20-12-2018.
5. Mechanism for Vendor pre-qualification The firm has submitted detailed procedure for Vendor
qualification and evaluation within organization.
6. Certificate of analysis of the API, reference Valsartan: The firm has submitted copy of COA of API and
standards and impurity standards working standards from M/s Zhejiang Tiianyu Pharmaceutical
which are as follows:
Valsartan Secondary standard…....99.5%
Valsartan impurity A…………….99.9%
Valsartan impurity B…………….98.3%
Valsartan impurity C…………….99.0%
Nebivolol HCl: Copy of COA of API and working standard
from M/s Cadila Pharmaceuticals Ltd is submitted.
excipients used in product development? invoices/COAs of the excipients used in the formulation of
applied product
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in R&D
development with relevant experience. department.
Production Data
development & stability testing of trial Development of Valsartan/Nebivolol HCl Tablets 80/5mg” and
batches. stability protocols for Address plus tablets 5/80mg.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing
three stability batches. Records of following 03 Batches:
Trial#01 1500 tablets 11-2017
11. Record of remaining quantities of stability Trial No Tablets Tablets used Remaining
batches. for for stability Quantities
Blistering testing of tablets
Trial#01 420Tabs 224Tabs 196Tabs
Trial#02 420 Tabs 224Tabs 196Tabs
Trial#03 420 Tabs 224 Tabs 196Tabs
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for Real
temperature and humidity monitoring of Time stability chamber starting from 01-11-2017 to 25-05-2018
stability chambers (real time and and accelerated stability chamber starting from 01-11-2017 to
accelerated) 25-05-2018.
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material
COA. Specifications, Raw Material Testing Procedures along with
COAs for Valsartan and nebivolol HCl.
complete record of testing of stability Procedure for Address Plus Tablets 5/80mg along with Stability
batches (i.e. chromatograms, lab reports, Study Reports.
15. Reports of stability studies of API from Valsartan: The firm has submitted photocopy of 06 Months
manufacturer. Accelerated (40oC±2oC/75%±5% RH) and 24 Months Real
Time Stability Study Data (30oC±2oC/65%±5% RH) of 03
Batches of Valsartan from M/s Tianyu Pharm, China.
Nebivolol HCl: The firm has submitted photocopy of 06
Months Accelerated (40oC±2oC/75%±5% RH) and 60 Months
Real Time Stability Study Data (30oC±2oC/65%±5% RH) of 03
Batches of Nebivolol HCl from M/s Cadila Pharmaceuticals,
India.
excipients used.
17. Drug-excipients compatibility studies. The firm has reported “not found” results under the heading of
physical and chemical incompatibilities referring to the
handbook of pharmaceutical excipients. Moreover, the
qualitative composition of applied formulation is different from
that of innovator.
18. Record of comparative dissolution data. The firm has performed comparative dissolution studies in three
media including pH 1.2, pH 4.5 and pH 6.8 buffers with
Byvalson 5/80mg Tablets (Lot#W00551) distributed by
Allergan USA, Inc. The firm‘s product results are comparable
to that of the comparator product.
19. Compliance Record of HPLC software Audit trail on testing reports of Address Plus Tablet 5/80mg
21CFR & audit trail reports on product from 21-11-2017 to 25-05-2018 was submitted by the firm.
testing.
● The firm has procured Valsartan from M/s Zhejiang Tianyu Pharmaceuticals, China.
● EMA has updated on medicines containing valsartan from Zhejiang Tianyu, China.
“Company no longer authorised to manufacture valsartan active substance for EU medicines due to presence
of NDMA”.
https://www.ema.europa.eu/documents/press-release/update-medicines-containing-valsartan-zhejiang-
tianyu_en.pdf
Decision: Registration Board decided to approve registration of “ADDRESS PLUS TABLETS 5mg/80mg by
M/s. Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.” Manufacturer will place first
three production batches on long term stability studies throughout proposed shelf life and on accelerated
No. Manufacturer / (Proprietary Name + Initial Diary & Availability /
Applicant Dosage Form + Date, Fee Local
Strength), Composition, (including Availability
Pharmacological Group, differential fee),
Finished Product Demanded Price / GMP Inspection
Specification Pack size Report Date
881. M/s Genome Arcox 90mg Tablets Form 5 ARCOXIA® 90 Deferred for
Pharmaceuticals, Each film coated tablet 18-6-2012 mg film-coated evidence of me-too
Hattar. contains:- Dy No. 488 tablets -MHRA status.
Etoricoxib Rs.8000/- GMP inspection (M-264)
…….90mg Rs.12,000/- conducted on
26-11-2014 12-05-2018
(NSAID) 10’s showed good
As Per SRO level of
Manufacturer’s Specs compliance.
Drug Arcox 90mg Tablets
Name of Manufacturer M/s Genome Pharmaceuticals, Hattar
Manufacturer of API M/s Kekule Pharma Limited, Telangana state, India
API Lot No. ACE12917
Description of Pack 10’s; Alu-Alu Blister pack
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 06 (months) Real Time: 06 (months)
Frequency Accelerated: 0,1,2,3,4,6 (Months) Real Time: 0,1,2,3,6 (Months)
Batch No. ARCX-01 ARCX-02 ARCX-03
No. of Batches 03
No.
1. COA of API. Copy of COA from M/s Kekule Pharma Limited,
Telangana state, India is submitted.
2. Approval of API by regulatory authority of country of Copy of GMP certificate for M/s Kekule Pharma
origin or GMP certificate of API manufacturer issued by Limited, Telangana state, India issued by Drug
regulatory authority of country of origin. Control Administration, Government of
Telangana, India has been provided. It is valid
until 30-03-2017.
3. Protocols followed for conduction of stability study and Yes
details of tests.
invoice attested by ADC, DRAP, Peshawar dated
19-09-2017.
6. All provided documents will be attested (name, sign and Yes
● The firm has submitted 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 Batches.
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
1. Reference of last onsite panel inspection for Registration Board approved registration of Metolazone 5
instant dosage form conducted during last two mg Tablets (Metolazone USP.....5mg) applied by M/s.
years. Genome Pharmaceuticals (Pvt.) Ltd., Hattar. Manufacturer
will place first three production batches on long term
stability studies through proposed shelf life and on
 The HPLC software is 21 CFR compliant but not
activated.
 Audit trail on the testing reports cannot be made.
However, equipment log books confirm performance
of tests at required intervals.
2. Documents for the procurement of API with Copy of commercial invoice attested by ADC, DRAP,
approval from DRAP (in case of import). Peshawar dated 19-09-2017 has been submitted.
3. Documents for the procurement of reference The firm has not submitted copy of invoice of working
standard and impurity standards. standard.
4. Approval of API/ DML/GMP certificate of API Copy of GMP certificate for M/s Kekule Pharma Limited,
manufacturer issued by regulatory authority of Telangana state, India issued by Drug Control
country of origin. Administration, Government of Telangana, India has been
provided. It is valid until 30-03-2017.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API, reference  Copy of COA of API submitted.
standards and impurity standards  Copy of COA of working standard has been submitted
 Copies of COAs of impurity standard has been
submitted.
7. Documents for the procurement of excipients The firm has submitted photocopy of Commercial
used in product development? invoices/COAs of the excipients used in the formulation of
applied product.
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in
development with relevant experience. R&D department.
Production Data
9. Authorized Protocols/SOP for the development The firm has submitted photocopy of “Protocols/SOP for
& stability testing of trial batches. the Development of Arcox 90mg Tablet”.
10. Complete batch manufacturing record of three The firm has submitted photocopy of Batch
stability batches. Manufacturing Records of following 03 Batches:
ARCX-01 4000 tablets 09-17
11. Record of remaining quantities of stability
batches. Trial No Total no. Tablets Remaining
of Tablets used for Quantities
testing of tablets
ARCX-01 4000 3258 742
ARCX-02 4000 3258 742
ARCX-03 4000 3258 742
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of digital data logger
and humidity monitoring of stability chambers record for Accelerated stability chamber from 01-09-2017
(real time and accelerated) to 27-04-2018 and for Real Time stability chamber starting
from 01-09-2017 to 27-04-2018.
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material
COA. Specifications, Raw Material Testing Procedures along
with COAs for Etoricoxib.
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product
record of testing of stability batches (i.e. Testing Procedure for Etoricoxib 90mg Tablets along with
chromatograms, lab reports, raw data sheets etc.) Stability Study Reports.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months
manufacturer. Accelerated and 60 Months Real Time Stability Study Data
of 03 Batches of Etoricoxib from M/s Kekule Pharma
Limited, Telangana state, India
excipients used.
17. Drug-excipients compatibility studies. The firm has stated that “All the excipients used in the
development of Arcox 90mg Tablet are similar with
innovator product Arcoxia 90mg Tablet. The excipient
compatibility studies are performed by innovator.
Therefore the excipient compatibility studies are not
performed in our lab.
18. Record of comparative dissolution data. The firm has performed comparative dissolution studies in
0.1 N HCl dissolution medium with Arcox 90mg Tablet
manufactured by M/s. Merck sharp and Dohme Ltd (MSD)
with Batch No.M007196. The firm‘s product results are
comparable to that of the comparator product.
19. Compliance Record of HPLC software 21CFR Audit trail on testing reports of Arcox 90mg Tablet from
& audit trail reports on product testing. 27-09-2017 to 04-04-2018 was submitted by the firm.
Shortcomings communicated to the Response of the firm

firm
The submitted GMP certificate of API The firm has submitted that the supplier claimed that GMP is
manufacturer could not be verified verifiable from CENTRAL DRUGS STANDARD CONTROL
from online licensing system.ORGANIZATION.
Clarification is required. However, the GMP of API manufacturer could not be verified.
The date of initiation of stability data is
The date of initiation and implementation in of stability data is 04-
20-10-2017 while the date for 1st month 10-2017 in all three batches. But during compilation of stability
stability analysis is 04-11-2017 for schedule reports, the date is not changed and the same date is
Batch # ARCX-01. The same was repeated mistakenly in all stability reports i.e., 20-10-2017.
observed in Batches ARCX-02 & The stability reports were corrected and correct date of initiation of
ARCX-03. Clarification is required. stability study included in the schedule.
Therefore it is requested to consider the typographical error in
provided in stability data reports and allow us to submit corrected
stability schedule to become the part of this dossier.
The comparative dissolution has been The firm responded that
carried out at 0.1 N HCl dissolution “As in-vitro dissolution in 0.1 N HCl is equally fast (>85% within
media while it is required to perform at 15 minutes) for both the test and reference product in comparative
three different dissolution media. dissolution. Similarly, the dissolution test conducted at batch
Clarification is required. release also performed in 0.1N HCl.
Previous Decision: Registration Board deferred the case for following:(M-285)
 Submission of embassy attested GMP certificate of API manufacturer
 Submission of dissolution studies at 1.2 pH, 4.5 pH and 6.8 pH.
Evaluation by PEC:
The firm has informed that they have applied and they will submit the attested copy of GMP certificate at the
earliest.
The firm has performed comparative dissolution studies at pH 1.2, pH 4.5 and pH 6.8 of innovator brand
Arcoxia 90mg Tablet manufactured by M/s. Merck sharp and Dohme Ltd (MSD) with Batch No.M007196.
The firm‘s product results are comparable to that of the comparator product.
Decision: Registration Board decided to approve registration of “Arcox 90mg Tablets by M/s Genome
Pharmaceuticals, Hattar.” Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Registration Board further directed the firm to provide legalized GMP certifacte of API manufacturer
before issuance of registration letter & the Board authorized its Chairman to issue registration letter
after submission of legalized GMP certificate
Evaluator PEC-VI
Sr. Name & Address of Brand Name Type of Form, International Availability /
No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Local Availability
Applicant Form + Strength), Date, Fee
Composition, (including GMP Inspection Report
Pharmacological Group, differential fee), Date & Remarks
Finished Product Specification Demanded Price /
Pack size
882. M/s Genix Pharma, Sartril 50mg Tablets Form 5D FDA
(Pvt.) Ltd. 44,45-B Each film coated tablet 04-02-2016, Entresto Tablets
Korangi Creek, Road contains: - DY: 161 24mg+26mg,
Karachi Sacubitril ………24mg Fee: 50,000/- M/s Novartis
Valsartan……….26mg Pharmaceutical UK Ltd.
7’s, 14’s, 28’s Firm is operating
Angiotensin receptor- As per SRO at acceptable
neprilysin inhibitor level of GMP
(Manufacturer’s compliance as per
Specifications) inspection dated 16-2-2018
Drug Sartril 24mg + 26mg Tablets
M/s Genix Pharma, (Pvt.) Ltd. 44,45-B Korangi Creek, Road
Name of Manufacturer
Karachi
Manufacturer of API Nantong Chanyoo Pharmatech Co., Ltd. China
API Lot No. 201701002
Description of Pack
Alu-Alu Blister Pack
Stability Storage Condition
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Real Time: 06 months
Accelerated: 0, 1, 2,3,4 & 6 (Months)
Frequency
Real Time: 3,6 (Months)
Batch No. TR001 TR002 TR003
Date of Initiation 11-2017 11-2017 11-2017
No. of Batches 03
Sr.
Documents to Be Provided Status
No.
1. COA of API Yes
The firm has submitted GMP of M/s
Approval of API by regulatory authority of country of Nantong Chanyoo Pharmaech Co, Ltd
2. origin or GMP certificate of API manufacturer issued by China issued by Nantong Chemical and
regulatory authority of country of origin. Medical Industry Assocition. This
certificate is valid until Dec 05, 2019.
Protocols followed for conduction of stability study and
3. Yes
details of tests.
Data of 03 batches will be supported by attested
4. respective documents like chromatograms, laboratory Yes
Copy of Form 6 (License to Import drug for
5. Documents confirming import of API etc. clinical trial examination, test or analysis)
issued by ADC (Karachi) dated 19-5-2017,
for the import of Sacubitril + Valsartan (2
Kg) from the M/s Changzhou
Pharmaceutical Factory, Manufacturer by
M/s Nantong Chanyoo Pharmatech Co.,
Ltd, China has been submitted.
Copy of Commercial Invoice (invoice no.
CY117159) attested by ADC (Karachi)
dated 16-5-2017 has been submitted.
All provided documents will be attested (name, sign and
6. Yes
Commitment to continue real time stability study till
7. Yes
REMARKS OF EVALUATOR (AD PEC-VI)

1. GMP of API Certificates of the concerned manufacturer is available.
2. The firm has provided 26 weeks Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale
Batches.
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter no. RA/145/18, dated 17-07-2018 and provided the following documents in conjunction with the
checklist approved by the Registration Board in its 278th Meeting:
Reference of last onsite panel Firm has referred to onsite inspection report of their product
1. inspection for instant dosage “WYMLY Tablets 25mg (Tenofovir Alafenamide)”, which was
form conducted during last two conducted on 06-02-2018, and was presented in 281th meeting of
years. Registration Board held on 11-13th April, 2018.
Registration Board decided to approve registration of WYMLY
Tablets 25mg (Tenofovir Alafenamide)”, by M/s. Genix Pharma
(Pvt.) Ltd., Karachi.
Documents for the procurement Copy of Form 6 (License to Import drug for clinical trial
2. of API with approval from examination, test or analysis) issued by ADC (Karachi) dated 19-05-
DRAP (in case of import). 2017, for the import of Sacubitril + Valsartan (2 Kg) from the M/s
Changzhou Pharmaceutical Factory, Manufacturer by M/s Nantong
Chanyoo Pharmatech Co., Ltd, China has been submitted.
Copy of Commercial Invoice (invoice no. CY117159) dated attested
by ADC (Karachi) dated 16-05-2017 has been submitted
Documents for the procurement The firm has submitted copy of letters from
3. of reference standard and M/s Changzhou Pharmaceutical Factory in the name of M/s Genix
impurity standards. Pharma (Pvt.) Ltd, Karachi, declaring the submission of following
reference standards on behalf of their principal i.e. M/s Nantong
Chanyoo Pharmatech Co., Ltd, China.
Particulars Batch No. Quantity
Working standard WS201610001 2gm
Related Substance -- 20mg
Isomers -- 20mg
Sacubitril Hemi calcium -- 20mg
Approval of API/ DML/GMP The firm has submitted GMP of M/s Nantong Chanyoo Pharmaech
4. certificate of API manufacturer Co, Ltd China issued by Nantong Chemical and Medical Industry
issued by regulatory authority of Assocition. This certificate is valid until Dec 05, 2019.
country of origin.
Mechanism for Vendor pre- The firm has submitted photocopy of “SOP for Selection of
5. qualification manufacturer for API/Excipient and Procurement Procedure”,
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.
Version no: 01
Copy of “Vendor’s Audit form” filled for M/s Nantong Chanyoo
Pharmatech Co., Ltd, China, dated 24-02-2017.
Certificate of analysis of the Photocopy of COAs of Sacubitril +Valsartan, working standards and
6. API, reference standards and impurity standards issued by M/s Nantong Chanyoo Pharmatech Co.,
impurity standards Ltd, China.is submitted. Detail is as under
Particulars Batch no
Sacubitril + Valsartan 201701002
working standards WS201610001
Documents for the procurement The firm has submitted photocopy of Purchase Order/Invoices for the
7. of excipients used in product procurement of excipients used in product development
development?
List of qualified staff involved in The firm has submitted photocopy of List of qualified staff involved
8. product development with in product development & regulatory affairs comprising of 4
relevant experience. members.
Production Data
Authorized Protocols/SOP for The firm has submitted photocopy of Development Protocol for Lab
9. the development & stability scale batch manufacturing of Sartril 50mg Tablets.
Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Record of
10. record of three stability batches. the following 03 Batches:
BATCH NO BATCH SIZE MFG DATE
TR001 1500 Tablets 11-2017
TR002 1500 Tablets 11-2017
TR003 1500 Tablets 11-2017
Record of remaining quantities Batch No. TR001
11. of stability batches. Date Sample Balance Stability/Interval
Quantity Quantity
25-12-2017 3packs 15 Packs 1st month
24-1-2018 3 Packs 12Packs 2nd month
25-2-2018 3 Packs 9 Packs 3rd month
28-3-2018 3 packs 6 packs 4th month
Batch No. TR002
Date Sample Balance Stability/Interval
Quantity Quantity
Batch No. TR003
Quantity Quantity
24-5-2018 3 packs 16packs 6th month
QA / QC DATA
Record of Digital data logger for The firm has submitted manual record of temperature and
12. temperature and humidity humidity.
monitoring of stability chambers
(real time and accelerated)
Method used for analysis of API The firm has submitted photocopy of raw material specifications,
13. along with COA. raw material testing procedures and report for Sacubitril &
Valsartan Trisodium Hemipentahydrate (LCZ696) (batch #
201701002) along with chromatograms, FTIR spectrum, lab
reports, raw data sheets.
Method used for analysis of FPP & The firm has submitted photocopy of Finished Product Testing
14. complete record of testing of Procedure (QC-NPNS-126 issued on 09-11-2017) for Sartril 50mg
stability batches (i.e. Tablet along with Stability Study Report of stability batches.
data sheets etc.)
Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated and
15. from manufacturer. 12 Months Real Time Stability Study (25oC+2 oC, 60+5%) Data
of 03 Batches of Sacubitril & Valsartan from M/s Nantong
Chanyoo Pharmatech Co., Ltd, China
Analysis reports for excipients The firm has submitted photocopies of its own Analytical reports
16. used. for all excipients used in product development of Sartril tablets.
Drug-excipients compatibility The firm has not performed Drug-excipients compatibility studies
17. studies. and stated that the qualitative composition of their product (Sartril
Tablet) is similar to that of innovator’s product i.e. Entresto tablet
and also stability studies have not shown any incompatibility or
significant degradation.
Record of comparative dissolution Firm has submitted reports dated 17-04-2018. The details of
18. data. reference product & Sample product are as follows:
feature Reference product Product of M/S Genix
Pharma
Brand name Entresto Tablets Sartril Tablets
24mg+26mg 24mg+26mg
Batch No TK706 TR001
Expiry Date 10-2018 11-2019
Comparative dissolution studies have been performed in following
mediums:
i. pH 0.1N HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
Compliance Record of HPLC Firm has submitted audit trail reports of stability studies of applied
19. software 21CFR & audit trail formulation from 25-11-2017 to 30-05-2018
Remarks of the Evaluator: The firm has submitted manual temperature and humidity record.
Firm has submitted summary sheets of comparative dissolution study but
did not submit relevant analytical record.
Real time stability study data of API conducted as per Zone-IVA are not
provided.
Exemption case
Sr. Name & Brand Name Type of Form, International Previous

No. Address of (Proprietary Name + Initial Diary Availability / Local DRB
Manufacturer Dosage Form + Strength), & Date, Fee Availability Decision
/ Applicant Composition, (including /
Pharmacological Group, differential GMP Inspection Remarks
Finished Product fee), Report Date & (if any)
Specification Demanded Remarks
Price / Pack
size
883. M/s Genix Sartril 100mg Tablets Form 5D FDA -
Pharma, (Pvt.) Each film coated tablet 04-02-2016, Entresto Tablets
Ltd. 44,45-B contains: - DY: 160 49mg+51mg,
Korangi Sacubitril ………49mg Fee: 50,000/- M/s Novartis
Creek, Road Valsartan……….51mg Pharma UK Ltd.
Karachi 7’s, 14’s, 28’s Firm is operating at
Angiotensin receptor- As per SRO acceptable level of
neprilysin inhibitor GMP compliance as
(Manufacturer’s per inspection
Specifications) dated16-2-2018
Drug Sartril 100mg Tablets

Name of Manufacturer M/s Genix Pharma, (Pvt.) Ltd. 44,45-B Korangi Creek, Road, Karachi
API Lot No. 201701002
Description of Pack
Real Time: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0, 1, 2,3,4 & 6 (Months) Real Time: 3,6 (Months)
No. of Batches 03
 COA of API Yes
 origin or GMP certificate of API manufacturer issued by China issued by Nantong Chemical
regulatory authority of country of origin. and Medical Industry Assocition. This
 Yes
details of tests.
 respective documents like chromatograms, laboratory Yes
Copy of Form 6 (License to Import
drug for clinical trial examination, test
or analysis) issued by ADC (Karachi)
dated 19-05-2017, for the import of
Sacubitril + Valsartan (2 Kg) from the
M/s Changzhou Pharmaceutical
 Documents confirming import of API etc. Factory, Manufacturer by M/s
Nantong Chanyoo Pharmatech Co.,
Ltd, China has been submitted.
Copy of Commercial Invoice (invoice
no. CY117159) attested by ADC
(Karachi) dated 16-5-2017 has been
submitted.
 Yes
 Yes
 Commitment to follow Drug Specification Rules, 1978. Yes
(AD PEC-I)
Batches.
1. inspection for instant dosage form “WYMLY Tablets 25mg (Tenofovir Alafenamide)”, which was
conducted during last two years. conducted on 06-02-2018, and was presented in 281th meeting
of Registration Board held on 11-13th April, 2018.
Registration Board decided to approve registration of WYMLY
Tablets 25mg (Tenofovir Alafenamide)”, by M/s. Genix Pharma
(Pvt.) Ltd., Karachi.
Documents for the procurement of Copy of Form 6 (License to Import drug for clinical trial
2. API with approval from DRAP (in examination, test or analysis) issued by ADC (Karachi) dated
case of import). 19-05-2017, for the import of Sacubitril + Valsartan (2 Kg)
from the M/s Changzhou Pharmaceutical Factory, Manufacturer
by M/s Nantong Chanyoo Pharmatech Co., Ltd, China has been
submitted.
Copy of Commercial Invoice (invoice no. CY117159) dated
attested by ADC (Karachi) dated 16-05-2017 has been
submitted
Documents for the procurement of The firm has submitted copy of letters from M/s Changzhou
3. reference standard and impurity Pharmaceutical Factory in the name of M/s Genix Pharma (Pvt.)
standards. Ltd, Karachi, declaring the submission of following reference
standards on behalf of their principal i.e. M/s Nantong Chanyoo
Pharmatech Co., Ltd, China.
Isomers -- 20mg
Approval of API/ DML/GMP The firm has submitted GMP of M/s Nantong Chanyoo
4. certificate of API manufacturer issued Pharmaech Co, Ltd China issued by Nantong Chemical and
by regulatory authority of country of Medical Industry Assocition. This certificate is valid until Dec
origin. 05, 2019.
Version no: 01
Copy of “Vendor’s Audit form” filled for M/s Nantong
Chanyoo Pharmatech Co., Ltd, China, dated 24-02-2017.
Certificate of analysis of the API, Photocopy of COAs of Sacubitril +Valsartan, working
6. reference standards and impurity standards and impurity standards issued by M/s Nantong
standards Chanyoo Pharmatech Co., Ltd, China.is submitted. Detail is as
under
Documents for the procurement of The firm has submitted photocopy of Purchase Order/Invoices
7. excipients used in product for the procurement of excipients used in product development
development?
List of qualified staff involved in The firm has submitted photocopy of List of qualified staff
8. product development with relevant involved in product development & regulatory affairs
experience. comprising of 4 members.
Production Data
Authorized Protocols/SOP for the The firm has submitted photocopy of Development Protocol for
9. development & stability testing of trial Lab scale batch manufacturing of Sartril 50mg Tablets.
batches.
Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing
10. of three stability batches. Record of the following 03 Batches:
TR001 1500 Tablets 11-2017
TR002 1500 Tablets 11-2017
TR003 1500 Tablets 11-2017
Record of remaining quantities of Batch No. TR001
11. stability batches. Date Sample Balance Stability/Interval
Quantity Quantity
24-2-2018 3 packs 19 packs 3rdth month
Batch No. TR002
Quantity Quantity
Batch No. TR003
Quantity Quantity
QA / QC DATA
12. temperature and humidity monitoring humidity.
of stability chambers (real time and
accelerated)
Method used for analysis of API The firm has submitted photocopy of raw material
13. along with COA. specifications, raw material testing procedures and report for
Sacubitril & Valsartan Trisodium Hemipentahydrate (LCZ696)
(batch # 201701002) along with chromatograms, FTIR
spectrum, lab reports, raw data sheets.
14. complete record of testing of stability Procedure (QC-NPNS-126 issued on 09-11-2017) for Sartril
batches (i.e. chromatograms, lab 100mg Tablet along with Stability Study Report of stability
reports, raw data sheets etc.) batches.
Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated
15. from manufacturer. and 12 Months Real Time Stability Study (25oC+2 oC, 60+5%)
Data of 03 Batches of Sacubitril & Valsartan from M/s Nantong
Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical
16. reports for all excipients used in product development of Sartril
tablets.
Drug-excipients compatibility The firm has not performed Drug-excipients compatibility
17. studies. studies and stated that the qualitative composition of their
product (Sartril Tablet) is similar to that of innovator’s product
i.e. Entresto tablet and also stability studies have not shown any
incompatibility or significant degradation.
feature Reference product Product of M/s Genix
Pharma
Brand name Entresto Tablets Sartril Tablets
49mg+61mg 49mg+61mg
Expiry Date 10-2018 11-2019
following mediums:
Compliance Record of HPLC Firm has submitted audit trail reports of stability studies of
19. software 21CFR & audit trail reports applied formulation from 25-11-2017 to 30-05-2018
on product testing.
Remarks of the The firm has submitted manual temperature and humidity record. Firm has
Evaluator submitted summary sheets of comparative dissolution study but did not submit
relevant analytical record. Real time stability study data of API conducted as per
Zone-IVA are not provided.
Exemption case
Sr. Name & Address Brand Name Type of Form, International Previous
No. of Manufacturer (Proprietary Name + Dosage Initial Diary & Availability / Local DRB
/ Applicant Form + Strength), Date, Fee Availability Decision /
Composition, (including Remarks
Pharmacological Group, differential fee), GMP Inspection (if any)
Finished Product Demanded Report Date &
Specification Price / Pack size Remarks
884. M/s Genix Sartril 200mg Tablets Form 5D FDA -
Pharma, (Pvt.) 04-02-2016, Entresto Tablets
Ltd. 44,45-B Each film coated tablet DY: 159 97mg+103mg,
Korangi Creek, contains: - Fee: 50,000/- M/s Novartis
Road Sacubitril ………97mg Pharmaceutical UK
Karachi Valsartan……….103mg 7’s, 14’s, 28’s Ltd.
As per SRO Firm is operating
Angiotensin receptor- at acceptable level
neprilysin inhibitor of GMP
compliance as per
(Manufacturer’s inspection dated
Specifications) 16-02-2018
Drug Sartril 200mg Tablets

M/s Genix Pharma, (Pvt.) Ltd. 44,45-B Korangi Creek, Road
Karachi
API Lot No. 201701002
Description of Pack
Real Time: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0, 1, 2,3,4 & 6 (Months) Real Time: 3,6 (Months)
No. of Batches 03

1. COA of API Yes
2. origin or GMP certificate of API manufacturer issued China issued by Nantong Chemical and
by regulatory authority of country of origin. Medical Industry Assocition. This
Protocols followed for conduction of stability study
3. Yes
4. respective documents like chromatograms, laboratory Yes
Copy of Form 6 (License to Import
drug for clinical trial examination, test
or analysis) issued by ADC (Karachi)
dated 19-05-2017, for the import of
Sacubitril + Valsartan (2 Kg) from the
M/s Changzhou Pharmaceutical
5. Documents confirming import of API etc. Factory, Manufacturer by M/s Nantong
has been submitted.
Copy of Commercial Invoice (invoice
no. CY117159) attested by ADC
(Karachi) dated 16-5-2017 has been
submitted.
All provided documents will be attested (name, sign &
6. Yes
stamp) for ensuring authenticity of data/documents.
7. Yes
Commitment to follow Drug Specification Rules,
8. Yes
1978.
REMARKS OF EVALUATOR (AD PEC-I)
Batches.
1. inspection for instant dosage form “WYMLY Tablets 25mg (Tenofovir Alafenamide)”, which
conducted during last two years. was conducted on 06-02-2018, and was presented in 281th
meeting of Registration Board held on 11-13th April, 2018.
Registration Board decided to approve registration of
WYMLY Tablets 25mg (Tenofovir Alafenamide)”, by M/s.
Genix Pharma (Pvt.) Ltd., Karachi.
Documents for the procurement of Copy of Form 6 (License to Import drug for clinical trial
2. API with approval from DRAP (in examination, test or analysis) issued by ADC (Karachi) dated
case of import). 19-05-2017, for the import of Sacubitril + Valsartan (2 Kg)
from the M/s Changzhou Pharmaceutical Factory,
Manufacturer by M/s Nantong Chanyoo Pharmatech Co., Ltd,
China has been submitted.
Copy of Commercial Invoice (invoice no. CY117159) dated
attested by ADC (Karachi) dated 16-05-2017 has been
submitted
Documents for the procurement of The firm has submitted copy of letters from M/s Changzhou
3. reference standard and impurity Pharmaceutical Factory in the name of M/s Genix Pharma
standards. (Pvt.) Ltd, Karachi, declaring the submission of following
reference standards on behalf of their principal i.e. M/s
Nantong Chanyoo Pharmatech Co., Ltd, China.
Isomers -- 20mg
Approval of API/ DML/GMP The firm has submitted GMP of M/s Nantong Chanyoo
4. certificate of API manufacturer issued Pharmaech Co, Ltd China issued by Nantong Chemical and
by regulatory authority of country of Medical Industry Assocition. This certificate is valid until Dec
origin. 05, 2019.
Version no: 01
Certificate of analysis of the API, Photocopy of COAs of Sacubitril +Valsartan, working
6. reference standards and impurity standards and impurity standards issued by M/s Nantong
standards Chanyoo Pharmatech Co., Ltd, China.is submitted. Detail is as
under
Documents for the procurement of The firm has submitted photocopy of Purchase Order/Invoices
7. excipients used in product for the procurement of excipients used in product development
development?
List of qualified staff involved in The firm has submitted photocopy of List of qualified staff
8. product development with relevant involved in product development & regulatory affairs
experience. comprising of 4 members.
Production Data
Authorized Protocols/SOP for the The firm has submitted photocopy of Development Protocol
9. development & stability testing of trial for Lab scale batch manufacturing of Sartril 200mg Tablets.
batches.
Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing
10. of three stability batches. Record of the following 03 Batches:
TR001 1500 Tablets 11-2017
TR002 1500 Tablets 11-2017
TR003 1500 Tablets 11-2017
Record of remaining quantities of Batch No. TR001
11. stability batches. Date Sample Balance Stability/Interval
Quantity Quantity
Batch No. TR002
Quantity Quantity
Batch No. TR003
Quantity Quantity
QA / QC DATA
12. temperature and humidity monitoring humidity.
of stability chambers (real time and
accelerated)
Method used for analysis of API along The firm has submitted photocopy of raw material
13. with COA. specifications, raw material testing procedures and report for
Sacubitril & Valsartan Trisodium Hemipentahydrate
(LCZ696) (batch # 201701002) along with chromatograms,
FTIR spectrum, lab reports, raw data sheets.
14. complete record of testing of stability Procedure (QC-NPNS-126 issued on 09-11-2017) for Sartril
batches (i.e. chromatograms, lab 100mg Tablet along with Stability Study Report of stability
reports, raw data sheets etc.) batches.
Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated
15. from manufacturer. and 12 Months Real Time Stability Study (25oC+2 oC,
60+5%) Data of 03 Batches of Sacubitril & Valsartan from
M/s Nantong Chanyoo Pharmatech Co., Ltd, China
Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical
16. reports for all excipients used in product development of
Sartril tablets.
Drug-excipients compatibility studies. The firm has not performed Drug-excipients compatibility
17. studies and stated that the qualitative composition of their
product (Sartril Tablet) is similar to that of innovator’s product
i.e. Entresto tablet and also stability studies have not shown
any incompatibility or significant degradation.
feature Reference Product of M/S
product Genix Pharma
Brand name Entresto Tablets Sartril Tablets 97mg
97mg +103mg +103mg
Expiry Date 10-2018 11-2019
following mediums:
Compliance Record of HPLC software Firm has submitted audit trail reports of stability studies of
19. 21CFR & audit trail reports on product applied formulation from 25-11-2017 to 30-05-2018
testing.
Remarks of the Evaluator: The firm has submitted manual temperature and humidity record.
Firm has submitted summary sheets of comparative dissolution study but did
not submit relevant analytical record.
Real time stability study data of API conducted as per Zone-IVA are not
provided.
Decision of 285th: Deferred for submission of digital temperature and humidity record, analytical record i.e.
chromatograms for comparative dissolution study and stability data of API as per Zone IV.
Remarks of the Evaluator: Firm has submitted digital temperature and humidity record,
analytical record i.e. chromatograms and stability data of API
as per Zone IV.
Decision: Registration Board decided to approve registration of “Sartril 200mg Tablets (Sacubitril
…97mg+Valsartan…103mg), Sartril 100mg Tablets (Sacubitril …49mg+Valsartan…51mg), Sartril
50mg Tablets (Sacubitril …24mg+Valsartan…26mg) M/s Genix Pharma, (Pvt.) Ltd. 44,45-B Korangi
Creek, Road Karachi. Manufacturer will place first three production batches of both products on
long term stability studies throughout proposed shelf life and on accelerated studies for six months.
Case No. 08: Miscellaneous Cases.
a. Manufacturing facility for steroidal and non-steroidal hormones

Sub-section 5. 2 of Section-I (Premises) of Schedule - B of Drugs (Licensing, Registering &
Advertising) Rules, 1976, describes the dedicated facilities for production and is reproduced
as under:
“ Dedicated facilities & self-contained facilities for the production of a particular drug
shall be provided in addition to the general facilities such as highly sensitizing
materials ( e.g., penicillin) or biological preparations(e.g., live microorganisms) or
cytotoxic substances or radiopharmaceuticals or veterinary immunological
preparations or sterile products or for that matter such other highly active
pharmaceutical products, antibiotics, hormones as may be identified by the CLB at
any stage in order to minimize the risk of a serious medical hazard due to cross
contamination………………”.
Registration Board during consideration of registration applications of firms applied
against the sections approved as;
a) Tablets (Hormone) (Human),
b) Capsules (Hormone) (Human),
c) Ampoules (Hormone) (Human).
Deliberated that vide Section 5.2 of Schedule B of L.R.& A Rules, 1976, separate
(dedicated/ self-contained) manufacturing facilities are required for hormones to avoid cross-
contamination of these drugs with other drugs, being highly active drugs. But, the hormones
are classified into steroidal and non-steroidal groups/ categories.
The examples of non-steroid hormones are, norepinephrine, dopamine, serotonin,
epinephrine and insulin. They are generally composed of amino acids. While, Steroid
hormones are a group of hormones that belong to the class of chemical compounds known
as steroids; they are secreted by three “steroid glands”—the adrenal cortex, testes, and
ovaries—and during pregnancy by the placenta. All steroid hormones are derived from
cholesterol. Hence, steroidal hormones especially the sex hormones are regarded as highly
active drugs. These drugs are even hazardous to the employees of the firm directly involved
in the manufacturing of these drugs since these drugs have high potential for causing adverse
effects and the reported effects of steroid exposure in men include gynecomastia, decreased
libido, reduced testicular size, increased pigmentation of the nipple area, nipple sensitivity,
dysspermia, weight loss, and headaches. Reported effects in females include menstrual
disorders (such as increased flow or intermenstrual spotting), nausea, headaches, breast pain,
leukorrhea, and swollen ankles. In a few cases, steroid worker’s children also have been
adversely affected after coming in contact with contaminated clothing. Although the
symptoms of steroid exposure generally disappear following cessation of exposure, repeated
exposure may have serious long-term effects on worker’s health. For example, there have
been reports of death from breast cancer among male workers who were inadequately
protected from steroids during OC production.
Therefore, Registration Board has developed an understanding and concluded that
separate approvals for manufacturing facilities/ sections be granted to hormone (steroid)
products and/from hormone (non-steroid) products namely as Hormone (Steroid) and
Hormone (Non-Steroid).
In the light of above deliberation, Registration Board advised the firms to get approval
for separate/self-contained manufacturing facilities by the Central Licensing Board for above
categories and to send a reference on the subject matter to Licensing Division for necessary
approval by Central Licensing Board regarding taking safety and protective measures by the
manufacturers for workers and personnel which remain in direct contact or are involved in
close handling of these drugs and granting separate manufacturing facility/section approval to
avoid cross-contamination of these drugs with other non-steroidal drugs.
 In this regard M/s Pacific Pharmaceuticals Ltd., Multan Road, Lahore, has also made a
submission in response to their cases of newly granted Tablet (Hormone) Section, which
were deferred in 281st meeting of Registration Board for following reasons:
“The Board deferred product and advised the firm to get approval from Licensing Division
particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal Hormone) for
further processing by Registration Board.”
Now the firm has referred to following extracts of various guidelines with a claim that there
is no dedicated manufacturing facility required for the Steroidal Hormones as per ICH
guidelines & WHO guidelines.
Reference–I: ICH GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE

PHARMACEUTICAL INGREDIENTS Q7
4.4 Containment:
“Dedicated production areas should also be considered when material of an infectious
nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or
cytotoxic anti-cancer agents) unless validated inactivation and/or cleaning procedures are
established and maintained.”
Reference–II: Annex 3 of WHO good manufacturing practices for pharmaceutical

products: main principles (WHO Technical Report Series, No. 961, 2011)
“Production areas
12.24 In order to minimize the risk of a serious medical hazard due to cross-contamination,
dedicated and self-contained facilities must be available for the production of particular
pharmaceutical products, such as highly sensitizing materials (e.g. penicillins) or biological
preparations (e.g. live microorganisms). The production of certain other highly active
products, such as some antibiotics, hormones, cytotoxic substances and certain non-
pharmaceutical products, should not be conducted in the same facilities. In exceptional
cases, the principle of campaign working in the same facilities can be accepted provided that
specific precautions are taken and the necessary validations (including cleaning validation)
are made. The manufacture of technical poisons, such as pesticides and herbicides, should not
be allowed in premises used for the manufacture of pharmaceutical products.”
Decision:
 Registration Board after thorough deliberation decided that registrations may be
granted either for hormone (steroidal) or hormone (non-steroidal) drugs in hormone
section. Registration Board decided to consider the instant cases based on selection
provided by the firm for hormone (steroidal) section or otherwise.
 The Board further decided that in future such cases shall be considered by the
Board after approval of the section by CLB and instant registration letters shall be
issued after change of name for hormone (steroidal) section from Licensing Division.
Based on above the following cases are placed before the Board for its consideration.
Tablet (Hormone) Section
08 Products/ 08 Molecule
M/s Pacific Pharmaceuticals Ltd, requested that kindly process our steroidal Tablet hormones against this
section.
885. Name and Address of Manufacturer / M/s Pacific Pharmaceuticals Ltd,
Applicant 30-km, Multan Road, Lahore.
Brand Name+Dosage Form+ Strength Exestane 25mg Tablets
Diary No. Date of R & I & fee Diary No:10938, 26/03/2018, Rs. 20,000/-
Exemestane…25mg
Pharmacological Group Aromatase inhibitors (Steroidal)
Type of Form Form-5
Approval Status of Product in Aromasin 25 mg coated tablets by M/s Pfizer Limited
Me-too Status Ph&T Exemestane 25mg Coated Tablets by M/s Mehran
International (Reg#078122)
GMP Status 07-11-2017. Panel recommends grant of Additional
sections
Decision of 281st meeting:
The Board deferred product and advised the firm to get approval from Licensing Division
particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal Hormone) for further
processing by Registration Board.
Decision: Deferred for clarification whether the applied product is hormone or otherwise.
Brand Name + Dosage Form + Fina-Grow 1mg Tablets
Strength
Finasteride…25mg
Pharmacological Group Testosterone-5-alpha reductase inhibitors
Type of Form Form-5
Approval Status of Product in Finasteride 1 mg Film-coated Tablets by M/s TEVA UK
Reference Regulatory Authorities. Ltd (MHRA Approved)
Me-too Status Hairfin Tablets 1mg by M/s Elko Organization
(Reg#034771)
Panel recommends grant of Additional sections
Remarks of the Evaluator. Finasteride is a 5α-reductase inhibitor, and hence is an
antiandrogen.
Finasteride is a synthetic 4-azasteroid.
G GENITO URINARY SYSTEM AND SEX
HORMONES
G04 UROLOGICALS
G04C DRUGS USED IN BENIGN PROSTATIC
HYPERTROPHY
G04CB Testosterone-5-alpha reductase inhibitors
ATC code Name
G04CB01 finasteride
Decision: Clarification required whether the applied product is steroidal hormone or
otherwise.
Brand Name + Dosage Form + Pill Plus Tablets
Strength
Gestodene… 0.075mg
Ethinylestradiol… 0.02mg
Pharmacological Group Hormonal contraceptives for systemic use (Progestogens
and estrogens, fixed combinations)
Type of Form Form-5
Approval Status of Product in Aidulan 20/75 microgram film-coated tablets by M/s
Reference Regulatory Authorities. Lupin (Europe) Ltd (MHRA Approved)
Me-too Status Meliane Tablets by M/s Medipharm (Pvt) Ltd
(Reg#024076)
Remarks of the Evaluator. Gestodene is a progestogen steroidal hormonal
contraceptive.
Ethinylestradiol: A Steroidal Sex hormone
Decision: Approved. The Board further advised the firms to get approval for steroidal
hormone section from Licensing Division before issuance of Registration letter.
Brand Name + Dosage Form + Pro-Gest (Dydrogest, ,Gestogest) Tablets
Strength
Dydrogesterone… 10mg
Pharmacological Group Progestogens (Pregnadien derivatives)
Type of Form Form-5
Approval Status of Product in Duphaston 10 mg film-coated tablets by M/s Mylan IRE
Reference Regulatory Authorities. Healthcare Limited (Ireland Approved)
Me-too Status Duphaston 10mg Tablets by M/s HIGHNOON
(Reg#006654)
Remarks of the Evaluator. Alternative brand name:
Dydrogesterone is a progestin, (a synthetic progestogen)
HORMONES
G03 SEX HORMONES AND MODULATORS OF THE
GENITAL SYSTEM
G03D PROGESTOGENS
G03DB Pregnadien derivatives
ATC code Name
G03DB01 dydrogesterone
Brand Name + Dosage Form + Femme-Safe Tablets 1.5mg
Strength
Levonorgestrel … 1.5mg
Pharmacological Group Hormonal contraceptives for systemic use (Progestogens)
Type of Form Form-5
Approval Status of Product in Levonorgestrel 1.5 mg tablet by M/s Gedeon Richter Plc.
Me-too Status Not confirmed
Remarks of the Evaluator. ● Me-too Status not confirmed from available database.
● Levonorgestrel: (Synthetic Progestogen) is a synthetic
estrane steroid and a derivative of testosterone
HORMONES
GENITAL SYSTEM
G03A HORMONAL CONTRACEPTIVES FOR
SYSTEMIC USE
G03AC Progestogens
ATC code Name DDD U Adm.R Note
G03AC03 levonorgestrel
processing by Registration Board
Brand Name+Dosage Form+Strength Androstat Tablets 50mg
Cyproterone acetate … 50mg
Pharmacological Group Antiandrogen
Type of Form Form-5
Approval Status of Product in Androcur 50 mg tablets by M/s Bayer plc (MHRA
Me-too Status Androcur 50 mg tablets by M/s ALI GOHAR & CO
(Reg#010221)
Remarks of the Evaluator. Cyproterone acetate: A synthetic steroidal antiandrogen.
CPA, also known as 1α,2α-methylene-6-chloro-17α-
acetoxy-δ6-progesterone or as 1α,2α-methylene-6-chloro-
17α-hydroxypregna-4,6-diene-3,20-dione acetate, is a
synthetic pregnane steroid and an acetylated derivative of
17α-hydroxyprogesterone
Decision: Deferred for further deliberation upon requirements of manufacturing facility for
Brand Name+Dosage Form+Strength Allure Tablets 0.035/2mg
Cyproterone acetate … 2mg
Ethinylestradiol… 0.035mg
Pharmacological Group Antiandrogens and estrogens
Type of Form Form-5
Approval Status of Product in Acnocin 2000/35 Tablets by M/s Sandoz Limited (MHRA
Me-too Status DIANE-35 Tablets by M/s Ali Gohar & Co. (Reg#011467)
Remarks of the Evaluator. Cyproterone acetate: A synthetic steroidal antiandrogen.
Ethinylestradiol: A Steroidal Sex hormone
Previous Decision: The Board deferred product and advised the firm to get approval from
Licensing Division particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal
Horomone) for further processing by Registration Board.
Brand Name+Dosage Form+Strength Pro-Man Tablets 25mg
Mesterolone… 25mg
Pharmacological Group Androgen (5-androstanon (3) derivative)
Type of Form Form-5
Approval Status of Product in Pro-viron Tablets by M/s Bayer plc (MHRA Approved)
Me-too Status Androviron 25mg Tablets by M/s Global Pharmaceutical
(Reg#030471)
Remarks of the Evaluator. Mesterolone is an androgen and anabolic steroid.
Mesterolone belongs to the group of medicines known as
androgens, which are male sex hormones.
HORMONES
GENITAL SYSTEM
G03B ANDROGENS
G03BB 5-androstanon (3) derivatives
ATC code Name
G03BB01 mesterolone
Tablets (Hormones)
10 Products / 10 Molecules
M/s Pharmasol Ltd, Raiwind road, Lahore has given undertaking that we shall only manufacture steroidal
hormonal drug/products in our hormone section.
893. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Northon Tablet 5mg
Strength
Diary No. Date of R& I & fee Diary No: 24171 , 13-12-2017 , Rs: 20,000/-
Norethisterone ……….5mg
Pharmacological Group Progestogen
Type of Form Form-5
Pack size & Demanded Price 30`s/ As per SRO
Approval status of product in Primolut-N by Bayer Pharma AG, Germany
Me-too status Primolut N by Bayer Health Care (Reg. No. 000677)
GMP status New License (Inspection Date: 29-05- 2017, 30-05-2017,
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Norethisterone, also known as Norethindrone (USAN), is a
synthetic progestational hormone with actions similar to
those of progesterone.
HORMONES
GENITAL SYSTEM
SYSTEMIC USE
G03AC Progestogens
ATC code Name
G03AC01 norethisterone
th
Decision of 278 : The Board deferred product and advised te firm to get approval from Licensing
Division particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal Horomone) for
further processing by Registration Board.
Brand Name +Dosage Form + Stoviron Tablet 25 mg
Strength
Mesterolone ……….25mg.
Pharmacological Group Androgens, Dihydrotestosterone
Type of Form Form-5
Pack size & Demanded Price 20`s / As per SRO
Approval status of product in Pro-Viron 25 Tablet by M/s Bayer plc, MHRA
Reference Regulatory Authorities. Approved
Me-too status Proviron 25mg Tablet by M/s Bayer Health Care
(Reg. # 000697)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Firm has given undertaking that we shall only manufacture
steroidal hormonal drug/products in our hormone section.
Mesterolone is an androgen and anabolic steroid.
Mesterolone belongs to the group of medicines known as
androgens, which are male sex hormones.
HORMONES
GENITAL SYSTEM
G03B ANDROGENS
G03BB 5-androstanon (3) derivatives
ATC code Name
G03BB01 mesterolone
Brand Name +Dosage Form + Valedot Tablet 2 mg
Strength
Estradiol Valerate ……….2mg.
Pharmacological Group Estrogens.
Type of Form Form-5
Finished Product Specification Innovator
Pack size & Demanded Price 21’s / As per SRO
Approval status of product in TGA Approved
Me-too status Progynova by Bayer Health Care (Reg No. 017864)
13-07-2017, 03-10-17 and 04-10-2017
Estradiol valerate is a synthetic estrogen
Brand Name +Dosage Form + Dinopros E-2 Tablet 3mg
Strength
Composition Each vaginal tablet contains
Dinoprostone ……….3mg.
Pharmacological Group Prostaglandin
Type of Form Form-5
Pack size & Demanded Price 1`s, 4’s / As per SRO
Approval status of product in Prostin E2 Pharmacia & Upjohn Division of Pfizer USA.
Reference Regulatory Authorities. MHRA approved Vaginal tablet
Me-too status Prostin E-2 by Pfizer vaginal tablets (Reg. No. 009821)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. The applied product is synthetic analogue of the naturally
occurring prostaglandin F2 alpha.
Prostaglandins are lipid autacoids.
HORMONES
G02 OTHER GYNECOLOGICALS
G02A UTEROTONICS
G02AD Prostaglandins
ATC code Name
G02AD02 dinoprostone
Brand Name+Dosage Form+Strength Estasol- D Tablets
Composition Each pink film coated tablet contains:
Ethinyl Estradiol …..........0.02mg
Each white film coated tablet (hormone free) contains:
Drospirenone ……………3.0mg
Pharmacological Group Estrogen/ Progestogens
Type of Form Form-5
Finished Product Specification Innovator’s specs
Approval status of product in Loryana By Sandoz Inc.USA
Me-too status YAZ by Bayer Health Care (Reg. No. 059087)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Firm has given undertaking that we shall only
manufacture steroidal hormonal drug/products in our
hormone section.
Ethinylestradiol: A Steroidal Sex hormone.
Drospirenone is a synthetic progestin.
HORMONES
GENITAL SYSTEM
SYSTEMIC USE
G03AC Progestogens
G03AC10 drospirenone
Brand Name+Dosage Form+ Strength Stroges Tablet
Diary No. Date of R& I & fee Diary No: 24176, 13-12-2017, Rs: 20,000/-
Ethinyl Estradiol ……….0.02 mg
Gestodene ……………… 0.075 mg
th
| 529
Pharmacological Group Estrogen/progestogen
Type of Form Form-5
Finished Product Specification Innovator’s specs
Approval status of product in Stroges tablet 20/75 microgm film coated tablets (MHRA
Me-too status Meliane by Bayer Health Care (Reg. No. 024076)
13-07-2017, 03-10-17 and 04-10-2017
hormone section.
Ethinylestradiol: A Steroidal Sex hormone.
Gestodene is a progestogen steroidal hormonal
contraceptive
899. Name
c and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Brand Name+Dosage Form+Strength Bivol Tablet 2.5mg
Composition Each core tablet contains:
Tibolone ………...2.5 mg
Pharmacological Group Gonadomimetic
Type of Form Form-5
Pack size & Demanded Price 10’s, 28’s / As per SRO
Approval status of product in Tibelia 2.5 mg uncoated tablets by M/s Mithra
Reference Regulatory Authorities. Pharmaceuticals S.A, (MHRA approved )
Me-too status TIBOPAUSE by Zafa (Reg. No.024213),
13-07-2017, 03-10-17 and 04-10-2017
steroidal hormonal drug/products in our hormone section
Tibolone: A synthetic steroid with estrogenic, androgenic,
and progestagenic properties.
HORMONES
GENITAL SYSTEM
G03C ESTROGENS
G03CX Other estrogens
G03CX01 tibolone 2.5 mg O
Brand Name+Dosage Form+ Strength Promen Tablets
Composition Each white film coated tablet contains:
Estradiol valerate …………….2.0 mg
Each pink film coated tablet contains:
Estradiol valerate……………...2.0 mg
Cyproterone acetate……….......1.0 mg
Pharmacological Group Antiandrogens and estrogens
Type of Form Form-5
Approval status of product in Climen by Bayer Schering Pharma AG Germany
Me-too status Climen by Bayer Health Care (Reg. No. 018207)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. In Reference country the applied product is coated, while
firm has applied film coating.
Firm has given undertaking that we shall only manufacture

 For further deliberation upon requirements of manufacturing facility for applied
formulation.
 Evidence of approval of applied formulation in reference regulatory authorities/ agencies
Brand Name+Dosage Form+ Strength Prodiol Tablets
Ethinyl Estradiol……………….0.035mg
Cyproterone Acetate…………….2mg
Pharmacological Group Anti-androgen/estrogen
Type of Form Form-5
Approval status of product in Dermapil film coated tablet, TGA Approved.
Me-too status DIANE-35 by Bayer Health care (Reg. No. 011467), Eva-
35 tablet by M/s Hansel (Reg#064796)
13-07-2017, 03-10-17 and 04-10-2017
Brand Name+Dosage Form+ Strength Dyrone Tablet 10mg
Dydrogesterone (trans- isomer) …….10mg
Type of Form Form-5
Approval status of product in Duphaston by BGP Products (Swissmedic Approved)
Me-too status Duphaston by Abbott (Reg. No. 006654)
13-07-2017, 03-10-17 and 04-10-2017
hormone section.
Dydrogesterone is a progestin, (a synthetic progestogen)
Brand Name+Dosage Form+ Strength Danacare Capsule 200mg
Danazol….……………200mg
Pharmacological Group Antigonadotropins
Type of Form Form-5
Pack size & Demanded Price 30`s/ As per SRO
Approval status of product in Danocrine by Sanofi Avents, UK
Me-too status Danzol by Platinum Pharma (Reg. No. 034832)
13-07-2017, 03-10-17 and 04-10-2017
hormone section.
Danazol is a derivative of the synthetic steroid ethisterone,
a modified testosterone.
HORMONES
GENITAL SYSTEM
G03X OTHER SEX HORMONES AND MODULATORS
OF THE GENITAL SYSTEM
G03XA Antigonadotropins and similar agents
G03XA01 danazol 0.6 g O
Licensing Division particularly for either Capsule (Steroidal Hormone) or Capsule (Non-steroidal
Brand Name+Dosage Form+ Strength Klomin Capsule 50mg
Clomiphene citrate ….……………50mg
Pharmacological Group Estrogen Agonists-Antagonists
Type of Form Form-5
Pack size & Demanded Price 10`s , 30’s / As per SRO
Approval status of product in Clomifene Citrate capsules by Penta Labs, Australia
Reference Regulatory Authorities. (Could not be confirmed)
Me-too status Prolifen by Chiesi Pharma (Reg. No. 010250)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. International availability in RRA could not be confirmed.
HORMONES
GENITAL SYSTEM
G03G GONADOTROPINS AND OTHER OVULATION
STIMULANTS
G03GB Ovulation stimulants, synthetic
G03GB02 clomifene 9 mg O
Deferred for following:
agencies which were declared/approved by the Registration Board.
 For further deliberation upon requirements of manufacturing facility for applied
formulation.
Brand Name+Dosage Form+ Strength Progesol Injection 250mg
Composition Each ml contains :
Hydroxyprogesterone caproate……………250mg
Pharmacological Group Progestogens
Type of Form Form-5
Pack size & Demanded Price 3’s(1ml) /As per SRO
Approval status of product in Makena IM (1ml) Injection, Lumara Health, A Division
Reference Regulatory Authorities. Of Amag Pharmaceuticals, Inc Waltham, MA. USA
Me-too status Hydroxy Progesterone Injection by ZAFA 250mg/ml(Reg.
# 003531)
13-07-2017, 03-10-17 and 04-10-2017
Hydroxyprogesterone caproate is a synthetic steroid
hormone
Licensing Division particularly for either Ampoule (Steroidal Hormone-Human) or Ampoule (Non-
steroidal Horomone- Human) for further processing by Registration Board.
Brand Name+Dosage Form+ Strength Steradol Injection IM
Composition Each ml contains :
Hydroxyprogesterone caproate …250mg
Estradiol Valerate……...5mg
Pharmacological Group Estrogen/progestogen
Type of Form Form-5
Pack size & Demanded Price 1’s(1ml) , / As per SRO
Approval status of product in Gravibinian by Bayer Health Care Germany (Could not be
Reference Regulatory Authorities. confirmed)
Me-too status Gravibinian Inj (1ml) by Bayer Pakistan (oily preparation)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. International availability could not be confirmed.
Brand Name+Dosage Form+ Strength Tesfour Injection 250mg
Composition Each ml of the oily Solution contains:
Testosterone Propionate .....30 mg
Testosterone Phenyl propionate ........60mg
Testosterone Isocaproate ....................60mg
Testosterone Decanoate .....................100mg
Pharmacological Group Androgen
Type of Form Form-5
Pack size & Demanded Price 1’s(1ml) /As per SRO
Approval status of product in Sustanon 250mg IM (1ml) Oily solution for Injection,
Reference Regulatory Authorities. MHRA Approved
Me-too status Sustanon Injection By Organon(1ml) (Reg. No.002446)
13-07-2017, 03-10-17 and 04-10-2017
Brand Name +Dosage Form + Tesviron Injection 250mg
Strength
Testosterone Enanthate .............250mg
Type of Form Form-5
Pack size & Demanded Price 3’s, 1’s(1ml) /As per SRO
Approval status of product in 250mg/ml Injection in oily solution in 1ml MHRA
Reference Regulatory Authorities. Approved
Me-too status Testofort Injection Reg # 025060 1ml ampoule
13-07-2017, 03-10-17 and 04-10-2017
Testosterone enanthate, is an androgen and anabolic
steroid
Brand Name +Dosage Form + Northon injection 200mg/ml
Strength
Norethisterone Enanthate …..200mg (in oily solution)
Type of Form Form-5
Finished Product Specification Innovator’s Specs
Pack size & Demanded Price 1’s(1ml) / As per SRO
Approval status of product in Noristerat 200mg, Solution for Intramuscular Injection,in
Reference Regulatory Authorities. oily solution(1ml) by Bayer PLC, UK
Me-too status Doryxas Injection in oily solution (1ml) Reg # 011082
13-07-2017, 03-10-17 and 04-10-2017
hormone section
Brand Name +Dosage Form + Medpro Injection 150mg/ml
Strength
Medroxyprogesterone acetate …….150mg
Pharmacological Group Synthetic progestogen
Type of Form Form-5
Pack size & Demanded Price 1’s (1ml) / As per SRO
Approval status of product in Depo-Provera 150mg/ml Sterile Suspension for Injection
Reference Regulatory Authorities. (1ml) Vial by Pfizer, UK
Me-too status Depo-Provera (1ml) Vial (Reg. No. 014862)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Me-too & reference product is in vial 1ml form, while firm
has applied in 1ml ampoule.
Medroxyprogesterone acetate is a Synthetic progestogen
authorities/agencies which were adopted by the Registration Board in its 275th meeting and
me-too status of the applied product.
Brand Name +Dosage Form + Uterotonic Injection 0.2mg/ml
Strength
Diary No. Date of R& I & fee Diary No: -24167 , 13-12-2017 , Rs: 20,000/-
Methylergometrine maleate ……0.2mg
Pharmacological Group Synthetic analogue of ergonovine
Type of Form Form-5
Pack size & Demanded Price 50’s (1ml) / As per SRO
Approval status of product in Methylergonovine Maleate Injection 0.2mg/ml (1ml) by
Reference Regulatory Authorities. American Regent, Inc, USA
Methergine Injection by Novartis Pharma, USA
Me-too status Ergomin Injection 0.2 mg (1ml) Reg # 066614
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Methylergometrine is a synthetic analogue of
ergonovine, a psychedelic alkaloid found in ergot.
HORMONES
G02A UTEROTONICS
G02AB Ergot alkaloids
ATC code Name
G02AB01 methylergometrine
Brand Name+Dosage Form+ Strength Dinopros Injection 5mg/ml
Dinoprost (as tromethamine)………... 5 mg
Pharmacological Group Prostaglandin
Type of Form Form-5
Pack size & Demanded Price 1`s (1ml) / As per SRO
Me-too status Prostin F2 ALPHA, Pfizer Pakistan 5mg/ml (1ml)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. The applied product is synthetic analogue of the naturally
occurring prostaglandin F2 alpha.
Prostaglandins are lipid autacoids.
HORMONES
G02A UTEROTONICS
G02AD Prostaglandins
ATC code Name
G02AD02 dinoprostone
Brand Name+Dosage Form+ Strength Estol Injection 10mg/ml
Composition Each ml ampoule contains:
Estradiol valerate ................10mg
Pharmacological Group Estrogen
Type of Form Form-5
Pack size & Demanded Price 3’s/As per SRO
Approval status of product in Delestrogen 10mg/ml (5ml)by JHP Pharmaceuticals, LLC,
Reference Regulatory Authorities. Michigan, USA
Me-too status Progynon Depot Injection 10mg SCHERING Germany
Imported by Ali Gohr and Company Reg No. 000796
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Regulatory product pack size is in 5ml while firm has
provided pack size in 1ml
authorities/agencies which were declared/approved by the Registration Board in its 275th
meeting
Brand Name+Dosage Form+ Strength Durasol Injection 50mg
Composition Each ml of the oily solution contains:
Nandrolone Decanoate……….50 mg
Pharmacological Group Anabolic Steroid
Type of Form Form-5
Pack size & Demanded Price 1`s (1ml) / As per SRO
Approval status of product in Deca Duraboli, by MSD (1ml) USFDA Approved
Me-too status Deca-Durabolin by OBS Pharma (1ml) (Reg. No.
002443)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Nandrolone, also known as 19-nortestosterone, is an
androgen and anabolic steroid
A ALIMENTARY TRACT AND METABOLISM
A14 ANABOLIC AGENTS FOR SYSTEMIC USE
A14A ANABOLIC STEROIDS
A14AB Estren derivatives
A14AB01 nandrolone 2 mg P
915. Name and address of manufacturer / M/s Walt Danzay Pharmaceuticals, Plot No 35-A, Small
Applicant Industrial Estate, Taxila, Pakistan
Brand Name +Dosage Form + WALPAUSE 2.5mg tablet
Strength
Diary No. Date of R& I & fee Dy No: 2364 : 11-05-2017 PKR 20,000/- : 11-05-2017
Tibolone ……….…2.5mg
Pharmacological Group Other estrogens
Type of Form Form-5
Finished product Specifications BP
Pack size & Demanded Price As Per SRO
Approval status of product in Livial 2.5mg tablets by MSD
Reference Regulatory Authorities (MHRA Approved)
Me-too status Tibopause by Zafa
GMP status Inspection report dated 15-02-2017, the panel
recommended the grant of drug manufacturing license
Remarks of the Evaluator  Firm has applied for film coated tablet, while the
formulation is available as uncoated tablet in MHRA
Decision of previous meeting Registration Board deferred all the applications applied for
Tablet (Hormone) section for clarification from the firm
whether it specifies/retains the section for steroidal
preparations or for non-steroidal preparations. Registration
Board further deferred the case for clarification of
formulation since the reference product is available as
uncoated tablet while the applied product is film coated
tablet. (M-271)
Evaluation by PEC  Firm has stated that they want to specify the tablet
hormone section for steroidal hormonal preparations
 Firm has submitted revised formulation for uncoated
tablet
Previous Decision: Registration Board deliberated that applied formulation is steroidal hormone
whereas CLB has approved section as "Tablet Hormone" only. Thus the Board deferred products
and advised to get approval from Licensing Division for Steroidal hormone tablets for further
Decision: Deferred for submission of Form 5 from the M/s Horizon Healthcare (Pvt.) Ltd.,
35-A, Punjab Small Industrial Estate, Taxila along with fee of Rs. 20,000/-
Brand Name +Dosage Form + WALTEROLON 25mg tablet
Strength
Composition Each tablet contains
Mesterolone ……….…25mg
Type of Form Form 5
Finished product Specifications INNOVATORS
Pack size & Demanded Price 1×`10’s; 3×`10’s/ As Per SRO
Approval status of product in Proviron by Bayer
Reference Regulatory Authorities (MHRA Approved)
Me-too status Proviron by Bayer
Remarks of the Evaluator Firm has claimed in house specifications without providing
documents required as per 267th RB meeting
preparations or for non-steroidal preparations. (M-271)
35-A, Punjab Small Industrial Estate, Taxila along with fee of Rs. 20,000/-
Brand Name+Dosage Form+Strength ETHITERONE Tablet
Diary No. Date of R& I & fee Dy No: 2366 (11-5-20172017)PKR 20,000/-11-5-2017
Ethinyl estradiol …………0.035 mg
Cyproterone acetate ……..2.00mg
Pharmacological Group Hormonal contraceptive
Type of Form Form-5
Approval status of product in Alisma tablets by Gynial
Reference Regulatory Authorities (Austria Approved)
Me-too status Diane-35 by Bayer
Remarks of the Evaluator Firm has claimed in house specifications without providing
documents required as per 267th RB meeting
 EMA has issued an assessment report along with final
decision of European commission after serious adverse
reactions i.e. thromboembolism was reported by ANSM
france. According to the final decision various changes in
SmPC were made including changes in
o clinical indications: 1. for moderate to severe acne
only after topical and systemic antibiotic therapy has
been failed 2. It should not be used with other
hormonal contraceptives
o Posology
o Contraindications
o Adverse reactions
o Patient information leaflet etc.
preparations or for non-steroidal preparations. (M-271)
35-A, Punjab Small Industrial Estate, Taxila along with fee of Rs. 20,000/-.
Brand Name +Dosage Form + Strength ETHIDROS Tablet
Ethinyl estradiol …………0.02 mg
Drospirenone ……….…..3.00mg
Pharmacological Group Hormonal contraceptive
Type of Form Form 5
Pack size & Demanded Price 1×`28’s
As Per SRO
Approval status of product in Reference Yaz tablets by Bayer
Regulatory Authorities (USFDA Approved)
Me-too status Yaz tablets by Bayer
Remarks of the Evaluator Firm has claimed in house specification while the
formulation is present in USP
Decision of previous meeting Registration Board deferred all the applications applied
for Tablet (Hormone) section for clarification from the
firm whether it specifies/retains the section for steroidal
preparations or for non-steroidal preparations.(M-271)
Decision: Registration Board deliberated that applied formulation is steroidal hormone whereas
CLB has approved section as "Tablet Hormone" only. Thus the Board deferred products and advised
to get approval from Licensing Division for Steroidal hormone tablets for further processing by
Registration Board.
Decision: Deferred for submission of Form 5 from the M/s Horizon Healthcare (Pvt.) Ltd., 35-
A, Punjab Small Industrial Estate, Taxila along with fee of Rs. 20,000/-
Brand Name +Dosage Form + Strength WALSTONE 5mg Tablet
Norethindrone………………….…..5 mg
Pharmacological Group Progestin
Type of Form Form-5
Approval status of product in Reference Aygestin by Duramed Pharmaceuticals, Inc
Regulatory Authorities (USFDA Approved) available as acetate
Me-too status Noregyn by Zafa
Remarks of the Evaluator Firm has claimed in house specifications while the
formulation is present in USP
 Firm has applied for film coated tablet, while
internationally available as uncoated tablet
 Firm has applied for norethindrone base while the
USFDA approved formulation contains norethindrone
acetate
Decision of previous meeting Registration Board deferred all the applications applied
for Tablet (Hormone) section for clarification from the
firm whether it specifies/retains the section for steroidal
preparations or for non-steroidal preparations.
Registration Board further deferred this case for
clarification of formulation since the product approved in
reference regulatory authorities is “norethindrone acetate”
uncoated tablet while applied formulation is without salt
and as film coated tablet. (M-271)
 Firm has submitted revised formulation of uncoated
tablet with norethindrone acetate
Decision: Deferred for submission of Form 5 from the M/s Horizon Healthcare (Pvt.) Ltd., 35-
A, Punjab Small Industrial Estate, Taxila along with fee of Rs. 20,000/-
b. Common Technical Document (CTD)

Federal Government has approved the amendment in rule 26 of Drugs (Licensing,
Registering and Advertising) Rules, 1976 for incorporation of Common Technical Document
(CTD) as Form 5-F for application of registration of pharmaceuticals and biological drugs
which has been notified vide S.R.O. 713(I)/2018 dated 09.06.2018.
Registration Board in its 264th meeting has considered and in order to facilitate and
encourage the submissions on CTD, Registration Board also approved various exemptions in
the modules and sub-modules. Registration Board was also apprised of the approval of
amendments in rule 26 of Drugs (Licensing, Registering and Advertising) Rules, 1976 by
Federal Government. In the same meeting Registration Board advised to present
implementation plan for consideration by the Board.
The exemptions and explanatory notes of module-1 already approved by Registration
Board in its 264th meeting is again presented before the Board for further consideration and
approval.
Explanatory Notes:
Section Sub- Heading
Section
1.1  Covering letter on the Applicant company / manufacturer / importer letter head
in context to the application for the registration of the Pharmaceutical Drug
Product shall be submitted, which should be dully signed by owner/ authorized
person on behalf of company/ manufacturer/ importer.
 An original cash deposit slip endorsed by Budget & Accounts Division, DRAP
of prescribed fee as per Schedule F for specified category shall be attached
therewith.
1.2  A comprehensive Table of Contents shall contain Module and sub module
heading with page number on the pharmaceutical dossier. The contents of all
the Module from 1 to 5 shall be covered. Comprehensive Table of Contents is
different form individual table of contents in the beginning of each Module.
 Also, a complete list of all documents provided in the application dossier by
Module, Section and sub-section shall be included
 For hardcopy submissions, the location of each document should be identified
by the volume number and tab identifiers (name of document or section
heading according to PDF format)
1.3 Applicant Information
1.3.1  In this section, administrative information related to the applicant is required.
 It is necessary to provide the complete particulars of the applicant, which shall
contain:
 Name of Licensed Pharmaceutical Manufacturer / Licensed Importer
having Drug Sale License by respective licensing authority
 Manufacturing Site Address of Pharmaceutical Company
 Contact details, including postal address, telephone contact number,
Fax number, website and email address.
1.3.2
1.3.3 The applicant must select one of the above mentioned options. A manufacturer will
provide all the requisite information as per Registration procedure of Pakistan,
subsequently mentioned in 1.3.4-1.3.5.
 An importer shall provide Drug Manufacturing License from respective
Licensing authorities in the country of origin, Certificate of Pharmaceutical
Product (CoPP) confirming Market authorization / Free Sale and GMP status
of the Manufacturer firm in this section.
 c is for Contract Manufacturing as per Rule 20-A of Drugs (Licensing,
Registering and Advertising) Rules, 1976.
1.3.4  To be provided if selected a, b or c of sub-section 1.3.3
(Attested copy of valid DML or Drug Sale License / renewal of DML or Drug
Sale License including initial date of grant of license and subsequent renewals.
1.3.5  To be provided if selected a of sub-section 1.3.3
(Attach New Section / Area Approval, if applicable), which should be verified
from the data given by the Licensing Division.)
1.3.6  List of already approved registered drugs with brand names, generic,
registration number, strength, dosage form along with finished product
specification and current granted price. Section / manufacturing facility wise of
approved drugs shall be followed.
 To be provided irrespective of selection of option in sub-section 1.3.2 and
mandatory for all type of Applicants.
1.3.7  The List of the name and designation of the signatory with specimen
Signatures, present in any part of the Pharmaceutical Dossier.
1.3.8  Site master file contains information regarding Management, Human Resource
(Technical Staff), Layout Plan, HVAC, Water Treatment Facilities, List of
Analytical Equipment, List of Manufacturing Equipment, Storage Facilities
(both for API and Finished Product), Fire Management and Risk Management
Plan.
 ISO certification and any other accreditations (if applicable).
 Relevant SOPs dually approved by the management and Technical Head of the
production facility. Each page of the Site Master File/Credential shall be dully
signed by respective technical heads.
1.4 Type of Application
1.4.1  New Drug Product include New Molecule/ New strength / Novel dosage form/
New Formulation / New Container Closure System
 It is important to specify here whether the Applicant has submitted the CTD
for a New Drug Product Registration or a Generic Drug Product. The
information in the subsequent dossier and exemptions in provision of relevant
information depends upon the type of application.
 In case of a New Drug Product (New Drug Product contains New Molecule/
New strength / Novel dosage form/ New Formulation/ New Container Closure
System), which is not already registered in the country, the information to be
provided shall be comprehensive fulfilling all the parameters of Safety,
Efficacy and Quality as per international requirements endorsed and
recommended by ICH.
1.4.1 -
1.4.2 -
1.4.3 Specify the names of Contract acceptor along with DML, Recent GMP, Evidence of
Section / facility approval from CLB and notarized copy of Contract between the
parties as per Rule 20A of Drugs (L,R & A) Rules, 1976.
1.5 Detailed Information of Drug, Dosage From & Labelling Claims
1.5.1  The following necessary information shall be provided in this sub-section:
(a) (Recommended) International Non-proprietary name (INN):
(b) Compendial name, if relevant:
(c)Chemical name(s):
(d)Company or laboratory code:
(e) Other non-proprietary name(s) (e.g. national name, USAN, BAN):
(f) Chemical Abstracts Service (CAS) registry number:
1.5.2  Strength of Active ingredient should be stated clearly. In case API is in the
form of salt, specify the equivalent strength of the base e.g., AAA sodium 50
mg (equivalent to AAA) etc.
 For example, each tablet contains, each ml contains in case of Injectable.
However, description like each ampoule / vial contains should be avoided, or
in case of syrup / suspension / dry powder for suspension each 5 ml (after
reconstitution) contains etc.
1.5.3  The proposed brand name should be justified along with an assessment /
analysis report considering the LASA (Look alike and Sound alike) with
specific emphasis on prefix, mid-name and suffix.
 The FDA guidance namely “Best Practices in Developing Proprietary Names
for Drugs” may also be consulted. An undertaking in this regard that the
applicant shall be responsible to change the name in case the name after
approval will resemble with already approved / registered names.
 The company should also submit the approval of Trade Mark before
submitting the proposed brand name.
1.5.4 
1.5.5  Indicate Pharmacological class of the API with proper reference. Also, state
WHO ATC code for each distinct therapeutic indication.
 There should be no spacing in between the characters.
 If WHO ATC code is not available at the time of application submission,
pending status should be mentioned in this section.
1.5.6  Attach reference monograph from respective Pharmacopeia) This should also
include the reason / justification of following the specific pharmacopoeia or
manufacturer’s specification in the light of Drugs (Specification) Rules, 1978.
1.5.7 -
1.5.8 -
1.5.9  Reference regulatory authorities include: United States Food Drug
Administration USFDA, Health Canada, European Medicine Agency (EMA),
Therapeutic Goods Administration (TGA) Australia, PMDA Japan, MHRA,
Regulatory authorities of Germany, France, Switzerland, Netherlands, Austria,
Denmark, Sweden and Norway, Drugs registered in at least three European
Union counties.
1.5.10  Dosage form of applied drug shall be mentioned clearly, with complete
description of a unit like “Film Coated Tablet” & “Sugar Coated Tablet” etc.
 Also description of the tablet shape, dimensions, capsule color schemes,
diameters, ampoule color and dimensions, granular powder for Dry
Suspension, color of solution for reconstitution in amber glass bottle with
Aluminum cap, etc. shall be provided.
1.5.11  In case, where secondary packaging is done on other site, the name of
“Secondary Packager” should be added on the label after the name of
manufacturer. For products intended to be marketed outside Pakistan (for
Export purpose) labels should be in accordance with the requirements of
importing country (for which an undertaking should be submitted by the
company.
1.5.12 -
1.5.13 -
1.5.14 i) Following format may be used with appropriate modifications / amendments
for development of SmPC & PI. This should also include black box warnings
& highlights of prescribing information in conformity with US FDA.
1. Name of Medicinal Product along with dosage forms
2. Composition of Product
3. Pharmaceutical Form
4. Clinical Particulars
4.1. Therapeutic Indications
4.1.1. Adults
4.1.2. Children & Adolescent
4.2. Posology & Method of Administration
4.2.1. Adults
4.2.2. Children & Adolescent
4.2.3. Geriatric Patients
4.2.4. Renal & hepatic impairment
4.2.5. Pregnant women
4.2.6. Method of Administration
4.2.7. Appearance of reconstituted product
4.3. Contraindication
4.4. Special warning & precautions for use
4.5. USE IN SPECIFIC POPULATIONS
4.5.1 Pregnancy
4.5.2 Paediatric Use
4.5.3 Geriatric Use
4.5.4 Renal impairment
4.5.5 Hepatic impairment
4.6. Interactions
4.5.1 Drug- Drug
4.5.2 Drug-Food
4.5.3 Drug-Laboratory
4.7. Pregnancy & lactation
4.7.1. Pregnancy
4.7.2. Lactation
4.8. Effects on ability to drive & use machine
4.9. Undesirable effects &/or Adverse Drug Reactions
4.10. Overdose
5. Pharmacological Properties
5.1. Pharmacodynamics
5.2. Pharmacokinetics
5.2.1. Absorption
5.2.2. Distribution
5.2.3. Metabolism
5.2.4. Elimination
5.3. Clinical Pharmacology
5.4. Preclinical Safety data
6. Pharmaceutical Particulars
6.1. List of Excipeints
6.2. Incompatibilities
6.3. Shelf Life
6.4. Special precautions for storage
6.5. Nature & contents of container
6.6. Special precautions for disposal & other handling
7. Name & Address of manufacturer
8. Product Registration Number
9. Date of Registration & Last Renewal
10. Date of Last Revision of text
 Following format may be used with appropriate alterations / adjustments for
development of PIL.
1. Brief description of medicine
2. How does it work?
3. Who should take this medicine?
4. Do not take this drug if you are taking ___ medicine or ___food.
5. What should I tell my doctor / health care provider before taking this medicine?
6. How should I take this medicine?
7. What should I avoid while taking this medicine?
8. What are possible side effects of this medicine?
9. How should I store this medicine?
10. What are the ingredients (actives / inactives) of this medicine?
1.5.15 -
1.5.16 -
1.5.17 -
1.5.18 -
1.5.19 -
1.5.20 -
1.5.21 -
1.5.22 -
1.6 Miscellaneous Information
1.6.1 -
1.6.2 -
1.6.3 -
1.6.4 -
1.6.5  COA of API
 Importation Documents of API
Exemptions approved by Registration Board

Module Section Sub-section New Drug Generic Drug
Product Product
2 2.4 Non-Clinical Overview Not Exempted Exempted
2.5 Clinical Overview Not Exempted Exempted
2.6 Non-Clinical Written and Tabulated Not Exempted Exempted
Summaries
2.7 Clinical Summary Not Exempted Exempted
3 3.2.S.2 3.2.S.2.3 Not Exempted Exempted
(3.2.S) Drug Brief Description of Manufacturing
Substance Process and Process Controls
3.2.S.3.4 Exempted Exempted
Control of critical steps and
Intermediates (Closed Part)
3.2.S.3.5 Not Exempted Exempted
Summary of Process Validation and/or
Evaluation
Brief Manufacturing Process
Development
3 Drug 3.2.P.2.2.1 Not Exempted Not Exempted
(3.2.P) Product Pharmaceutical Equivalence through
Comparative Dissolution Profile
3.2.R 3.3.R.3 Exempted Exempted
Bioequivalence Exempted Exempted
4 4.2.3 4.2.3.3 Exempted Exempted
Genotoxicity
4.2.3.4 Exempted Exempted
Carcinogenicity
Reproductive and Developmental
Toxicity
Local Tolerance
Other toxicity studies
5 Clinical Innovator (In-house and Published) Not Exempted Not
Studies Applicable
New Drug Generic version (Published Not Applicable Not Exempted
data)
Decision: Registration Board discussed that S.R.O. 713(I)/2018 was promulgated on
8th June 2018. Under the aforesaid SRO “The Registration Board may
issue necessary explanations and exemptions in this regard if needed”.
The Board in its 264th meeting held on 28-29th December 2016, already
granted/approved exemptions in different sub-sections of CTD (Form 5-
F). The Board decided to adopt already granted exemptions in line with
the provisions of S.R.O. 713(I)/2018 as mentioned below:
Module Section Sub-section New Drug Generic Drug

Product Product
2 2.4 Non-Clinical Overview Not Exempted Exempted
2.5 Clinical Overview Not Exempted Exempted
2.6 Non-Clinical Written and Tabulated Not Exempted Exempted
Summaries
2.7 Clinical Summary Not Exempted Exempted
3 3.2.S.2 3.2.S.2.2 Description of Manufacturing Not Exempted Exempted
(3.2.S) Drug Process and Process Controls
Substance 3.2.S.2.3 Control of Materials Not Exempted Exempted
Control of critical steps and
Intermediates (Closed Part)
3.2.S.2.5 Not Exempted Exempted
Process Validation and/or Evaluation
Manufacturing Process Development
3 Drug 3.2.P.2.2.1 Formulation development Not Exempted Not Exempted
(3.2.P) Product (Pharmaceutical Equivalence through
Comparative Dissolution Profile)
3.2.R 3.2.R.3 Product Interchangeability Exempted Exempted
(Bioequivalence Study Reports)
Bioequivalence Exempted Exempted
4 4.2.3 4.2.3.3 Exempted Exempted
Genotoxicity
Carcinogenicity
Reproductive and Developmental
Toxicity
Local Tolerance
Other toxicity studies
5 Clinical Innovator (In-house and Published) Not Exempted Not
Studies Applicable
New Drug Generic version (Published Not Applicable Not Exempted
data)
c. Case of Genix Pharmaceuticals in which stability study data was rejected by
Registration Board.
Applicant Dosage Form + Strength), Date, Fee
Composition, (including GMP Inspection Report Date &
920. M/s Genix Pharma Carlep Tablets 200mg Form 5-D Aptiom Tablets by Sunovion
(Pvt) Ltd., 44, 45-B, Each tablet contains: Dy No. 351 Pharms (USFDA Approved)
Korangi Creek Road, Eslicarbazepine 14-3-2016
Karachi acetate……200mg PKR 50,000/- Last inspection report dated
(Anti-epileptic) (14-3-2016) 8.8.2017 confirms satisfactory
10’s, 20’s, 30’s: compliance to GMP
Rs. 2250/ tablet
251st meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 17881 dated 15-5-2018)
Drug Carlep Tablets 200mg
Name of Manufacturer M/s Genix Pharma (Pvt) Ltd., 44, 45-B, Korangi Creek Road, Karachi
Manufacturer of API Ami Lifesciences Pvt. Ltd., Block No. 82/B, ECP Road, AT & Post
Karakhadi, Tal Padra, City Karakhadi, District: Vadodara Gujrat State, India.
API Lot No. ECA/50010117
Description of Pack
Alu-Alu blister packed in unit carton
Frequency Accelerated: 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 26 (Weeks)
Real Time: 0, 1, 2, 3, 4, 6, 8 (Months)
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of country Firm has submitted copy of GMP certificate of
of origin or GMP certificate of API manufacturer M/s Ami Lifesciences Pvt. Ltd., Block No. 82/B,
issued by regulatory authority of country of origin. ECP Road, AT & Post Karakhadi, Tal Padra, City
Karakhadi, District: Vadodara Gujrat State, India.
Valid till 26-4-2019 issued by Food and Drugs
Control Administration Gujrat State India.
3. Protocols followed for conduction of stability study
Yes
respective documents like chromatograms, laboratory Yes
5. Documents confirming import of API etc. Firm has submitted ADC attested commercial
invoice dated 24-2-2017confirming import of 3
Kg Eslicarbazepine acetate. The commercial
invoice contains the address of head office of the
firm.
documents.
Yes
Yes
1978.
Shortcoming communicated Response by the firm

Justify the partial mode of testing i.e. without Firm has submitted that they have performed stability studies
dissolution and assay at 1st and 3rd months in as per guidelines of Registration Board.
real time stability study data of all the three The guidelines of Registration Board in 251st meeting specify
batches. weekly testing intervals while firm has used monthly testing
intervals and claimed that they are following guidelines of
Registration Board.
Justify the specifications of dissolution (i.e. Firm has submitted that as per correspondence document by
NLT 80% of the labeled amount in 45 CDER “it seems to be unacceptableof dissolution criteria Q
minutes) submitted under finished product at 15 minutes as mentioned”. Firm has also provided a
specification, since the reference product reference link for this data
approved by USFDA Aptiom Tablets have https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/02
updated the dissolution specification for 200 2416Orig1s000AdminCorres.pdf
mg strength, to a single point Q* at 15
minutes since its dissolution profile was not- As per the details of the reference shared the exact
similar to the appropriate comparator as recommendations from FDA is “Your proposal for a
specified in the executive summary of the dissolution acceptance criterion of Q= at 15 minutes for the
chemistry review for NDA 22416 (Ref: 200 mg tablets is not acceptable. Based on the provided data,
https://www.accessdata.fda.gov/drugsatfda_d a dissolution acceptance criterion of Q= at 15 minutes is
ocs/nda/2013/022416Orig1s000ChemR.pdf). appropriate. Nevertheless, it must be recognized that some
For elaboration on the value of “Q” FDA in batches may require Stage 2 and, occasionally, Stage 3
its draft guidance for industry on dissolution testing. Revise you dissolution acceptance criterion for the
testing of immediate release solid oral 200 mg tablets from Q= at 15 minutes to Q at 15 minutes,
dosage forms under “setting dissolution and submit a revised specifications table for the drug
specifications” have recommended “for product.”
highly soluble and rapidly dissolving drug Firm has submitted a reference of EDQM
products (BCS classes 1 and 3), a single- http://www.edqm.eu/en/Helpdesk-1683.html?rubrique=801
point dissolution test specification of NLT which specifies that in most of the cases Q can be 75% and
85% (Q=80%) in 60 minutes or less is overall dissolution limit can be 80% (Q+5).
sufficient as a routine quality control test for Since the reference product is FDA approved and upon
batch-to-batch uniformity” (Ref: approval the firm will be granted “innovator’s specification”
https://www.fda.gov/downloads/drugs/guida therefore the guidelines of FDA should be implemented for
nces/ucm070237.pdf) this product.
Rs 2500 / tablet
(Dy.# 15519 dated 26-4-2018)
Description of Pack
Real Time: 0, 1, 2, 3, 4, 6, 8 (Months)
No. of Batches 03
1. COA of API Yes
Yes
invoice dated 24-2-2017 confirming import of 3
firm.
documents.
Yes
Yes
1978.
xiii.
Justify the partial mode of testing i.e. without Firm has submitted that they have performed
dissolution and assay at 1st and 3rd months in real timestability studies as per guidelines of Registration
stability study data of all the three batches. Board.
The guidelines of Registration Board in 251st
meeting specify weekly testing intervals while firm
has used monthly testing intervals and claimed that
they are following guidelines of Registration Board.
Justify the specifications of dissolution (i.e. NLT 80% Firm has submitted a reference of EDQM
of the labeled amount in 45 minutes) submitted under http://www.edqm.eu/en/Helpdesk-
finished product specification, since FDA in its draft 1683.html?rubrique=801 which specifies that in
guidance for industry on dissolution testing of most of the cases Q can be 75% and overall
immediate release solid oral dosage forms under dissolution limit can be 80% (Q+5).
“setting dissolution specifications” have recommended Since the reference product is FDA approved and
“for highly soluble and rapidly dissolving drug upon approval the firm will be granted “innovator’s
products (BCS classes 1 and 3), a single-point specification” therefore the guidelines of FDA
dissolution test specification of NLT 85% (Q=80%) in should be implemented for this product.
60 minutes or less is sufficient as a routine quality
control test for batch-to-batch uniformity” (Ref:
https://www.fda.gov/downloads/drugs/guidances/ucm0
70237.pdf).
Rs 3000/ tablet
(Dy.# 15519 dated 26-4-2018)
Description of Pack
Real Time: 0, 1, 2, 3, 4, 6, 8 (Months)
No. of Batches 03
1. COA of API Yes
Yes
respective documents like chromatograms, laboratory Yes
invoice dated 27-4-2017 confirming import of 7
firm.
documents.
Yes
Yes
1978.
Justify the partial mode of testing i.e. without Firm has submitted that they have performed
dissolution and assay at 1st and 3rd months in real stability studies as per guidelines of Registration
time stability study data of all the three batches. Board.
The guidelines of Registration Board in 251st
meeting specify weekly testing intervals while firm
has used monthly testing intervals and claimed that
they are following guidelines of Registration Board.
Justify the specifications of dissolution (i.e. NLT Firm has submitted a reference of EDQM
80% of the labeled amount in 45 minutes) submitted http://www.edqm.eu/en/Helpdesk-
under finished product specification, since FDA in its 1683.html?rubrique=801 which specifies that in
draft guidance for industry on dissolution testing of most of the cases Q can be 75% and overall
immediate release solid oral dosage forms under dissolution limit can be 80% (Q+5).
“setting dissolution specifications” have Since the reference product is FDA approved and
recommended “for highly soluble and rapidly upon approval the firm will be granted “innovator’s
dissolving drug products (BCS classes 1 and 3), a specification” therefore the guidelines of FDA
single-point dissolution test specification of NLT should be implemented for this product.
85% (Q=80%) in 60 minutes or less is sufficient as a
routine quality control test for batch-to-batch
uniformity” (Ref:
https://www.fda.gov/downloads/drugs/guidances/uc
m070237.pdf).
Previous Decision: Registration Board in its 284th meeting after thorough discussion decided to reject the
stability data of above presented applications on the basis of following reasons:
 Adaptation of dissolution specification NLT 80% of the labeled amount in 45 minutes, while the FDA
approved reference product Aptiom tablets have used dissolution specifications NLT 85% in 45
minutes.
 Results of dissolution below 85% in 45 minutes at various time intervals.
Registration Board further directed the firm to repeat the stability studies as per the recommendations laid down
in 278th meeting and finished product specifications as per the approved reference / innovator product.`
Firm’s Reply:
 Firm has referred to following literature:
i. CDER review of reference product approved by USFDA which declares that BCS class of drug
Eslicarbazepine Acetate is not established while Eslicarbazepine Acetate has very low aqueous solubility.
ii. Following text from Section 6.1 (Immediate release dosage forms) of USP chapter <1092> (The
Dissolution Procedure; Development and Validation)
“Although release and stability data are collected during dosage form development, it is common to record
the entire dissolution profile or the amount of drug dissolved at specified intervals, such as 10, 20, 30, 40,
50, and 60 min or 15, 30, 45, and 60 min. At registration, dissolution for an immediate-release tablet
usually becomes a single-point test. The acceptance criterion and test time are established by evaluating the
dissolution profile data. The acceptance criterion for a dissolution test is a function of Q, which Is
expressed as a percentage of label claim of drug dissolved at a specified time. Typical Q values are in the
range of 75%-80% dissolved. Q values in excess of 80% are not generally used because allowance needs to
be made for assay and content uniformity ranges.”
iii. Following text of a review article titled as “Pharmacokinetics & Drug interactions of Eslicarbazepine
acetate”:
“Therefore, Eslicarbazepine Acetate is a highly permeable-poorly soluble (BCS class II), drug, whereas
Eslicarbazepine is a highly soluble-highly permeable (BCS class I) drug.
 Moreover firm has submitted as under:
a. Practically we performed BCS class identification tests, material does not belong to BCS Class I.
b. Due to low solubility of drug dissolution limit Not less than 80% and as per USP General Chapter,
<1092> Q-values in the range of 75% to 80%.
Decision: Registration Board deferred the above cases of Carlep Tablets 200mg, 400mg and 800mg for
further deliberation.
Registration-I Section
I. CASES DEFERRED IN 285th MEETING
A. HUMAN CASES
Case No.1:- Request of M/s. Bayer Pakistan (Pvt) Limited, Karachi for change of
company name from M/s. Bayer Pharma AG to M/s. Bayer AG.
M/s. Bayer Pakistan (Pvt) Limited, Karachi requested for change of company name
for their following registered products. The details are as under;
Table-I
S. Regn. Name of Product/ Existing Name of Proposed Name Initial Remarks
# No. Composition Site(s)-as per of site(s)-as per registration
approval firms request with
renewal
I II III IV V VI VII
1. 072540 Gadovist Solution Manufactured by: Manufactured 14-12-2012 Dy.No.6677
for injection M/s. Bayer Pharma by: DDC (Reg-I)
1 ml solution for AG, 13342, Berlin, M/s. Bayer AG, 23-01-2017 dated 21-02-
injection contains: Germany. Mullerstrasse 2018
Gadobutrol Product license 178, 13353
..…604.72mg holder: Berlin,
M/s. Bayer Vital Germany.
GmbH, 51368 Product license
Leverkusen, holder:
Germany. M/s. Bayer
Vital GmbH,
51368
Leverkusen,
Germany.
2. 072541 Gadovist prefilled -do- -do- 14-12-2012 Dy.No.6677
syringe DDC (Reg-I)
1 ml solution for 23-01-2017 dated 21-02-
injection contains: 2018
Gadobutrol
…….…604.72mg
3. 059089 Nebido 1000mg Manufactured by: Manufactured 21-10-2009 Dy.No.6677
Solution for M/s. Bayer Schering by: DDC (Reg-I)
injection Pharma AG, M/s. Bayer AG, 25-06-2015 dated 21-02-
Each ml contains: Germany. Mullerstrasse 2018
Testosterone 178, 13353
undecanoate…250 Berlin, Addition of
mg Germany. product
(eq. to 157.9mg of Product license license
Testosterone) holder: holder.
M/s. Jenapharm
GmbH & Co.
KG, Otto-
Schott-Str. 15,
07745 Jena
Germany.
4. 052224 Nexavar 200mg Manufactured by: Manufactured 25-09-2008 Dy.No.6677
Tablets M/s. Bayer Pharma by: DDC (Reg-I)
Each film coated AG, 51368 M/s. Bayer AG, 25-06-2015 dated 21-02-
tablet contains: Leverkusen, Kaiser- 2018
Sorafenib (as Germany. Wilhelm-Allee,
tosylate)…200mg Product license 51368 Change of
holder: Leverkusen, name of
M/s. Bayer Pharma Germany. product
AG, 13342, Berlin, Product license license
Germany. holder: holder.
M/s. Bayer AG,
51368
Leverkusen,
Germany.
5. 074794 Xarelto 2.5mg Marketing Marketing 20-08-2015 Dy.No.6677
Tablets authorization holder: authorization DDC (Reg-I)
Each film coated M/s. Bayer Pharma holder: dated 21-02-
tablet contains: AG, 13342, Berlin, M/s. Bayer AG, 2018
Rivaroxaban…2.5 Germany. 51368
mg Manufactured by: Leverkusen,
M/s. Bayer Pharma Germany.
AG, 51368 Manufactured
Leverkusen, by:
Germany. M/s. Bayer AG,
Secondary Kaiser-
packaging:- Wilhelm-Allee,
M/s. Stegemann 51368
Lohnverpackung & Leverkusen,
Logistischer Service Germany.
e.K., Up’n Nien Esch Secondary
14, 48268 Greven, packaging:-
Germany. M/s. Stegemann
Lohnverpackun
g &
Logistischer
Service e.K.,
Up’n Nien Esch
14, 48268
Greven,
Germany
6. 059057 Xarelto 10mg Manufactured by: Manufactured 14-09-2009 Dy.No.6677
Rivaroxaban…10 Germany. Wilhelm-Allee,
mg Product license 51368 i. Status of
holder: Leverkusen, MAH is “a”
M/s. Bayer Pharma Germany.
AG, D-13342, Marketing ii. CoPP
Berlin, Germany. authorization issued by
holder: EMA
M/s. Bayer AG,
51368
Leverkusen,
Germany.
7. 072549 Xarelto 15mg Manufactured by: Manufactured 20-02-2013 Dy.No.6677
Rivaroxaban…15 Germany. Wilhelm-Allee,
mg Secondary 51368 i. Status of
packaging:- Leverkusen, MAH is “a”
M/s. Stegemann Germany.
Lohnverpackung & Secondary ii. CoPP
Logistischer Service packaging:- issued by
e.K., Up’n Nien Esch M/s. Stegemann EMA
14, 48268 Greven, Lohnverpackun
Germany. g &
Logistischer
Service e.K.,
Up’n Nien Esch
14, 48268
Greven,
Germany.
Marketing
authorization
holder:
M/s. Bayer AG,
51368
Leverkusen,
Germany.
8. 072550 Xarelto 20mg -do- -do- -do- -do-
Tablets
Each film coated
tablet contains:
Rivaroxaban…20
mg
9. 059087 Yaz Tablets Bulk manufactured Bulk 21-09-2009 Dy.No.6677
Each film coated by: manufactured DDC (Reg-I)
tablet contains: M/s. Bayer Weimer by: 25-06-2015 dated 21-02-
Drospirenone…3m GmbH und Co. KG, M/s. Bayer 2018
g Doebereinerstrasse Weimer GmbH
Ethinylestradiol 20, 99427, Weimer, und Co. KG, CoPP issued
betadex Germany. Packed Doebereinerstra by German
clathrate…0.02mg and Released By: sse 20, 99427, authority.
M/s. Bayer Pharma Weimer,
AG, 13342 Berlin, Germany. Change of
Germany. Packed and Product
Product license Released By: License
holder: M/s. Bayer AG, Holder
M/s. Bayer Vital Mullerstrasse
GmbH, 51368 178, 13353
Leverkusen, Berlin,
Germany. Germany.
Product license
holder:
M/s. Jenapharm
GmbH & Co.
KG, Otto-
Schott-Str. 15,
07745 Jena
Germany
The firm has deposited fee of Rs.5000/- for each product and provided the following
supporting documents;
a. Initial registration letter and last renewal status.
b. Original and legalized CoPPs for all above mentioned products.
The case was considered in 6th PRVC meeting and on the recommendations of
Committee, firm was advised to provide clarifications/documents for further processing. The
details of clarifications sought along with the reply from the firm is stated below.
Table-II
S.No Name of Product Clarifications / shortcomings Reply by the firm
1. Gadovist solution for Approved address of manufacturer Approved manufacturer is the same as
injection (i.e. M/s Bayer Pharma AG, 51368 mentioned on CoPP i.e. Bayer Pharma
Leverkusen, Germany) differ from AG, Berlin Germany. Applied change is
the one mentioned in COPP (i.e for company name change Bayer
M/s Bayer AG, Mullerstrasse 178, Pharma AG to Bayer AG as follows:
13353 Berlin Germany) Manufactured by:
Bayer AG, Mullerstrasse 178
13353 Berlin, Germany.
There is no impact on manufacturing
site, only name will be changed however
postal codes are being aligned globally.
2. Gadovist prefilled
syringe
3. Nexavar 200mg Tab Difference in name of There is no difference in manufacturer
manufacturer and market and marketing authorization holder as
authorization holder as the status only the shorter from of address is used
of marketing authorization holder for marketing authorization holder, we
is “a” (as per CoPP) which means undertake here that both are same.
4. Xarelto 2.5mg Tab that manufacturer and market
5. Xarelto 10mg Tab authorization holder are the same.
6. Xarelto 15mg Tab However, the same could not be
7. Xarelto 20mg Tab confirmed from the CoPP.
8. Yaz Tab Approved address of packager and There is no difference of the site only
releaser (i.e. M/s Bayer Pharma the postal code is aligned globally.
AG, 13342 Berlin, Germany)
differ from the one mentioned in
CoPP (i.e. M/s Bayer AG,
Mullerstrasse 178, 13353 Berlin,
Germany)
The firm has provided a legalized declaration that manufacturing sites remains the same. It is
pertinent to mention that with reference to products at Sr.No. 5, 7 and 8 (Table-I) i.e Xarelto
2.5mg Tablets, Xarelto 15mg Tablets and Xarelto 20mg Tablets the firm has requested for
withdrawal of company name change request as the subject change will be applied along with
request for change of site.
The case was again considered in 12th PRVC and the committee decided to place the case
before registration Board for further consideration.
Furthermore, the firm has requested for grant of grace period of 06 months so that they can
incorporate the change in their packaging artworks and simultaneously ensure timely supply
of products in the market with new name.
Decision:- Registration Board decided as follow;
a. For product at Sr.No. 4 and 6 approved the change of name of
manufacturer as per following details on same terms and conditions;
Reg.No Name & Composition Previous name & address of New approved name of
of product(s) manufacturer/Product License Holder manufacturer/Product
License Holder along
with complete address.
052224 Nexavar 200mg Manufactured by: Manufacturer & Product
Tablets M/s. Bayer Pharma AG, 51368 license holder:
Each film coated tablet Leverkusen, Germany. M/s. Bayer AG, Kaiser-
contains: Product license holder: Wilhelm-Allee, 51368
Sorafenib (as M/s. Bayer Pharma AG, 13342, Berlin, Leverkusen, Germany.
tosylate)…200mg Germany.
059057 Xarelto 10mg Tablets Manufactured by: Manufacturer & Product
Each film coated tablet M/s. Bayer Pharma AG, 51368 license holder:
contains: Leverkusen, Germany. M/s. Bayer AG, Kaiser-
Rivaroxaban…10mg Product license holder: Wilhelm-Allee, 51368
M/s. Bayer Pharma AG, D-13342, Berlin, Leverkusen, Germany.
Germany.
b. For products at Sr.No. 5, 7 and 8 as the firm has withdrawan their request
for company name change, so the case stands disposed off.
c. For products at Sr.No.1-3 and 9 the cases have been deferred for
provision of clarification/documents regarding the difference of postal
codes in address of manufacturer/product license holder for current
approved and demanded sites.
Case.No.02:- Request of M/s. Bayer Pakistan (Pvt) Limited, Karachi for change of
company name and secondary packaging site for their approved
products.
M/s. Bayer Pakistan (Pvt) Limited, Karachi requested for change of secondary
packaging site and company name for their following registered products as per details
mentioned below;
S.No Reg # Name of Name of Site(s)-as per Name of Site(s)- as per Remarks
Product(s) approval firms request
1. 074794 Xarelto 2.5mg Manufactured by: Manufactured by: Firm has
Tablets M/s. Bayer Pharma AG, M/s. Bayer AG, Kaiser- informed that
Each film coated 51368 Leverkusen, Wilhelm-Allee, 51368 their approved
tablet contains: Germany. Leverkusen, Germany. manufacturer
Rivaroxaban Marketing authorization Marketing authorization will also now
…2.5mg holder: holder: be performing
M/s. Bayer Pharma AG, M/s. Bayer AG, 51368 the activity of
13342, Berlin, Germany. Leverkusen, Germany. secondary
Secondary packaging:- packaging.
M/s. Stegemann Secondary packaging:-
Lohnverpackung & M/s. Bayer AG, Kaiser-
Logistischer Service Wilhelm-Allee, 51368
e.K., Up’n Nien Esch 14, Leverkusen, Germany.
48268 Greven, Germany.
2. 072549 Xarelto 15mg Manufactured by: -do- -do-
Tablets M/s. Bayer Pharma AG,
Each film coated 51368 Leverkusen,
tablet contains: Germany.
Rivaroxaban Secondary packaging:-
…15mg M/s. Stegemann
Lohnverpackung &
Logistischer Service
e.K., Up’n Nien Esch 14,
48268 Greven, Germany.
3. 072550 Xarelto 20mg -do- -do- -do-
Tablets
Each film coated
tablet contains:
Rivaroxaban
…20mg
The firm has deposited fee of Rs.10,0000/- and provided the following documents;
a. Application of Form-5A.
b. Original, valid and legalized CoPPs issued by EMA.
c. Copies of initial registration letters and last renewal status.
Furthermore, the firm has requested for grant of grace period of 06 months so that they can
incorporate the change in their packaging artworks and simultaneously ensure timely supply
of products in the market with new name.
Decision:- Registration Board approved the following changes in respect of below
mentioned registered products of M/s. Bayer Pakistan (Pvt) Limited,
Karachi as per policy for imported finished drug registration on same
terms & conditions;
S. Reg.No Name of Product(s) Previously approved site(s) New approved site(s)
No
1. 074794 Xarelto 2.5mg Manufactured by: Manufacturer and
Tablets M/s. Bayer Pharma AG, 51368 Marketing
Each film coated Leverkusen, Germany. authorization holder:
tablet contains: Marketing authorization holder: M/s. Bayer AG,
Rivaroxaban M/s. Bayer Pharma AG, 13342, Berlin, Kaiser-Wilhelm-Allee,
…2.5mg Germany. 51368 Leverkusen,
Secondary packaging:- Germany.
M/s. Stegemann Lohnverpackung &
Logistischer Service e.K., Up’n Nien Esch
14, 48268 Greven, Germany.
2. 072549 Xarelto 15mg Manufactured by: -do-
Tablets M/s. Bayer Pharma AG, 51368
Each film coated Leverkusen, Germany.
tablet contains: Secondary packaging:-
Rivaroxaban…15mg M/s. Stegemann Lohnverpackung &
Logistischer Service e.K., Up’n Nien Esch
14, 48268 Greven, Germany.
3. 072550 Xarelto 20mg -do- -do-
Tablets
Each film coated
tablet contains:
Rivaroxaban…20mg
Furthermore, regarding the request of firm for grant of 06 months grace period
for incorporation of change in packaging artworks, the Board advised Pharma Bureau
decided to submit position paper for consideration of Registration Board.
Case.No.03:- Request of M/s. Medinet Pharmaceuticals, Rawalpindi for Change of

Name of manufacturer for registered products Varedet Injection (Reg.
No. 031391), Varedet Injection (Reg. No. 031392), Duvig Injection (Reg.
No. 031393) & Anfotericina Fada Injection (Reg.No. 033128).
M/s. Medinet Pharmaceuticals, Rawalpindi requested for change of name of
manufacturer for registered products the details are as under:-
S.# Regn. Existing Name/ Existing Proposed Name of Initial Remarks/
No. Composition Name of manufacturer & registration Diary No.
manufacturer Market with renewal R&I
(as per CoPP)
1. 031391 Varedet Injection M/s. FADA Manufacturer & 27-7-2004 Dy. No.
Each vial contains:- Pharma S.A., Product License Last renewal 7355 R&I
Vancomycin HCI Argentina. Holder:- submitted on dated
...............500mg M/s. Laboratorio 17-7-2014 27-2-2018.
Inernacional
Argentino S.A., 1641,
Tabare St. C.A.B.A.
Argentine Republic.
2. 031392 Varedet Injection -do- -do- 27-7-2004 -do-
Each vial contains:- Last renewal
Vancomycin submitted on
HCI...............1000mg 17-7-2014
3. 031393 Duvig Injection -do- -do- 27-7-2004 -do-
Each vial contains:- Last renewal
Dobutamine HCI submitted on
………….250mg 17-7-2014
4. 033128 Anfotericina Fada -do- M/s. Laboratorio 03-12-2004 -do-
Injection Internacional Last renewal
Each vial contains:- Argentino S.A. Av. submitted on
Amphotericin B 12 de Octubre 21-11-2014
………….50mg 4444, Quilmes,
Buenos Aires,
Republica
Argentina.
The firm has deposited fee of Rs.5,000 x 4 = 20,000/- and submitted the following supporting
documents:-
i) Copies of registration letters.
ii) Copies of renewal status.
iii) Original & legalized CoPP issued by Argentian Authority.
iv) Original & Legalized GMP issued by Argentian Authority.
v) Copy of Drug Sale License.
vi) Copy of change of corporate name amendment of the articles in corporation.
It is pertinent to mentioned that the firm has requested for change of name of manufacturer
for all the products from M/s. FADA Pharma S.A., Argentina to M/s. Laboratorio
Inernacional Argentino S.A., 1641, Tabare St. C.A.B.A. Argentine Republic. However, as per
CoPP of product at Sr. No.4, the name and address of manufacturer is mentioned as M/s.
Laboratorio Internacional Argentino S.A. Av. 12 de Octubre 4444, Quilmes, Buenos Aires,
Republica Argentina. which is different from the one requested by the firm. Similarly the
address of the manufacturer abroad was not mentioned on initial registration letter.
The case was deferred in 2nd PRVC meeting for getting clarifications from the firm on
following points:
(i) As per firm’s request for product, Anfotericina Fada Injection (033128), the
demanded manufacturing site with new name i.e. M/s. Laboratorio Internacional
Argentino S.A. is located at 1641, Tabare St. C.A.B.A. Argentine Republic,
whereas, as per CoPP the manufacturer is located at Av. 12 de Octubre 4444,
Quilmes, Buenos Aires, Republica Argentina.
(ii) As per CoPP the manufacturer and product license holder for products at Sr. No.1-
3 is M/s. Laboratorio Inernacional Argentino S.A., 1641, Tabare St. C.A.B.A.
Argentine Republic while as per GMP certificate is the manufacturing facility and
is located at different address.
(iii) Submission of approval of change of name of manufacturer with no change in
address from country of origin for the aforesaid products.
The firm in response informed that there are five plants of M/s. Laboratorio Internacional
Argentino S.A. in Argentina including following mentioned in the GMP and CoPP. The
entrance of the first pant (a) has different doors which resulted in slight difference in address
in GMP and CoPP:-
(a) The first plant is 1641/45/47 Tabare St. and 3668 Crespo St. (zip code 1437)
of the Autonomous City of Buenos Aires.
(b) The third plant is 4444 12 de Octubre Av., Quilmes (Zib code 1879), province
of Buenos Aires.
The case was again deferred 6th PRVC meeting for clarification of response of the firm and
subsequently in 9th PRVC meeting following clarification of the firm considered and it was
decided to place the case for consideration of Registration Board.
S.No Query Observed in 2nd PRVC meeting Firms Reply
1. As per firm’s request for product, Anfotericina Name and address of manufacturer as per CoPP:
Fada Injection (033128), the demanded M/s. Laboratorio Internacional Argentino S.A.,
manufacturing site with new name i.e. M/s. Av. 12 de Octubre 4444, Quilmes, Buenos Aires,
Laboratorio Internacional Argentino S.A. is Republica Argentina.
located at 1641, Tabare St. C.A.B.A. Argentine
Republic, whereas, as per CoPP the
manufacturer is located at Av. 12 de Octubre
4444, Quilmes, Buenos Aires, Republica
Argentina.
2. As per CoPP the manufacturer and product Name and address of manufacturer as per CoPP:
license holder for products at Sr. No.1-3 is M/s. Laboratorio Internacional Argentino S.A.,
M/s. Laboratorio Inernacional Argentino S.A., Tabare 1641, C.A.B.A. Argentine Republic.
1641, Tabare St. C.A.B.A. Argentine Republic The plant has different entrance doors with
while as per GMP certificate the different numbers. In the GMP is Tabare
manufacturing facility is located at different 1641/45/47. Tabare 1641 is the main entrance
address door.
3. Submission of approval of change of name of Firm has provided a copy of English Translation of
manufacturer with no change in address from document issued by Ministry of Health Policies
country of origin for the aforesaid products. Regulations and institutes Secretariat, ANMAT
(Argentine National Drug Food and Medical
Devices Administration) wherein it is mentioned
that the M/s. Fada Pharma S.A has been acquired
by M/s. Laboratorio Internacional Argentino S.A.
The case was presented before Registration Board in its 283rd meeting and the Board decided
as follow;
“Registration Board deferred the case for confirmation of address of
manufacturer from previous import clearance documents in order to ascertain
that the manufacturing site(s) is/are the same.”
The firm has now provided previous import documents wherein it can be confirmed that, for
products at Sr.No.1-3, the manufacturing site remains the same.
a. For products at Sr.No.1-3, approved the change in name of
manufacturer from M/s. FADA Pharma S.A., Argentina to M/s.
Laboratorio Inernacional Argentino S.A., 1641, Tabare St. C.A.B.A.
Argentine Republic on same terms and conditions.
b. For product at Sr.No.4, deferred the case for seeking clarification
from the firm regarding the address/status of manufacturer.
Case.No.04:- Request of M/s. Novartis Pharma (Pakistan) Limited, Karachi for

permission to Import International Packs of Sandostatin 0.5mg/ml
Ampoule.
M/s. Novartis Pharma (Pakistan) Limited has requested for import of international
packs of their following registered product in quantity as mentioned alongside and making up
the labeling deficiencies at their licensed premises.
S. Regn. Name of Product/ Source Packing Demanded
# No. Composition Quantity
1. 086485 Sandostatin Manufacturer: - 1ml x 5’s 7000 packs
0.5mg/ml Ampoule M/s. Novartis Pharma Stein
Each1ml ampoule AG, Schaffhauserstrasse, 4332
contains:- Stein, Switzerland.
Octreotide….0.5mg
The firm has deposited fee of Rs.5000/- and informed that due to very low quantity their
principal is unable to provide Pakistan specific packs. The firm further informed that they
will print the following information on the packs, before release of this product, at their
licensed premises located at 15th West Wharf, Karachi (DML.No.000193).
i. Urdu text
ii. MRP
iii. Registration number
iv. Sole agent
v. Other particulars
Decision:- Keeping in view the limited usage of the above-mentioned product,
Registration Board acceded to firm’s request for import of 7000 packs
(1ml x 5’s) of Sandostatin 0.5mg/ml Ampoule (Reg.No. 086485)
without urdu text, registration number & MRP and printing the same
at the licensed premises of M/s. Novartis Pharma (Pakistan) Limited,
15th West Wharf (DML #000193) before sale/release into the market in
compliance to Drug (Labeling and Packing) Rules, 1986 on same terms
and conditions. Furthermore, in the mean time firm will make
necessary arrangements for ensuring import of packs with all requisite
information in compliance to Drug (Labelling & Packaging) Rules,
1986.
Case.No.05:- Request of M/s. Fresenius Medical Care, Lahore for change of address
(local) for their registered products.
The firm has requested for change of local address to “Tanwir Ahmad Medical Centre
(TAMC), First Floor MM Alam Road 27-C/3, Gulberg-III, Lahore” in accordance with new
DSL for following products.
S.No Reg.No. Name of Drugs / Composition / Reg. No.

1. 039884 CAPD/DPCA 2 Stay safe Peritoneal Dialysis Solution.
Each Liter contains: -
Sodium Chloride 5.786gm.
Sodium Lactate 3.925gm.
Calcium Chloride 0.2573gm.
Magnesium Chloride 0.1017gm.
Glucose Monohydrate 16.5gm (Anhydrous glucose 15gm.)
Glucose Monohydrate 46.75gm (Anhydrous glucose 42.5gm)
Glucose Monohydrate 46.75gm
(Anhydrous glucose 22.73gm)
The firm has deposited fee of Rs.5000/- for each product and submitted the following
supporting documents;
a. Initial registration letters, post registration variations and last renewal. With
reference to renewal of the products it is submitted that the case has been referred to
renewal section for confirmation of renewal status as the firm submitted the last
renewal with double fee after due date but within 60 days.
b. Copy of previous and new drug sales license.
The above mentioned products were initially registered at importer premises/office address of
“52 Atta Turk Block, New Garden Town, Lahore”. Later the firm shifted their premises/office
to a new address i.e “137-A, Faisal Town, Lahore” and intimated the DRAP on 16-03-2015.
Now the firm has shifted to new premises/office and having valid drug sales license for it.
Decision:- Registration Board approved the change in address of importer i.e M/s.
Fresenius Medical Care, Lahore for below mentioned registered products
from “52 Atta Turk Block, New Garden Town, Lahore” to “Tanwir Ahmad
Medical Centre (TAMC), First Floor MM Alam Road 27-C/3, Gulberg-III,
Lahore” in accordance with Drug Sales License and on same terms and
conditions subject to verification of local storage facilities.
S. No Reg.No. Name of Drug(s)
Case.No.06:- Request of M/s. Wyeth Pakistan Limited, Karachi for change of address
(local) for their registered product.
M/s. Wyeth Pakistan Limited, Karachi has requested for change of local address for
their following registered product from the one mentioned on DML (i.e 000006) to the
address mention on DSL, as the manufacturing premises has been sold to M/s. ICI Pakistan
Limited.
S.No Product Name & Reg.No Current Name & Proposed Name Renewal Status
Composition Address of & Address of
importer (as per Importer (as per
initial reg. letter) DSL)
1. Tygacil injection 045642 M/s. Wyeth M/s. Wyeth Initial registration date:
Each vial contains: Pakistan Limited, Pakistan 30-05-2007
Tigecycline…50mg S-33, Hawkes Limited, B-2, Source change:
Bay Road, S.I.T.E. Room 29-07-2008
S.I.T.E, Karachi. No.002 & 003, 1st Renewal: 25-02-2013
Karachi. 2nd Renewal: 03-05-2018
Firm has deposited fee of Rs. 10,000/- and provided the following documents:
a. Copy of initial registration letters and last renewal status. With reference to the
renewal of the said product it is informed that renewal fee deposited in February
2013 is not clear. As per DRAP endorsement by Statistical Officer the deposited fee
is Rs.10,000/- while State Bank Challan of the particular renewal mentions the
deposited fee as Rs.20,000/-
b. Copy of Drug Sale License.
Decision:- Registration Board acceded to firm’s request for change of address (local)
for registered product Tygacil injection (Reg.No. 045642) from M/s.
Wyeth Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E, Karachi to M/s.
Wyeth Pakistan Limited, B-2, S.I.T.E. Room No.002 & 003, Karachi in
accordance with DSL, on same terms and conditions. Fee challan shall be
verified as per procedure adopted by Registration Board.
Case.No.07:- Request of M/s. Apex Pharmaceutical (Pvt) Ltd, Karachi for

registration of products in their name.
M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21-A/1, SITE, super Highway, Karachi has
submitted applications for registration of Azastrole 1mg Tablet, Bicalox 50mg Tablet &
Gynotril 2.5mg Tablet from the name of M/s. Merixil Pharma, Islamabad to their own name.
Details of each proposed product is as under:
Product-1: Azastrole 1mg Tablet (Reg.No.081807)
S# Name / detail of documents Documents / information provided by firm
1. Product Name / Composition Azastrole 1mg Tablet
Each film coated tablet contains:
Anastrozole…..1mg
2. Name and address of Applicant M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21-A/1, SITE, super
(transferee) Highway, Karachi.
3. Name of Transferor M/s. Merixil Pharma, Office No. 28, 2nd Floor, Rose Plaza I-8
Markaz, Islamabad.
4. Detail of Drug Sale License M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21, A/1, SITE, Super
Highway, Karachi.
5. Name and address of As per initial registration letter:-
manufacturer. M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
Melbourne VIC 3205, Australia.
As per Form-5A & CoPP
Manufacturing Site
M/s. Douglas Manufacturing Ltd, Central Park Drive Lincoln
Auckland, New Zealand.
Marketing authorization holder & release for supply:-
M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
Melbourne VIC 3205, Australia.
6. Name and address of marketing M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
authorization holder (as per Melbourne VIC 3205, Australia.
Form-5A)
7. Name of exporting country Australia
8. Diary No. & Date of R& I Dy. No. 20662 Dated 08-06-2018
9. Finished Product Specification (Manufacturer spec)
10. Shelf life 36 months (as per approval & Form-5A)
11. Pack Size Blister of 30’s Tablets, (as per approval)
12. Remarks:
 The name of manufacturer (as per COPP & Form-5A) differ from the one mentioned in initial
registration letter. However, the firm has informed that now manufacturing will be performed by
M/s. Douglas Manufacturing Ltd, Central Park Drive Lincoln Auckland New Zealand while M/s
Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South Melbourne VIC 3205, Australia is the
legal license holder of the product.
Product-2: Bicalox 50mg Tablet (Reg.No.081809)
1. Product Name / Composition Bicalox 50mg Tablet
Bicalutamide…..50mg
2. Name and address of Applicant M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21-A/1, SITE, super
3. Name of Transferor M/s. Merixil Pharma, Office No. 28, 2nd Floor, Rose Plaza I-8
Markaz, Islamabad.
4. Detail of Drug Sale License M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21, A/1, SITE, Super
Highway, Karachi
5. Name and address of Same as in product 1
manufacturer
6. Name and address of marketing M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
authorization holder Melbourne VIC 3205, Australia.
9. Finished Product Specification USP Specifications
11. Pack Size 28’s & 10’s
12. Remarks:
 Same as for product 1
Product-3: Gynotril 2.5mg Tablet (Reg.No.081808)
1. Product Name / Composition Gynotril 2.5mg Tablet
Each film coated tablet contains
Letrozole …..2.5mg
2. Name and address of Applicant M/s Apex Pharmaceuticals (Pvt) Ltd, D-21-A/1, SITE, super
3. Name of Transferor M/s Merixil Pharma, Office No. 28, 2nd Floor, Rose Plaza I-8
Markaz, Islamabad.
4. Detail of Drug Sale License M/s Apex Pharmaceuticals (Pvt) Ltd, D-21, A/1, SITE, Super
Highway, Karachi
5. Name and address of Same as in product 1
manufacturer
6. Name and address of marketing M/s Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
authorization holder Melbourne VIC 3205, Australia.
9. Finished Product Specification USP Spec
11. Pack Size 30’s
12. Remarks:
The firm has submitted the following supporting documents / information for
approval of registration of above mentioned products: -
a) Fee of Rs.100,000/- for each product.
b) Applications on Form-5A.
c) Copy of initial registration letter (renewal valid as registration granted on
15-09-2016).
d) Copy of Termination letter from manufacturer / product license holder in favor
of current registration holder i.e. M/s. Merixil Pharma, Islamabad.
e) Authority letter (original & notarized) issued by manufacturer / product license
holder for new proposed sole agent.
f) Original & legalized CoPPs for above products issued by TGA Australia.
g) Original GMP certificate of M/s Douglas Manufacturing Ltd, New Zealand
issued by Ministry of Health, New Zealand.
h) Copy of valid DSL.
i) NOC from M/s. Merixil Pharma, Office No. 28, 2nd Floor, Rose Plaza I-8
Markaz, Islamabad issued on 26th December, 2017.
Decision:- Registration Board deferred the case for provision of fresh NOC from the
current registration holder as more than six months have elapsed for the
available NOC (dated 26th December, 2017) and original notaried
termination letter from product license holder.
Case.No.08:- Request of M/s. OBS Pakistan (Pvt) Ltd, Karachi for registration of
products in their name.
M/s. OBS Pakistan (Pvt) Ltd, Karachi has submitted applications for change of
registration status of following products from the name of M/s. GSK Pakistan Ltd, Karachi to
their own name. Details are as under: -
Product-1: Arixtra Injection 2.5mg/0.5ml (Reg.No.044824)
1. Product Name / Composition Arixtra Injection 2.5mg/0.5ml solution for injection syringe.
Each 0.5ml contains:
Fondaparinux Sodium….…2.5mg.
2. Name and address of Applicant M/s. OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, SITE,
(transferee) Karachi
3. Name of Transferor M/s. GSK Pakistan Ltd, 35-Dockyard Road, West Wharf, Karachi
4. Detail of Drug Sale License M/s. OBS Pakistan (Pvt) Ltd, C-14 Manghopir Road, SITE,
Karachi
5. Name and address of As per approval letter:-
manufacturer. M/s. Glaxo Wellcome Production, France.
th
| 564
As per CoPP & Form-5A:-
M/s. Aspen Notre Dame de Bondeville, 1 Rue de I’Abbaye Notre
Dame de Bondeville 76960, France.
6. Name and address of marketing M/s. Aspen Pharmacare Australia Pty Ltd 34-36 Chandos Street
authorization holder (as per ST Leonards NSW 2065, Australia.
CoPP)
7. Name of exporting country France (Form-5A)
8. Diary No. & Date of R& I Dy. No. 11619 Dated 30/03/2018
9. Pharmacological class Factor Xa Inhibitor
10. Shelf life 24 months (as per Form-5A/CoPP issued by TGA)
11. Pack Size 10’s (as per initial registration letter)
12. Remarks: -
 The name of manufacturer mentioned in Form-5A and approval letter differ from the one
mentioned in CoPP. The firm has informed that the name of manufacturer has been
changed from GSK to Apsen Notre Dame de Bondeville since Aspen has acquired GSK
anaesthetic portfolio globally and the firm provided revised Form-5A accordingly.
Product-2: Arixtra Injection 5mg/0.4ml (Reg.No.044825)

1. Product Name / Composition Arixtra Injection 5mg/0.4ml solution for injection syringe
Fondaparinux Sodium….…5mg.
2. Name and address of Applicant M/s. OBS Pakistan (Pvt) Ltd, C-14 Manghopir Road,
(transferee) SITE, Karachi
3. Name of Transferor M/s. GSK Pakistan Ltd, 35-Dockyard Road, West Wharf,
Karachi
4. Detail of Drug Sale License M/s. OBS Pakistan (Pvt) Ltd, C-14 Manghopir Road,
SITE, Karachi
5. Name and address of manufacturer. As per Form-5A & approval letter:-
M/s. Glaxo Wellcome Production, France.
As per COPP:-
M/s. Aspen Notre Dame de Bondeville, 1 Rue de I’Abbaye
Notre Dame de Bondeville 76960, France.
6. Name and address of marketing M/s. Aspen Pharmacare Australia Pty Ltd 34-36 Chandos
authorization holder (as per COPP) Street ST Leonards NSW 2065, Australia.
12. Remarks:
 The name of manufacturer mentioned in Form-5A and approval letter differ from the one
mentioned in CoPP. The firm has informed that the name of manufacturer has been
changed from GSK to Apsen Notre Dame de Bondeville since Aspen has acquired GSK
anaesthetic portfolio globally and the firm provided revised Form-5A accordingly.
 The CoPP mentions the comment as “This product has been evaluated and approved by the
TGA and is permitted to be supplied in Australia. Further the CoPP also mentions Sponsor
comments as “The product is approved for supply in Australia but is not marketed at
present for commercial reasons.”
Product-3: Arixtra Injection 7.5mg/0.6ml (Reg.No.044826)
1. Product Name / Composition Arixtra Injection 7.5mg/0.6ml solution for injection syringe.
Fondaparinux Sodium….…7.5mg.
2. Name and address of Applicant M/s. OBS Pakistan (Pvt) Ltd, C-14 Manghopir Road, SITE,
Karachi
Karachi
M/s Glaxo Wellcome Production, France.
As per COPP:-
M/s Aspen Notre Dame de Bondeville, 1 Rue de I’Abbaye
12. Remarks:- Same as for product 2.
Product-4: Arixtra Injection 10mg/0.8ml (Reg.No.044827)

1. Product Name / Composition Arixtra Injection 10mg/0.8ml solution for injection syringe
Fondaparinux Sodium….…10mg.
Karachi
Karachi
M/s. Glaxo Wellcome Production, France.
As per COPP:-
M/s. Aspen Notre Dame de Bondeville, 1 Rue de I’Abbaye
12. Remarks:-
Product-5: Tracrium Injection 25mg/2.5ml (Reg.No.009570)

1. Product Name / Composition Tracrium Injection 25mg/2.5ml
Each 2.5ml ampoule contains:
Atracurium Besilate….…25mg.
Karachi
Karachi
M/s. Glaxo Wellcome SpA, Pharma, Italy.
As per COPP:-
M/s. GlaxoSmithKline Manufacturing SPA, Strada
Provinciale Asolana 90 San Polo Di Torrile PARMA
43056 Italy.
7. Name of exporting country Italy (Form-5A)
9. Pharmacological class Non-Depolarizing neuromuscular blocking agent
12. Remarks: -
 The name of firm and manufacturer mentioned in Form-5A and approval letter is differs
from the one mentioned in COPP. The firm has provided revised Form-5A with name &
address of manufacturer as “M/s. GlaxoSmithKline SPA, Strada Provinciale Asolana 90 San
Polo Di Torrile PARMA 43056 Italy”.
Product-6: Tracrium Injection 50mg/5ml (Reg.No.009571)

1. Product Name / Composition Tracrium Injection 50mg/5ml
Each 5ml ampoule contains:
Atracurium Besilate….…50mg.
2. Name and address of Applicant M/s. OBS Pakistan (Pvt) Ltd, C-14 Manghopir Road,
(transferee) SITE, Karachi
Karachi
4. Detail of Drug Sale License M/s. OBS Pakistan (Pvt) Ltd, C-14 Manghopir Road,
SITE, Karachi
M/s. Glaxo Wellcome SpA, Pharma, Italy.
As per COPP:-
M/s. GlaxoSmithKline Manufacturing SPA, Strada
Provinciale Asolana 90 San Polo Di Torrile PARMA
43056 Italy.
6. Name and address of marketing M/s Aspen Pharmacare Australia Pty Ltd 34-36 Chandos
7. Name of exporting country Italy (Form-5A)
9. Pharmacological class Non-Depolarizing neuromuscular blocking agent
12. Remarks:-
 Same as for product 5.
The firm has submitted the following supporting documents / information for approval of
above stated request.
a) Fee of Rs.100,000/- for each product.
b) Applications on Form-5A.
c) Copies of initial registration letters and renewal status.
d) Original legalized CoPPs (issued by TGA).
e) Authority / sole agency letter (original and notarized) from manufacturer / marketing
authorization holder.
f) NOC (original and notarized) from existing registration holder (i.e. from M/s. GSK
Pakistan, Karachi) dated 12-12-2017.
g) Termination letter (original and notarized) from manufacturer in favor of existing
importer.
The Board has been informed that the firm has provided fresh NOC from the current
registration Holder dated 27th September, 2018.
a. Approved cancellation of registration of products-1-6 from the
name of M/s. GSK Pakistan Ltd, 35-Dockyard Road, West Wharf,
Karachi.
b. Approved the registration of products-1, 5 and 6 in the name of
M/s. OBS Pakistan (Pvt) Ltd, C-14 Manghopir Road, SITE,
Karachi as per policy for imported finished drug registration (in
accordance with details of composition and manufacturer as per
CoPP).
c. For products-1, 5 and 6 a reference shall be sent to Costing &
Pricing Division for their comments regarding MRP of the said
products.
d. For products-2, 3 and 4 the firm shall be advised to provide the
free sale status of the said products in any RRA prescribed by
Registration Board for not being in market of exporting country
i.e Australia.
Case.No.09:- Request of M/s Martin Dow Limited, Karachi for registration of

products in their name.
M/s. Martin Dow Limited, Karachi has submitted an application for Registration of
Kytril Tablet 1mg from the name of M/s. Roche Pakistan Limited, Karachi their own name.
Detail of product is as under:
Kytril Tablet 1mg (Reg.No.020690)
1. Product Name / Composition Kytril Tablet 1mg
Granisetron Hydrochloride…..1.120mg.
(equivalent to 1mg granisetron)
2. Name and address of Applicant M/s. Martin Dow Limited, Plot No. 37, Sector, 19, Korangi
(transferee) Industrial Area, Karachi.
3. Name of Transferor M/s. Roche Pakistan Limited, 37-C,Block 6, P.E.C.H.S., Karachi
4. Detail of Drug Sale License Address: M/s Martin Dow Limited, Plot No. 37, Sector, 19,
Korangi Industrial Area, Karachi.
5. Name and address of As per approval:-
manufacturer / packager M/s Hoffmann La Roche Ltd, Basel Switzerland.
As per Form-5A & COPP:-
M/s Roche S.p.A., Via Morelli 2, Seqrate (Milan) I-20090, Italy.
6. Name and address of marketing M/s Atnahs Pharma UK Ltd, Sovereign House, Miles Gray Road
authorization holder (as per Basildon, Essex, SS14 3FR, UK.
COPP)
7. Name of exporting country Italy
9. Finished Product Specification Manufacturer spec’s
10. Shelf life 5 Years (as per Form-5A & COPP issued by MHRA)
11. Pack Size 1’s (as per approval)
12. Remarks:
 Firm has demanded 1’s, 10’s & 20’s while as per initial Reg. letter the granted Pack size is 1’s.
Firm has now informed that they may be granted the already approved pack size.
 Firm claim that name of manufacturer is same. However, as per COPP & approval it seems
different. The firm, regarding the name of manufacturer informed that “M/s Roche Pakistan
Limited has submitted the transfer of manufacturer of Kytril 1mg tablet from M/s F. Hoffman-
La Roche Ltd, Basel, Switzerland to M/s Roche S.p.A, Millan, Segrate, Italy, but approval is not
granted yet. However, it is requested to consider our application as transfer of registration
from along with change of manufacturing site from M/s. F. Hoffman-La Roche Ltd, Basel,
Switzerland to M/s Delpharm Milano S.r.L, Italy.”
The firm has submitted the following supporting documents / information for approval of
above transfer of registration: -
a) Fee of Rs.100,000.
b) Application on Form-5A.
c) Copy of valid Drug Sale License.
d) Initial registration letter with renewal status.
e) Original Termination letter in favor of current registration holder and authority letter
for new proposed importer from manufacturer.
f) NOC from current registration holder i.e M/s. Roche Pakistan Limited, Karachi
dated: 08-02-2018
g) Original legalized CoPP for Kytril Tab 1mg issued by MHRA.
Decision:- Registration Board deferred the case for provision of fresh NOC from the
current registration holder as more than six months have elapsed for the
available NOC (dated 08th February, 2018).
Case.No.10 Request of M/s. BF Biosciences for cancellation of registration of their

registered product.
M/s. BF Biosciences Ltd, Lahore has submitted an application for de-registration of
product Anfogen 50 Injection details is as under: -
Alternative
Reason for De-Reg (provided by the
S.No Firm Name Product Name registered
firm)
product
1 M/s BF Anfogen 50 M/s Laboratorios Bago S.A Argentina The firm has
Biosciences Injection. has ceased its license for the product informed that no
Limited, Lahore Each vial contains: - “Anfogen” (Liposomal Amphotericin alternate brands
Amphotericin B B) and is no longer selling the product are registered /
50.000mg in Argentina or any other export available
Reg. No.045800 markets, including Pakistan.
The firm has submitted following supporting documents: -

a. Initial registration letter, renewal status & post registration variation.
b. Undertaking that no case is pending.
c. Declaration of discontinuation from principle.
Decision:- Registration Board referred the case to Committee of availability of life
saving drugs for their views/comments.
B. VETERINARY CASES
Case.No.11:- M/s. Attabak Pharmaceuticals, Islamabad.
Federal Inspector of Drugs-IV, Islamabad has informed that a routine GMP inspection
of M/s. Attabak Pharmaeucticals, Islamabad was conducted on 29-06-2018 wherein it has
been observed that the firm has seven registered penicillin products but has no separate
penicillin manufacturing section. The Federal Inspector of Drugs further informed that at
present lay out has been approved for new penicillin section. Federal inspector of Drugs has
provided the following list of registered products having penicillin of M/s. Attabak
Pharmaceuticals alongwith registration letters.
S. No. Regn. No. Name of Drug(s)/Composition
1. 063822 Salinobak Water Soluble Powder
Each 100gm contains:-
Lincomycin as Hcl ………. 5.0gm
Spectinomycin as Hcl ……..5.0gm
Amoxicillin Trihydrate ……10gm
2. 069629 Amoxibak LA Injection.
Each ml contains:-
Amoxicillin as Trihydrate 15% w/v
3. 071053 Moxin-L Water Soluble Powder
Lincomycin as HCl …….…5gm
Colistin Sulphate.….. ….50MIU
Amoxicillin Trihydrate .…10gm
Bromhexine HCl ……….0.5gm
4. 071054 Amox-C Maarson Powder
Amoxicillin as Trihydrate…50gm
Colistin Sulphate … …….50MIU
5. 071061 Amoxibak Water Soluble Powder
Colistin sulphate …………50MIU
6. 071062 Amoxitin-C Water Soluble Powder

Colistin sulphate ……….. 80MIU
7. 071063 As-Plus Water Soluble Powder.
Spectinomycin as HCl .… 5.0gm
Colistin Sulphate .………50MIU
Amoxicillin Trihydrate ..…10gm
Bromhexine HCl ………. 0.5gm
With reference to product at Sr. No.1 it is submitted that the product has already been
transferred to M/s. D-Maarson Pharmaceuticals, Rawat, Rawalpindi.
Decision:- Registration Board decided to issue show cause notice to M/s. Attabak
Pharmaceuticals, Islamabad for cancellation/suspension of registration of
above mentioned products registered in the name of M/s. Attabak
Pharmaceuticals, Islamabad for not possessing the penicillin
manufacturing facility.
Case No. 12:- Request of M/s. Nawan Laboratories (Pvt) Ltd., Karachi for Grant
of Additional Packs for their already Registered Veterinary Drugs.
M/s. Nawan Laboratories (Pvt) Ltd., Karachi has applied for grant of additional packs
of their following registered veterinary drugs as per details mentioned against each:-
S. Regn. Name of Drug(s)/ Already Demanded Initial Justification
No. No. Composition (as per initial Pack Size Additional registration
registration letter) Granted Pack with renewal
1. 053999 VIM-SEL Oral Solution 100ml 1 Liter 31-03-2009  Marketing
Each vial contains:- demand.
Alpha Tocopheryl Acetate 21-02-2014  Customer
(Vitamin E) B.P…100mg convenience.
Sodium Selenite B.P.2mg  Economical,
easier to
administration and
affordable for
farmers, suppliers
and customers.
2. 035064 Nawazan Plus Bolus 30’s Bolus 10’s Bolus 14-12-2004 -do-
Each bolus contains:-
Levamisole HCl..1.125gm 10-12-2014
Oxyclozanide.…2.250gm
Cobalt Sulphate
.....0.286gm
Sodium Selenite
……0.026gm
3. 082489 PSB-Excel Powder 100gm 5 Kg 30-10-2017 -do-
Each kg powder 250gm
contains:- 500gm
Procaine Penicillin B.P 1Kg
……………12gm 25Kg
Streptomycin Sulphate
B.P ……………36gm
Zinc Bacitracin 10% B.P
Vet …………52gm
Neomycin Sulphate
B.P……………..10gm
(As per Innovator's
Specification*)
4. 035063 ADE Minerals 1Kg 25Kg 13-12-2004 -do-
Each kg contains:- 5Kg
Vitamin A……0.5MU 10-12-2014
Vitamin D…0.080MU
Vitamin E….0.300gm
Calcium……225.0gm
Phosphorous…120.0gm
Magnesium…25.0gm
Sodium………..20.0gm
Iron (as Ferrous)..1.0gm
Zinc…………….3.0gm
Manganese…...2.0gm
Copper……….0.600gm
Cobalt ………0.010gm
Iodine………..0.020gm
Selenium ……0.003gm
5. 082488 Colibac-SP 160 Powder 100gm 5Kg 30-10-2017 -do-
Each Kg powder 250gm
contains:- 500gm
Procaine Penicillin 1Kg
B.P……………..16gm 2.5Kg
Streptomycin Sulphtae 25Kg
B.P……………..40gm
Zinc Bacitracin 10% B.P.
Vet………100gm
Colistin
Sulphate.B.P…80MIU
(As per Innovator's
Specification*)
6. 021306 L.S. Minerals Powder 1Kg 25Kg 11-05-1998 -do-
Each kg contains: - 5Kg
Calcium………155gm 08-05-2018
Phosphorous…135gm
Magnesium……55gm
Sodium………...45gm
Iron (as Ferrous)..1gm
Zinc……………..3gm
Maganese……….2gm
Copper………..0.6gm
Cobalt……….0.01gm
Iodine……….0.04gm
Selenium…...0.003gm
M/s. Nawan Laboratories (Pvt) Ltd., Karachi has deposited the required fee of
Rs.5,000x6 = Rs. 30,000/- and submitted following supporting documents:-
(i) Attested copies of initial registration letters and latest renewal status..
(ii) Details of previously granted pack size.
(iii) Undertaking that the provided information/documents are true/correct.
(iv) GMP inspection conducted by DRAP during last 12 months.
(v) Attested copy of Drug Manufacturing License.
(vi) Attested copy of CRF provided.
(vii) Justification of proposed change.
The demanded packs are not given to other firms.

a. For products at Sr.No. 1, 2, 3 & 5 approved the grant of additional
pack sizes as per following details on same terms and conditions;
Reg. No. Name of Drug(s) Approved Additional Pack sizes
053999 VIM-SEL Oral Solution 1 Liter
035064 Nawazan Plus Bolus 10’s Bolus
082489 PSB-Excel Powder 5 Kg
082488 Colibac-SP 160 Powder 5Kg
b. For products at Sr.No.4 & 6 referred the case to Expert Working

Group on veterinary drugs for their recommendations on
demanded additional pack sizes.
Case No.13:- Request of M/s. Selmore Pharmaceuticals (Pvt) Ltd, Lahore for
Change of Composition of already registered Veterinary Drugs.
M/s. Selmore Pharmaceuticals (Pvt) Limited, Lahore has requested for change of
composition of their following registered drug as per detail mentioned against each:-
S. Regn. Product Granted Composition Demanded Composition
No. No.
I II III IV
1. 029612 Oxy-5 Injection Oxy-5 Injection
Each 100ml contains:- Each ml contains:-
Oxytetracycline Dihydrate B.P. 5.495g Oxytetracycline (as HCI) BP....50mg
(equivalent to base 5gm)
2. 033254 Duasol Injection Duasol Injection
Oxytetracycline Dihydrate B.P. equivalent to Oxytetracycline (as HCI) BP…300mg
30gm FlunixineMeglumine USP……..20mg
Oxytetracycline base
FlunixineMeglumine B.P…… 2gm
3. 035014 OXY-LA Injection OXY-LA Injection
Oxytetracycline (base)…… 20gm Oxytetracycline (as HCI) BP…. 200mg
4. 035015 OXY-PVP Injection OXY-PVP Injection
Oxytetracycline dihydrate (base) 10gm Oxytetracycline (as HCI) BP…100mg
5. 071091 Oxyfen LA Injection. Oxyfen LA Injection
Each ml contains:- Each ml contains:-
Oxytetracycline………..200mg Oxytetracycline (as HCI) BP….200mg
Ketoprofen……………..30mg Ketoprofen (BP)…….………..….30mg
The firm submitted the following reason for change of composition of above stated
products:-
Solubility of Material:
According to official books, Oxytetracycline base is practically insoluble in water,
therefore they have to use Oxytetracycline HCI (freely soluble in water) instead of
Oxytetracycline Dihydrate/Oxytetracycline base. They will use Oxytetracycline HCI
equivalent to Oxytetracycline.
M/s. Selmore Pharmaceuticals (Pvt) Limited, Lahore has deposited required fee of
Rs.5,000 x 5 = Rs.25,000/- and submitted following supporting documents:-
(i) Copy of initial registration letters and renewal status.
(ii) Copy of CRF.
The case was considered in 8th PRVC meeting and was defer for provision of
clarification from the firm that whether the fill volume of products/injections remains the
same or otherwise.
In response the firm has submitted the following reply:-
“It is stated that we are changing the salt form of Oxytetracycline Dihydrate
to Oxytetracycline (as HCI) due to its free solubility in water in this form.
We have approved volumes of 10 to 100ml in these applied products which
are fairly large and by this change it will not affect fill volume).
The case was again considered in 12th PRVC meeting and the Committee decided to
place the case before Registration Board for further consideration.
Decision:- Since the requested salt i.e Oxytetracycline HCl is also available in B.P
monographs so the Registration Board approved M/s. Selmore
Pharmaceuticals (Pvt) Limited, Lahore’s request for change of salt form
of API Oxytetracycline for following registered products as details
mentioned alongside each on same terms and conditions;
S. Regn. Previous Composition New Approved Composition
No. No.
1. 029612 Oxy-5 Injection Oxy-5 Injection
Oxytetracycline Dihydrate B.P. Oxytetracycline (as HCI)....50mg
5.495g (equivalent to base 5gm)
2. 033254 Duasol Injection Duasol Injection
Oxytetracycline Dihydrate B.P. Oxytetracycline (as HCI) …300mg
equivalent to 30gm FlunixineMeglumine ……..20mg
Oxytetracycline base
FlunixineMeglumine B.P…… 2gm
3. 035014 OXY-LA Injection OXY-LA Injection
Oxytetracycline (base)…… 20gm Oxytetracycline (as HCI) …. 200mg
4. 035015 OXY-PVP Injection OXY-PVP Injection
Oxytetracycline dihydrate (base) Oxytetracycline (as HCI) …100mg
10gm
5. 071091 Oxyfen LA Injection. Oxyfen LA Injection
Oxytetracycline………..200mg Oxytetracycline (as HCI) ….200mg
Ketoprofen……………..30mg Ketoprofen …….………..….30mg
Case No.14:- Brand Names Resemblance.

M/s. Biogen Pharma, Chakbeli Road, Rawat has requested that brand name of their
registered product is in resemblance with another registered product. Details are as under:-
S.# Regn. No. Product Name of Resemblance with Firm Name Reason provided by the firm
M/s. Biogen Pharma
I II III IV V VII
1. 048233 Sensidec Oral Sensidec Super Water M/s. Decent The similarity in names is
Powder Soluble Powder Pharma, causing prescription issues
Each 100gm Each 1000g contains:- Rawat, at physician level as well as
contains:- Tylosin Tartrate……..100g Islamabad. confusion at pharmacy
Tylosin Tartrate Doxycycline HCI.........200g level. Both products have
B.P…...10gm Bromhexine HCI……5g almost same brand names.
Doxycycline (Regn. No. (074055)
HCL B.P....20gm
The firm M/s. Biogen Pharma has requested that the other firm may be advised to
change their brand name. The case was considered in 8th PRVC meeting which decided as
under:-
“The Committee evaluated the case and on the recommendations of the
Committee, Chairman, Registration Board decided to advise M/s. Decent
Pharma, Rawat, Islamabad which got the registration of their product namely
Sensidec Super Water Soluble Powder (Reg.No.074055) later, to change the
brand name of their product by submitting alternate brand names for further
consideration/ approval”.
Accordingly M/s. Decent Pharma, Rawat, Islamabad was advised vide letter to
propose alternate brand names and subsequent reminder has also been issued. However, no
response has been received from the firm as yet.
Board was informed that now M/s. Biogen Pharma, Rawat requested for change of
their brand. Firm has been informed to provide the requisite documents in accordance with
SOP prescribed by Registration Board for change of brand name.
Decision:- Registration Board deferred the case with the directions to bring up the
case in next Registration Board meeting with full detail background.
Case No.15:- Request of M/s. Hilton Pharma (Pvt) Ltd., Karachi for Change of
Primary Packaging from “Glass Bottle” to “HDPE Bottle” of
already registered Veterinary Drugs.
M/s. Hilton Pharma (Pvt) Ltd., Karachi has requested for change in primary
packaging material from glass bottle to HDPE bottle for their following already registered
products. Details are as under:-
S. No. Reg. No. Name of Drug(s) & Composition
1. 004831 Darvisul Liquid
Contains:-
Diaveridine BP (Vet)…………0.64% w/v
Sulphaquinoxaline BP (Vet)…..2.56%w/v
2. 005127 Oxafax Liquid
Each ml contains:-
Oxfendazole…………..22.65mg
Firm has deposited required fee Rs.5,000 x 2 = Rs. 10,000/- and submitted following
supporting documents:-
i) Copy of initial registration letters and renewal status.
ii) Copy of CRF.
iii) The firm has provided 6 months accelerated and 6 months real time stability
data.
iv) Justification for change of primary packaging for products Darvisul Liquid &
Oxafax Liquid: in order to avoid unnecessary breakage during transportation
and for better product presentation.
Decision:- Registration Board approved M/s. Hilton Pharma (Pvt) Ltd., Karachi
request for change of primary container closure from glass bottle to
HDPE bottle for their following already registered products on same
terms and conditions.
S. No. Reg. No. Name of Drug(s)
1. 004831 Darvisul Liquid
2. 005127 Oxafax Liquid
NEW CASES
A. HUMAN CASES
Case No.16:- Request of M/s. Atco Pharma International (Pvt) Ltd, Karachi for change
of name of manufacturer for their approved product Trozet Tablet
2.5mg.
M/s. Atco Pharma International (Pvt) Ltd., Karachi has requested for grant of
registration certificate with updated principal name i.e M/s. Fresenius Kabi Oncology
Limited, India for their approved product “Trozet Tablet 2.5mg”.
The details of the case are as follow:-
a. Registration Board in its 257th meeting approved the following product of M/s.
Atco Pharma International (Pvt) Ltd, Karachi as per details mentioned below.
S# Name of importer / Name and Demanded Pack Decision of
manufacturer Composition of size & Price Board
Drug(s)
1. M/s Atco Pharma TROZET Tablet Rs. 8139 Pack of 28’s Approved.
International (Pvt) Each film coated tablet Firm will provide
Limited, Karachi contains: valid legalized
Manufacturer:- Letrozole USP CoPP as present
Dabur Pharma Limited, ……2.5mg has been expired
Village Kishanpura PO
Guru Majra Tehsil
Nalagarah Distt. India
b. The firm informed that initially the case was discussed in 254th Registration
Board meeting held on 11-12th Nov, 2015 and the Board deferred the case for
submission of legalized CoPP, Sole agency agreement and drug sale license.
c. In compliance to decision made by Registration Board in 254th meeting the firm
had submitted the requisite documents vide letter dated 08-03-2016 and along
with the said letter they also informed about the change of name of manufacturer
from M/s. Dabur Pharma Limited, India to M/s. Fresenius Kabi Oncology
Limited, India, as while submitting the registration application in Oct, 2008 the
name of the manufacturer was M/s. Dabur Pharma Limited, India. Copy of the
said letter is provided by the firm.
d. However, while approval of the said product in 257th Reg. Board meeting the
firm’s request was not considered inadvertently and manufacturer name was
mentioned as “M/s. Dabur Pharma Limited”.
e. The firm further informed that, previously, for various registered products they
have been granted change of name of manufacturer from M/s. Dabur Pharma
Limited, India to M/s. Fresenius Kabi Oncology Limited, India.
Now, the firm has requested to change of name of manufacturer from M/s. Dabur
Pharma Limited, India to M/s. Fresenius Kabi Oncology Limited, India for their said
approved product.
It is pertinent to mention that recently the firm has provided original, valid and
legalized CoPP issued by Indian authority for the said product, which mentions the name of
manufacturer as “M/s. Fresenius Kabi Oncology Limited”.
The case has been discussed in 5th PRVC meeting held on 22-02-2018 and the
committee decided to place the case before Registration Board.
Registration Board in its 279th meeting considered the firm request and decided to
defer the case for provision of revised sole agency agreement from the manufacturer abroad
having the new name of manufacturer. Now the firm has provided notarized copy of revised
sole agency agreement/distribution agreement from manufacturer M/s. Fresenius Kabi
Oncology Limited, India.
Decision:- Keeping in view the above stated position, Registration Board approved
M/s. Atco Pharma International (Pvt) Ltd., Karachi request’s for change
of name of manufacturer from M/s. Dabur Pharma Limited, India to M/s.
Fresenius Kabi Oncology Limited, India for approved product “Trozet
Tablet”.
Case.No.17:- Request of M/s. Hakimsons (Impex) (Private) Ltd, Karachi for Exemption
of Inspection of Manufacturing Facilities in India for their Approved
Products.
Registration Board in its 252nd meeting held on 07-08th September, 2015 approved the
registration of following products manufactured by M/s. Cadila Healthcare Ltd, India for
import in the name of M/s. Hakimsons (Impex) (Private) Ltd., Karachi subject to inspection
of manufacturer abroad, verification of storage facilities and MRP fixation / calculation etc.
as per policy:
S. No. Name of Drug (s). Price approved by the Price Shelf Life
Advisory Committee.
1. Mycophenolate Mofetil Tablets 500mg Revised/ Proportionate Price 02 years
Each tablet contains: - Rs.5350.00/50's
Mycophenolate Mofetil Ph.
Eur...500mg
(Immunosuppressant )
2. Azathioprine Tablets USP 50mg Rs.1035.00/100's 02 years
Each tablet contains: - 6th DPC DRAP
Azathioprine USP…..50mg
(Immunosuppressant)
M/s Hakimsons (Impex) Karachi subsequently requested to waive off the inspection
manufacturing facilities of M/s Cadile Healthcare Ltd, District Ahmedabad, Gujarat India
with reference to above products.
The firm initially submitted a letter from FDA (USA) clarifying their facility
acceptable. The facilities are, however, not formally certified. Subsequently, M/s Hakimsons
(Impex) Karachi provided a copy of the Establishment Inspection Report of M/s Cadila
Healthcare Ltd, survey No.417,419 & 420 Sarkhej Ahmedabad, Gujarat India claiming it as
evidence of approval of the site by the Administration.
The inspection report covers the Quality facilities and equipment, material,
Production, Packaging, Labeling and Laboratory control systems. The inspection was carried
out in February, 2017. M/s Hakimsons (Impex) Karachi requested for exemption from
inspection of M/s Cadial Healthcare Ltd, Ahmedabd Gujrat, India on the basis of above
mentioned documents.
The case was discussed in 277th Registration Board meeting and the Board, inter alia,
decided as follow;
“Registration Board defer the case of M/s Hakimsons (Impex) (Private) Ltd, Karachi
for exemption of inspection of manufacturing facilities for clarification/confirmation
of address of manufacturer.”
The above referred EIR report does not appear to be conclusive with regards to GMP
status of the manufacturer as it mentions the detail of inspection process carried out by the
US-FDA panel of the site and no information is present regarding the
conclusion/recommendation.
The firm later informed that M/s. Cadila Healthcare Limited is listed at official
website of US-FDA under the title of “Drug Establishment Current Registration Site” and
claims that the GMP status of the firm can be confirmed from there. The details mentioned on
the official website includes Firm name, FDA Establishment Identifier (FEI), Business
operation, address and expiration date.
Furthermore, in response to query related to the evidence of facility approval by US-
FDA, the firm has presented the scope/purpose of “Drug Establishment Current Registration
Site” from official website which states that “Drug Establishment Current Registration Site
(DECRS) is a publication of currently registered Establishment (facilities) which
manufacture, prepare, propagated, compound or process drugs that are commercially
distributed in the US of offered for import in the US”.
The Board was informed that an email has been sent to US-FDA for confirmation of
status of “Drug Establishment Current Registration Site” as an evidence of GMP
conformation for which reply was awaited. The case was discussed in 284th meeting of
Registration Board and the Board decided to defer the case till obtaining clarifications/reply
from the US-FDA.
Reply/clarification (from Tammie Bell, International Programs, Strategic Initiatives,
Office of the Center Director, Center for Drug Evaluation and Research, U.S. Food and Drug
Administration) to the email from this office has been received. Details are as follow;
S.No Query Reply/Clarification from US-FDA
1. Whether US-FDA, formally, The U.S. Food and Drug Administration (FDA) does not approve
approve/certify the GMP of or certify drug manufacturing facilities. Rather, FDA reviews
foreign manufacturing drug manufacturing facilities for compliance with current good
facilities. manufacturing practice (CGMP) requirements for the
manufacture of specific drug(s).
2. If US-FDA certify any In general, FDA’s Center for Drug Evaluation and Research
foreign manufacturing (CDER) does issue post-marketing export certificates that, among
facility, then, whether a other things, attest to the current good manufacturing practice
formal certificate of GMP (CGMP) compliance status of facilities (both domestic or foreign).
compliance is being issued The attestation of CGMP compliance in the certificate is unique to
by US-FDA. the manufacturing of a specific FDA-regulated drug. For more
information on CDER’s Export Certificate Program, please refer
to the following links:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm1257
89.htm
https://www.fda.gov/drugs/guidancecomplianceregulatoryinform
ation/importsandexportscompliance/ucm348825.htm
3. If no such certificate is As noted above, export certificates for drugs explain the CGMP
issued, then from where the status of a specific drug manufacturing facility. Further, the
GMP compliance of any outcome of CGMP inspections are maintained online in FDA’s
foreign manufacturer, Inspection Classification Database. This database is updated
inspected by US-FDA, can monthly and indicates how a facility was classified after a CGMP
be confirmed. inspection.
https://www.fda.gov/iceci/inspections/ucm222557.htm
4. At times the applicant in Foreign establishments (facilities) that manufacture, repack,
Pakistan refers to listing of relabel or salvage drugs that are offered for import in the United
manufacturing facilities at States are required to register with FDA. The Drug
“Drug Establishments Establishments Current Registration Site is a publication of
current Registration site” establishments (facilities) that are currently registered with FDA
available at US-FDA official and that manufacture, prepare, propagate, compound or process
website as drugs that are commercially distributed in the United States or
evidence/certification of offered for import in the United States. FDA’s Drug
GMP by US-FDA. Is it true? Establishments Current Registration Site does not provide any
evidence that a particular site has been inspected by FDA for
compliance with current good manufacturing practice (CGMP)
requirements.
Decision:- Registration Board deferred the case till next meeting for presenting the
case with complete details of all requests by various firms regarding
exemption from inspections of manufacturers on the basis of their
claimed approval/accreditation by regulatory authority of USA i.e US-
FDA.
Case.No.18: Request of M/s Pharmatel, Lahore for withdrawal of Registration

Application.
M/s. Pharmatel, Lahore has requested for cancellation / withdrawal of registration
applications of their following approved product. Details are as under;
S.No Firm Name/importer Product name & Demanded Board Reason for
Composition Pack Size & Decision cancellation/
MRP withdrawal
stated by
firm
1. M/s. Pharmatel, LETRO tablet As per Leader Approved as Due to
Office No. 06, first floor, 2.5mg price per Policy for devaluation
11-civic centre, Faisla town, Each film coated 30’s inspection of of the
Lahore. tablet contains: Manufacturer Pakistani
Name and address of Letrozole… 2.5 abroad Rupee and
manufacturer & marketing mg some other
authorization holder:- M-279 reasons, the
M/s Pharmacare Premium said product
Ltd. HHF003, Hal Far is not feasible
Industrial Estate Birzebbuga for us to
BBG3000, Malta import.
The firm informed that they are not interested in this product and are not interested in
inspection abroad. “we surrender our said product”.
Decision:- Registration Board acceded to firm’s request and accordingly rejected the
registration application of product “Letro tablet 2.5mg” of M/s.
Pharmatel, Lahore.
Case No.19:- Request for Change of Importer of Registered Imported Veterinary

Drugs by M/s. Hipra Pakistan (Private) Limited, Lahore.
M/s. Hipra Pakistan (Private) Limited, Lahore request for registration of following
registered imported veterinary drugs from the name of previous importer M/s. Marush (Pvt)
Limited, K-123, Model Town, Lahore to their name. The details are submitted as under:-
Sr. Regn. Name of Drug (s) Composition & Pack Size Manufacturer (as per
No. No. CoPP)
1. 080158 Selectan Injection 300mg/ml M/s. Laboratorios Hipra,

Each ml contains:- S.A, Avda. La Selva, 135,
Florfenical…300mg 17170-Amer, Spain.
100ml polypropylene bottle
2. 080159 Eficur Injectable Suspension 50mg/ml -do-
Each ml contains:-
Ceftiofur as Hydrochloride..50mg
100ml type II glass vial
3. 080160 Gentamox Injection -do-
Each ml contains:-
Amoxicillin trihydrate……150mg
Gentamicin as Sulphate………40mg
(equivalent to 40,000 I.U) as per CoPP & Form 5A)
100ml Type II glass vial
4. 048139 Hiprachok-Amino Oral Solution -do-
Each 100ml contains:
Vitamin A…1200.000 IU
Vitamin D3…320.000 IU
Vitamin E…32%
Vitamin K…0.08%
Vitamin C…0.4%
Vitamin B1…0.2%
Vitamin B6…0.12%
Folic Acid…0.03%
Calcium Pantothenate…0.4%
Aminoacids Solution…2.0%
(1000ml)
5. 017080 Hipralona Enro-S oral Solution -do-
Each ml contains:
Enrofloxacin…100mg
(1000ml pack size)
6. 017081 Hipralona Enro-I injectable Solution -do-
Each ml contains:
Enrofloxacin…50mg
(100ml vial pack size)
The firm has deposited required fee of Rs.100,000 x 6 = Rs. 600,000/- and submitted
the following documents:-
i) No Objection Certificate from M/s. Marush (Pvt) Ltd, K-123, Model Town,
Lahore with no date on it.
ii) Legalized Certificate of Pharmaceutical Products for above products except
for product at Sr.No.4 wherein firm has provided a free sale certificate without
leglaization/ attestation.
iii) Certificate of GMP compliance of a manufacturer.
iv) Termination of Distribution Agreement.
v) Copies of initial registration letters.
vi) Letter of Appointment.
vii) Undertaking.
viii) Copy of Drug Sale License having address M/s. Hipra Pakistan (Pvt) Ltd,
Office 3 & 4, 5th Floor, 105-B-II, Ali Tower, M.M.Alam Road, Gulberg,
District Lahore.
ix) Form-5A mentions the address of Head Office i.e. M/s Hipra Pakistan (Pvt)
Ltd, 191-A Block, Shami Road, Cavalry Ground, Lahore Cantt, Lahore,
Pakistan.
With reference to the instant case it is submitted that products at Sr.No.1-3 have
already been considered by Registration Board in its 283rd meeting and decided to defer the
case for confirmation of NOC from M/s. Marush, (Pvt) Ltd., Lahore. However, later
Biological Division has informed that M/s. Marush (Pvt) Ltd, Lahore vide letter denied
issuance of any NOC to M/s. Hipra Pakistan.
Furthermore, Registration Board in its 285th meeting, while considering M/s. Hipra
Pakistan Limited, Lahore’s request for transfer of registration of veterinary vaccines from the
name of M/s. Marush (pvt) Ltd, Lahore to their own name, decided to issue show cause
notices to M/s. Marush Private Limited, Lahore to explain why not the registrations of all
registered products manufactured / authorized by M/s Laboratorios Hipra, S.A. (Hipra), Av.
De La Selva, 135, in Amer (Girona), Spain be cancelled as sole agency agreement has been
terminated. Accordingly show cause notice has been issued to M/s. Marush (pvt) Ltd, Lahore
to submit their reply within five (05) days and if desired to be heard in person, they may
come in 286th meeting of Registration Board.
Discussion:-
The Board was informed that, in response to show cause and personel hearing notice
issued by this office, M/s. Marush (Pvt) Ltd, Lahore responded as follow;
“… it is submitted that there is need to see and consult the relavent record for preparation
and submission of reply. M/s. Marush Pvt Ltd has to consult with lawyer in this regard
because litigation is also pending adjudication before courts of law at Lahore with regard to
registration and termination of Distribution agreement, details of which can only be given
after getting information from lawyer who is not available due to his illness. Therefore
reasonable time period at least one month may kindly be given to M/s. Marush Pvt Ltd for
submission of reply and to plead its case before the Drug Registration Board.”
Mr. Carlos Montane’s Managing Director & Member of the Board and Ms. Elia
Torroella Research and Development and Registration Division Worldwide from M/s
Laboratorios Hipra, S.A., Spain attended the meeting and informed the Board that M/s
Laboratorios Hipra, S.A., Spain appointed M/s Marush Private Limited, Lahore as their
authorized agent in 2010 and done the business with them for over 07 years. They had some
payment issues with M/s Marush Private Limited, Lahore and came to know about the legal
troubles of M/s Marush Private Limited, Lahore in May, 2017. Hence, they terminated the
sole agent authorization of M/s Marush Private Limited, Lahore and appointed M/s Hipra
Pakistan (Private) Limited, Lahore as their sole agent for above products. They also
submitted the legalized termination letter in name of M/s Marush Private Limited, Lahore and
legalized authorization letter in name of M/s Hipra Pakistan (Private) Limited, Lahore.
The Biological Division further informed that M/s. Marush (Pvt) Ltd, Lahore had
filed a petition in Court of Senior Civil Judge Lahore regarding the change of registration
status from their name to M/s Hipra Pakistan (Private) Limited Lahore. Wherein the court did
not allow any interim relief to the firm. The Legal Affair Division of DRAP was of the view
that DRAP and the Registration Board should proceed with the applications for
change/transfer of registration under the law as the courts have refused to grant interim
injunction/stay order to Marush private Ltd.
Decision:- Keeping in view the facts stated above including termination of

distribution agreement by M/s. Laboratorios Hipra SA, Spain in favour of
M/s. Marush (Pvt) Ltd, Lahore for the above mentioned products, the
Board decided as follow;
a. Approved the cancellation of registration of products at Sr.No.1-6
(of above table) from the name of M/s. Marush (Pvt) Ltd, Lahore.
b. Approved the registration of products at Sr.No.1-3, 5 and 6 in the
name of M/s. Hipra Pakistan (Private) Limited, Lahore as per
policy for imported finished drug registration.
c. Deferred the case for grant of registration of product at Sr.No.4 to
M/s. Hipra Pakistan (Pvt) Ltd, Karachi for provision of legalized
CoPP/Free sale certificate by the firm.
B. VETERINARY CASES
Case No.20:- M/s. D-Maarson Pharmaceuticals, Rawat, Rawalpindi.
Secretary Central Licensing Board has forwarded the case of M/s. D-Maarson
Pharmaceuticals, Rawat Rawalpindi wherein it has been informed that while considering the
case of renewal of Drug Manufacturing License of M/s. D-Maarson Pharmaceuticals Plot No.
17, SS-2, RCCI Rawat, Rawalpindi in 259th meeting of the Central Licensing Board, held on
29-30, March 2018, the Board observed that the firm have registration of following
veterinary products contains penicillin but firm does not possess separate section for
manufacturing of these products.
1. 063514 LOX-20 Water Soluble Powder
Each 100gm contains:
Amoxycillin Trihydrate……20gm
Colistin Sulphate…..……..50MIU
2. 072682 CLAU MOX-28 Water Soluble Powder
Each 100g contains:-
Amoxicillin trihydrate………20g
Clavulinic acid ………............4g
Colistin sulphate …….............4g
3. 062175 MOXIBAK-C Water Soluble Powder
Each 100gm powder contains:-
Amoxicillin as Trihydrate…….15gm
Colistin Sulphate…………….50MIU
The case was considered in 282nd meeting of Registration Board wherein, the Board
was also informed that in addition to the above mentioned products identified by Central
Licensing Board, the following product containing penicillin is also found registered in the
name of M/s. D-Maarson Pharmaceuticals, Rawat, Rawalpindi.
Lincomycin as Hcl ………. 5.0gm
Spectinomycin as Hcl ……..5.0gm
Amoxicillin Trihydrate ……10gm
Registration Board decided to issue show cause notice to M/s. D-Maarson

Pharmaceuticals, Rawat, Rawalpindi for cancellation/suspension of registration of above
mentioned products registered in the name of M/s. D-Maarson Pharmaceuticals, Rawat,
Rawalpindi for not possessing the manufacturing facilities.
Show Cause Notice issued to the firm. In response the firm has requested for personal
hearing. Accordingly personal hearing letter has been issued to the firm.
Mr. Daulat Khan, CEO of M/s. D-Maarson Pharmaceuticals, Rawat appeared before
the Board and informed the Board that they had already suspended the manufacturing of their
registered penicillin containing products. He further informed that they are in process of
developing a separate veterinary penicillin manufacturing section and in the mean time
arrangements will be made for contract manufacturing of these products from M/s. Farm Aid
Group, Hattar.
Decision:- Registration Board suspended the registration of below mentioned
products registered in the name of M/s. D-Maarson Pharmaceuticals,
Rawat for not possessing the penicillin manufacturing facility till the firm
make necessary arrangements for contract manufacturing of these
products.
S. No. Regn. No. Name of Drug(s)
1. 063514 LOX-20 Water Soluble Powder
2. 072682 CLAU MOX-28 Water Soluble Powder
3. 062175 MOXIBAK-C Water Soluble Powder
Case No.21:- Registration of Drugs under the Drugs Act, 1976-Inspection

Report of Manufacturer Abroad.
The Registration Board approved the drugs manufactured by M/s. BC World Pharm.
Co. Ltd, Korea in respect of different applicants in its 271st & 274th meetings subject to
inspection of manufacturer abroad as per import policy. The inspections of the
aforementioned manufacturers was accordingly carried out by the approved inspection panel.
The details of the case are given as under:-
(A) PRODUCT APPLIED BY M/S. OBS PHARMA (PVT) LTD., KARACHI.

S. No. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/ Date
Manufacturer & meeting of inspection
number
1. M/s. OBS Pharma (Pvt) Ltd., Tipem Injection (i) Dr. Hafsa Karam Elahi,
Karachi-75600./ Each vial contains:- Deputy Director/ Additional
Manufacturer:- Imipenem (monohydrate), Director, Drug Regulatory
M/s. BCWorld Pharm. Co. Ltd. U.S.P……………500mg Authority of Pakistan,
872-23, Yeojunam-ro, Ganam- Cilastatin Sodium, U.S.P.., Islamabad.
eup, Yeoju-si, Gyeonggi-do, equivalent to
Republic of Korea. Cilastatin……500mg (ii) Dr. Najam-us-Saqib,
Product license holder M/s. (Carbapenem Antibiotics). Additional Director, Drug
Myungmoon Pharmaceutical Regulatory Authority of
Co. Ltd., Hwaseong-Si, (M-271) Pakistan, Karachi.
Gyeonggi-Do, Korea.
17th & 18th September, 2018
(B) PRODUCT APPLIED BY M/S. PHARMAWELL PVT., LTD., LAHORE.
S. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/ Date of

No. Manufacturer & meeting inspection
number
1. M/s. Pharmawell Pvt., Ltd., MEPEM IV Injection 500mg (i) Dr. Hafsa Karam Elahi, Deputy
22-Y Block, Phase III, Powder for solution for Director/ Additional Director, Drug
DHA, Lahore./ injection Regulatory Authority of Pakistan,
Manufactured by M/s. BC Each vial contains:- Islamabad.
World Pharm. CO., Ltd., Meropenem……….. 500mg
872-23, Yeojunam-ro, Antibiotic (Carbapenem) (ii) Dr. Najam-us-Saqib, Additional
Ganam-eup, Yeoju-si, Director, Drug Regulatory Authority
Gyeonggi-do, Republic of (M-274) of Pakistan, Karachi.
Korea. 17th & 18th September, 2018
2. -do- MEPEM IV Injection 1gm -do-
Powder for solution for
injection
Meropenem……..…. 1gm
Antibiotic (Carbapenem)
(M-274)
Overall evaluation of Inspection Report……..Un-satisfactory

Final Remarks…………………………………Not Recommended.
General Remarks/Comments of the Panel. Not recommended
M/s. BCWorld Pharm. Co. Ltd. 872-23, Yeojunam-ro, Ganam-eup, Yeoju-si,

Gyeonggi-do, Republic of Korea, is an old multi product/multi-dosage form pharmaceutical
manufacturing facility was license in year 1957. Carbapenem section is a small section
situated in the Block “1”, 2nd Floor. Following are some discrepancies that were observed by
the panel during the inspection of the firm:
 HVAC system of the carbapenem section is not a dedicated section. Three
different AHU were supplying air in following pattern:
AHU-1= Supplying air in the packing area of the carbapenem. The same
AHU is also supplying air in general corridor and solid oral (Tablet and
Capsule) product section located on same floor.
AHU-2=This AHU is dedicated for the Compounding and filling areas of the
carbapenem section.
AHU-3=This AHU is supplying air in the Vial washing and drying areas.
The same AHU is also supplying air in the adjacent liquid ampoule section
having multiple products including various potent products as well.
 There was no qualified engineer appointed for the handling of the HVAC
system only a technician was available to perform these engineering related
tasks with the help of three assistants for whole of the firm.
 Quality Control Laboratory generally seen well equipped, however, Q.C
Laboratory longs and record could not provide evidence that allows a
complete overview of the technical ability of the staff and overall quality
control procedures. Moreover, audit trail of the test/analysis of the products
in question could not be adequately be established.
 Ware housing facility is a one roof facility observed congested, wherein
various types of raw material, packaging materials and components,
quarantine materials, released materials and finished goods was placed in
dedicated high rise racks, but these do not generally allows good storage and
ware housing facility. Transfer passage for the different types of materials
from ware house to production areas was also not seen well segregated, but
also there was some printing operations were underway for small quantities
of several products.
 Recalled/Rejected store seen dumped with various products without
satisfactory records of the same.
Decision:- In view of the shortcomings highlighted and the recommendations given

by the inspection panel, the Board decide to reject the registration
applications of Tipem Injection ( of M/s. OBS Pharma (Pvt) Ltd.,
Karachi) and MEPEM IV Injection 500mg and 1gm ( of M/s. Pharmawell
Pvt., Ltd., Lahore).
Case No.22:- Registration of Drugs under the Drugs Act, 1976-Inspection

The Registration Board approved the drug manufactured by M/s. Xi’an Libang
Pharmaceutical Co. Ltd. Keji Yi Road, Xi’an Hi-Tech Development Zone, China in 279th
meeting subject to inspection of manufacturer abroad as per import policy. The inspection of
the aforementioned manufacturer was accordingly carried out by the approved inspection
panel. The details of the case is given as under:-
PRODUCT APPLIED BY M/S. MEDIAIR PHARMA, RAWALPINDI.
S. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/ Date of
No. Manufacturer & meeting inspection
number
1. M/s. Mediair Pharma MEDIFOL Injection I.V (i) Mr. Asim Rauf, Additional
178-A, Firduosi Lane, Tariq 200mg/20ml Director, Drug Regulatory
Abad, Rawalpindi Cantt./ Each 20ml ampoule contains:- Authority of Pakistan, Lahore.
Manufacturer & Marketing Propofol…….. ……200mg
Authorization Holder:- (Sedative/hypnotic) (ii) Mr. Manzoor Ali Bozdar,
M/s. Xi’an Libang Deputy Director/ Additional
Pharmaceutical Co. Ltd. Keji Director, Drug Regulatory
Yi Road, Xi’an Hi-Tech Authority of Pakistan,
Development Zone, China. Islamabad.
18th & 19th July, 2018
Overall evaluation of Inspection Report……..Un-satisfactory
Final Remarks…………………………………Not Recommended.
General Remarks/Comments of the Panel. Not recommended
 The firm comprises of separate block for manufacturing, quality control and
raw material stores. Raw material stores were maintained while quality
control was poor. There was one room for QA for documentation review.
Production facility was under maintenance since 15th July, 2018. Last
inventory release was on 14th July, 2018. The access to production rooms was
totally blocked, due to upgradation/maintenance by the firm, therefore, the
status of equipment’s/machinery, HVAC ducting the floors, walls could not
be evaluated.
 The documentation level of the firm was satisfactory, however operational
issues like “out of order: stability chamber was seen having products.
 The facility and equipment were not properly maintained. Facility was found
closed from 15th July, 2018 for maintenance whereas bin card reflect release
of raw material on 14th July, 2018. Firm did not wait for panel inspection
through it was pre scheduled.
 Equipments were not properly maintained. Refrigerator were not calibrated,
stability chambers were showing no RH only temperature was
maintained/monitored, balance was out of order.
 Packaging was carried in a big hall having multiple machines. Different
products were packed on different machines. Products were temperature
sensitive but there were no temperature and humidity control in the hall. Heat
index was apparent.
 Poor condition of micro lab. With no air controls. Exhaust fan was working
for temperature and air control. Personal luggage was lying in sterility area,
sterility was carried under ceiling fan. Refrigerators were out of order.
Reagents were lying without label balance was out of order. Windows were
open in QC without air control. Stability chamber were recording only
temperature having no humidity/monitoring. Moreover, 5 stability chambers
were out of order.
Decision:- In view of the shortcomings highlighted and the recommendations given
by the inspection panel, the Board decide to reject the registration
application of MEDIFOL Injection I.V 200mg/20ml of M/s. Mediair
Pharma, Rawalpindi.
Case No.23: Registration of Drugs under the Drugs Act, 1976-Inspection

The Registration Board approved the drug manufactured by M/s. Hebei Hope
Harmony Pharmaceutical Co., Ltd. Industry Area, Yuanshi County, Shijiazhuang City, Hebei
Province, People’s Republic of China in 272nd meeting subject to inspection of manufacturer
abroad as per import policy. The inspection of the aforementioned manufacturer was
accordingly carried out by the approved inspection panel. The details of the case is given as
under:-
(E) PRODUCT APPLIED BY M/S. CREED PHARMACEUTICALS, RAWALPINDI.
S. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/ Date
No. Manufacturer & meeting of inspection
number
1. M/s. Creed Pharmaceuticals, Moxne LA Suspension 15% (i) Mr. Asim Rauf,
House No.CB83, Street No.02, Injectable Suspension Additional Director, Drug
Shally Valley, Range Road Each ml contains:- Regulatory Authority of
Saddar, Rawalpindi./ Amoxicillin Pakistan, Lahore.
Manufactured by :- (as trihydrate) ………..150mg
M/s. Hebei Hope Harmony (Antibiotic) (ii) Mr. Manzoor Ali
Pharmaceutical Co., Ltd. (M-272) Bozdar, Deputy Director/
Industry Area, Yuanshi Additional Director, Drug
County, Shijiazhuang City, Regulatory Authority of
Hebei Province, People’s Pakistan, Islamabad.
Republic of China.
Product License Holder:- 16th & 17th July, 2018
M/s. Hebei Hope Harmony
Pharmaceutical Co., Ltd.
Industry Area, Yuanshi
County, Shijiazhuang City,
Hebei Province, People’s
Republic of China.
2. -do- Penten 20/20 Injectable -do-
Suspension
Each ml contains:-
Penicillin G Procaine……200mg
Dihydrostreptomycin (as
sulphate)…………………200mg
(Antibiotics for systemic use-
combination of antibiotics
ATC vet code: QJ01RA01)
(M-272)
3. -do- Ivectin 2% Injection -do-
Each ml contains:-
Ivermectin …………20mg
(Antiparasitic drugs)
(M-272)
4. -do- Ener 10% Oral Solution -do-
Each ml contains:-
Enrofloxacin…..100mg
(M-281)
5. -do- Oxipro 20% Injection -do-

Each ml contains:-
Oxytetracycline Dehydrate (as
Oxytetracycline)…200mg
(M-281)
6. -do- Oxipro 5% Injection -do-
Each ml contains:-
Oxytetracycline…50mg
(M-281)
Overall evaluation of Inspection Report……..Good

Final Remarks recommended for non Penicillin products i.e. Ivectin 2% Injection, Ener
10% Oral Solution, Oxipro 20% Injection & Oxipro 5% Injection. Not recommended for the
products Moxne LA Suspension 15% Injectable Suspension & Penten 20/20 Injectable
Suspension.
General Remarks/Comments of the Panel.
 The firm was established on vast area of land divided into blocks. There was a
separate block for each type of drugs like there was separate facility for
injectables and oral solution products etc.
 However, there was no dedicated facility for manufacturing of penicillins which
was under construction.
Keeping in the above position the panel could not recommended products at Sr. No. 1
& 2 recommended and the products at Sr. No. 3-6 is recommended
Decision:- Registration Board deferred the case for obtaining clarification/details
from the inspection panel regarding the area/section where, at present,
their penicillin containing products are being manufactured.
Case No. 24:- Request of M/s. Prix Pharmaceutica (Pvt) Ltd, Lahore for Grant of
Additional Packs for their already Registered Veterinary Drugs.
(A) M/s. Prix Pharmaceutica (Pvt) Ltd, Lahore has applied for grant of additional packs of
their following registered veterinary drugs as per details mentioned against each:-
S. Regn. No. Name of Drug(s)/Composition Already Demanded Initial Justification
No. Pack Size Additional registration
Granted Pack with renewal
1. 041282 Zoben 25 Oral Drench 150ml 2.5 Liter 03-12-2005 Livestock markets in each
Each 5ml contains:- 100ml administrative unit of a
Albendazole……..125mg 500ml 30-1-2015 country increase day by
1000ml day. The number of farms
peaked steadily with
increase number of cattle
and productivity rises.
Thus, it will be difficult to
meet the demand of farmers
with a pack of smaller size.
Farmers demand larger
packs for their farms
because they fulfill their
needs and they are much
more economical than
smaller packs.
2. 043274 Pri-ox Oral Drench 100ml 2.5 Liter 26-4-2006 -do-
Each 5ml contains:- 500ml
Oxfendazole…113.250mg 1000ml 4-4-2016
3. 043275 Combat Oral Drench 150ml 2.5 Liter 23-6-2006 -do-
Each 5ml contains:- 100ml
Levamisole (as hydrochloride) 500ml 2-5-2016
……..75.00mg 1000ml
M/s. Prix Pharmaceutica (Pvt) Ltd, Lahore has deposited the required fee of
Rs.5,000x3= Rs. 15,000/- and submitted following supporting documents:-
(i) Attested copies of initial registration letters and latest renewal status.
(ii) Copy of approval additional pack of veterinary drugs.
(iii) Details of previously granted pack size.
(iv) Undertaking that the provided information/documents are true/correct.
(v) GMP inspection conducted by DRAP during last 12 months.
(vi) Attested copy of Drug Manufacturing License.
(vii) Justification of proposed change.
Decision:- Registration Board approved M/s. Prix Pharmaceutica (Pvt) Ltd, Lahore
request’s for grant of additional pack sizes of following registered
products as per details mentioned alongside each on same terms and
conditions;
S.No. Regn. No. Name of Drug(s)/Composition Approved Additional Pack Sizes
1. 041282 Zoben 25 Oral Drench 2.5 Liter
Each 5ml contains:-
Albendazole……..125mg
2. 043274 Pri-ox Oral Drench 2.5 Liter
Each 5ml contains:-
Oxfendazole…113.250mg
3. 043275 Combat Oral Drench 2.5 Liter
Each 5ml contains:-
Levamisole (as
hydrochloride)……..75.00mg
(B) M/s. N.B Sons (Pvt) Ltd, Lahore has requested for grant of additional pack sizes for
their following registered imported veterinary products. Details are mentioned alongside each
product.
S. # Reg. No. Name of Drug (s) / Existing Demanded Initial Date of Justification
Composition Pack Additional Regn. Letter/
packs Renewal
Dairy No. &
Date
1. 049586 Doxycycline 20% Water 100gm 2.5Kg 02-09-2008 Due to high
Soluble Powder 250gm 4Kg 29-08-2018 consumer
Each 1 gram contains:- 500gm Dy. No. 30815 demand and
Doxycycline HCI..200mg 1Kg & 35499-R&I cost effectives
Dated 12-9-2018 of the required
& 25-10-2018 pack sizes.
M/s. N.B Sons (Pvt) Ltd, Lahore has deposited the required fee of Rs.5000 x 2 =
Rs.10,000/- and submitted required supporting documents including;
(i) Copy of initial Registration letter and latest renewal status.
(ii) Copy of Drug Sale License.
(iii) Original legalized free sale certificate (alongwith approval of the pack sizes)
issued by Regulatory Authority of Exporting Country i.e. Netherlands.
(iv) Justification of proposed change.
(v) Undertaking that the provided information/ documents are true/ correct.
(vi) Detail of previously granted pack sizes.
(vii) Undertaking submitted documents regarding the drug Doxycycline 20% Water
Soluble Powder are true to the best of knowledge.
Decision:- Registration Board approved M/s. N.B Sons (Pvt) Ltd, Lahore request’s
for grant of additional pack sizes of 2.5kg and 4kg of their registered
product Doxycycline 20% Water Soluble Powder (049586) on same terms
and conditions.
Case No. 25: Cancellation of Registration of Oxytocin Multi-Dose Vials.

Registration Board in its 278th meeting, while considering the QA/LT Division
agenda’s case of Manufacture & Sale of Adulterated & Sub-Standard “Oxytocin Injection
(for vet only)” Batch No. 2876 Manufactured by M/S. Elko Organization Pvt, Ltd, Karachi,
inter alia, took following general decision regarding registered multi-dose vials of Oxytocin
injection:-
 Registration Board advised PE&R Division to present case regarding alleged use
of Oxytocin multi-dose vials for enhancement of milk production in the animals.
 The Board agreed to issue show cause notice of multi-dose vials on the same lines
which have been adopted by India. They allow only one ml Oxytocin ampoule for
human use only.
Accordingly, show cause notices to the registration holders of multi-dose vials of
Oxytocin Injection have been issued. The case is submitted for consideration of Registration
Board.
Decision:- Registration Board noted and endorsed the action taken.
Case No. 26: Proceedings of Meetings of Expert Working Group on Veterinary Drugs.
Registration Board in its 281st meeting held on 11-13th April, 2018 constituted an
Expert Working Group on veterinary drugs for provision of expert opinion and
recommendations to the Registration Board on matters relating to veterinary drugs referred to
it by the Board including review of existing/new veterinary drug formulations.
The proceedings of the 1st and 2nd meetings of the Group was already presented before
the Registration Board in its 284th meeting. The minutes of 3rd and 4th meeting of Expert
Working Group on Veterinary Drugs are submitted as under: -
A. MINUTES OF THE 3RD MEETING OF EXPERT WORKING GROUP ON

VETERINARY DRUGS HELD ON 13TH SEPTEMBER, 2018
The 3rd meeting of Expert Working Group on Veterinary Drugs was held on 13th
September, 2018 in the Committee Room of DRAP 4th Floor TF Complex, Islamabad. Dr.
Qurban Ali, Member Registration Board chaired the meeting which was also attended by the
followings: -
(i) Dr. Mazhar Ul Haq,
Veterinary Pharmacologist,
PMAS, Arid Agriculture University, Rawalpindi
(ii) Urooj Fatima,
Deputy Director (Reg-I)/Secretary Expert Working Group
DRAP, Islamabad.
Dr. Hafsa Karam Elahi, Additional Director QA&LT Division also attended the
meeting on invitation as representative from QA&LT Division. Mr. Syed Adnan Ali Shah,
Assistant Director (Reg-I) DRAP, Islamabad assisted the Working Group.
Meeting started with recitation of Holy Quran. The Working Group was informed that
the previous proceedings of the meetings of Expert Working Group were placed for
consideration of the Board in its 284th meeting. The formal minutes of the Registration Board
meeting are awaited for finalization/approval.
Awaiting formal minutes of the Registration Board the Working Group further
deliberated on the issue of the pending registration applications of the products which are not
in free sale in country of origin or those molecules which are not available/approved in
reference regulatory authorities prescribed by the Registration Board. The Group, in view the
current requirement of availability of the product/molecule in its country of origin/reference
country as one of the pre-condition for consideration of registration, discussed the issue of
product/molecule which are claimed to be required locally but not fall under the above
mentioned requirement laid down by the Registration Board. The Group considered the
possibility of identifying such product/molecule in consultation with the relevant experts for
further deliberation regarding genuineness of their claim.
It was decided that;
i. For products which are not on free sale in country of origin/manufacturer,
the prevailing pre-conditions/import policy shall be adhere to.
ii. For molecules which are not available/approved in any reference regulatory
authority, a list of such molecules shall be develop by Expert Working
Group/Committee keeping in view their safety, efficacy and quality, for
consideration of relevant experts with respect to their requirement in
Pakistan veterinary sector.
The Group further decided to take up the remaining agenda after finalization of minutes
th
of 284 meeting of Registration Board as its previous proceedings are already placed in the
aforementioned meeting of the Board for its consideration.
B. MINUTES OF THE 4TH MEETING OF EXPERT WORKING GROUP ON
VETERINARY DRUGS HELD ON 15TH OCTOBER, 2018.
The 4th meeting of Expert Working Group on Veterinary Drugs was held on 15th
October, 2018 in the Committee Room of DRAP 4th Floor TF Complex, Islamabad. Dr.
Qurban Ali, Member Registration Board chaired the meeting which was also attended by the
followings:
(i) Dr. Mazhar UlHaq,
Veterinary Pharmacologist,
PMAS, Arid Agriculture University,Rawalpindi.
(ii) Mr. Zaheeruddin M.Babar,
Deputy Director (Reg-I)/
Secretary Expert Working Group
DRAP, Islamabad.
(iii) Dr. Muhammad Kashif Saleemi,
Assistant Professor, University of Agriculture Faisalabad (Co-
opted member).
Mr. Syed Adnan Ali Shah, Assistant Director (Reg-I) DRAP, Islamabad assisted the
Working Group. Meeting started with recitation of versus from Holy Quran. The Chairman
welcomes the participants and proceeded on the agenda.
Item No. I:- Minutes of 3rdmeeting of Expert Working Group on Veterinary
Drugs were confirmed.
Item No. II:- Policy Guidelines Regarding Reference Regulatory Authorities For
Registration of Veterinary Drugs.
The Expert Working Group on Veterinary Drugs, with reference to its earlier decision ,
taken in 3rd meeting, was of the view that as per its jurisdiction, the evaluation of the cases are
to be confined to the evaluation of technical aspects of the referred formulations / molecules
keeping in view their local requirement. The Policy issues regarding their registration,
however, are to be addressed by the Registration Board. The agenda items are accordingly
taken up as per following details: -
A. Following drug formulations, which were earlier referred to Dr. Qurban Ali in 236th
meeting of Registration Board, are re-evaluated and recommendations are made as per details
mentioned against each.
S. Name of Importer/ Name of Drug (s)/ Decontrolled/ Shelf Recommendations
No Manufacturer Composition Approved Pack Life
Size(s)
1. M/s. Welldone Amcosul Injection 50ml 3 Formulation is
Marketing Lahore. /M/s. Each ml contains:- 100ml years recommended for
FlorisVeterinaireProdukt Amoxycillin ……100mg being me too.
en B.V. Colistine
Kempenlandstraat Sulphate…….2,50,000IU
33,5262 GK Vught, The (Antibiotic / Bactericidal)
Netherlands.
2. M/s. Welldone Flucosul Water Soluble 100gm 3
Marketing Lahore. / Powder 200gm years
M/s. Each gm powder contains:- 500gm
FlorisVeterinaireProdukt Flumequine…….200mg 1Kg -do-
en B.V. Colistine
Kempenlandstraat Sulphate……1,20,000 IU
33,5262 GK Vught, The (Antibiotic / Bactericidal)
Netherlands.
3. M/s. Welldone Tycosine Water Soluble 100gm 3 Formulation is
Marketing Lahore. / Powder 200gm years recommended for
M/s. Each gm powder contains:- 500gm being rational
FlorisVeterinaireProdukt Doxyciline HCL….200mg 1Kg and similar
en B.V. Tylosine Tartrate…100mg formulations
Kempenlandstraat Colistine with difference in
33,5262 GK Vught, The Sulphate……..540,000 IU quantities are
Netherlands. Bromhexine……….50mg already
(Antibiotic / Bactericidal) registered.
4. M/s. Welldone Coliflor Powder 100gm 3 Formulation is
Marketing Lahore. / Each gm powder contains:- 200gm years recommended
M/s. Colistine 500gm for being me too.
FlorisVeterinaireProdukt Sulphate…5,000,000 IU 1Kg
en B.V. (Antibiotic / Bactericidal)
Kempenlandstraat
33,5262 GK Vught, The
Netherlands.
5. M/s. Welldone Amcosul Water Soluble 100gm 3 Formulation is
Marketing Lahore. / Powder 200gm years recommended
M/s. Each gm powder contains:- 500gm for being rational
FlorisVeterinaireProdukt Amoxicillin……….230mg 1Kg and similar
en B.V. Colistine formulations
Kempenlandstraat Sulphate…….1,000,000 IU with difference in
33,5262 GK Vught, The (Antibiotic / Bactericidal) quantities are
Netherlands. already
registered
6. M/s. Welldone Amoxycillin Injectable 50ml 3 Formulation is
Marketing Lahore. / Suspension 100ml years recommended
M/s. FIT Business Each ml contains:- for being me too.
Holland BV Amoxycillin……..150mg
Netherlands. (Antibiotic / Bactericidal)
7. M/s. Welldone AmoxycillinTrihydrate 100gm 3 Formulation is
Marketing Lahore. / Water Soluble Powder 200gm years recommended
M/s. FIT Business Each gm contains:- 500gm for being rational
Holland BV Amoxycillin 1Kg and similar
Netherlands. Trihydrate………250mg formulations
(Antibiotic / Bactericidal) with difference in
quantities are
already
registered
8. M/s. Welldone Tycodox-3 WS Liquid 250ml 3
Marketing Lahore. / Each ml contains:- 500ml years
M/s. FIT Business DoxycilineHCl…....200mg 1 Liter
-do-
Holland BV Tylosine Tartrate….100mg
Netherlands. ColistineSulphate
…..2500,000IU
(Antibiotic / Bactericidal)
9. M/s. Ani Cure Veterinary Macrolan-200 Injection 100ml 3 Formulation is
Services, Rawalpindi. / Each ml contains:- years recommended
M/s. InterchemieWerken Tylosin Base……200mg for being me too.
”De Adelaar” B.V. (Antibacterial)
Metaalweg, CG Venray,
Holland.
10. M/s. Ani Cure Veterinary Penstrep 400 LA Injection 100ml 3
Services, Rawalpindi. / Each ml contains:- years
M/s. InterchemieWerken Benzathine
”De Adelaar” B.V. Pencilline G…..100,000IU
-do-
Metaalweg, CG Venray, Procaine
Holland. Penicillin G…...100,000IU
Dihydrostreptomycin
Sulphate…………200mg
11. M/s. Ani Cure Veterinary Intracox Oral Liquid 1000ml 3
M/s. InterchemieWerken Toltrazuril………25mg
-do-
”De Adelaar” B.V. (Symmetric Triazinone)
Holland.
12. M/s. Ani Cure Veterinary Penstrep-400 Injection 100ml 2 Formulation is
M/s. InterchemieWerken Procaine with change of
”De Adelaar” B.V. Benzylpenicillin200,000IU name (as the
Metaalweg, CG Venray, Dihydrostreptomycin name is similar
Holland. Sulphate………….200mg to product at Sr.
No.10) for being
me too.
13. M/s. Ani Cure Veterinary Biocillin 150 LA Injection 100ml 2 Formulation is
Services, Rawalpindi. / Each ml contains:- years recommended for
M/s. InterchemieWerken Amoxycillin base…150mg being me too and
”De Adelaar” rational. LA
B.V.Metaalweg, CG mentioned in the
Venray, Holland. brand name may
be removed as it
is not long active
formulation.
14. M/s. Ani Cure Veterinary Intremectin Injection 50ml 3
M/s. InterchemieWerken Ivermectin………10mg
-do-
”De Adelaar” B.V.
Holland.
15. M/s. Ani Cure Veterinary Dimoxan Water Soluble 100gm 3 Formulation is
Services, Rawalpindi. / Powder 500gm years recommended
M/s. InterchemieWerken Each gm contains:- 1000gm for being rational
”De Adelaar” B.V. ColistinSulphate….1,200,0 and similar
Metaalweg, CG Venray, 00IU formulations
Holland. AmoxycillinTyrihdrate… with difference in
……..200mg quantities are
already
registered.
16. M/s. Ani Cure Veterinary Interspectin-L Injection 100ml 3 Formulation is
M/s. InterchemieWerken Lincomycin base as for being me too.
”De Adelaar” B.V. HCl……………..50mg
Metaalweg, CG Venray, Spectinomycin base as
Holland. HCl……………100mg
17. M/s. Ani Cure Veterinary Coli-4800 Water Soluble 100gm 3
Services, Rawalpindi. / Powder 500gm years
M/s. InterchemieWerken Each gm contains:- 1000gm
-do-
”De Adelaar” B.V. Colistin
Metaalweg, CG Venray, Sulphate........4,800,000IU
Holland.
B. Following drug formulations, which were earlier referred to Committee comprises of

Dr.Qurban Ali, Director General, NVL, Dr. Muhammad Arshad, PVMC Islamabad and DDC
(R-I), in 237thmeeting of Registration Board,are re-evaluated and recommendations are made
as per details mentioned against each.
S. Name of Importer/ Name of Drug (s)/ Approved Shelf Recommendations

No Manufacturer Composition Pack Size(s) Life
1. M/s. Better Traders Tilmi 25% Oral Liquid 100ml 03 Formulation is
International, Each ml contains:- 250ml years recommended for
Faisalabad. / Tilmicosin (as Tilmicosin 500ml being me too.
M/s. Kepro B.V. phosphate)……..….250mg 1 Liter
Maagdenburgstraat, (Anti-microbial drug). 2.5 Liter
Deventer, Holland. 5 Liter
2. M/s. Better Traders L.S. Water Soluble Powder 100g 03
International, Faisalabad. / Each gm contains:- 150g years
M/s. Kepro B.V. Lincomycin HCI…..222mg 1000g -do-
Maagdenburgstraat, Spectinomycin HCI.444mg
Deventer, Holland. (Antibiotic)
3. M/s. Better Traders L.S. Injection 100ml 02
International, Faisalabad. / Each gm contains:- years
M/s. Kepro B.V. Lincomycin
Maagdenburgstraat, (as HCI H2O)………50mg -do-
Deventer, Holland. Spectinomycin
(as HCI 5 H2O)……100mg
(Antibiotic)
4. M/s. Better Traders Florum 10% Oral Solution 1000ml 03
International, Faisalabad. / Each ml contains:- years
M/s. Kepro B.V. Florfenicol………100mg -do-
Maagdenburgstraat, Holland. (Synthetic Broad Spectrum
Antibiotic).
5. M/s. Fine Traders Agdoxytyl Water Soluble 100gm 03 Formulation is
International, Powder 500gm years recommended for
Faisalabad./ Each gram powder 1 Kg being rational and
M/s. AGRAR HOLLAND contains: 2.5 Kg similar formulations
BV, Soest, Holland. Doxycycline Hyclate 5 Kg with slight difference
………….150mg/g in quantities are
Tylosin Tartrate..200mg/g already registered
(Broad Spectrum
Antibiotic).
6. M/s. Ani Cure Veterinary Coli-2400 Oral 1000ml 03 Formulation is
M/s. InterchemieWerken ColistinSulphate being me too.
”De Adelaar” B.V. ……..2,400,000 IU
Metaalweg, CG Venray, (Antibiotic).
Holland.
7. M/s. Ani Cure Veterinary Introflor-100 Oral 100ml 03
-do-
M/s. InterchemieWerken Florfenicol……100mg
”De Adelaar” B.V. (Antibiotic).
Holland.
8. M/s. Ani Cure Veterinary Macrotyl 250 Oral 500ml 03
Services, Rawalpindi. / Each ml contains:- 1000ml years
M/s. InterchemieWerken Tilmicosin
-do-
”DeAdelaar” (TilmicosinPhosphate)……
B.V.Metaalweg, CG Venray, …...250mg
Holland. (Antibiotic).
9. M/s. Ani Cure Veterinary Coliflox Oral 100ml 03 Formulation is
M/s. InterchemieWerken ColistinSulphate….1,200,0 being rational and
”De Adelaar” B.V. 00 IU similar formulations
Metaalweg, CG Venray, Enrofloxacin……..100mg with difference in
Holland. (Antibiotic). quantities are
already registered
10. M/s. Ani Cure Veterinary Norflox-200 Oral 100ml 03 Formulation is
M/s. InterchemieWerken Norfloxacin………200mg being me too.
”De Adelaar” B.V. (Antibiotic).
Holland.
11. M/s. PantexPharmaceutica, Pantril 100 Oral Solution 100ml 02 Recommended for
Lahore. / Each ml contains:- 500ml years being me too.
M/s. Pantex Holland B.V. Enrofloxacin………10gm 1 Liter
Duizel, Holland. Excipients……………q.s
12. M/s. PantexPharmaceutica, Pantadox Water Soluble 100gm 03 Formulation is
Lahore. / Powder 250gm years recommended for
M/s. Pantex Holland B.V. Each gm contains:- 500gm being rational and
Duizel, Holland. Doxycycline 1000gm similar formulations
Hydrochloride….150mg with difference in
TylosinTartrate…..200mg quantities are
(Antibiotic) already registered
C. M/s. Orient Traders International, Karachi’s request for transfer of registration of their
various approved imported veterinary drugs from the name of previous importer M/s. Orient
Animal Health (Pvt) Ltd, Karachi to their name was approved in its 236th& 237th meetings
through sub-committee constituted by the Board. The registration letters, however, were not
issued. The firm subsequently applied for change of name of importer and
manufacturers/packager etc. The detail of the drugs along with status of documentation as
provided by the applicant is given as under:-
Approved
S. Name of Drug (s)/ Manufacturer/ Product Recommendati
manufacturer as Remarks
No Composition License Holder as per CoPP ons
per Minutes
1. Iverveto-1 Solution M/s. Manufacturer: i) As per CoPP of Belgium Formulation
for Injection V.M.D.N.V. M/s. LaboratoiresBiove, 3 the products is not is
Each ml contains:- HogeMauw Rue de Lorraine, 62510 licensed for marketing in recommende
Ivermectin…….….. 900, B-2370 Arques, France. Belgium as the marketing d for being
.10mg Arendonk (bulk manufacturer, authorization was not me too.
Glycerol Belgium. packaging, lot analysis) requested (as perCoPP this
formal……0.4ml Labelling& Batch Release: product is not use in
Water for injection M/s. V.M.D. n.v/s.a.Hoge, animal producing milk for
q.s.ad……………..1 Mauw 900, 2370, human).
ml Arendonk, Belgium. ii) The product is
Product License Holder: marketed in Hungary.
M/s. V.M.D. n.vHoge,
Mauw 900, 2370, iii) The shelf life 36
Arendonk, Belgium. months as per Form-5A.
2. Enroveto-20 Manufacturer: i) As per CoPP of Belgium
Concentrate for M/s. LaboratoiresBiove, 3 the products is not
Oral Solution Rue de Lorraine, BP 45 licensed for marketing in
Each ml contains:- 62510 Arques, France. Belgium as the marketing
Enrofloxacin……2 (bulk manufacturer, authorization was not
00mg packaging, lot analysis) requested
Glacial Acetic Labelling, & Batch
-do- -do-
Acid………….100m Release: M/s. V.M.D. ii) The product is
g n.v/s.a.Hoge, Mauw 900, marketed in Hungary.
Purified Water 2370, Arendonk, Belgium.
q.s.ad…………….1 Product License Holder: iii) The shelf life 36
ml M/s. V.M.D. n.vHoge, months as per Form-5A.
Mauw 900, 2370,
Arendonk, Belgium.
3. Florattacq-10 Oral Manufacturer: i) As per CoPP of Belgium
Solution M/s. LaboratoiresBiove, 3 the products is not
Each ml contains:- Rue de Lorraine, BP 45 licensed for marketing in
Florfenicol………1 62510 Arques, France. Belgium as the marketing
00mg (bulk manufacturer, authorization was not
packaging, labeling , lot requested (as per CoPP
analysis) this product is not
-do- Labelling& Batch Release: approved for use in food -do-
M/s. V.M.D. n.vHoge, producing animal).
Mauw 900, 2370, ii) The product is
Arendonk, Belgium. marketed in Hungary.
Product License Holder:
M/s. V.M.D. n.v. iii) The shelf life 36
HogeMauw 900, 2370, months as per Form-5A.
Arendonk, Belgium.
D. M/s. Orient Traders International, Karachi requested for transfer of registration of

following registered imported veterinary drugs from the name of importer M/s. Orient
Animal Health (Pvt) Ltd, Karachi to their name and also change of manufacturer and
marketing authorization holder was considered by the Registration Board in its various meetings
and deferred for not being in free sale in country of origin.
Packing as Manufactu Manufacturer Remarks/ Status as per
S. No. Regn. No.
Name of Drug per Regn. rer as per as per CoPP Shortcomings information/ Recommend
(s)/ composition Letter/ Registratio documents provided ations
Shelf life n Letter by the firm.
1. 049548 Diminaveto 100 M/s. Applicant for Not free sale Legalized GMP of
Soluble Sachets V.M.D. Certificate: in Belgium M/s. Formulatio
Granules per carton N.V. M/s. V.M.D. (For export LaboratoriaSmeets n
Each gm Belgium n.vHogeMau only). NV. recomende
contains:- 10 Sachets . w900 B-2370 Legalized GMP d
Diminazene per carton Arendonk, GMP not agreement of the
Diaceturate… Sachet Belgium. provided. manufacturer
……445mg Bulk, under contract
Antipyrine… 05 years manufacturer Availability VMD NV & M/s.
……...555mg , packing, lot status in LaboratoriaSmeets
analysis, reference NV.
batch release: country Letter stating that
M/s. needs disease not
LaboratoriaS clarification. prevalent in mfg.
meets country or
BVBA, countries due to
Fotografielaa cold climate & are
n 42, 2610, free from
Wilrijk, trypanasomiasis
Belgium. by Office
International des
Epizooties
(“OIE”). (Free sale
status in reference
countries not
provided).
2. 023475 Pen- 50ml M/s. Bulk Not Free Generic and Meet Formulatio
Dihydrostrep 100ml V.M.D. Manufacture Sale in to product, CoPP n is
20/20 N.V. r, Primary & Belgium. for export only recommen
Injection 02 years Belgium Secondary from Belgian ded for
Each ml . Packaging, No GMP for authorities already being me
contains:- Batch UK submitted. too.
Procaine Analysis: (No evidence of
Penicillin G M/s. Availability free sale in
200mg Norbrook status in reference
Dihydrostrept Laboratories referene countries
omycin base Ltd., Newry country provided).
(as (Northern needs
sulphate)…… Ireland). Co. clarification.
……200mg Down,
United
Kingdom.
Secondary
packaging,
batch
release:
M/s. V.M.D.
nv,
HogeMauw
900, 2370
Arendonk,
Belgium.
3. 020807 Albeveto-10 100ml M/s. -do- Not free sale Generic and Meet
Oral 500ml V.M.D. in Belgium to product, CoPP
Suspension 1000ml N.V. (For export for export only
Each ml Belgium only). from Belgian
contains:- 03 years . Availability authorities already
-do-
Albendazole status in submitted.
……..100mg referene (No evidence of
country free sale in
needs reference countries
clarification provided).
4. 020849 Gentaveto-15 30ml M/s. M/s. V.M.D. No Generic and Meet
Injectable 100ml V.M.D. n.vHogeMau certificate to product, CoPP
Solution N.V. w 900 B- (CoPP/GMP) for export only
Each ml Belgium 2370 provided. from Belgian
contains:- 03 years . Arendonk, authorities already
Gentamycin Belgium. submitted. -do-
Sulphateequiv (No evidence of
alent to free sale in
150mg reference
Gentamycin countries
base provided).
5. 023471 VMD-Tylosin 1Kg M/s. M/s. V.M.D. No Generic and Meet
Phosphate 2.5Kg V.M.D. n.vHogeMau certificate to product,
25% Premix 10Kg N.V. w 900 B- (CoPP/GMP) Antibiotic Growth
Each gm 25Kg Belgium 2370 provided. Promoterss
contains:- . Arendonk, (AGPs) are -do-
Tylosin 03 years Belgium. banned in EU so
.250mg CoPP for export
only from Belgian
authorities already
submitted.
(No evidence of
free sale in
reference
countries provided
E. Other cases considered by Registration Board in various meetings.

S. Recommendation of
Name of Importer/ Name of Drug Decision of recommendat
No Dr. Muhammad
Manufacturer. (s)/Composition. R.B ions
. Ashraf, UVAS, Lahore
1. M/s. Better Traders Thiacol 10% Oral Solution Recommended Deferred for Formulation
International, Each ml contains:- confirmation of is
Faisalabad. / Thiamphenicol……100mg status in recommended
M/s. Kepro B.V. (Broad Spectrum reference for being me
Maagdenburgstraat, Antimicrobial Agent). regulatory too.
Holland. agencies
2. Noble PharmaMirpur ENTRO-5 Powder Drug which are “Me Deferred for Formulation
Azad Kashmir. Each 1000gm contains:- too” like drugs with further is
Tylosin Tartrate BP…10% minor modifications deliberation on recommended
Doxycycline which may or may not recommendatio for being me
Hyclate USP…….20% be considered. n of expert too.
ColistinSulphate…450
MIU
Bromhexine HCI…..0.5%
Neomycin SO4…….3.6%
(Antibacterial).
3. M/s. Mallard Centrum Liquid Drug which are “Me Deferred for
Pharmaceuticals (Pvt) Each 100ml contains:- too” like drugs with further
Ltd., Multan. Enrofloxacin HCI minor modifications deliberation on
…....7500mg which may or may not recommendatio
Sulphamethoxypyridazine be considered. n of expert -do-
…………7500mg
Sulphamethazine...5000mg
Trimethoprim….2500mg
(Antibiotic).
4. M/s. D-Maarson CRD-555 Water Soluble Drug which are “Me Deferred for Deferred as
Pharmaceuticals, Powder too” like drugs with further the
Rawat, Islamabad. Each 1000g contains:- minor modifications deliberation on formulation is
Doxycycline HCl which may or may not recommendatio already under
.........200g be considered. n of expert review by the
Tylosin tartrate Registration
………100g Board.
Colistinsulphate...500MIU
Amantadine HCl ……40g
The Board was informed that the cases at Sr.No.2 to 4 of Table-E above, pertain to local
manufacturing applciations and are not related to the matter under reference. These cases will be
placed before the Board separately in an other meeting.
Decision:- The Board dicussed that as these formulations are not allowed for free
sale in their country of origin or any other reference regulatory authority
so the efficacy and quality of the above mentioned products could not be
ascertained as such approvals ensure that the efficacy and quality profiles
are evaluated and thus guranteed. The Board decided that above cases
should be dealt in accordance with the prevailing policy guidlines for
registration of finished imported drugs and, therefore, rejected all the
above referred applications/cases pertaining to import of finished drugs.
Registration-II Section
Case No.27. Request for Change of Name/Title of Manufacturer from Merck (Pvt) Ltd
to Martin Dow Marker Limited (Manufacturing site remains the same).
M/s Martin Dow Marker Ltd., has informed that the name/title of their company has
been changed from Merck (Private) Limited, 7, Jail Road, Quetta to Martin Dow Marker
Limited, 7 Jail Road, Quetta (manufacturing site remains the same) and they have requested
for change of name/title of manufacturer of their below mentioned registered products. As per
SOP they have submitted the following for consideration of their request. The detail of
products under consideration is as under:
S. Reg.No. Name of Drug(s) Initial Date of Remarks of International Remarks
No. Reg. / Renewal RRR Availability
Status
1. 030378 Merceclav 375mg Tablet 12-08-2003 The product UK MHRA The firm has
Each tablet contains:- was initially now applied
Amoxycillin trihydrate eq. registered for film
to Amoxycillin … 250mg through coated tablet
Clavulanic Acid as contract
Potassium Clavulanate e.q manufacturing Formulation
to Clavulanic Acid by M/s. Bosch is available in
………… 125mg Pharmaceutical, USP
Karachi.
2. 030379 Merceclav 625mg Tablet 12-08-2003 -do- -do- -do-
Each tablet contains:-
Amoxycillin trihydrate eq.
to Amoxycillin … 500mg
Clavulanic Acid as
Potassium Clavulanate e.q
to Clavulanic Acid
………… 125mg
3. 030381 Merceclav 312.5mg 12-08-2003 -do- -do- Formulation
Suspension is available in
Each 5ml contains:- USP
to Amoxycillin … 250mg
Clavulanic Acid as
Potassium Clavulanate e.q
to Clavulanic Acid
………… 62.5mg
4. 030380 Merceclav 156.25 12-08-2003 -do- UK MHRA Formulation
Suspension is available in
Each 5ml contains:- USP
to Amoxycillin base…
125mg
Clavulanic Acid as
Potassium Clavulanate eq.
to Clavulanic acid ..…
31.25mg
5. 027245 Merceclav 1gm Tablet  04-07-2001 The product UK MHRA The firm has
Each tablet contains:-  Change of was initially now applied
Amoxycillin trihydrate eq. name from registered for film
to Amoxycillin base… “clamoxyl” through coated tablet
875mg to contract
Clavulanic Acid as “merceclav” manufacturing Formulation
Potassium Clavulanate dated 22- by M/s. Cirin is available in
..… 125mg 01-2002 Pharma, USP
 Renewal Hattar..
submitted on
21-02-2013
with fee of
Rs.10,000/-
The management of the firm has provided following documents:-

i. Form-5 along with Fee of Rs. 50,000/- for each product (duplicate challan for
product at S.No.4 has been provided).
ii. Copies of initial letter of registration.
iii. Approval of new name / title from CLB dated 18-12-2017.
iv. Undertaking that:
a. The formulation, API source & Specifications, manufacturing process, release
& shelf life specifications have not changed.
b. Provided information is true & correct.
v. The product was registered on contract manufacturing basis but the firm has
submitted its renewal application and did not applied for extension in contract
manufacturing.
Decision: Registration Board deferred the case for further deliberation after
submission of remaining fee and documents as per approved SOP, required
for extension of contract manufacturing permission, by the firm.
Case No.28. Change of Registration Status of Drug(s) by M/s. Wyeth Pakistan,

Karachi.
M/s Wyeth Pakistan, Karachi have applied for change of registration of their
product from Finished Import/bulk import and local repackaging to bulk import and local
repackaging from their old DML to new DSL with permission for contract manufacturing
from M/s Pfizer Pakistan Limited, B-2, S.I.T.E, Karachi (DML No. 000025).
S.No Name of Drug and Composition Initial Date of Existing approvalApplied for change of registration status.
Reg./Renewal status.
Status
1 Efexor XR Capsule 150mg 22-07-2007 The product Now, the firm has requested for
Each capsule contains:- 1st renewal was registered registration in the name of M/s. Wyeth
Venlafaxine Hydrochloride 24-07-2009 in finished Pakistan Limited (DSL) Room No.
169.7mg equivalent to 150mg 2nd renewal import by M/s. 002 & 003, PGS Admin Block, First
Venlafaxine base 25-06-2014 Wyeth Floor, Plot No. B-2 S.I.T.E Karachi
Pakistan and bulk import from M/s. Pfizer
(Fee deposited Rs.160,000/-) Limited S-33, Ireland Pharmaceuticals Little
(Reg.No. 031368) Hawks bay Connell, Newbridge, Co. Kildare,
Road, S.I.T.E, Ireland and local contract repacking
Karachi (DML and release site is
No. 000006) M/s. Pfizer Pakistan Limited B-2,
Manufactured S.I.T.E, Karachi-Pakistan.
& packaged by Manufacturer is responsible for
M/s. Wyeth manufacturing of uncoated spheroids,
Medica Ireland coating of spheroids, Encapsulation,
New bridge, in process quality control monitoring
Co. Kildare & Batch Analysis with Release in
Ireland. Drums/large containers.
Packaging & release site is
responsible for Primary packaging in
blisters, secondary packaging in
folding cartons, labeling quality
control release for finished products.
Information as per legalized CoPP
Product License Holder: Manufacturer: Applicant for Certificate:
M/s. Pfizer Healthcare Ireland M/s. Pfizer Ireland M/s. Pharmalink Consulting Floor 3
9 Riverwalk National Digital Pharmaceuticals, Little Connell Adelaide Exchange 24-26 Adelaide
Park City Business Campus Newbridge, Co. Kildare, Ireland Street Belfast BT2 8GD Northern
Dublin 24, Ireland Ireland
2. Efexor XR Capsule 75mg 24-06-1999 The product Now the firm has requested for
Each capsule contains:- Transfer of was registered registration in the name of M/s. Wyeth
Venlafaxine Hydrochloride registration in bulk import Pakistan Limited (DSL) Room No.
84.85mg equivalent to 75mg dated and local 002 & 003, PGS Admin Block, First
Venlafaxine base 25-09-200 repacking by Floor, Plot No. B-2 S.I.T.E Karachi
Change of M/s. Wyeth and bulk import from M/s. Pfizer
(Fee deposted Rs. 155,000/-). manufacturing Pakistan Ireland Pharmaceuticals Little
(Reg.No. 023658) site dated Limited S-33, Connell, Newbridge, Co. Kildare,
26.3.2002 Hawks bay Ireland and local contract repacking
Renewal Road, S.I.T.E, and release site is M/s. Pfizer Pakistan
application Karachi (DML Limited B-2, S.I.T.E, Karachi-
dated No. 000006) Pakistan.
03-04-2017 Manufactured Manufacturer is responsible for
by M/s. Wyeth manufacturing of uncoated spheroids,
Medica Ireland coating of spheroids, Encapsulation,
New bridge, inprocess quality control monitoring
Co. Kildare & Batch Analysis with Release in
Ireland. Drums/large containers.
Packaging & release site is
responsible for Primary packaging in
blisters, secondary packaging in
folding cartons, labeling quality
control release for finished products.
Information as per legalized CoPP
Product License Holder: Manufacturer: Applicant for Certificate:
M/s. Pfizer Healthcare Ireland M/s. Pfizer Ireland M/s. Pharmalink Consulting Floor 3
9 Riverwalk National Digital Pharmaceuticals, Little Connell Adelaide Exchange 24-26 Adelaide
Park City Business Campus Newbridge, Co. Kildare, Ireland Street Belfast BT2 8GD Northern
Dublin 24, Ireland Ireland
3. Tazocin EF 4.5gm Injection 01-11-1993 The product The firm has requested to change the
Each vial contains: Transfer of was registered registration status in the name of M/s.
registration in bulk import Wyeth Pakistan Limited (DSL) Room
Piperacilin Sodium…… 4gm dated and local No. 002 & 003, PGS Admin Block,
Tazobactum Sodium ... 500mg 29-03-2008 repacking by First Floor, Plot No. B-2 S.I.T.E
(Fee deposted Rs.160,000/-). Renewal M/s. Wyeth Karachi.(DSL not attached)
application Pakistan Manufacturer:
(Reg.No. 014624) dated Limited S-33, M/s. Wyeth Lederle S.r.I., Via Franco
26-04-2016 Hawks bay Gorgone Zona Industrial Catania (CT)
Road, S.I.T.E, 95100-Italy.
Karachi (DML Contract Release & packaging site:
No. 000006) M/s. Pfizer Pakistan Limited B-2
Manufactured S.I.T.E., Karachi.
by M/s. Wyeth Manufacturer is responsible for
Lederle S.P.A manufacture of freeze dried drug
Via Franco product, packaging of unlabeled vial,
Gorgone Zona testing and quality control release for
Industrial supply.
Catania (CT) Secondary packaging site is
95100-Italy. responsible for Labeling and
secondary packaging with folding
carton of finished product, quality
control batch release supply to
market.
Information as per CoPP:
Finished Product Marketing Authorization Bulk manufactured and destination is
Manufacturer: Holder: Pakistan.
M/s. Wyeth Lederle S.R.L. M/s. Pfizer Limited-Ramsgate
with manufacturing site Road, Sandwich Kent CT13
located at Via F.Gorgone,Z.I.- 9NJ- United Kingdom
95100 Catania
Accordingly, firm has submitted following documents:
1. Request with Form 5 and requisite fee.
2. Copies of initial letter of registrations.
It is submitted that for change of registration status of above mentioned products for
import, the firm has submitted acknowledgement receipts for Drug Sale License from Health
department Government of Sindh.
Registration Board in its 281st deferred the case for submission of Drug Sales License
of M/s Wyeth Pakistan, Karachi. Meanwhile, reference was sent to RRR section for
confirmation of renewal status. The RRR section has communicated the renewal status as the
renewal application seems to be submitted within time, however, the post registration
variations need to be verified at the end of Reg-II section and the firm has also submitted
copy of DSL for above said products.
Decision: Registration Board decided as follows:

a. Cancellation of registration of above mentioned products from the name
of M/s Wyeth Pakistan Ltd, S-33, Hawks bay Road, S.I.T.E Karachi,
DML No.000006.
b. Approved registration of products at S.No.1-3 with “USP Specifications”
in name of M/s Wyeth Pakistan Ltd, Room No. 002 & 003, PGS Admin
Block, First Floor, Plot No. B-2 S.I.T.E Karachi, DSL No.3242 on contract
manufacturing basis from M/s Pfizer Pakistan Limited, B-2, S.I.T.E,
Karachi (DML No. 000025). The products will be imported in bulk form
and locally repacked alongwith final Quality Control release at M/s Pfizer
Pakistan Limited, B-2, SITE Karachi (DML No.000025). Details of
repacking operations will be as mentioned vide last column of above table.
The Board further advised to standardise the label claim of product at
Sr.No.1, 2 & 3 in accordance with the standard formulations approved by
c. Reference will be sent to Cost and Pricing Division for confirmation of
maximum retail price (MRP).
Case No.29: Change in Name of Manufacturer Abroad.

M/s Bayer Pakistan (Pvt) Limited, C-21, S.I.T.E, Karachi have requested for change
in the name of principal manufacturer of their following products registered in bulk import
and local repackaging:
S. Reg. Name of Drug(s) & Current Name of Proposed Name of Documents
No No Composition Manufacturing Site Manufacturing Submitted
1 048466 Ciproxin XR Tablet 500mg Manufactured By: Manufactured by: Original
Each film coated tablet Bayer Schering, Pharma Bayer AG, Kaiser- Legalized
contains:- AG Leverkusen, Wilhelm-Allee CoPP is
334.5mg Ciprofloxacin HCl Germany 51368, provided.
Monohydrate Ph.Eur. and Packed By: Leverkusen,
253mg Ciprofloxacin Bayer Pakistan (Pvt) Germany
Hydrous, Corresp. To Limited, C-21. S.I.T.E, Packed By:
Ciprofloxacin …… 500mg Karachi No Change
2 048468 Ciproxin XR Tablet 1000mg Manufactured By: Manufactured by: Original
Each film coated tablet Bayer Pharma AG, Bayer AG, Kaiser- Legalized
contains:- Leverkusen, 51368, Wilhelm-Allee CoPP is
669.4mg Ciprofloxacin HCl Germany 51368, provided.
Monohydrate Ph.Eur. and Leverkusen,
506mg Ciprofloxacin Packed By: Germany.
Hydrous, Corresp. To Bayer Pakistan (Pvt)
Ciprofloxacin… 1000mg Limited, C-21. S.I.T.E, Packed By:
Karachi No Change
The firm has submitted following documents:

1. Fee of Rs. 5,000/- for each product.
2. Copy of initial registration letter and renewal submissions.
3. Approval of last change of name of manufacturer.
4. Response of RRR Section is awaited.0
5. As per CoPP product is a not available in country of origin
Decision: Registration Board deferred the case for following reasons:
i. Submission of clarification, by the firm, regarding unavailability of
product in the country of origin.
ii. Confirmation of renewal status from RRR section.
Case No.30: Submission of Stability Data by M/s Sante (Pvt) Ltd., Karachi for
Registration of Drug(s).
Registration Board in its 243rd meeting deferred registration of following
products of M/s Sante (Pvt) Ltd., Karachi and decided as recorded in last column.
Xenase Rs.800/15ml 1.Form-5D 1. PATANASE Deferred for
Ear/Nasal drops Nasal Spray Plastic Bottle 2. 23-11-2011 (ALCON PHARMS (i) expert
(General) Each100 micro Dy.No.379 LTD) SPRAY, opinion
section vide liter contains: Rs.15000/- METERED;NASAL (ii) Product
letter no F.2- Olopatadine 3. 08-04-2013 OLOPATADINE Specific
12/2006-lic hydrochloride… Rs.35,000/- HYDROCHLORIDE Inspection
dated 25-02- ………..665mcg 0.665MG/SPRAY for
2011 equivalent to (FDA) manufacturin
0.6% (600mcg) 2.Acceptable level of g facility.
of base. GMP (09.05.13)
(Anti Allergic)
According to the decision of 243rd meeting of Registration Board the Product Specific
Inspection of premises was conducted by Director DTL (Mr. Abdul Razzaq Jawinda) and
Area FID (Syed Hakim Masood) on 16th April, 2015. The panel was of the view to
recommend Registration of Xenase Nasal Spray (Olopatadine HCl 0.6% w/v) to the firm
subject to the approval of Competent Authority. Regarding expert opinion since product is
FDA approved there is no need to take opinion as per M-250 decision of Registration Board.
Registration Board in its 256th meeting approved the request of the firm for grant of
registration of above product i.e. Xenase Nasal Spray.
At the time of issuance of registration letter it was observed that the product is new
molecule and registration letter was not issued. The firm was asked to provide stability
studies as per decision of the Registration Board. Now the firm has provided stability studies
and requested to issue the registration letter of above mentioned product.
Accelerated Stability Studies Report
Product Name : Xenase Nasal Spray Batch No. : 03T

Batch Size : 1.0 Litre Manufacturing Date : 05-2016
Master Formula No. : BMR-TR-010 Expiry Date : 05-2018
Stability Storage 40°C ± 2°C and 75% ±
Shelf Life : 02 Years
Condition : 5% RH
Batch Type (Commercial/Export/Validation): Trial
Reference Specification # : QC-FP-S-TR-006

Reference Test Method # : QC-FP-TM-TR-006
API : Olopatadine HCl
Label Claim : Olopatadine 6mg/ml
Primary Packaging : LDPE Plastic Bottle
Pack Size : 15ml
Storage Condition : Store between 15°C to 30°C
0th *1st 3rd 6th
Month Month Month Month Conclusion/
Test Acceptance Criteria
Remarks
05-2016 - 08-2016 11-2016
Clear Transparent
Description Complies - Complies Complies Satisfactory
Solution.
The retention time of the
principal peak in Sample
Preparation must comply
Identification Complies - Complies Complies Satisfactory
with the Retention time of
principal peak in Standard
Preparation.
pH 3.5 - 3.7 3.56 - 3.58 3.54 Satisfactory
NLT 90% of the label
Assay 100.39% - 100.40% 101.07% Satisfactory
claim
Microbial Enumeration Tests SOP Ref No: QC-MIC-001
Total Aerobic
Microbial Nil Nil Nil
NMT 102 CFU/ml - Satisfactory
Count CFU/ml CFU/ml CFU/ml
(TAMC)
Total Yeast
And Mold Nil Nil Nil
NMT 101 CFU/ml - Satisfactory
Count CFU/ml CFU/ml CFU/ml
(TYMC)
Pathogens Absent Absent - Absent Absent Satisfactory
Regular / Long Term Stability Studies Report
Product Name
Xenase Nasal Spray Batch No.: 03T
:
Batch Size Manufacturing
1.0 Litre 05-2016
: Date:
Master Formula No.
BMR-TR-010 Expiry Date: 05-2018
:
Stability Storage Condition 30°C ± 2°C and 65% ± 5%
Shelf Life: 02 Years
: RH
Batch Type
Trial
(Commercial/Export/Validation)
Reference
QC-FP-S-TR- Label Claim
Specification # Olopatadine 6mg/ml
006 :
:
Reference Test
QC-FP-TM- Primary Packaging
Method # LDPE Plastic Bottle
TR-006 :
:
API Olopatadine Pack Size
15ml
: HCl :
Storage Condition Store between
: 15°C to 30°C
0th 3rd 6th 9th 12th 18th 24th Conclusio
Acceptance
Test Name Month Month Month Month Month Month Month n/
Criteria 05-2016 08-2016 11-2016 02-2017 05-2017 11-2017 05-2018 Remarks
Clear Transparent Compl Compl Compl Compl Compl Compl Compl Satisfact
Description
Solution. ies ies ies ies ies ies ies ory
The retention time
of the principal
peak in Sample
Preparation must
Compl Compl Compl Compl Compl Compl Compl Satisfact
Identification comply with the
ies ies ies ies ies ies ies ory
Retention time of
principal peak in
Standard
Preparation.
Satisfact
pH 3.5 - 3.7 3.56 3.59 3.51 3.61 3.55 3.57 3.59
ory
NLT 90% of the 100.39 100.88 100.87 91.29 102.17 109.76 101.80 Satisfact
Assay
label claim % % % % % % % ory
Total Aerobic
Nil Nil Nil Nil Nil Nil Nil
Microbial Satisfact
NMT 102 CFU/ml CFU/ CFU/ CFU/ CFU/ CFU/ CFU/ CFU/
Count ory
ml ml ml ml ml ml ml
(TAMC)
Total Yeast
Nil Nil Nil Nil Nil Nil Nil
And Mold Satisfact
NMT 101 CFU/ml CFU/ CFU/ CFU/ CFU/ CFU/ CFU/ CFU/
Count ory
ml ml ml ml ml ml ml
(TYMC)
Satisfact
Pathogens Absent Absent Absent Absent Absent Absent Absent Absent
ory

Stability Storage 40°C ± 2°C and 75% ± 5%
Condition : RH

Pack Size : 15ml
0th *1st 3rd 6th
Remarks
09-2016 - 12-2016 03-2017
Description Clear Transparent Solution. Complies - Complies Complies Satisfactory
Identification Preparation must comply with Complies - Complies Complies Satisfactory
the Retention time of principal
peak in Standard Preparation.
pH 3.5 - 3.7 3.51 - 3.58 3.56 Satisfactory
Assay NLT 90% of the label claim 102.24% - 99.89% 98.98% Satisfactory

Total Aerobic
Nil Nil Nil
Microbial Count NMT 102 CFU/ml - Satisfactory
CFU/ml CFU/ml CFU/ml
(TAMC)
Total Yeast And
Nil Nil Nil
Mold Count NMT 101 CFU/ml - Satisfactory
(TYMC)
* If the initial results are on lower side then testing should be done at 1st month.
Product Name: Xenase Nasal Spray Batch No.: 04T

Manufacturing
Batch Size : 1.0 Litre 09-2016
Date:
Master Formula No. : BMR-TR-010 Expiry Date: 09-2018
30°C ± 2°C and 65% ± 5%
Stability Storage Condition : Shelf Life: 02 Years
RH
Batch Type
(Commercial/Export/Validation) Trial
:
Reference
006 :
:
Reference Test
TR-006 :
:
15ml
: HCl :
: 15°C to 30°C
0th 18th 24th

Acceptance 3rd Month 6th Month 9th Month 12th Month
Test Name Month Month Month Conclusion
Criteria / Remarks
09-2016 12-2016 03-2017 06-2017 09-2017 03-2018
Clear
Description Transparent Complies Complies Complies Complies Complies Complies Ongoing
Solution.
0th 18th 24th
Acceptance 3rd Month 6th Month 9th Month 12th Month
Test Name Month Month Month Conclusion
Criteria / Remarks
09-2016 12-2016 03-2017 06-2017 09-2017 03-2018
The
retention
time of the
principal
peak in
Sample
Preparation
must
Identification Complies Complies Complies Complies Complies Complies Ongoing
comply
with the
Retention
time of
principal
peak in
Standard
Preparation.
pH 3.5 - 3.7 3.51 3.53 3.57 3.58 3.63 3.66 Ongoing
NLT 90%
of the
Assay 102.24% 100.005% 98.83% 106.71% 100.58% 99.13% Ongoing
label
claim
Total
Aerobic
NMT 102 Nil Nil Nil Nil Nil Nil
Microbial Ongoing
CFU/ml CFU/ml CFU/ml CFU/ml CFU/ml CFU/ml CFU/ml
Count
(TAMC)
Total
Yeast And
Mold Ongoing
Count
(TYMC)
Pathogens Absent Absent Absent Absent Absent Absent Absent Ongoing

Stability Storage 40°C ± 2°C and 75% ± 5%
Condition : RH

Pack Size : 15ml
0th *1st 3rd 6th
Remarks
09-2016 - 12-2016 03-2017
Compli
Description Clear Transparent Solution. - Complies Complies Satisfactory
es
Compli
Identification Preparation must comply with - Complies Complies Satisfactory
es
pH 3.5 - 3.7 3.52 - 3.59 3.57 Satisfactory
101.32
Assay NLT 90% of the label claim - 99.82% 98.51% Satisfactory
%

Total Aerobic Nil
Nil Nil
Microbial Count NMT 102 CFU/ml CFU/m - Satisfactory
CFU/ml CFU/ml
(TAMC) l
Total Yeast And Nil
Nil Nil
Mold Count NMT 101 CFU/ml CFU/m - Satisfactory
CFU/ml CFU/ml
(TYMC) l

Pack Size : 15ml
0th *1st 3rd 6th
Remarks
09-2016 - 12-2016 03-2017
Description Clear Transparent Solution. Complies - Complies Complies Satisfactory
Identification Preparation must comply with Complies - Complies Complies Satisfactory
pH 3.5 - 3.7 3.52 - 3.59 3.57 Satisfactory
Assay NLT 90% of the label claim 101.32% - 99.82% 98.51% Satisfactory
Total Aerobic
Nil Nil Nil
Microbial Count NMT 102 CFU/ml - Satisfactory
(TAMC)
Total Yeast And
Nil CFU/ Nil CFU/ Nil CFU/
Mold Count NMT 101 CFU/ml - Satisfactory
ml ml ml
(TYMC)
Product Name
Xenase Nasal Spray Batch No. : 05T
:
Batch Size
1.0 Litre Manufacturing Date : 09-2016
:
Master Formula No.
BMR-TR-010 Expiry Date : 09-2018
:
30°C ± 2°C and 65% ±
5% RH
:
Batch Type
(Commercial/Export/Validation) Trial
:
Reference
006 :
:
Reference Test
TR-006 :
:
15ml
: HCl :
: 15°C to 30°C
24th
0th 3rd 6th 9th 12th 18th
Mont Conclusio
Acceptanc Month Month Month Month Month Month
Test Name h n/
e Criteria
09- 12- 03- 06- 09- 03- Remarks
2016 2016 2017 2017 2017 2018
Clear
Description Transparent Complies Complies Complies Complies Complies Complies Ongoing
Solution.
The retention
time of the
principal
peak in
Sample
Preparation
Identificatio must comply Complie Complie Complie Complie Complie Complie
Ongoing
n with the s s s s s s
Retention
time of
principal
peak in
Standard
Preparation.
pH 3.5 - 3.7 3.52 3.54 3.58 3.59 3.64 3.59 Ongoing
NLT 90% of 101.32 106.63 100.47
Assay 99.79% 98.50% 99.90% Ongoing
the label claim % % %
Total Aerobic
Microbial Ongoing
Count (TAMC)
Total Yeast
And Mold Ongoing
Count (TYMC)
24th
0th 3rd 6th 9th 12th 18th
Mont Conclusio
Acceptanc Month Month Month Month Month Month
Test Name h n/
e Criteria
09- 12- 03- 06- 09- 03- Remarks
2016 2016 2017 2017 2017 2018
Pathogens Absent Absent Absent Absent Absent Absent Absent Ongoing
Decision: Registration Board deferred the case for onsite investigation to confirm
genuineness/ authenticity of stability data and associated documents
submitted by the firm. The Board further advised that the panel shall be
constituted without waiting for confirmation/ finalization of minutes of 286 th
meeting.
Case No.31. Approved Product of M/s Pharmatec Pakistan (Pvt) Ltd. Karachi
Following product of M/s Pharmatec Pakistan (Pvt) Ltd. Karachi was
approved vide 262nd meeting of Registration Board as per details below:
S.No. Brand name (Proprietary Name Type of form Remarks on the formulation (if any Decision
+Dosage Form+ Strength Initial Date, Diary including international status in
)Composition ,Pharmacological Fee, including stringent DRA ,me too status, GMP
Group, Finished Product Differential Fee, status as depicted in the latest
Specification Demanded Price, inspection report(with date)by the
Pack size Evaluator
1. Levefil XR 1000mg Tablet Form5 Keppra XR by UCB group of Approved
Each film coated tablet contains: 14-05-2014 companies (USA),
Levetiracetam USP….1000mg Dy.No.727 Keppra of UCB Pharma
Pyrrolidone derivative. Routine
(Manufacturers Specs) Rs.20,000/- Inspection report dated
10’s/As per PRC 23-10-2013 showing compliance of
GMP as Good”.
The case was referred to Pharmaceuticals Evaluation Cell for confirmation of dosage
form and description of the product as the brand name of above product mentioned “XR” as
dosage form of the drug whereas Pharmaceutical form/ description of the product was
presented as “film coated tablet”. PEC later on confirmed that the firm has applied for “Film
coated XR tablet”. Furthermore, MRP has also been fixed for the above mentioned
formulation, vide S.R.O 252(I)/2018. However, approval status of “Levetiracetam XR
1000mg Tablet” could not be verified in Reference Regulatory Authorities.
The firm has now submitted revised form-5 for registration of “Levetiracetam
1000mg Film coated Tablet” i.e., approved by USFDA and requested for issuance of
registration letter.
Registration Board in its 283rd meeting deferred the case for submission of fresh fee
of Rs.20,000/-. Now the firm has provided original challans of Rs. 20,000/-.
Decision: Registration Board approved the grant for registration for “Levefil
1000mg Tablet” with following composition:
Levetiracetam ……….1000mg
(USP Specifications)
Case No. 32. Correction in Formulation of Drug of M/s. Sante (Pvt.) Limited, Karachi
M/s. Sante (Pvt.) Limited A/97, S.I.T.E Super Highway, Karachi has stated
that the registration letter issued to them for the following product approved in 274 th meeting
is not in line with their request:-
S.No Regn No Name of drug(s) Decision of the Registration Board in 274th
meeting.
1 021611 Blephapred Sterile Opthalmic Decision: Registration Board decided as follows:
Suspension  Cancellation of Blephapred Opthalmic Suspension
Each ml contains: from the name of Elko Organization, Karachi.
Sulfacetamide sodium ….100  Approved registration of Blephapred Opthalmic
mg Suspension in name of M/s Sante (Pvt) Ltd Karachi
Prednisolone Acetate…. 2 mg with revised formulation of mercury organic salt of
Phenylephrine HCl…1.2 mg Phenyl mercuric nitrate.
 Send a reference to Cost and Pricing Division for
confirmation of MRP
It is submitted that the above case was presented in 274th meeting of Registration
Board and same contents of the formulation were mentioned in minutes of the meeting as
stated above. Therefore letter was issued to the firm in line with the decision of the
Registration Board.
However, the case was previously presented in 263rd meeting of the Board, and
revised formulation (FDA approved) as per below mentioned detail was presented and the
Board decided the case as under:-
Name of Existing Composition Revised Composition Decision of Registration Board
drug(s) (Reference FDA) in 263rd meeting
I II III IV
Blephapred Each ml contains: Each ml contains: Registration Board deferred the
Sterile Sulfacetamide sodium...100 mg Sulfacetamide case for the clarification
Opthalmic Prednisolone Acetate…. 2 mg sodium….100 mg regarding use of mercury organic
Suspension Phenylephrine HCl…1.2 mg Prednisolone salt of Phenylmercuric nitrate as
Acetate…. 2 mg preservative in the formulation
and submit revised formulation as
per permissible limits approved
by reference regulatory
authorities.
When the case was considered again in 274th meeting, the revised formulation as
stated above was not mentioned in the minutes. Therefore, approved formulation as per
details in 274th meeting was issued.
Decision: Registration Board approved the correction in formulation of
“Blephapred Sterile Opthalmic Suspension” in accordance with the
standard formulation approved by Reference Regulatory Authorities i.e.,
as under:
Each ml contains:
Sulfacetamide Sodium……100 mg
Prednisolone Acetate……..2 mg
Case No.33. Progress Report on Local Manufacturing Project of Ms. Novartis Pharma
(Pakistan) Ltd, Karachi.
M/s. Novartis Pharma (Pakistan) Limited 15 West Wharf, Dockyard Road P.O.Box-
100 Karachi-74000 has submitted progress report for their contract manufacturing products
through contract manufacturing by M/s. Glaxo SmithKline OTC (Private) Limited, Karachi.
M/s. Novartis had informed that they have re-establish proprietary manufacturing in Pakistan
through an expansion of its existing Karachi West Warf facility. During the second half of
2017, Novartis undertook an extensive review of their existing West Warf manufacturing
facility (including three site visits by their global technical operations teams) and has
concluded that West Warf does not provide sufficient space for expansion to install the
necessary capacity required to meet their business needs for the next 15 years. Novartis is
looking for long term solution for its portfolio in Pakistan and would prefer to proceed with
an option, which will provide a strong platform for the future growth of the business.
Novartis would like to reiterate to DRAP its commitment to Pakistan and ask for DRAPs
kind support in allowing Novartis effect a solution, which maximizes the benefit to Pakistan
as well as Novartis.
As a result determination that West Wharf is unlikely to be a suitable option, Novartis
began considering all other options available to it which would ensure compliance with the
regulatory requirements and also provide adequate support, as well as the right quality and
cost base for the business going forward. The options considered included:
 Acquisition of an existing manufacturing business.
 Acquisition of an existing site.
 Acquisition of a land parcel to enable construction of a new Novartis
manufacturing facility.
Novartis has continued to assess all three options during the second half of 2017.
They have further stated that there are few available options in the market for acquisition of
an existing site/business of sufficient size and providing adequate scope for expansion. The
project therefore, narrowed the scope of their efforts to identifying a suitable a location for a
potential newly constructed site and undertaking initial concept design and construction
planning. The preferred location for a newly constructed site would be the Port Qasim
Industrial Zone in Karachi.
Novartis technical team has now made several visits to Pakistan & and has made
significant progress, including the preparation of an initial concept design, identification of
potential land suitable parcels, soliciting quotes from three potential construction contractors,
identifying and sourcing of equipment and project planning. They have provided draft project
schedule.
They have requested to a continued partnership with the Government of Pakistan in
improving the access to medicines for patients in Pakistan.
Registration Board in its 279th meeting discussed that project completion timelines as
submitted by M/s Novartis, Pakistan at the time of permission of contract manufacturing
under Rule 20A (c) and commitments made by the firm for completion of extension of their
own facility is till December, 2019 and same has already been communicated to M/s
Novartis, Pakistan
Accordingly, Registration Board decided to direct M/s Novartis, Pakistan for

completion of the submitted extension project of West Wharf facility by the firm within
stipulated time period as required in Rule 20A (c) of Drug (Licensing, Registering and
Advertising) Rules, 1976 and commitments / undertaken by the firm.
Now M/s. Novartis Pharma (Pakistan) Limited 15 West Wharf, Dockyard

Road, Karachi has submitted that updated progress plan to restart local manufacturing
operations in Pakistan. The details are as under:-
1. Novartis appreciates the permissions granted by DRAP as far to continue sourcing
their locally manufactured portfolio from its divested manufacturing facility located
at Jamshoro.
2. Novartis continue to evaluate available options to enable continued local
manufactuirng in Pakistan and has allocated a significant amount of global senior
management time over the past 9 months to indentify the best possible route to
continue serving patients with locally manufactured quality medicines at affordable
rates.
3. As stated in their progress report, they are reviewing the two final options, which
include the acquisition by Novartis of an existing drug-manufacturing facility and
upgrading their existing West Wharf facility.
4. One option under review was deemed not suitable for Novartis long-time plans in
Pakistan and a new acquisition opportunity was presented to Novartis, which they
are currently exploring. This acquisition opportunity would provide a stable platform
for the growth of the portfolio in Pakistan in the long term, however, the proposed
commercial terms remain under negotiation. They also believe that this option will
enable Novartis to re-establish proprietary local manufacturing on a shorter timeline
than the re-development of West Wharf site.
5. During the period of analysis and negotiation in respect of this potential opportunity,
Novartis has continued to progress its plans to expand the West Wharf facility and
the most recent engineering concept design is attached.
6. As there is one existing manufacturing line at the West Wharf facility, which is
intended to manufacture Psychotropic products. We hope that this line will be able
to be commercialized once the future manufacturing footprint decision is final and
the ramp up of Novartis proprietary operations can begin.
They envisage and will be able to communicate the details of the final decision on the
future Novartis manufacturing footprint in Pakistan by the end of 2018 and will provide the
progression of the plans for the re-development of West Wharf during October, 2018 in any
event.
Decision: Registration Board directed the firm to comply with the timelines and
commitments made by the firm for completion of extension of their own
facility till December, 2019, at the time of permission of contract
manufacturing under Rule 20A (c) of Drug (Licensing, Registering and
Case No.34. Change in Specifications of Registered Products of Atco Laboratories

Limited, Karachi.
M/s Atco Laboratories Limited Karachi have requested that they would like to
adopt following specifications for their already registered products:
S. Reg. No. Name of drug(s) & Current Proposed/Dema Initial Registration Remarks
# Composition Finished nded Date and Renewal
product specification Status
specification
1. 005999 Doxyn Capsule - BP 15th August, 1981. USP monograph is
Each capsule Specification Change of Brand available for
contains: For API Name on doxycycline capsule.
Doxycycline “Doxycycline 28-01-1982. Standard formulation
…….…. 100 mg Hyclate” approved by RRA is
USP Last Renewal Doxycycline as
Specification submitted on Hyclate..100mg
For Finished 20-7-2016
product
2 032004 Terbiderm Cream - BP 01st July, 2004. JP monograph is
Each 100 gm Specification Correction in available for
contains: For API composition 23rd Terbinafine cream.
Terbinafine HCl “Terbinafine January, 2007 Standard formulation
… 1.00 gm HCl” Last Renewal approved by RRA is
submitted on 19- Terbinafine as HCl.
06-2014
Registration Board in its 269th meeting deferred the request of the firm for
confirmation of registration renewal status of the above mentioned product. Now renewal
section has informed vide letter dated 12-02-2018 that their renewal application was received
within time in the year 2017. Later on, in 279th meeting, Registration Board deferred the case
for submission of prescribed fee. Now, the firm has submitted fee of Rs. 5000/- for each
product.
Registration Board in its 282nd meeting decided as follows:

i. Deferred the case at S.No.1 for confirmation of availability of Doxycycline
Capsule monograph in British Pharmacopeia.
ii. Deferred the case at S.No.2 and advised to seek clarification from the firm
regarding finished product specifications as JP monograph is available for
Terbinafine Cream.
The firm has requested to grant them the registration of product at Sr.No. 1 with USP
specifications and they have provided copy of USP monograph. For product at Sr.No. 2, the
firm wants grant of JP specifications and they have enclosed JP monograph.
Decision: Registration Board approved the following changes in finished product

specifications of above mentioned products:
i. “USP specifications” for Doxyn Capsule with standardization of
formulation to “Doxycycline (as Hyclate)………..100mg”
ii. “JP specifications” for Terbiderm Cream with standardization of
formulation to “Terbinafine (as HCl)…………..1.00 gm”
Case No.35. Extension in Contract Manufacturing of Drug of M/s. Xenium

Pharmaceuticals, P-62-A, St # 11, Afghanabad # 1, Faisalabad Through
Contract Manufacturing by M/s Medicaids Pakistan (Pvt.) Ltd; Karachi.
M/s. Xenium Pharmaceuticals, Faisalabad has requested for extension of contract

manufacturing of following product. The details are as under:-
S.# Regn. No. Existing Name Remarks
I II III VII
1. 020439 Spor-3 Injection 1gm Dy # 205
Each vial of dry substance contains:- Dated 23-01-2018
Ceftriaxone Sodium eq. to Ceftraxone base ………. 1gm
Brief of the case is as under:-

i. The products was registered in import vide letter dated 13-07-1998.
ii. The product was transferred from import to local contract manufacturing for
05 years vide letter dated 27-1-2004 through contract manufacturing by M/s
Medicaids Pakistan (Pvt.) Ltd; Karachi.
iii. The firm applied for further extension and application was received on 29-9-
2010 but the firm did not provide fee for this purpose and the firm requested to
grant them interim permission till 30-06-2015.
iv. The firm again applied extension for contract manufacturing vide dairy dated
19-06-2015 and not deposited fee for this purpose.
vi. Now the firm has deposited fee of Rs. 1,50,000/- for above stated product
along with undertaking and requested to grant them extension in contract
manufacturing by M/s. Medicaids Pakistan (Pvt.) Ltd; Karachi.
vii. The firm has also provided Form-5 from M/s. Medicaids Pakistan (Pvt.) Ltd;
Karachi and contract agreement.
The case was considered in the 4th meeting of PRVC where it was deferred for
presentation before Registration Board and the Board in its 279th meeting deferred the case
for the opinion of Legal Affairs Division.
The Legal Affairs Division opined that “it is clarified that the S.R.O. 1005(I)/2017
dated 19-07-2018 only cover the renewal of regular registered products and not the
extension of contract manufacturing.” However, the firm has submitted fee of Rs.
1,50,000/- for above said product.
Decision: Registration Board deferred the case for further deliberation in

coordination with Legal Affairs Division of DRAP.
Case No.36. Change of Contract Manufacturer of Already Registered Products of M/s.

AGP, Karachi.
Following products of M/s AGP (Pvt) Ltd., B-23, S.I.T.E. Karachi are
registered through contract manufacturing by M/s UDL Pharma (a divison of First UDL
Modarbah) Plot No. E-44 & E-45, North Western Industrail Zoen, Port Qasim Authority,
Karachi for a period upto 30-06-2020: -
S. # Reg. No. Name of drug(s) & Composition
1 018301 Neogene 250mg IM injection
Each vial contains:
Ceftriaxone (as Sodium) ...250mg
2. 018007 Neogene 250mg IV injection
Each vial contains:
Ceftriaxone (as Sodium)...250mg
3. 018302 Neogene 500mg IM injection
Each vial contains:
4. 018303 Neogene 1gm IM injection
Each vial contains:
Ceftriaxone (as Sodium)...1gm
5. 018009 Neogene 1gm IV injection
Each vial contains:
Ceftriaxone (as Sodium)...1gm
6. 018008 Neogene 500mg IV injection
Each vial contains:
7. 003755 Kefzol 500mg Injection
Each vial contains:
Cefazolin as sodium……..500 mg
8. 003756 Kefzol 1g Injection
Each vial contains:
Cefazolin as sodium ……….1gm
Now, the firm has requested to change the contract manufacturer from M/s UDL
Pharma (a divison of First UDL Modarbah) Plot NO. E-44 & E-45, North Western Industrial
Zone, Port Qasim Authority, Karachi to M/s. Seraph Pharmaceutical Plot # 210, Industrial
Triangle Kahuta Road, Islamabad. They have submitted following documents:-
i. Fee of Rs. 50,000/- for each product.
ii. NOC from new manufacturer dated 26-07-2018.
iii. Approval of manufacturing facility and GMP report of new manufacturer.
iv. The firm has applied all above products with USP specifications.
v. Contract agreement.
vi. NOC from UDL, Karachi.
Decision: Registration Board acceded to the firm’s request for change in contract
manufacturer of above mentioned products from UDL Pharma (a divison
of First UDL Modarbah), Karachi to M/s Seraph Pharmaceutical Plot #
210, Industrial Triangle Kahuta Road, Islamabad. This permission shall
be valid upto 30-06-2020.
Case No.37. Change of Primary Packaging Material of Drug(s) of M/s. Atco

Laboratories, Karachi.
M/s. Atco Laboratories Ltd; Karachi has requested for change of primary
packaging material from Alu-PVC to Alu-Alu to improve the product presentation:-
S.No. Name of Drug(s) Reg.No. Registration history
1. A-Fantrine Tablet 047214 Date of reg. 02-11-2007
Each tablet contains:- Renewal applied on 23-10-2017
Artemether ………… 20mg
Lumefantrine ……… 120mg
(Manufacturer’s Specification)
a) Copy of fee of Rs. 5,000/- verified by ABL is provided.
b) Copy of initial letter of registration dated 02-11-2007 and renewal status attached.
c) NOC for CRF clearance valid upto 31-12-2017.
d) Copy of availability in reference country is attached.
The firm has not provided stability protocols and relevant documents to stability data sheets.
The Committee in 3rd meeting deferred the case for further deliberation.
The firm has now submitted copy of SmPc of UK MHRA approved Riamet 20/120mg
Tablet stating nature and contents of container as under:
PVC/PE/PVDC/aluminium blisters
The Registration Board in its 282nd meeting deferred the case for confirmation of renewal
status. Now the RRR Section has communicated that the renewal application of year 2017
received within time, was considered under the Rule 27 of Drug Licensing, Registering &
Advertising Rule, 1976.
The Board was further informed that the firm has submitted stability data sheets with
6 months of accelerated and 24 months of real time stability data along with copy of
monograph of “Artemether and Lumefantrine Tablets” from International Pharmacopoeia.
Decision: Registration Board deferred the case for evaluation of stability data in the
light of relevant SOP approved by the Registration Board, vide its 283rd
meeting.
Case No.38. Change of Formulation of Septem Cough Syrup (Reg.No.002537).

M/s. Pakistan Pharmaceutical Products (Pvt.) Ltd; D-122, S.I.T.E, Karachi-Pakistan
has requested for change of formulation of their registered product Septem Cough Syrup
(Reg.No.002537) and the formulation of the product is not mentioned in the initial letter of
registration. They have proposed following formulation:-
Septem Cough Syrup
Each 5ml of liquid contains:-
Carbetapentane Citrate ………. 10mg
Chlorpheniramine Maleate …... 4mg
Potassium Cuaiacol Sulfonate … 130mg
Terpine Hydrate ……………….. 10mg
Sodium Citrate ………………… 65mg
Menthol ………………………... 0.5mg
S.No. Name of Ingredients Qty / Batch Qty / 5ml (mg) Overage Added
(Kg) (%)
1. Carbetapentane Citrate 3.4 10.00 --
2. Chlorpheniramine Maleate 1.36 4.00 --
3. Potassium Gauiacol 46.40 136.50 5.0%
Sulfonate
4. Terpine Hydrate 3.739 11.00 10.00%
5. Menthol 0.170 0.5 --
6. Sucrose 262.082 770.83 --
7. Sodium Benzoate 3.540 10.41 --
8. Citric Acid Monohydrate 9.139 26.88 --
9. Sodium Citrate 22.099 65.00 --
10. Sodium Saccharine 4.957 14.58 --
11. C.M.C - 1190 4.957 14.58 --
12. Rectified Spirit 85Lits 0.25ml --
13. Sorbitol Solution 70% 2.832 8.33 --
14. Sodium Cyclamate 2.614 7.691 --
15. Methyl Paraben 0.707 2.08 --
16. Ponceau Red Color 0.381 1.125 --
17. Essence Pineapple 3.4Lit 0.01ml --
18. Essence Rasperry 3.739Lit 0.011 --
19. De-ionized Water Q.S to 1700Lit Q.S to 5ml --
The management of the firm has deposited fee of Rs. 20,000/- for this purpose and
provided copy of initial registration letter. It is pertinent to mention here that the firm already
possesses the registration which is in accordance with the approved formulations and
ephedrine containing products of other firms which are also available in the market and
approved. The renewal of the drugs registration is also required to be clarified from RRR
section.
The PRVC in its 5th meeting deferred the case for confirmation of existing formulation
and processing the case in light of SOPs approved by Registration Board. As evidence, the
firm has provided copy of letter issued by Pricing Section for re-fixation of price as per
existing formulation.
Existing composition as stated vide letter (regarding re-fixation of price) issued by
Pricing Division is as under:
Septem Cough Syrup
Each 5ml of liquid contains:-
Carbetapentane Citrate ………. 10mg
Chlorpheniramine Maleate …... 4mg
Potassium Cuaiacol Sulfonate … 130mg
Terpine Hydrate ……………….. 10mg
Sodium Citrate ………………… 65mg
Menthol ………………………... 0.5mg
Ephedrine HCl………………….5mg
Decision: Registration Board deferred the case for following reasons:
i. Confirmation of renewal status from RRR section.
ii. Confirmation of generic/ me-too status of the formulation.
iii. Clarification regarding use of Sodium Cyclamate by the firm.
Case No.39. Request of M/s. Baxter Pharmaceuticals, Karachi for Grant of Contract
Manufacturing Permission for Their Registered Products.
The Registration Board, in its 282nd meeting considered the request of M/s.
Baxter Pharmaceuticals, A-1/A, Scheme 33, S.I.T.E, Super Highway, Karachi wherein it was
informed that they are renovating their cephalosporin injectable facility for renewal
inspection of their DML and requested for contract manufacturing of their following
registered products by M/s. Palpex Pharmaceuticals (Pvt.) Ltd; FD-46-A8, ST-1, Sector 38,
Korangi Creek Industrial Park, Karachi.
S.# Regn. No. Existing Brand Name Initial registration with renewal status
1. 067587 Xodtrix 250mg Dry Powder Injection i) Initial registration dated 11-04-2011
Each vial contains:- ii) Renewal applied on 23-11-2017 with
Ceftriaxone as Sodium …… 250mg the fee of Rs. 30,000/-
(USP Specification)
2. 067588 Xodtrix 500mg Dry Powder Injection i) Initial registration dated 11-04-2011
Ceftriaxone as Sodium ……500mg the fee of Rs. 30,000/-
(USP Specification)
3. 067589 Xodtrix 1gm Dry Powder Injection i) Initial registration dated 11-04-2011
Ceftriaxone as Sodium …… 1gm the fee of Rs. 30,000/-
(USP Specification)
The management of the firm provided following documents for this purpose.
i. Fee Challans of Rs. 50,000/- for each product.
ii. Copy of Contract Agreement.
iii. Copy of initial letter of registration.
iv. Form-5 by M/s. Palpex Pharmaceuticals, Karachi.
v. The Registration Board in its 277th meeting approved the renewal of above
products till 10-04-2021, however, RRR section has not yet intimated Reg-II
section.
vi. Last GMP inspection of M/s. Palpex dated 08-05-2018.
vii. NOC for CRF of M/s Baxter valid upto 31-12-2017
viii. Approval of dry powder injectable (cephalosporin) Section issued to M/s
Palpex by Licensing Division dated 12-06-2017
The Board was further informed that in addition to above mentioned products the firm
had also been granted registration of some other products that fall under Cephalosporin Dry
Injectable Section vide letter dated 11-04-2011. However, the firm had not requested for
contract manufacturing permission for those products.
Decision of M-282:
Registration Board deferred the case with following directions to the firm:
i. Submission of renovation plan and approval of CLB if the plan includes any
structural change.
ii. Stipulated duration of time for which contact manufacturing facility is
being requested.
iii. Justification for not requesting contract manufacturing permission for rest
of the products registered under Cephalosporin Dry Injectable Section.
Now the firm has responded as under:
i. So far no renovation has been started and we have not finalized the
renovation plan. As soon as our contract manufacturing request gets
approved we will shift our products to M/s Palpex Pharmaceuticals Pvt.
Ltd. & will submit the new maps as well.
ii. The firm has requested for grant of contract manufacturing facility for 1.5
years.
iii. As justification the firm has stated that our major market share is based on
the above requested products. So, for now we will only be making these
products and once the renovation work is completed we will start the
manufacturing of other products as well.
Decision: Registration Board deferred the case for submission of final layout plan
approved by Central Licensing Board for the purpose of renovation / up
gradation along with an undertaking that they will not manufacture rest
of the products granted to the firm in Cephalosporin Section during
renovation period.
Case No.40. Approved Product of M/s Atco Lab. Karachi

The Registration Board in its 264th meeting approved the following product of M/s
Atco Lab. Karachi as per below mentioned details:
Name and Brand Name Type of Form Remarks on the Remarks Decision
address of (Proprietary name Initial date, formulation (if any) of the
manufacturer + Dosage Form + diary including International Evaluator.
/ Applicant Strength) Fee including status in stringent drug
Composition differential fee regulatory agencies /
Pharmacological Demanded authorities
Group Price / Me-too status
Finished product Pack size GMP status as depicted
Specification in latest inspection
report (with date) by
the Evaluator
M/s Atco Lab. Avotrexid 400mg Form-5 Zyvox by Pfizer USFDA Fee Approved.
Karachi Tablet 10-05-2012 challan is Reference will
Each tablet Dy.No.853 Nezocin by Brookes not in be sent to
contains: Rs.8000/- Pharma original. Budget &
Linezolid….400 mg Rs.12,000/- accounts
8-5-2013 Last inspection report Division for
(Antibiotic) 12’s 13-12-2016 verification of
Rs.200/- Firm is in compliance in challan and
Mfg Specs with GMP Chairman
Registration
Board will
authorize
issuance of
registration
letter
As per minutes the firm has demanded pack size of 12’s Rs.200/-. However, duplicate
dossier has been received from Pharmaceutical Evaluation Cell and as per Form-5 the firm
has demanded price of Rs.200/Tablet with pack size of 12’s. Furthermore, the firm previously
submitted a request informing that they demanded price was Rs.200/tablet with pack size of
12’s and requested to consider demanded MRP of Rs.2400/12’s. In this regard the firm has
also submitted an undertaking regarding their demanded pack and MRP as stated on Form-5.
Decision: Registration Board approved the correction in minutes of M-264 regarding

demanded pack and price of “Avotrexid 400mg Tablet” i.e., Rs.200/Tablet
with pack size of 12’s.
Case No.41. Deferred Product of M/s Pakistan Pharmaceutical Products Pvt Ltd, D-
122, S.I.T.E. Karachi
The Registration Board in its 275th meeting deferred the case of M/s Pakistan
Pharmaceutical Products Pvt Ltd, D-122, S.I.T.E. Karachi for submission of latest GMP
inspection report.
Name and Brand Name Type of Remarks on the Remarks by Decision of M-
address of (Proprietary name + Form formulation (if any) Evaluator 262
manufacturer / Dosage Form + Initial date, including International
Applicant Strength) diary status in stringent drug
Composition Fee regulatory agencies /
Pharmacological including authorities
Group differential Me-too status
Finished product fee GMP status as depicted
Specification Demanded in latest inspection
Price / Pack report (with date) by the
size Evaluator
Pakistan Levi 250mg Form 5 Not Provided SRA reference Deferred for
Pharmaceutic tablet 04/4/201 not Provided confirmation
als Products Levetiracetam + 3 D#214 Lerace Undertaking of approval
(Pvt)Ltd, tablet + 250mg Fee regarding no status by
Karachi Eah film coated submitted Hilton banned reference
tablet contains is 20,000 excipient, regulatory
2198 levetiracetam Price as Inspection report follow authorities,
250mg per Dated 8/6/2012 innovator product
Antiepileptics policy “GMP inspection” brand, & specifications
Specs not Pack of “Overall GMP stability studies
Provided 10’s Compliance is good” not provided.
tablets DML, CD not
provided
The firm later on provided GMP inspection report dated 12-12-2017 and QA section
was requested to furnish comments on the submitted inspection report. The QA section has
now responded stating that as per their available record the latest cGMP inspection was
conducted on 06-05-18 according to which the firm is found to be complying at a good level
of GMP compliance.
Decision: Registration Board approved the grant of registration for “Levi 250mg
Tablet” with “USP Specifications”.
Case No.42. Allocation of Controlled Drug Substance for Trial Batches.
The Registration Board, in its 276th meeting, considered the request of M/s
Aspin Pharma (Pvt) Limited, Karachi for allocation of controlled dug substance for
their products that are under process for registration as per following details:
S.No Name of Drug(s) Submission Date

1 Cibrex 5/2.5 mg Tablet 24-10-2017
Each tablet contains:- Form-5
Chlordiazepoxide…. 5 mg Fee Rs. 20,000/-
Clidinium bromide…. 2.5 mg
2 Nogadon 5 mg Tabet 24-10-2017
Each tablet contains:- Form-5
Nitrazepam… 5 mg Fee Rs. 20,000/-
The firm further submitted that they are building a segregated area as per approved
layout plan (Letter No. F.2-1/2005-Lic(Vol-I) dated 17th October, 2017 from Licensing
Division attached with subject of Approval of Revised Layout Plan for Additional Sections
under DML No. 000045 (Formulation)). Therefore, firm requested that below mentioned
quantities for controlled drug substances may be approved for trial/Stability batches:
S.No Controlled Drug Substance Quantity required for Trial/Stability Batch

1 Chlordiazepoxide 100 gm
2 Clidinium bromide 100 gm
3 Nitrazepam 100 gm
Decision of M-276: Registration Board deferred the case for submission of breakup of
quarantines of Chlordiazepoxide, Clidinium bromide and Nitrazepam
in the trial batches as stated by the firm.
The firm has now submitted break up of quantities as under:
S. Product API mg/ No. of No. of Quantity of API required
No Tab Tab/ batches
. batch Trial + For For QC Total
Stability formulation testing &
development Retention
mg g g g
1. Nogadon 5 Nitrazepam 5 3000 5 75000 75 25 100
mg Tabet
2. Cibrex 5/2.5 Chlordiazepoxide 5 3000 5 75000 75 25 100
mg Tablet
Clidinium bromide 2.5 3000 5 37500 37.5 25 62.5
Decision: Registration Board approved the allocation of controlled drug substance

i.e Chlordiazepoxide & Nitrazepam for trial batches of above mentioned
products. The Board further advised the firm to maintain records of used
substance and discard wastes properly.
Case No.43: Risks & Concerns Associated with Dydrogesterone.

A number of applications have been received by Pharmaceutical Evaluation &
Registration Division for registration of Dydrogesterone Tablets. While evaluation, it was
identified that the applied formulations were based on "Cis Isomer" of Dydrogesterone i.e not
in compliance with the USP monograph for dydrogesterone tablet & European
Pharmacopeial monograph for dydrogesterone API, both of which state "trans isomeric
form".
The observation was further confirmed by reviewing innovator’s formulation approved by
following Reference Regulatory Authorities:
a. ANSM France (Duphaston, Authorization Holder: MYLAN MEDICAL SAS)
b. CBGMEB Netherlands (Duphaston; Reg. No. RVG 107765/ 05619)
c. AGES Austria (Duphaston, Owner: BGP Products GmbH, Perfektastrasse 84A,
1230 Vienna, Austria)
d. Swissmedic Switzerland
Concerns Raised by Abbott Laboratories:

M/ s Abbott Laboratories (Pakistan) Ltd. has raised the same issue and highlighted
following points of concern & risks associated with the use of mislabeled Dydrogesterone:
 Solvay Pharmaceuticals is the only company in the world which manufactures
dydrogesterone because manufacturing requires a proprietary technique.
 In Pakistan, dydrogesterone was only marketed by Solvay’s agents, Highnoon
Laboratories Limited under the brand name of DUPHASTON i.e currently owned by
Abbott Laboratories.
 Dydrogesterone manufacturing process involves, as an essential step, a
photochemical reaction which leads to conversion of configuration. The
manufacturing of 6-dehydroprogesterone lacks the photochemical conversion step
resulting in substantially different 3D structure.
 Different structures lead to different pharmacological profile such that efficacy of
these two molecules differ significantly.
 The clinical data on efficacy and/or safety is not available for 6-dehydroprogesterone
lacking the proof that this is any beneficial for the patient. As there is no data in
support of 6- Dehydroprogesterone, it cannot be evaluated in comparison to
dydrogesterone in terms of safety & efficacy.
Furthermore, M/s Abbott has submitted following supportive studies:
i. Drug analysis conducted on products claiming as dydrogesterone at:
1) Abbott’s MS&T Analytical Sciences & Technology, Weesp, The Netherlands.
2) Industrial Analytical Center, HEJ Research Institute of University, University
of Karachi.
The results of the chemical analysis revealed the main component as 6-
dehydroprogesterone & not dydrogesterone.
ii. Results Deduced From Comparative Molecular Modeling Study:
Dydrogesterone possesses a biological potency significantly higher than progesterone
itself as it takes advantage both from its retro structure and from the presence of the
C6- C7 double bond, which constricts the molecule into a rigid conformation
probably suitable for the interaction with the progesterone receptor. Moreover, as a
consequence of its better bioavailability and the progestational activity of its main
metabolites (20-, 21- and 16-hydroxy derivatives), its equivalent dose, regarding the
endometrial proliferation, is 10-20 times lower than that of progesterone itself.
Previous Proceeding:
In 2008 M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd. Karachi, appealed before the
Appellate Board against the decision of Registration Board regarding stoppage of production
of their drug "Dirogest Tablets" containing "Dydrogesterone Cis Isomer", for local
manufacture. The Appellate Board in its 134th meeting held on 17-06-2008 after considering
the following arguments & merits of the case, accepted the appeal since no scientific
evidence contravened the arguments made by M/s Zafa.
Mr. Muhammad Amin Khan, C.E.O., Mr. Jawad Amin Khan, MD,
Mr.Muhammad Aslam Shah, GM Technical & Mr. Hassan Masood Naqvi,
Assistant Sales Manager of the firm appeared before the Board on behalf of
the firm & stated that "Dirogest Tablets" containing "Dydrogesterone Cis
Isomer was registered in 2002 and since then they are marketing the said
drug without any complaint from the doctors/ market. They had been selling
more than 100000 packs per year & no complaint had been received about
their efficacy. They further added that the said drug was also available in
Israel & Syria. They informed the board that comparative study of the two
different dosage of the drug had been conducted in John Hopkins Bloomberg
School of Public Health and some trials in different hospitals in Pakistan
had been conducted. They also informed the board that their drug was
cheaper than its competitors in the market.
It is however, submitted that Duphaston is the proprietary name of the dydrogesterone
containing product registered by Ministry of Health, Israel in the name of ABBOT
MEDICAL LABRATORIES LTD, ISRAEL. Moreover, M/s Zafa, in order to prove their
stance, is obliged to provide data regarding aforementioned comparative study.
Findings:
Besides progesterone, the natural progestational agent, many synthetic progestins are
known. One of the classes is represented by “Retrosteroids” and the most representative
compound among these is 6-dehydroretroprogesterone (dydrogesterone). Another progestin
considered in this regard is 6-deydroprogesterone (Cis Isomer), having a molecular structure
almost identical to that of 6-dehydroretroprogesterone (dydrogesterone), however in
dydrogesterone molecule, the hydrogen atom at C-9 is at beta position & methyl group at C-
10 is at the alpha position (Figure1). Whereas 6-Dehydroprogesterone has a reverse
configuration at position C-9 & C-10 (Figure2), hence the term ‘retro’ progesterone. The
acetyl group at C-17 in both structures have same configuration.
Structural Comparison of 6 – Dehydroprogesterone and Dydrogesterone
Figure1
Figure 2
Both the isomers have different physical properties confirming these to be different
pharmaceutical entities.
S.No. Attributes Cis Isomer Trans Isomer
1 Chemical Name 6-Dehydroprogesterone 6-Dehydroretroprogesterone
2 Molecular Weight 312.45 312.45
4 CAS Number 1162-56-7 152-62-5
5 Specific Rotation +170º- +182º -469-485(dried
substance)measured at 25ºC
6 Melting point 142-148ºC 167-171ºC
7 Relative Retention Time towards 1.17 min 1min
Dydrogesterone
(Reverse phase HPLC with UV
Detector)
USP38-NF33
The Registration Board in its 281st meeting deferred the case for final comments from
PPMA. The board advised the observers of the PPMA to submit their response in the matter
within 15 days without waiting for any letter from DRAP. Board further directed to present
all the deferred cases in the next meeting.
Decision of M-284:
Registration Board deferred the case for final comments from PPMA. The board
advised the observers of the PPMA to submit their response in the matter within 15 days
without waiting for any letter from DRAP. Board further directed to present all the deferred
cases in the next meeting.
In this regard, a reminder has also been issued to PPMA dated 22-10-2018 to
comments within 07 days for consideration and finalization of the case by PPMA.
Decision: Registration Board deliberated the case in the light of above stated facts
and findings and decided as under:
Since USP monograph for Dydrogesterone states CAS No. “152-62-5” i.e
assigned to “Trans Isomeric Form; 6-Dehydroretroprogesterone” and as
per Drugs Specification Rules 1978, “drug products registered with any
official pharmacopoeial specifications shall follow specifications present
in the latest edition of that publication”. Furthermore, as per information
available on web, approval status of “Cis Isomeric Form” of
dydrogesterone could neither be confirmed in any Reference Regulatory
Authority nor in Syria and Israel. Therefore, the Board referred the case
to the Appellate Board with the request to review the decision taken vide
its 134th meeting, held on 17-06-2008.
Case No. 44: Change in Name of Manufacturer Abroad.

M/s Bayer Pakistan (Pvt) Limited, Karachi has requested for change in the name of
their principal manufacturer for following products registered for bulk import and local
repackaging:
S.No Reg. No Name of Drug(s) & Current Name of Proposed Name of
Documents
Composition Manufacturing Site Manufacturing
Submitted
1 044278 Adalat LA 20 mg Manufactured By: Manufactured by:
Original
Tablet Bayer Schering, Pharma Bayer AG, Kaiser-
Legalized CoPP
Each tablet contains:- AG Leverkusen, Wilhelm-Allee
from Germany.
Nifedipine … 20mg Germany 51368, Leverkusen,
Australian
Not available in Packed By: Bayer Germany Register of
Germany but Pakistan (Pvt) Limited, C- Packed By:Therapeutic
available in Australia. 21. S.I.T.E, Karachi No Change Goods
Certificate.
2 044279 Adalat LA 30 mg Manufactured By: Manufactured by: Original
Tablet Bayer Pharma AG, Bayer AG, Kaiser- Legalized CoPP
Each tablet contains:- Leverkusen, 51368, Wilhelm-Allee from Germany.
Nifedipine … 30mg Germany 51368, Leverkusen, Original
Not available in Product License Holder: Germany. Legalized CoPP
Germany but Bayer Vital GmbH, Product License from UK.
available in MHRA. 51368, Leverkusen, Holder:
Germany Bayer AG, Kaiser-
Packed By: Wilhelm-Allee 1
Bayer Pakistan (Pvt) 51368, Leverkusen,
Limited, C-21. S.I.T.E, Germany.
Karachi Packed By:
No Change
3 044280 Adalat LA 60 mg Manufactured By:Bayer Manufactured by:
Tablet Pharma AG, Leverkusen, Bayer AG, Kaiser-
Each tablet contains:- 51368, Germany Wilhelm-Allee
Nifedipine … 60mg Product License Holder: 51368, Leverkusen,
Not available in Bayer Vital GmbH, Germany.
Germany but 51368, Leverkusen, Product License
available in Australia. Germany Holder:
Packed By: Bayer AG, Kaiser-
Bayer Pakistan (Pvt) Wilhelm-Allee 1
Limited, C-21. S.I.T.E, 51368, Leverkusen,
Karachi Germany.
Packed By:
No Change
4 024653 Avelox Tablets Manufactured By:Bayer Manufactured by: Original
Each film coated Pharma AG, Leverkusen, Bayer AG, Kaiser- Legalized CoPP
tablet contains:- 51368, Germany Wilhelm-Allee from Germany
Moxifloxacin HCl eq. Product License Holder: 51368, Leverkusen,
to Moxifloxacin base Bayer Vital GmbH, Germany.
…….. 400mg 51368, Leverkusen, Product License
Germany Holder:
Packed By: Bayer No Change
Pakistan (Pvt) Ltd, C-21. Packed By:
S.I.T.E, Karachi No Change

1. Fee of Rs. 5,000/- for each product.
2. Copy of initial registration letter and renewal submissions.
3. Approval of last change of name of manufacturer.
The Post Registration Variation Committee in its 8th meeting deferred the case for
clarification of renewal status and further evaluation of CoPPs submitted by the firm.
The RRR section has conveyed the renewal that the renewal application of year 2015
received within time, was considered under the Rules 27 of Drug Licensing, Registering &
Advertising Rules, 1976.
Decision: Registration Board approved the change in name of principal
manufacturer of above mentioned products from “Bayer Schering,
Pharma AG Leverkusen, Germany” to “Bayer AG, Kaiser-Wilhelm-Allee
51368, Leverkusen, Germany”
Case No.45. Change of Contract Manufacturer of Drug(s) of M/s. High-Q

Pharmaceuticals, Karachi.
M/s. High-Q Pharmaceuticals B 64, KDA-1, Karsaz Raod, Karachi has
requested for change of contract manufacturer of following product from M/s. Nabiqasim
Industries Pvt. Ltd, Karachi to M/s. English Pharmaceutical Industries, Link Kattar Bund
Road, Thokar Niaz Baig, Multan Road, Lahore:-
S.No. Name of Drug(s) Reg.No.
1. Ruling 40mg I.V Injection 045616
Omeprazole (as Sodium) ………. 40mg
i. Form-5 and Fee of Rs. 50,000/- (Duplicate)
ii. Contract agreement.
iii. Section Approval and GMP Certificate (dated 20-02-2018) of new manufacturer.
iv. Copy of initial letter of registration and the registration is valid till 30-06-2020.
Decision: Registration Board deferred the case for assessment and confirmation of
manufacturing capacity of Injectable section of M/s English
Pharmaceutical Industries, Lahore.
Case.No.46: Change in Pack Presentation of Composition of Registered Drug(s) of

M/s. Nabiqasim Industries (Pvt.) Ltd; Karachi.
M/s. Nabiqasim Industries (Pvt.) Ltd; Karachi has requested for change in pack
presentation of composition (delivered dose) of their registered products as per following
details:
S# Name of Drug(s) with existing Approved Name of Drug(s) with demanded Reg.No.
formulation pack formulation
I II III IV V
1. Kleen Enema 120 ml Kleen Enema 006715
Each 100ml contains:- Each 120ml (delivered dose) contains:-
Monobasic Sodium Phosphate..16gm Monobasic Sodium Phospahte..19.2gm
Dibasic Sodium Phosphate..6gm Dibasic Sodium Phosphate …. 7.2gm
(USP Specification) (USP Specification)
-do- 60 ml Kleen Enema

(Additi Each 60ml (delivered dose) contains:-
onal Monobasic Sodium Phospahte.. 9.6gm
Pack) Dibasic Sodium Phosphate …. 3.6gm
(USP Specification)

i. Fee of Rs. 5000/- .
ii. Copies of initial letter of registration and copies of renewal applications.
iii. Reference Material
The firm has further informed that like innovator brand “FLEET ENEMA” of C.B.
Fleet Company Inc,. USA, we and all other companies like UNI-MA-ENEMA of Unison
Laboratories Co. Ltd; Thailand and NEET ENEMA of M/s. Risma Laboratories, Karachi
mentioned the delivered dose on packaging. Their distributor abroad requested them to
provide DRAP approval to mention the 120ml and 60ml delivered dose composition on
packaging of their product Kleen Enema.
The PRVC in its 14th meeting deferred the case of 120ml pack for presentation before
Registration Board.
Decision: Registration Board acceded to the firm’s request regarding change in

pack presentation as mentioned vide Column IV of above table. Letter
will be issued after confirmation of renewal status from RRR section.
Case No.47: Change in Registration Status of products of Ms. Scilife Pharma (Pvt.)
Ltd; Karachi.
M/s. Scilife Phamra (Pvt.) Ltd; 16, K.O.C.H.S, Amir Khusro Road P.O.Box # 8935
Karachi-75350 has requested for change in registration status of following products from
M/s. Opal Laboratories (Pvt.) Ltd, LC-41, L.I.T.E, Landhi, Karachi to their name:-
S.No. Name of Drug(s) Reg.No.
1. Vpride 1mg Tablet 039350
Glimepride ……………. 1mg
The management of the firm provided Form-5 and fee of Rs. 20,000/- for each
product and provided following products:-
i. Form-5 along with fee of Rs.20,000/-each.
ii. Copy of initial letter of registration and renewal status.
iii. NOC from M/s. Opal Laboratories (Pvt.) Ltd, Karachi (dated nil).
iv. Copy of inspection report dated 10-07-2018.
M/s Opal Laboratories has submitted 3 times renewal fee on 18-10-2017 & 30-11-
2017 under SRO 1005(I)/2017.
Decision: Registration Board deferred the case for confirmation of renewal status
from RRR section and submission of fresh NOC from M/s Opal
Laboratories (Pvt.) Ltd, Karachi, issued within last 6 Months.
Case No.48: Deferred Products of M/s. SJ&G, Fazul Ellahi, Karachi.

The Registration Board in its 213th & 214th meetings deferred the following products of M/s.
S.J&G Fazul Ellahi, Karachi for reasons as mentioned below:-
S.No. Name of Drug(s) Pack size Demanded Decision of
MRP Registration
Board
1 Trispa Injection 6 ampoules Rs. 210.00 Deferred for
Each 4ml ampoule contains:- review committee
Hydrated Phloroglucinol......40mg M-213
Trimethylphloroglucinol…0.04mg
2. Trispa Tablet 30’s Rs. 150.00 Deferred for fate
Each film coated tablet contains:- in the light of
Hydrated Phloroglucinol F.P. … 80mg review
Trimethylphloroglucinol M.S … 80mg Committee’s
decision. M-214
The management of the firm later on provided following documents:-
i. Form 5 and original challans of remaining fee of Rs. 12000/- for each product.
ii. Copies of challans of Rs. 8000/- for each product.
Registration Board in its 278th meeting deferred the case to obtain comments from QA
Division on GMP status of the firm in the light of latest GMP inspection report.
The firm has now submitted copy of inspection report dated 02nd May, 2018 with the
comments that “the firm has complied / improved according to the directions of the FID. The
panel was satisfied for the improvements undertaken by the firm to comply with the
observations dated 12th July, 2017. Further the panel advised the firm to continue the
improvements.”
Furthermore, in the light of 268th meeting of Registration Board, the firm has also
provided revised form-5 for Trispa Tablet stating “sugar coated tablets” in accordance with
the standard formulation approved by Reference Regulatory Authorities.
Decision: Registration Board approved the grant of registration for above
mentioned products with finished product specifications “As per
Innovator’s” and correction in formulation of product at S.No.2 from
“film coated tablet” to “sugar coated tablet” in accordance with the
standard formulation approved by Reference Regulatory Authorities. The
Board further advised to adopt the procedure for verification of duplicate
deposit slips as approved vide its 264th meeting.
Case No.49: Change in Contract Manufacturer of Drug(s) of M/s. Standard

Pharmaceutical Manufacturer, Hyderabad.
M/s. Standard Pharmaceutical Manufacturer, E-6-A, S.I.T.E, Hyderabad has
requested for change in contract manufacturer of following products from M/s. Medicaids
Pakistan (Pvt.) Ltd; Karachi to M/s. Inventor Pharma, Plot No. K/196, S.I.T.E, (SHW) Ph-II,
Karachi. The details are given as under:-
S.No. Name of Drug(s) Reg.No. Registration History
1. Temcef 400mg Capusle 070752 The permission is
Each capsule contains:- valid till 30-06-2020.
Cefixime trihydrate eq. to Cefixime …. 400mg
2. Temcef Dry Suspension 070753 -do-
Each 5ml contains:-
3. Temcef Dry Suspension 070751 -do-
Each 5ml contains:-
The management of the firm has provided following documents.

ii. Application on Form-5.
iii. NOC from new manufacturer dated 17-09-2018.
iv. Approval of relevant Section from Licensing Division.
v. Contract agreement.
vi. Copy of inspection report conducted on 01-10-2018 with following
conclusion:
“Based on people met, documents reviewed and findings of the inspection, the firm
was found capable enough to carry out manufacturing and required tests on raw,
packaging materials, intermediates and finished drugs. The panel is of the opinion to
recommend the resumption of their manufacturing operations with periodic surprise
inspection of FID to check their GMP compliance level during working conditions.”
The Board was further informed that the Appellate Board, vide its 147th meeting held
on 28-08-2017, decided to suspend the operation of impugned order of CLB dated 15th
March, 2017 communicated on 24th April, 2017 and remand the appeal back to the CLB and
constituted a panel to inspect the premises of the Appellant who shall submit its report within
30days from communication of this decision. The report of the panel will be placed before
the CLB in its forthcoming meeting. Meanwhile, the production of the firm will remain
suspended till recommendation by the panel for resumption of production and approval
thereof by the CLB.
Decision: Registration Board approved the change in contract manufacturer of
above mentioned products from M/s Medicaids Pakistan (Pvt.) Ltd.,
Karachi to M/s. Inventor Pharma, Plot No. K/196, S.I.T.E, (SHW) Ph-II,
Karachi subject to decision of Central Licensing Board regarding
resumption of production activities of M/s Standard Drug Company,
Hyderabad.
Case No.50: Correction in Formulation of Anafe-F Syrup of M/s Reign

Pharmaceuticals, Karachi.
The Registration Board in its 249th meeting approved the following product of M/s
Reign Pharmaceutical PCSIR KLC, Karachi as per following details:
1 Anafe-F Syrup As per As per 21-05-2013
Each 15ml contains: PRC PRC Dy.No.527
Iron Protein Succinylate….800mg Form-5
eq. to elemental Iron…….40 mg Rs.20,000/-
Folic acid………..2.5 mg
(Anaemia, Haematinic)
Later on, in 271st meeting, the firm informed that their product was approved with the
error in composition i.e 2.5mg of Folic Acid instead of 5mg. The firm has requested for
issuance of registration letter with correct specification i.e. Folic Acid 5mg. The Registration
Board in 271st meeting deferred the request for submission of fresh Form-5 with prescribed
fee and latest GMP report.
The firm has now submitted Form-5 along with fresh fee of Rs.20,000 and last
inspection report dated 18-11-2017 indicating good level of GMP compliance. Furthermore,
the same formulation is already approved as Sucrofer-F Syrup (R#057525) for M/s CCL
Pharmaceuticals (Pvt) Ltd, Lahore.
Decision: The Registration Board approved the correction in formulation of
“Anafe-F Syrup” as per following details:
Each 15ml contains:
Iron Protein Succinylate….800mg eq. to elemental Iron…….40 mg
Folic acid………..5 mg
Case No.51. Standardization of Formulation in Accordance with Revised WHO

Formulation.
M/s Nabiqasim Industries (Pvt) Ltd., has applied for standardization of formulation of
their following registered products in accordance with the revised WHO formulation. Details
are as under:
S.No. Reg. No. Existing Brand name & Proposed Brand name & Proposed Revised
Formulation WHO Formulation
I II III IV
1. 080782 Normolyte ORS Sachet Normolyte Low Osmolarity ORS Sachet
(Lemon Flavor) (Lemon Flavor)
Each sachet contains: Each sachet contains:
Sodium Chloride………….3.5g Sodium Chloride BP…….2.6g
Sodium Citrate………….2.9gm Trisodium Citrate Dihydrate BP..2.9gm
Potassium Chloride………..1.5g Potassium Chloride BP……..1.5g
Dextrose anhydrous…….…20g Glucose Anhydrous BP…….13.5g
(Manufacturer’s Specification) (BP Specification)
2. 080783 Normolyte ORS Sachet Normolyte Low Osmolarity ORS Sachet
(Orange Flavor) (Orange Flavor)
Each sachet contains: Each sachet contains:
Sodium Chloride………...3.5g Sodium Chloride BP…….2.6g
Sodium Citrate………..2.9gm Trisodium citrate Dihydrate BP..2.9gm
Potassium Chloride……...1.5g Potassium Chloride BP……..1.5g
Dextrose anhydrous…..…20g Glucose Anhydrous BP…….13.5g
(Manufacturer’s Specification) (BP Specification)
In the light of SOP approved in 283rd meeting of Registration Board, the management of
the firm has provided following documents.
a) Application with fee of Rs. 20,000/- for each product.
b) Copy of registration letter dated 21-06-2016.
c) Document in support of proposed correction including WHO approved formulation,
BP monograph and Health Ministry’s Circular No.F.13-3/2008-Reg-II-(M-214)
(dated 15-09-2009) regarding WHO revised formulation of ORS.
d) Undertaking that the provided information/ documents are true/ correct.
It is further submitted that the applied formulation has been verified from WHO 20th
Model List of Essential Medicine (March 2017).
Decision: Registration Board acceded to the firm’s request regarding
standardization of formulation along with Brand Names (as mentioned
vide column IV of above table) in accordance with the WHO revised
formulation of ORS. The Board further advised that MRP shall,
accordingly, be issued for revised formulation.
Case No.52: Correction in Demanded Pack size/ Price of Obsamox 400mg Tablet of
M/s OBS Pakistan, Karachi.
The Registration Board in its 259th meeting approved the following product of
M/s OBS Pakistan, Karachi as per below mentioned details:
Name and Brand Name Type of Form Remarks on the formulation (if Remarks Decision
address of (Proprietary name + Initial date, any) including International of the
manufacturer / Dosage Form + diary status in stringent drug Evaluator.
Applicant Strength) Fee including regulatory agencies / authorities
Composition differential fee Me-too status
Pharmacological Demanded Price GMP status as depicted in latest
Group / inspection report (with date) by
Finished product Pack size the Evaluator
Specification
M/s OBS Tablet Obsamox Form 5 with MHRA approved Avelox – Challan Approved
Pakistan (Pvt.) Each film coated fee Rs Bayer receipt
Ltd, C-14, tablet contains :- 20,000/- Abomox - Abbott required.
S.I.T.E, Moxifloxacin HCl Pack size of GMP compliant section vide
Manghopir 436.40mg eq to 30’s Rs. inspection report dated 08-4-
Road, Karachi Moxifloxacin 984.96/- 2015
Priority # 400mg
2323 swapped Antibiotics
Manufacture
specification
As per minutes the firm has demanded pack size/price of 30’s Rs. 984.96/- . The
firm later on informed that they applied for Rs.790/5’s. The original dossier couldn’t be
traced. However, the firm has now submitted copy of form-5(as per initial application) along
with undertaking stating detail of applied pack and price i.e Rs.790/5’s. Furthermore, the firm
has now requested for issuance of registration letter with pack size of 5’s and price as per
DPC.
Decision: Registration Board approved the correction in minutes of M-259 regarding

demanded pack and price of “Obsamox Tablet” i.e., Rs.790/5’s.
Case No.53: Approved Product of M/s OBS Pakistan (Pvt.) Ltd, Karachi
Following Product of M/s OBS Pakistan (Pvt.) Ltd, Karachi was approved as a
new molecule vide 235th meeting of Registration Board as per details below:
S.No. Name of Drug(s) with Demanded Demanded Decision of M-235
composition Pack Price
I II III IV V
1. D-Pristiq 50mg Tablet 10’s Rs.2450.00 Approved subject to
Each film coated tablet contains:- 20’s Rs.4900.00 submission of dissolution
Desvenlafexine Succinate 30’s Rs.7200.00 profile with the originator
76.0mg eq. to / brand leader and product
Desvenlafexine ....50mg specific inspection is also
(Anti depressant) required
The firm has now submitted following documents & requested for issuance of registration
letter:
i. Acknowledgment letter for dossier submission along with photocopy challan of
Rs.15,000/-.
ii. Acknowledgment & Photocopy challan of Rs.35,000/- as balance fee for D-
Pristiq 50mg Tablet in response to Ministry’s Letter No. F.6-4/2013-Reg-II dated
18-3-2013.
iii. Last Inspection Report dated 28-05-2018
The firm has also submitted fresh form-5 with standardized formulation as under:
Name of Drug(s) with Demanded Pack/Price RRAs/ Generic Status
composition
D-Pristiq 50mg Tablet As per DPC TGA approved Pistiq Tablet
Each film coated extended release by Pfizer Australia.
tablet contains:- Lafaxine ER 50mg Tablet
Desvenlafaxine Succinate eq. to By M/s Genix Pharma,
Desvenlafaxine ....50mg Karachi
.
Decision: Registration Board deferred the case for confirmation of formulation

applied by the firm at the time of submission of initial application i.e.,
whether “Film Coated” or “Film Coated Extended Release”
Case No.54: Deferred Products of Eros Pharmaceuticals Pvt. Ltd. Karachi.

Following Product of Eros Pharmaceuticals Pvt. Ltd. Karachi were deferred
vide 229th meeting of Registration Board as per details below:
S.No. Name of Drug(s) with composition Demanded Demanded Decision of M-229
Pack Price
I II III IV V
1. Oberon-P 75 Tabs 20’s As per Deferred for GMP &
Each coated tablet contains: 30’s SRO product specific
Diclofenac sodium….75mg 100’s inspection
(Anti Rheumatic)
2. Oberon- SR Tabs 20’s As per -Do-
Each sustained released tablet contains: 30’s SRO
Diclofenac sodium…100mg 100’s
(Anti Rheumatic)
The firm has now submitted following documents:

a. Acknowledgment letter for dossier submission along with photocopy challan of
Rs.8,000/-
b. Acknowledgment & Photocopy challan of Rs.12,000/- as balance fee.
c. Last Inspection Report dated 26-03-2018.
d. Licensing Division’s Letter No. F.8-2/2018-QA(M-259-CLB) communicating
decision of 259th meeting of Central Licensing Board regarding resumption of
production activities in following sections:
i. Tablet (General)
ii. Capsule (General)
iii. Syrup Oral (General)
iv. Ointment/ Cream
It is further submitted that as per minutes of M-229, the firm has applied for Oberon-P
75 Tabs (S.No.1 of above table) containing “Diclofenac Sodium”. However, the firm has now
requested for Oberon-P containing Diclofenac Potassium 75mg and same has been mentioned
on photocopy challans & acknowledgment copies provided by the firm.
Decision: The Registration Board decided as under:
i. Deferred the product at S.No.1 in the light of decision taken by the Board
vide its 258th meeting regarding de-registration of Diclofenac potassium
75mg and 100mg.
ii. Approved the grant of registration for product at S.No.2 with “USP
Specifications” subject to verification of duplicate deposit slips in the light
of decision taken by the Board vide its 264th meeting. Furthermore,
following composition will be mentioned on registration certificate:
Each sustained release film coated tablet contains:
Diclofenac sodium…100mg
Case No.55: Request For De- Registration of Old Local Products By M/s GSK
Pakistan Limited, Karachi.
M/s GSK Pakistan Limited, Karachi has applied for de-registration of their
following registered products.
S. Reg.No. Brand name and composition Justification Alternate Brands Date of
No. Registration &
Last Renewal
Status
I II III IV V VI
1. 004633 Cytexin Syrup Lysovit (Pfizer) 12-02-1975
Each 15ml contains:  Suitable
Thiamine HCl…3mg therapeutic Daviplex (Davis
Riboflavin………..3mg alternatives and Pharma)
Pyridoxin HCl…..2mg advanced Enervit (Himont 01-08-2013
Nicotinamide….23mg therapies are Pharma)
2. 009574 Capozide Tablet 50mg available in the Cortec Plus 26-02-1987
Each tablet contains: market. (Nabiqasim)
Captopril……….50mg Co-Renitec (OBS)
Hydrochlorothiazide….25mg Cardace-H (Zafa) 17-09-2015
3. 017305 Floxy IV 200mg  Better/ new Oflobid (Hilton) 21-06-1995
Each 100ml contains: molecules to Quinox (Brookes)
Ofloxacin HCl ….220mg cater the same Tarivid (Sanofi) 24-07-2014
eq.to Ofloxacin ….200mg portfolio are
4. 021769 Floxy Eye Drops also available in Not Provided 20-05-1998
Contains: the market.
Ofloxacin……..0.3%w/v 24-07-2014
5. 017304 Floxy Tablet 200mg Oflobid (Hilton) 21-06-1995
Each tablet contains: Quinox (Brookes)
Floxacin……….200mg  Virtually there Tarivid (Sanofi) 24-07-2014
6. 006244 Marzine Injection is no demand of Nausin (Siza) 18-04-1982
Each ml contains: this product in Dirinate (Elite)
Cyclizine lactate…….50mg local market. Gravinate (Searle) 01-08-2013
7. 006663 Uniplex Syrup Surbex (Abbot) 17-01-1985
Each ml contains: Polybion (Merck)
Thiamine HCl……10mg Lysovit (Pfizer)
Riboflavin………..5mg 01-08-2013
Pyridoxin HCl…..2mg
Nicotinamide….20mg
d-panthenol………..5mg
Cyanocobalatin……10mcg
8. 008489 Wellcodex Capsule Vibramycin (Pfizer) 31-07-1985
Each capsule contains: Supramycin-100
Doxycylcine Polyphosphate (Merck) 01-08-2013
sodium complex eq.to Etidoxin (Getz)
100mg Doxycycline base.
9. 004035 Tagmet Tablet 200mg Ulceloc (Bosch) 03-05-1979
Each tablet contains: Minatidine (Elite)
Cimetidine………200mg Ulcerine (Geofman) 22-08-2013
10. 006364 Tagmet Tablet 400mg Ulceloc (Bosch) 18-05-1982
Each tablet contains: Minatidine (Elite)
Cimetidine………400mg Ulcerine (Geofman) 08-08-2018
11. 000351 Amphyll Injection 250mg Amphiline (Elite) 17-04-1976
Each 10ml ampoule Phyllocontin (AGP)
contains: Asmolin (Irza) 22-08-2013
Aminophylline….250mg
In the light of SOP approved vide 283rd meeting, the firm has submitted following
documents:
a. Copy of Registration Letter & Last Renewal Status.
b. List of alternate brands available in the country.
c. Justification.
d. An Undertaking that:
i. No case is pending at any forum/ court of law regarding above mentioned
products.
ii. Provided information/ documents are true/ correct.
Decision: Registration Board referred the case to DRAP’s committee for availability
of drugs for their opinion.
Case No.56: Request of M/s. Muller & Phipps Pakistan (Private) Limited, Karachi.
M/s. Muller & Phipps Pakistan (Pvt.) Ltd. Uzma Court, Main Clifton Road,
P.O. Box3880-Karachi-75600 has requested that they have multinational distribution network
for national and multinational pharmaceuticals companies. On behalf of importers /
manufacturers they always participate in the institution tender business. As per the institution
requirements outer / secondary packs must be stamped / over printed with the same of
institution and wording “Not for Sale”. Their licensed warehouse has been approved by the
Drug Regulatory Authority of Pakistan for storage of biological and non-biological products.
They have provided following documents:-
i. Drug Regulatory Authority of Pakistan, Inspectors Approval reports.
ii. Provisional Establishment Certificate to Import Medical Devices provided in
schedule-D.
iii. Copy of valid sale license.
iv. Authority letters for institutions of different manufacturers.
v. Fee of Rs. 5000/- for this purpose.
They have further quoted the SRO 470(I)/2017 and the medical devices Rules 2017, as
under:-
1. Drugs (Labelling & Packing) Rules, 1986 (Rule 9A, Sub-rule (2):
“Where the imported drugs, at the time of import, do not confirm to the provision of
sub-rule (1), the person importing the drug shall make an arrangement at a local
facility licensed to manufactured drugs of sell the drugs in terms of clause (i) of Rule
(3) of the Drugs (Import & Export) Rules, 1976 with the prior approval of the
Registration Board to print the GSI Application, before the drug is placed in to the
Pakistani Market.”
2. Medical Devices Rules 2017: (Rule 38, Sub-rule (2):
“Where a medical devices has either not been appropriately labeled, or partially
labelled as mentioned in sub-rule (1), the importer on his request in this behalf may be
allowed by MDB to comply with these rules relating to labeling by printing the
information of establishment-license’s details, enlistment or registration number,
MRP or any other information which may be required by MDB at establishment’s
licensed premises”.
They have requested that the above stated proviso should also be extended to the
stamping / marketing on outer packs for Government Institution Supplies only, as the Drugs
(Labeling and Packing) Rules has been amended.
The PRVC in its 14th meeting referred the case for presenting in Registration Board.
Decision: Registration Board referred the case to Legal Affairs Division of DRAP
for opinion/ comments.
Case No.57: Correction in Brand Name of Drug(s) of M/s. Faas Pharmaceutical (Pvt.)
Ltd; Karachi.
M/s. Faas Pharmaceutical (Pvt.) Ltd; Karachi had requested for change of
brand name of their already registered drug(s). The details are as under: -
S.# Regn. No. Existing Brand Name Initial registration with renewal status
1. 085943 Ulciloc Insta 20mg Sachet i) Initial registration dated 18.01.2018
Each sachet contains:-
Omeprazole ………………...20mg
Sodium Bicarbonate ……… 1680mg
(As per *Innovator’s Specification)
2. 086085 Ulciloc Insta 40mg Sachet -do-
Each sachet contains:-
Omeprazole ………………..40mg
Sodium Bicarbonate ……… 1680mg
The firm had submitted fee of Rs. 20,000/- for each product and other documents for this
purpose and the PRVC approved the change of brand name from “Ulciloc” to “Tinkit Insta”.
Now the firm has informed that they have already been granted the registration of
Omeprazole pellets under the brand name Nomizil 40mg & 20mg (Reg.No.082167 &
082168). The firm has requested to correct the brand name as per their first priority name i.e
Nomizil Insta instead of Tinkit Insta.
The Committee deferred the case in its 9th meeting for provision of prescribed fee.
The firm has again requested that they have already been granted the registration of “Nomizil
40mg & 20mg Capsule” (Reg.No.082167 & 082168) and they may be granted the brand
name “Nomizil Insta” for uniformity of brand name.
The Committee in its 14th meeting deferred the case to present in Registration Board.
Decision: Registration Board deferred the case for submission of requisite fee for
change of brand name.
Case No.58: Correction in Formulation of Drug(s) of M/s. Zafa Pharmaceutical
Laboratories, Karachi.
M/s. Zafa Pharmaceuticals Laboratories (Private) Limited, L-1/B, Block 22,
Federal “B” Industrial Area, Karachi-75950 has informed that they were granted the
registration of following product since 2006 and were manufacturing the product but now the
Government Analyst, Government of Balochistan declared the drug misbranded with the
remarks that “the manufacturer does not labeled the sample portion (Tablet Novodol) as
required by B.P Ferrous Fumarate 75mg equivalent to 24.37mg of Ferrous Iron, hence the
sample portion violate the provision of Drugs Act, 1976. Therefore the firm has requested to
correct the label claim as under:-
Sr. Reg.No. Name of Drug(s) with existing formulation Name of Drug(s) with correct
No formulation
I II III IV
1. 031292 Novodol Pills Novodol Pills
i) 21 White coated tablets each contains: i) 21 White coated tablets each contains:
Levonorgestrel …………. 0.15mg Levonorgestrel …………. 0.15mg
Ethinyl Estradiol ……….. 0.03mg\ Ethinyl Estradiol ……….. 0.03mg\
(USP Specification) (USP Specification)
ii) 7 Brown coated tablets each contains: ii) 7 Brown coated tablets each contains:
Ferrous fumarate ………… 75mg Ferrous Fumarate 75mg equivalent to
(BP Specification) 24.37mg of Ferrous Iron
(BP Specification)
i. Fee of Rs. 5,000/-.
ii. Justification of DTL for this purpose.
iii. Copy of initial letter of registration.
iv. Pharmacopieal reference.
The PRVC in its 14th meeting deferred the case to present in Registration Board.
Decision: Registration Board approved the correction in formulation of “Novodol
Pills” as mentioned vide column IV of above table.
Case No. 59: Correction in Strength of Active Ingredient of Approved Drug (s) of M/s
Hilton Pharma (Pvt) Ltd, Karachi.
The following product of M/s Hilton Pharma (Pvt.) Ltd., Karachi was
approved in 274th Meeting of Registration Board held on 21 – 23rd September, 2017 in which
the pharmaceutical form of Georun SR 100mg Tablet was approved as “Each film coated
tablet contains” instead of “Each sustained release film coated tablet contains” due to
typographical mistake made in the application.
Name and address of manufacturer / M/s Hilton Pharma (Pvt.) Ltd., Karachi.
Applicant
Brand Name +Dosage Form + Strength Georun SR 100mg Tablet
Diclofenac sodium……100 mg
Type of Form Form 5
Pack size & Demanded Price 10’s,20’s,30’; As per DPC
Approval status of product in Reference Approved by USFDA
Me-too status Dicast S.R Tablets of M/s Winbrain Research Laboratories
(Reg.#078502)
GMP status Last GMP Inspection of conducted on 17-10-2016 with
conclusive remarks of cGMP compliant.
Decision: Approved.
However, as per dossier received from Pharmaceutical Evaluation Cell, revised form-
5 is attached, bearing no evidence acknowledgment/endorsement by Drap, wherein the
strength of active ingredient per unit is recorded as “Each sustained release film coated tablet
contains”. Now, the firm has requested to revise the registration letter as per Form-5.
Decision: Registration Board approved the correction in formulation along with
change in brand name of “Georun SR 100mg Tablet” as per following
details:
Each sustained release film coated tablet contains:
Diclofenac sodium……100 mg
Case No.60: Discontinuation of Drug Products of M/s Getz Pharma (Pvt) Ltd,
Karachi.
M/s Getz Pharma (Pvt) Ltd, Karachi has requested for discontinuation of their
following registered products:
Sr. No. Reg.No. Name of Drug (s) and composition
1. 076447 Dravix 500mg/5ml Injection
Each 5ml contains:
Tranexamic Acid………..500mg
(BP Specification)
2. 076449 Dravix 500mg capsule
Tranexamic Acid………..500mg
(Manufacturer’s Specification)
3. 034836 Montiget 4mg Chewable tablets
Montelukast (as sodium salt)………4mg
The firm has intimated that the demand of above products is far lesser than the
minimum batch quantity, which could be manufactured on the equipment. Therefore, they
have requested to discontinue the production of above mentioned products.
Decision: Registration Board referred the case to DRAP’s committee for availability
of drugs for their opinion.
Case No.61: Change of Registration Status of Drug (s) of M/s ICI Pakistan Ltd,
Karachi.
M/s ICI Pakistan Ltd S-33, Hawkes Bay Road, S.I.T.E Karachi has requested
for change of Registration status of following products from M/s. Wyeth Pakistan Limited,
Karachi to their of the firm as per following details.
S. Reg. No. Name of Drug Registration Remarks
No. Status
1. 008998 Entox-P Tablet 500mg I- Transfer of Firm has requested to change the
Each tablet contains: Registration registration status from M/s.
Activated attapulgite B.P. date 06-March- Wyeth Pakistan Ltd, S-33,
………..… 500 mg 2008 Hawksbay Road, S.I.T.E, to M/s.
ICI Pakistan Ltd, Karachi.
Registration Board in its 281st meeting deferred product for evidence of approval
status in reference regulatory authorities for product.
Entox-P Tablet 500mg:
The firm has submitted the evidence of Attapulgite Tablet 630mg licensed as a natural health
product in Canada. They have also submitted application on Form-5 alongwith fee of Rs.
20,000/- for change of formulation to standardize the formulation as approved in Health
Canada. They have requested to approve the new formulation of Entox-P as “Activated
attapulgite B.P.… 630 mg”.
Name of Drug(s) with Existing Name of Drug(s) with correct Demanded Price/ me-too
formulation formulation status and Specs
Entox-P Tablet 500mg Entox-P Tablet 500mg As per *Innovator’s
Each tablet contains: Each tablet contains: Specification
Activated attapulgite.…500mg Activated attapulgite.… 630mg Pack size 100’s
As per Existing MRP
Decision of 284th meeting of Registration Board:

Deferred for further deliberation.
The firm has now provided generic status of the product i.e., Tox Tablet
(Reg.No.039268) by M/s Farmaceutics, Karachi.
Decision: Registration Board decided to approve change of registration status of above

mentioned product in the new title of the firm i.e. M/s ICI Ltd S-33, Hawkes
Bay Road, S.I.T.E Karachi (DML No.000006) as per follwong details;
Entox-P Tablet 630mg
Activated attapulgite…..630mg
“As per Innovator’s Specifications”
Case No.62: Correction in Registration Letter of M/s Barrett Hodgson Pakistan (Pvt.)
Ltd, Karachi and M/s S.J.&G Fazul Ellahie (Pvt.) Ltd; Karachi.
a. M/s. Barrett Hodgson Pakistan (Pvt.) Ltd; Karachi has informed that they were
granted the registration of following product while there is some omission in the registration
letter: -
S.# Regn Product (s) with existing composition Product (s) with correct composition and
No. and Specifications. Specifications.
1. 083222 Bar-D Injection I.M Bar-D Injection
Vitamin D3 (Cholecalciferol) USP…5mg Vitamin D3 (Cholecalciferol)…… 5mg
(B.P Specification) (As per Innovator’s Specification)
The firm has requested to omit the B.P Specification and mention Innovator’s
Specification instead of B.P specification. They attached copies of minutes of various
meetings of Registration Board in which many firms have been granted Innovator’s
Specification without mentioned I.M. Furthermore, the Registration Board in its 262nd
meeting approved the product with Manufacturer’s Specification.
The PRVC in its 3rd meeting deferred the case for verification of calculation and
presentation the case before Registration Board.
b. M/s. S.J.&G Fazul Ellahie (Pvt.) Ltd; Karachi has informed that they were granted the
registration of following product while there is some omission in the registration letter:-
S.# Regn Product(s) with existing Product(s) with correct composition and
No. composition and Specifications Specifications.
1. 083164 Care-D Injection I.M Care-D Injection
Cholecalciferol …………… 5mg Cholecalciferol …………… 5mg
(200,000IU) (200,000IU)
(B.P Specification) (As per Innovator’s Specification)
The firm has requested to omit the B.P Specification and mention Innovator’s
Specification instead of B.P specification. They attached copies of minutes of various
meetings of Registration Board in which many firms have been granted Innovator’s
Specification without mentioned I.M. The product was approved in 262nd meeting of
Registration Board, however, specification was not mentioned in the minutes of the
Registration Board.
The PRVC in its 3rd deferred the case for verification of calculation and presentation
the case before Registration Board.
Now the firm has provided following calculations:
PARAMETERS CARE-D3 INJECTION (SJG) CHOLECALCIFEROL
(INNOVATOR’S SPECS) INJECTION (B.P.)
Composition (per ml) Each ml contains:- Each ml contains:-
Cholecalciferol ………. 5mg Cholecalciferol ……. 7.5ng
(200,000 IU)* (300,000 IU)
Composition (%) 0.5% w/w 0.75% w/w
Life of 0.45 tp 0.55% w/w or 180,000 to 220,000 0.87 to 0.83% w/v or 268,000 to
Cholecalciferol IU/ml i.e. 90.0% to 110.0 of the labeled 332,000 IU/ml i.e. 89.33 to 110.66%
amount. of the labeled amount.
Minimum %age 0.45%w/v 0.67%w/v
Maximum %age 0.55% w/v 0.83%w/v
Route of I.M. and orally I.M. only
administration
Registration Board in its 278th meeting deferred both cases for further deliberation
and to evaluate the case in the light of approval granted to the product by ANSM France.
Now, M/s. Barrett Hodgson Pakistan (Private) Limited, Karachi has provided copies
of label and SmPc (with English translation) of ANSM France approved Vitamin D3 BON
Injectable solution stating 200,000 U.I of vitamin D3/1ml ampoule and IM/ Oral routes of
administration. Registration Board in its 282nd deferred the case for further deliberation/
evaluation.
Decision of 284th meeting: Registration Board deferred the case for further deliberation/
evaluation.
The firm has now provided an undertaking that their formulation is not found
available in French Pharmacopeia as per ANSM website.
Decision: Registration Board acceded to the request of both the firms regarding
correction in finished product specifications of Cholecalciferol 5mg/ml
Injection from BP Specifications to “As per Innovator’s Specifications”
along with omission of “IM” (route of administration), mentioned
alongside the brand name. The Board further directed that finished
product specifications of all other registered products of instant
formulation shall be corrected accordingly.
Case No.63: Change of Registration Status of Drug(s) of M/s. AGP Limited B-23-C,
S.I.T.E, Karachi-75700.
M/s. AGP Limited B-23-C, S.I.T.E, Karachi-75700 has requested for change
of registration status of following products from the M/s. UDL Pharmaceutical, Plot No. E-
44/45, North West Industrial Zone, Port Qasim. Karachi to their name. The details are given
as under:-
S.No. Name of Drug(s) Reg.No. Registration History
1. Exotan Tablet 10mg/160mg 091164 Registration is valid till
Each film coated tablet contains:- 27-09-2023.
Amlodipine as besylate …… 10mg
Valsartan ………………….. 160mg
2. Exotan Tablet 5mg/80mg 091165 -do-
Each film coated tablet contains:-
3. Exotan Tablet 5mg/160mg 091166 -do-
The management of the firm has provided following products.
ii. Application on Form-5.
iii. NOC from UDL Pharmaceutical, Karachi dated 28-09-2018.
iv. Approval of relevant Section from Licensing Division.
v. Inspection report dated 07-05-2018.
M/s. UDL Pharmaceuticals, Karachi has informed that they have decided to close all the
operations performed on their licensed premises. Therefore, they have applied for voluntary
cancellation of DML.

i. Cancellation of registration of above mentioned products at S.No.1 to 3
from name of M/s. UDL Pharmaceutical, Plot No. E-44/45, North West
Industrial Zone, Port Qasim. Karachi
ii. Approved grant of registration for above mentioned products at S.No.1 to
3 with “USP Specifications”, in name of M/s. AGP Limited B-23-C,
S.I.T.E, Karachi-75700.
iii. Reference will be sent to Cost and Pricing division for confirmation of
Registration-III Section
Case No. 64: Change of registration from import to local manufacture under contract
manufacturing agreement
M/s. Drug’s Inn 1-I, Parkview Plaza, Markaz F-10, Islamabad have requested for
transfer of registration from import to local manufacture under contract manufacturing by
M/s EG Pharmaceuticals, Islamabad for following products:
S. Initial Product name & formulation Renewal status Local/international availability
No. registration (Remarks of RRR
date & section via letter F.
number No. 11-24/2007-RRR
dated 24-11-2017)
1. 017436 Ceftim 250mg Injection Renewal application Claforan injection of Aventis
10-07-1995 Each vial contains: of year 2015 (MHRA Approved)
Cefotaxime as sodium…250mg received within time
accompanied with Cefotax of Bosch
prescribed fee.
2. 016192 Ceftim 500mg Injection -do- Claforan injection of Aventis
07-02-1995 Each vial contains: (MHRA Approved)
Cefotaxime as sodium…500mg Cefotax of Bosch
3. 016193 Ceftim 1gm Injection Renewal application Claforan injection of Aventis
24-11-1994 Each vial contains: of year 2014
Cefotaxime as sodium…1000mg received within time Getex Dry powder Injection
accompanied with 1gm of M/s Amarant
prescribed fee.
4. 014957 Famodin 20mg Tablet -do- Pepcid by Valeant Pharms
06-06-1994 Each film coated tablet contains: (USFDA Approved)
Famotidine….20mg Ulfam tablet of Highnoon
5. 022691 Amkeen 100mg Injection -do- MHRA approved
16-02-1999 Each 2ml contains: Mifate Injection 100mg/2ml
Amikacin as sulphate…. 100mg of M/s Swiss Pharma
6. 022692 Amkeen 500mg Injection -do- MHRA approved
16-02-1999 Each 2ml contains:
Amikacin as sulphate…. 500mg Grasil of Sami
The firm has submitted following documents:-

i. Fee of Rs.50,000/- per product for this purpose.
ii. Form-5 from M/s EG Pharmaceuticals, Islamabad.
iii. Contract manufacturing agreement between M/S. Drug’s Inn, Islamabad and M/s EG
Pharmaceuticals, Islamabad.
iv. Copy of registration and renewal
v. Technical data and manufacturing process.
vi. Last GMP inspection report of M/s EG Pharmaceuticals, Islamabad (dated 22-06-
2017) concluding that the firm was considered to be operating at reasonable level of
compliance with GMP guidelines.
vii. Section approval letter of M/s EG Pharmaceuticals, Islamabad.
viii. Copy of Drug Sale License of M/s. Drug’s Inn, Islamabad (renewed upto 01-01-2015)
Decision of RB taken in its 278th meeting:

Registration Board deferred the request of M/s. Drug’s Inn, Islamabad for opinion of QA
Division regarding GMP status of M/s EG Pharmaceuticals, Islamabad.
Now the firm has submitted latest GMP inspection report of M/s EG Pharmaceuticals,
Islamabad (dated 29-08-2018 & 03-09-2018) concluding that the firm may be considered
operating in compliance with GMP guidelines.
Decision: Registration Board deferred the case for assessment and confirmation of
manufacturing capacity of M/s EG Pharmaceuticals by panel to be
constituted by Chairman Registration Board for further granting contract
manufacturing permission as the firm has already been granted approval
for contract manufacturing of numerous products.
Case No.65: Change in formulation (M/s. Rogen Pharmaceuticals, Islamabad).

M/s. Rogen Pharmaceuticals, Islamabad have requested for change of formulation of
following registered product.
S. Reg. No. Existing Name of Drug(s) & Desired change in formulation
No Composition
1 090271 Mecrogen 500mcg Tablet Mecrogen 500mcg Tablet
Each sugar coated tablet contains: Each film coated tablet contains:
Mecobalamin……..500mcg Mecobalamin……..500mcg
(JP Specifications) (JP Specifications)
The firm has submitted following in this regard:

i. Copy of registration letter dated 25-06-2018
ii. Fee of Rs. 5000/- dated 06-09-2018
It is submitted that the firm has applied for film coated tablet while Registration
Board approved the above product with sugar coating in its 246th meeting since approval by
PMDA Japan is for sugar coated tablet. The firm has submitted reference of “Mecolin Tablet
of M/s Drug International Limited, Bangladesh”.
Decision: Registration Board did not accede to the request of M/s Rogen
Pharmaceuticals since the desired change is not in line with the standard
formulation approved by RRAs.
Case No.66: Change of registration of already registered products from previous name
M/s Walt Danzay Pharmaceuticals, Taxila to new title M/s Horizon
Healthcare (Pvt) Ltd.
The firm has been granted approval for the change in management and title of the
firm from M/s Walt Danzay Pharmaceuticals, 35-A Punjab Small Industrial Estate Taxila to
M/s Horizon Healthcare (Pvt) Ltd., 35-A Punjab Small Industrial Estate Taxila vide letter no.
F.1-17/2012-Lic dated 06-07-2018 by the Central Licensing Board in its 262nd meeting held
on 23rd May, 2018. Now, the firm has requested for change in the name of firm for product
registered with their previous name.
S.No. Reg. Name of Drug(s) & Packing MRP Meeting No. Remarks
No. Composition & Date of
Initial
Registration
1. 085357 Iona Injection 100mg/5ml 5x5ml Rs.1475/- M-271
Each 5ml ampoule contains: 17-10-2017
Iron (III) hydroxide sucrose
complex eq. to Elemental
Iron……… 100mg
2. 085354 Zonlac 10mg/ml Injection 5x1ml Rs.280/- M-271 The firm has
Each 1ml ampoule contains: 17-10-2017 requested to
Ketorolac trometamol……… change the
10mg nomenclature
(USP Specifications) of API since
in USP the
product is
available as
Ketorolac
tromethamine
injection.
3. 087727 Zonlac 30mg/ml Injection 5'sx1ml Rs.430/- M-275
Each ml contains 19-02-2018
Ketorolac tromethamol.…
30mg
4. 087723 Pynetic 50mg Tablet 1x10’s Rs.180/- M-275
Each film coated tablet 19-02-2018
contains:
Itopride
hydrochloride……50mg
(As per *Innovator’s
Specifications)
5. 087728 Votadol 100mg Injection 1’s Rs.28/- M-275
Each 2ml Injection Contains 5’s Rs.140/- 19-02-2018
Tramadol as hydrochloride 10’s Rs.280/-
..….100mg
(As per *Innovator’s
Specifications)
The firm has provided following documents for this purpose: -

i. Application dossier (form-5).
ii. Fee of Rs.20,000/- for each product.
iii. Copies of registration letters.
iv. Undertaking that they have not manufactured/marketed any batch of any drug
product till date therefore they are unable to provide copy of NOC for CRF
clearance.
v. Copy of approval of new name/title from CLB.
vi. Undertaking that the formulation, API source and specifications,
manufacturing process, analytical test methods, release and shelf life
specifications have not been changed. And provided information is true and
correct.
Decision: Registration Board approved the change of registration status of the
products mentioned above in the new title of the firm i.e. M/s Horizon
Healthcare (Pvt) Ltd, Taxila.
Case No.67: Transfer of registration from M/s Wenovo Pharmaceuticals, Taxila to M/s
Horizon Healthcare (Pvt) Ltd., Taxila alongwith contract manufacturing
permission.
Registration Board in its 281st meeting considered the case wherein M/s Walt
Danzay Pharmaceuticals Pharmaceutical, Plot No. 35-A Small Industrial Estate, Taxila have
requested for transfer of following already registered products from the name of M/s Wenovo
Pharmaceuticals, Plot # 31 & 32 Punjab Small Industrial Estate, Taxila to their name
alongwith permission for contract manufacturing by M/s Wenovo Pharmaceuticals, taxila.
S.# Reg. Brand Name with Generic Initial Dy. No. and Status in reference
No. Registration date drug agencies
Letter Date
and Renewal
Status
1. 085367 Xilporin 125mg/5ml Dry 17-10-2017 409 DDC  ANSM-France
Suspension. (Renewal R-III  Evacef
Each 5ml reconstituted due: 16-10- 13-02-2018
suspension contains:- 2022) Suspension
Cefadroxil (as monohydrate) 125mg/5ml by
……….125mg M/s Highnoon
(USP Specifications) Laboratories
2. 085368 Xilporin 250mg/5ml Dry 17-10-2017 408 DDC  ANSM-France
Suspension (Renewal R-III  Evacef
Each 5ml reconstituted due: 16-10- 13-02-2018 Suspension
suspension contains:- 2022) 250mg/5ml by
Cefadroxil (as monohydrate) M/s Highnoon
……….250mg Laboratories
3. 077891 Xilporin 500mg Capsules 17-06-2014 400 DDC  UK-MHRA
Each capsule contains: (Renewal R-III  Roxif capsules
Cefadroxil (as monohydrate) due: 16-06- 13-02-2018 500mg of legacy
……….500mg 2019) Pharma
(USP Specifications) Approval for
change in
brand name
from
Bydroxil to
Xilporin :
07-09-2017
4. 078024 Pimazon Injection 1gm 16-09-2014 406 DDC  USFDA Approved
Each vial contains: (Renewal R-III  Maxipime 1gm
Cefepime as hydrochloride with due: 15-09- 13-02-2018 Injection by M/s
L-arginine eq. to 2019) GSK Pharma
Cefepime……1gm Approval for
(USP Specifications) change in
brand name
from Pimeriv
to Pimazon :
07-09-2017
5. 078023 Pimazon Injection 500mg 16-09-2014 405 DDC  USFDA Approved
Each vial contains: (Renewal R-III  Maxipime 500mg
Cefepime as hydrochloride with due: 15-09- 13-02-2018 Injection by M/s
L-arginine eq. to 2019) GSK Pharma
Cefepime……500mg Approval for
brand name
from Pimeriv
to Pimazon :
07-09-2017
6. 078022 Lacura Injection 1gm IM 16-09-2014 401 DDC  USFDA Approved
Each vial contains: (Renewal R-III  Amcef Injection of
Ceftriaxone as sodium ……1gm due: 15-09- 13-02-2018 M/s Linear Pharma
(USP Specifications) 2019)
Approval for
change in
brand name
from
Ceftabak to
Lacura : 06-
12-2017
7. 078021 Lacura Injection 500mg IM 16-09-2014 394 DDC  USFDA Approved
Each vial contains: (Renewal R-III  El-cef Injection of
Ceftriaxone as sodium due: 15-09- 13-02-2018 M/s Linear Pharma
……500mg 2019)
change in
brand name
from
Ceftabak to
Lacura : 06-
12-2017
8. 078020 Lacura Injection 250mg IM 16-09-2014 402 DDC  USFDA Approved
Each vial contains: (Renewal R-III  El-cef Injection of
Ceftriaxone as sodium due: 15-09- 13-02-2018 M/s Linear Pharma
……250mg 2019)
change in
brand name
from
Ceftabak to
Lacura : 06-
12-2017
9. 078025 Kors Injection 1gm 16-09-2014 404 DDC  PMDA Japan
Each vial contains: (Renewal R-III Approved
Cefoperazone as sodium due: 15-09- 13-02-2018  2SUMby Sami
……500mg 2019) Pharma
Sulbactum as sodium….500mg Approval for
(Wenovo’s Specifications) change in
brand name
from Ceatak
to Kors : 05-
10-2017
10. 078026 Kors Injection 2gm 16-09-2014 403 DDC  Approved in
Each vial contains: (Renewal R-III Europe (Poland,
Cefoperazone as sodium due: 15-09- 13-02-2018 Slovakia, Czech
……1gm 2019) Republic) by EMA
Sulbactum as sodium….1gm Approval for  Cebac Injection
(Wenovo’s Specifications) change in 2gm by M/s Bosch
brand name
from Ceatak
to Kors : 05-
10-2017
11. 078066 Iboxime Dry Suspension 100mg 05-11-2014 397 DDC  USFDA Approved
Each 5ml after reconstitution (Renewal R-III  Cef-OD by CCL
contains: due: 04-11- 13-02-2018
Cefixime as trihydrate 2019)
……100mg Approval for
brand name
from Bestcef
to Iboxime :
07-09-2017
12. 078067 Iboxime Dry Suspension 200mg 05-11-2014 396 DDC  USFDA Approved
Each 5ml after reconstitution (Renewal R-III  Cef-OD by CCL
contains: due: 04-11- 13-02-2018
Cefixime as trihydrate 2019)
……200mg Approval for
brand name
from Bestcef
to Iboxime :
07-09-2017
13. 078068 Lacura Injection 1gm IV 05-11-2014 398 DDC  MHRA Approved
Each vial contains: (Renewal R-III  3-zone of Zeb
Ceftriaxone as sodium ……1gm due: 04-11- 13-02-2018
(USP Specifications) 2019)
Approval for
change in
brand name
from BAC to
Lacura : 07-
09-2017
14. 078069 Lacura Injection 500mg IV 05-11-2014 395 DDC  MHRA Approved
Each vial contains: (Renewal R-III  3-zone of Zeb
Ceftriaxone as sodium due: 04-11- 13-02-2018
……500mg 2019)
change in
brand name
from BAC to
Lacura : 07-
09-2017
15. 078070 Lacura Injection 250mg IV 05-11-2014 399 DDC  MHRA Approved
Each vial contains: (Renewal R-III  Rocephin by
Ceftriaxone as sodium due: 04-11- 13-02-2018 Martin Dow
……250mg 2019)
change in
brand name
from BAC to
Lacura : 07-
09-2017
16. 077890 Iboxime Capsule 400mg 17-06-2014 407 DDC  USFDA Approved
Each capsule contains: (Renewal R-III  Dispel Capsules of
Cefixime as trihydrate due: 16-06- 13-02-2018 M/s Fynk
……400mg 2019) Pharmaceuticals
(Manufacturer’s Specifications) Approval for
change in
brand name
from Bestcef
to Iboxime :
07-09-2017
In support to the request the firm has provided following documents:

i) Application with prescribed fee amounting to Rs.50,000/- for each product.
ii) Initial Registration Letters and renewal status.
iii) NOC dated 02-04-2018 from M/s Wenovo Pharmaceuticals, Taxila.
iv) Latest inspection report of M/s Wenovo Pharmaceuticals, Taxila dated 19-10-
2017 concluding that firm is operating at Good level of GMP compliance.
v) Section approval letter of M/s Wenovo Pharmaceuticals, Taxila.
vi) DML of M/s Walt Danzay Pharmaceuticals dated 24-04-2017 and M/s
Wenovo Pharmaceuticals dated 03-02-2014.
vii) Contract manufacturing agreement between M/s Walt Danzay
Pharmaceuticals and M/s Wenovo Pharmaceuticals.
Decision of RB taken in its 281st meeting:

i) Cancellation of registration of above mentioned products from the name of M/s Wenovo
Pharmaceuticals, Taxila.
ii) Grant of registration of above mentioned products in name of M/s Walt Danzay
Pharmaceutical, Taxila alongwith permission for contract manufacturing by M/s
Wenovo Pharmaceuticals, Taxila.
iii) Reference will be sent to Cost & Pricing Division for MRP of the product.
The letter in the name of M/s Walt Danzay was withheld since the firm has been
granted approval for the change in management and title of the firm from M/s Walt Danzay
Pharmaceuticals, 35-A Punjab Small Industrial Estate Taxila to M/s Horizon Healthcare (Pvt)
Ltd., 35-A Punjab Small Industrial Estate Taxila vide letter no. F.1-17/2012-Lic dated 06-07-
2018 by the Central Licensing Board in its 262nd meeting held on 23rd May, 2018.
M/s Horizon Healthcare (Pvt) Ltd. have been granted with 10 sections and no product
has already been granted in the name of M/s Horizon Healthcare (Pvt) Ltd. for contract
manufacturing.
Now, the firm has requested to transfer the above mentioned products in the name of
new title along with contract manufacturing permission by M/s Wenovo Pharmaceuticals,
Taxila. In this regard firm has submitted fee of Rs.20,000/- per product.
Decision: Registration Board deferred the case for submission of differential fee of
Rs.30,000/- per product.
Case No.68: Issuance of registration letter for products already approved in 234th
meeting of Registration Board to M/s Medisynth Pharmaceuticals, Rawat,
Islamabad.
Registration Board considered the case in its 271st meeting wherein M/s Medisynth
Pharmaceuticals requested for issuance of registration letter for following product which was
earlier approved in 234th meeting.
S.No. Product name and Demanded Demanded Decision of 234th
composition pack size price Registration
Board meeting
1. Arlumed-S Dispersible Tablets 1x4’s As per SRO Approved
Each tablet contains: 1x6’s
Artemether……..80mg
Lumefantrine…..480mg
The firm has submitted the remaining fee of Rs.12,000/- dated 07-06-2017 (original
challan verified) for above product and requested to approve the registration of the above
mentioned products.
Decision taken in 271st meeting of RB: Registration Board deferred product for evidence of
approval status in reference regulatory agencies or recommendations of WHO.
Now the firm has applied for change of formulation from dispersible tablet to
uncoated tablet. The applied formulation is WHO prequalified. The firm has deposited fee of
Rs.5000/- dated 14-09-2018.
Decision: Registration Board approved the above product with following

composition:
Arlumed-S Tablets
Artemether……..80mg
Lumefantrine…..480mg
Case No.69: M/s Ambrosia Pharmaceuticals, Islamabad:
M/s Ambrosia Pharmaceuticals, Islamabad have requested for correction in
brand name, pack and MRP of their registered product with following details.
S. Reg. Existing Demanded Existing Demand pack Decision of 9th
No. No. Name of Corrections Pack & & MRP PRVC
drug(s) with MRP
formulation
1. 040815 Amrotose Amrotose Rs.70/120ml Rs.133/120ml The Committee
comples Complex Syrup evaluated the case
syrup Each 5ml in the light of SOPs
Each 5ml contains: approved by the
contains: Iron (III) Registration Board.
Iron (III) Hydroxide Chairman
Hydroxide Polymaltose Registration Board,
Polymaltose complex upon
complex …………50mg recommendation(s)
…..…50mg of Committee
decided to defer the
request of M/s
Ambrosia
Pharmaceuticals,
Islamabad for
submission of copy
of form-5 for
verification of brand
name and decided
to advise the firm to
apply in C & P
Division for
additional pack of
120ml.
Now the firm has submitted copy of Form-5 (Page 392-405/C) which shows that firm has
applied with the brand name of Polytose complex syrup.
Remarks of the section:

The approved price for Iron (III) Hydroxide Polymaltose complex 50mg/5ml syrup is
Rs.70/60ml. The demanded price i.e. Rs.133/120ml is not available in pricing minutes.
i. Copy of registration letter dated 13-07-2005 (pages 45-48/C)
ii. Last Renewal applied: 10-07-2015 (pages 43-44/C)
iii. NOC of CRF clearance valid till 31-12-2018 (pages 51-52/C)
Decision of Chairman RB taken in 11th meeting of PRVC:-
The Committee evaluated the case in the light of SOPs approved by the Registration Board.
Chairman Registration Board, upon recommendation(s) of Committee decided to approve the
request of M/s Ambrosia Pharmaceuticals, Islamabad for issuance of corrigendum in brand
name of above product while for correction of pack and MRP, the case is referred to
Registration Board.
Decision of RB taken in its 284th meeting: Registration Board deferred the request of the
firm for confirmation of demanded MRP and pack size from record.
Now the record has been checked and found that firm has demanded Rs.98.80 for 60ml pack.
Decision: Registration Board decided to refer the case to C & P Division.
Case No.70: Change of registration status from M/s Welwrd Pharmaceuticals, Hattar
to M/s Horizon Healthcare (Pvt) Ltd., Taxila.
Registration Board in its 283rd meeting considered the case wherein M/s Walt
Danzay Pharmaceuticals Pharmaceutical, Plot No. 35-A Small Industrial Estate, Taxila have
requested for transfer of following already registered products from the name of M/s Welwrd
Pharmaceuticals, Plot # 3, Block-A, Phase I-II, Industrial Estate, Hattar to their name.
S.# Reg. Brand Name with Generic Initial Registration Dy. No. and Status in
No. Letter Date and date reference drug
Renewal Status agencies & Me-too
a) 049374 NBF Injection 12-07-2008 410 DDC  USFDA
Each ml contains: Renewal due: R-III approved
Nalbuphine hydrochloride 11-07-2013 22-02-2018  Kinz 10mg/ml
….10mg Renewal applied: Injection by
15-02-2013 M/s Sami
Change of brand
name from
Nalbowin to NBF :
18-10-2017
b) 040341 Somaline Injection 11-06-2005 411 DDC  ANSM
Each 2ml contains: Change of brand R-III Approved
Citicoline as name from 22-2-2018  CT-Nol of M/s
sodium….250mg Welcoline to Uni-Tiech
Somaline : Pharmaceutials,
12-10-2009 (Reg.#047049)
Renewal due:
11-10-2014
Renewal applied:
29-01-2015
c) 076811 Lecoject Injection 08-04-2013 412 DDC  ANSM
Each ml contains: Renewal due: R-III Approved
Cholecalciferol ….5mg 07-04-2018 22-02-2018  Get D injection
(200,000 IU) Change of brand of M/s Getz
name from Wrd-D Pharma
to Lecoject: 18-10-
2017
Renewal not
required.
In support to the request the firm has provided following documents:

i) Application with prescribed fee amounting to Rs.50,000/- for each product.
ii) Initial Registration Letters and renewal status.
iii) NOC dated 02-04-2018 from M/s Welwrd Pharmaceuticals, Hattar.
iv) Latest inspection report of M/s Walt Danzay Pharmaceuticals 25-06-2018
concluding that company has shown good response and rectified the problems
and has shown good compliance as per schedule B-II.
v) Moreover the case of renewal of product at S. No. 2 was considered in 277 th
meeting of Registration Board and the Board decided to grant/regularize the
renewal of the product till 11-10-2019.
vi) Section approval letter of M/s Walt Danzay Pharmaceuticals (Liquid Injection
Ampoule General Section confirmed)
vii) DML of M/s Walt Danzay Pharmaceuticals dated 24-04-2017 and M/s
Welwrd Pharmaceuticals dated 20-05-2015.
The case was considered in 283rd meeting of registration Board and the Board decided as
follows:
a) Cancellation of registration of above mentioned products from the name of M/s
Welwrd Pharmaceuticals, Plot # 3, Block-A, Phase I-II, Industrial Estate, Hattar.
b) Grant of registration of above mentioned products in name of M/s Walt Danzay
Pharmaceutical, Taxila.
c) Reference will be sent to Cost & Pricing Division for MRP of the product.
The letter in the name of M/s Walt Danzay was withheld since the firm has been
granted approval for the change in management and title of the firm from M/s Walt Danzay
Pharmaceuticals, 35-A Punjab Small Industrial Estate Taxila to M/s Horizon Healthcare (Pvt)
Ltd., 35-A Punjab Small Industrial Estate Taxila vide letter no. F.1-17/2012-Lic dated 06-07-
2018 by the Central Licensing Board in its 262nd meeting held on 23rd May, 2018.
Now, the firm has requested to transfer the above mentioned products in the name of
new title. In this regard firm has submitted fee of Rs.20,000/- per product.
i) Cancellation of registration of above mentioned products from the name
of M/s Welwrd Pharmaceuticals, Plot # 3, Block-A, Phase I-II, Industrial
Estate, Hattar.
ii) Grant of registration of above mentioned products in name of M/s
Horizon Healthcare (Pvt) Ltd., Taxila.
Case No.71: Change in Contract Manufacturer:

M/s. Rogen Pharmaceuticals, Islamabad have requested for change in
contract manufacturer from M/s Shawan Pharmaceuticals, Rawat to M/s Seraph
Pharmaceuticals, Islamabad for the following registered products. Their previous approval
was granted by the Registration Board in its 250th & 254th meetings and the permission is
valid till 30-06-2020 as per detailed below:-
S. Name of Existing New Reg. Name of drug(s) & Date of Validity of
No Applicant Manufactu Manufactur No. Composition application, permissio
. rer er Diary No. n
& Form
1. M/s. M/s M/s Seraph 072363 Rogzone Injection 01-10-2018 30-6-2020
Rogen Shawan Pharmaceuti 250mg IM Dy.No.894 F.8-
Pharmace Pharmaceu cals, plot # Each Vial contain:- DD (R-III) 4/2015-
uticals, ticals, 210 Ceftriaxone as Rs.50,000/ Reg-III
Plot # 30, Rawat Industrial Sodium…..250mg = (M-250)
S-4, triangle, (USP Specs)
National Kahuta
Industrial Road,
Zone, Islamabad
Rawat,
Islamabad
2. -do- -do- -do- 072365 Rogzone Injection 01-10-2018 30-6-2020
1gm IV Dy.No.896 F.8-
Each Vial contain:- DD (R-III) 4/2015-
Ceftriaxone as Rs.50,000/ Reg-III
Sodium……..1gm = (M-250)
(USP Specs)
3. -do- -do- -do- 072364 Rogzone Injection 01-10-2018 30-6-2020
500mg IV Dy.No.895 F.8-
Each Vial contain:- DD (R-III) 8/2015-
Ceftriaxone as Rs.50,000/ Reg-III
Sodium…500mg = (M-254)
(USP Specs)
4. -do- -do- -do- 072362 Rogxime Capsules 01-10-2018 30-6-2020
Each capsule Dy.No.902 F.8-
contains: DD (R-III) 4/2015-
Cefixime as Rs.50,000/ Reg-III
Trihydrate….400mg = (M-250)
(USP Specs)
Remarks: The
product is available
in JP instead of
USP.
5. -do- -do- -do- 072361 Rogxime DS 01-10-2018 30-6-2020
Suspension Dy.No.901 F.8-
Each 5ml Contains:- DD (R-III) 4/2015-
Trihydrate..200mg = (M-250)
(USP Specs)
6. -do- -do- -do- 072360 Rogxime 01-10-2018 30-6-2020
Suspension Dy.No.900 F.8-
Each 5ml Contains:- DD (R-III) 4/2015-
Trihydrate...100mg = (M-250)
(USP Specs)
Firm has submitted following documents in this regard:
a) Application/Form 5 along with fee of Rs.50,000/- for each product.
b) Copy of contract manufacturing agreement between M/s. Rogen Pharmaceuticals,
Islamabad and M/s Seraph Pharmaceuticals, Islamabad dated 27-06-2018.
c) Panel GMP inspection report of M/s Seraph Pharmaceuticals, Islamabad (dated 11-
06-2018) concluding that panel unanimously recommended issuance of GMP
Certificate.
d) DML of both contract giver (19-07-2015) and acceptor (12-06-2017).
e) Copy of letter for Approval of Cephalosporin (Dry Vial, capsule, dry powder for oral
suspension) sections (M/s Seraph Pharmaceuticals, Islamabad).
The firm has submitted that they wish to change the contract manufacturer due to non-
availability of stock in time.
Decision: Registration Board acceded to the request of M/s. Rogen
Pharmaceuticals, Islamabad for change in contract manufacturer from
M/s Shawan Pharmaceuticals, Rawat to M/s Seraph Pharmaceuticals,
Islamabad. Permission is at same terms and conditions and shall not be
considered towards extension / renewal of the product.
Case No.72: Correction of address in Registration Letters/approval letters of M/s.

Shaigan Pharmaceuticals, Rawalpindi
M/s. Shaigan Pharmaceuticals Private Limited have requested (page 678A/C) for
correction of address in various letters issued by DRAP as per following details. The firm has
submitted that the letters are issued with following address:
M/s Shaigan Pharmaceuticals,
14km Adyala Road, Post Office Dahgal, Rawalpindi
While the correct address mentioned on DML is:
M/s. Shaigan Pharmaceuticals (Pvt) Ltd,
Sr # Letter Ref. No & Date
1. F.3-5/92-Reg-II (M-102) / 06th Feb, 1993.
2. F.3-1/93-Reg-II (M-103) / 5th Aug, 1993.
3. F.3-2/94-Reg-II (M-107) / 22nd June 1994.
4. F.3-6/94-Reg-II (M-111) / 2nd Feb, 1995.
5. F.3-1/95-Reg-II (M-112) pt / 31st May, 1995.
6. F.13-6/2005-Reg-II (M-193) / 18 November, 2005
7. F.13-6/2005-Reg-II (M-193) / 22nd Dec, 2005.
8. F.1-3/2005-Reg-II / 10th January 2005.
9. F.13-6/2005-Reg-II (M-193) / 19th January, 2006.
10. F.13-1/2006-Reg-II (M-195-A) / 14th Feb, 2006.
11. F.21-1/2006-Reg-II (North) / 22nd June, 2006.
12. F.13-5/2007-Reg-II (M-209) / 12th Feb, 2008.
13. F.13-5/2007-Reg-II (M-209) / 03rd April, 2008.
14. F.13-5/2007-Reg-II (M-209) / 5th May, 2008.
15. F.13-7/2007-Reg-II (M-211) / 09th Oct, 2008.
16. F.13-2/2008-Reg-II (M-213) / 16th Oct, 2008.
17. F.13-7/2007-Reg-II (M-211) / 17th November, 2008.
18. F.13-6/2007-Reg-II (M-210) / 21st November, 2008.
19. F.13-2/2008-Reg-II (M-213) / 24th July, 2009.
20. F.15-1/2009-RRR (M-215) / 31st March, 2009.
21. F.13-5/2007-Reg-II- (M-209) / 20th May, 2009.
22. F.13-1/2008-Reg-II (M-212) / 28th July, 2010.
23. F.13-7/2007-Reg-II (M-211) / 04th November, 2010.
24. F.8-6/2010-Reg-III (M-228) / 25th November, 2010.
25. F.15-1/2009-RRR (M-215) / 26th Feb, 2011.
26. F.8-2/2010-Reg-III (M-225) / 26th February, 2011.
27. F.8-5/2012-Reg-III (M-235) 5th Dec, 2012.
28. F.8-1/2013-Reg-III (M-237) / 18th April, 2013.
29. F.8-1/2013-Reg-III (M-237) 12th April, 2013.
30. F.11-82/2005-Reg-III (Pt) / 11th Dec, 2013
31. F.2-2/2010-DDC-Reg-III / 18th Aug, 2016.
32. F.2-2/2010-DDC-Reg-III/ 20th Dec, 2016.
33. F.8-5/2017-Reg-III (M-269) / 09th October, 2017.
34. F.14-4/2018-RegIII (PRVC-04) / 23rd Feb,2018
35. F.14-8/2018-Reg-III (PRVC-09) / 04th June, 2018.

i. Copies of above letters (Pages 682-743/C)
ii. Copy of DML (page 678B/C)
Decision taken by Chairman RB in 13th PRVC meeting:-

Chairman Registration Board, upon recommendation(s) of Committee referred the case to
Registration Board after verification of title of firm from DML issued in 1993.
Now the firm has submitted copy of DML issued to the firm in 1993 which shows the address
as following:
M/s Shaigan Pharmaceuticals,
However, the copies of DML issued on 07-01-1995 and afterwards shows the title of the firm
as follows:
M/s. Shaigan Pharmaceuticals (Pvt) Ltd,
i. Acceded to the request of M/s. Shaigan Pharmaceuticals, Rawalpindi for
correction in address of the firm in letters mentioned at. S. No. 4-35.
ii. Deferred the request of firm for letters at S. No. 1-3 for submission of fee
of Rs.5000/- per product mentioned in said letters.
Case No.73: Change in Registration Holder:

M/s Ambrosia Pharmaceuticals, Islamabad have applied for change in registration /
marketing authorization holder of following products from M/s Spencer & Company (Pvt)
Ltd., Karachi to their name.
(i) Infacol Suspension:
The Registration Board in its 246th meeting decided to cancel the registration from
name of M/s Spenser and grant of registration in name of M/s Ambrosia. Registration Board
also decided that Chairman, Registration Board will permit issuance of registration letter after
evaluation / completion of Form 5A as per check list approved by Registration Board,
renewal status and comments of Cost & Pricing Division about MRP of the drug.
S. Name of Name of Date of Registration Name of product with
No. applicant(s) existing application, No. composition
manufacturer Diary No. &
Form
1. M/s Ambrosia M/s Spencer 29-10-2014 008801 Infacol Suspension
Pharmaceuticals, & Dy.No.633 Each 5ml contains:-
Rawat Co, Karachi Form-5 Dicyclomine HCl….5mg
Rs.20,000/- Simethicone ……50mg
The product namely Infacol Suspension could not be transferred due to following reasons:
a) The product’s composition and dosage form are different in the initial registration
letter and the minutes of 246th meeting of Registration Board as indicated in the table
below.
b) Due to above ambiguity, the renewal of product couldn’t be confirmed by the RRR
section.
The details mentioned in initial registration letter dated 24-02-1986 are as follows:
S. No. Registration No. Name of product with Composition
1. 008801 Ifacol Syrup
Each 5ml contains:
Dicyclomine HCl……….0.10% w/v
Simethicone …...……… 3.33% w/v
Since approval by the Registration Board was after verification of renewal and price
from C & P, Division which couldn’t be confirmed. The firm claimed to have approval of
change in composition and dosage form, for which the case was forwarded to registration
section dealing with the registration matter of M/s Spencer Pharma, Karachi but no evidence
of change in composition and dosage form was found out.
Now the firm has requested to issue the registration letter as per details mentioned in
the initial registration letter. However, the approval of said product by reference regulatory
authorities could not be confirmed.
The case was again considered by Registration Board in its 275th meeting and RB
decided as follows:
Decision of RB taken in its 275th meeting: Registration Board deferred the case for
evidence of approval of applied formulation by reference regulatory authorities.
Now, M/s Ambrosia Pharmaceuticals, Islamabad stated that the product Infacol
suspension (Each 5ml contains: Dicyclomine HCL 5mg, Simethicone 50mg) was registered
in Pakistan in 1986 by Fisons (Pakistan) Limited. It is an important formulation as an anti-
spasmodic and anti-flatulent and widely prescribed in Pakistan. Fisons divested its operation
worldwide in the 1990’s and during the same period Fisons Pakistan also sold its operation in
the country. Fisons Pakistan was bought by spencer in 1991 and subsequently Infacol was
transferred to spencer form Fisons the same year.
Infacol was registered in Australia prior to its registration in Pakistan and copy
of the Free Sale Certificate of Theraputic Substances issued in 1984 by Department of Health
– Government of New South Wales, Australia included in the registration dossier at the time
of its registration in Pakistan is submitted by the firm. The firm referred to the case of ICI
Pakistan in the 284th meeting of the Registration Board for Citralka Liquid where TGA email
was considered acceptable. The firm also submitted copies of pages from the dossier
submitted at the time of registration of Infacol in Pakistan showing the formulation of the
product as mentioned below:
Infacol Syrup
Dicyclomine HCL 1mg/ml, Simethicone 10mg/ml
The firm has also submitted documents showing the transfer of registration of Infacol
Suspension from M/s Fisons Pakistan to M/s Spencer Pharma and from M/s Spencer Pharma
to M/s Spencer & Co. Karachi. The approval of Label/carton of Infacol suspension is also
submitted by the firm.
The firm also stated that Fisons operations in Australia were also sold including
the registration of Infacol. Infacol’s registration in Australia was later lapsed by the new
buyer for commercial reasons. Therapeutic Goods Administration (TGA) Australia has
confirmed the same by their email dated 18-09-2017 (copy provided) that the product was
cancelled on request / decision of the sponsor and subsequently removed from the Australian
Register of Therapeutic Goods (ARTG) and NOT by TGA due to any safety reason.
During the 1980’s, the same product Infacol with the same formulation as manufactured in
Australia by Fisons was also registered in New Zealand. However, again in the 1990’s after
the same of Fisons operations in Australia the registration in New Zealand also lapsed. Again
this was NOT due to an action for safety reason by New Zealand Medicines and Medical
Devices Safety Authority but rather for commercial reason. A print form MEDSAFE, New
Zealand Medicines and Medical Devices Safety authority, Ministry of Health, New Zealand
showing the registration of the same in New Zealand along with the formulation and
Australian Manufacturer details is also provided by the firm.
Decision: Registration Board has considered the fact that the product was earlier
approved by TGA and then was cancelled on request / decision of the
sponsor and subsequently removed from the Australian Register of
Therapeutic Goods (ARTG) and NOT by TGA due to any safety reason.
Therapeutic Goods Administration (TGA) Australia has confirmed the same
by their email dated 18-09-2017. In view of above Registration Board
decided as follows:
i) Cancellation of registration of above product from the name of M/s
Spencer & Company (Pvt) Ltd., Karachi.
ii) Grant of registration of above mentioned product in name of M/s
Ambrosia Pharmaceuticals, Islamabad after confirmation of renewal
status by RRR section, with following composition:
Infacol Suspension
Each 5ml contains:-
Dicyclomine HCl….5mg
Simethicone ……50mg
iii) Reference will be sent to Cost & Pricing Division for MRP of the
product.
(ii) Digeplex Syrup:
Registration Board considered the case in its 254th meeting and deferred for evidence
of approval of applied formulation by reference regulatory authorities.
S. Name of Name of Date of Registration Name of product with
No. applicant(s) existing application, No. composition
manufacturer Diary No. &
Form
1. M/s Ambrosia M/s Spencer 120ml 01- 000724 Digeplex Syrup
Pharmaceuticals, & 06-2015 Each 4ml contains:-
Rawat Co, Karachi Dy.No.904- Pepsin………………10mg
DDG(R.II) Diastase (1:2000)...12.5mg
Rs.20,000/= Vitamin B1…………..4ml
Vitamin B2……….0.5mg
Vitamin B12………...2mcg
Nicotinamide………..10mg
Alcohol………………2mg
(Enzyme vitamin compound)
Now, M/s Ambrosia Pharmaceuticals, Islamabad stated that all the active ingredient used in
Digeplex Syrup are available in the approved reference pharmacopeia as below:
1. Diastase: Japanese pharmacopeia (JP) and also available in Health Canada
2. Pepsin United States Pharmacopeia (USP) and also available in Health Canada
3. Pyridoxine HCl: United States Pharmacopeia (USP)
4. Cyanocobalamin / B12: United States Pharmacopeia (USP)
5. Panthenol: United States Pharmacopeia (USP)
6. Niacinamide/ Nicotinamide: United States Pharmacopeia (USP)
7. Riboflavin: United States Pharmacopeia (USP)
8. Thiamine Mononitrate: United States Pharmacopeia (USP)
The firm has informed that the actual composition is as follows:
Each 4ml contains:
Diastase (1:2000 in tablet form) 12.5mg (equivalent to 500mg Diastase 1:50) JP
Pepsin BP 10mg
Thiamine Mononitrate USP 4mg
Riboflavin BP 0.5mg
Pyridoxine Hydrochloride USP 0.5mg
DL-Pantothenyl Alcohol USP 2mg
Niacinamide BP 10mg
Cyanocobalamin 2mcg
The firm also referred to recent cases of Le Mendoza Pharmaceuticals Pvt Ltd and Martin
Dow Marker in the 277th Meeting of the registration board where similar vitamin products
have been approved by the Board for transfer of registration.
i) Cancellation of registration of above product from the name of M/s
Spencer & Company (Pvt) Ltd., Karachi.
ii) Grant of registration of above mentioned product in name of M/s
Ambrosia Pharmaceuticals, Islamabad after confirmation of renewal
status by RRR section, with following composition:
Digeplex Syrup
Each 4ml contains:
Diastase (1:2000 in tablet form)…12.5mg (eq.to 500mg Diastase 1:50)
Pepsin…..10mg
Thiamine Mononitrate……4mg
Riboflavin…..0.5mg
Pyridoxine Hydrochloride…..0.5mg
DL-Pantothenyl Alcohol…..2mg
Niacinamide……10mg
Cyanocobalamin……2mcg
Case No.74: Change of title of manufacturer

The firm has been granted approval for the change in title of the firm from M/s
Tayyab Laboratories (Pvt) Ltd, Plot No. 13, Street No. N-5, RCCI, Industrial Estate
Rawalpindi to M/s Arreta Pharmaceuticals (Pvt) Ltd., Plot No. 13, Street No. N-5, RCCI,
Industrial Estate Rawalpindi vide letter no. F.1-32/2011-Lic dated 10-09-2018 by the Central
Licensing Board in its 265th meeting held on 9th, 10th August, 2018.
The firm has requested to change the registration of following registered products
from their previous name i.e. M/s Tayyab Laboratories, Rawalpindi to their new name i.e.
Arreta Pharmaceuticals (Pvt) Ltd, Rawalpindi.
S. Reg. No. Name of Drug(s) & Composition Packing MRP Meeting No. & Remarks
No. Date of Initial
Registration
1. 088433 Nside Tablet 100mg 2x10’s Rs.90/- M-276
Each film coated tablet contains: March,2018
Nimesulide …..100mg
(As per *Innovator’s Specifications)
2. 083601 Timol Suspension 90ml Rs.53/- M-263
Each 5ml Contains: April, 2017
Paracetamol …….250mg
3. 083602 B-Profen Forte Suspension 90ml Rs.60/- M-263
Each 5ml Contains: April, 2017
Ibuprofen …….200mg
(BP Specifications)
4. 083603 B-Profen Suspension 90ml Rs.36/- M-263
Each 5ml Contains: 120ml Rs.46/- April, 2017
Ibuprofen …….100mg
(BP Specifications)
5. 083604 Tyzo 1mg Tablet 3x10’s Rs.214/- M-263
Each Tablet Contains: April, 2017
Alprazolam …….1mg
6. 083605 Tyvon 1mg Tablet 100’s Rs.57/- M-263
Lorazepam …….1mg
7. 083606 Tyvon 2mg Tablet 100’s Rs.70/- M-263
Lorazepam …….2mg
8. 083607 Tymide 2mg Capsule 6x10’s Rs.190/- M-263
Each Capsule Contains: April, 2017
Loperamide HCl…..2mg
(BP Specifications)
9. 083608 Rynac Tablet 10x10’s Rs.190/- M-263
Ibuprofen …..200mg
Pseudoephedrine Hydrochloride
…….30mg
10. 083609 Tdpam 2mg Tablet 1000’s Rs.100/- M-263
Diazepam …..2mg
(BP Specifications)
11. 083610 Premadol Tablet 10’s Rs.100/- M-263
Tramadol HCl ….37.5
Paracetamol …….325mg
12. 083611 Tyzo 0.5mg Tablet 3x10’s Rs.128/- M-263
Alprazolam ….0.5mg
13. 083612 Tyzo 0.25mg Tablet 3x10’s Rs.77/- M-263
Alprazolam …….0.25mg
14. 083613 T-Bram 3mg Tablet 30’s Rs.90/- M-263
Bromazepam…….3mg
15. 084356 Tdpam 5mg Tablet 30’s Rs.30/- M-267
Each Tablet Contains: August,
Diazepam …..……..5mg 2017
16. 084357 Rynac Suspension 60ml Rs.19/- M-267
Each 5ml Contains: August,
Ibuprofen …… 100mg 2017
Pseudoephedrine hydrochloride
…….15mg
17. 084358 Ozymap 20mg Capsule 14’s Rs.144/- M-267
Each Capsule Contains: August,
Omeprazole as enteric coated pellets 2017
eq. to Omeprazole……20mg
Source of pellets: M/s Vision
Pharmaceuticals
18. 084359 Ozymap 40mg Capsule 2x7’s Rs.250/- M-267
Omeprazole as enteric coated pellets 2017
eq. to Omeprazole……40mg
Pharmaceuticals
19. 084360 Timol Suspension 60ml Rs.28/- M-267
Each 5ml Contains: 100ml Rs.46/- August,
Paracetamol.……...120mg 2017
20. 084361 Wystaglobin syrup 60ml Rs.70/- M-267
Iron III hydroxide poly maltose 2017
complex eq. to elemental
Iron.…….50mg
Folic Acid…….0.35mg
21. 084362 Dyfend Syrup 60ml Rs.16/- M-267
Pseudoephdrine hydrochloride 2017
….30mg
Chlorpheniramine (as
maleate)…….…….2mg
Dextromethorphan
hydrobromide……..10mg
22. 084363 Ticclo SR 100mg Capsule 20’s Rs.100/- M-267
Each capsule contains: August,
Diclofenec sodium sustained 2017
released pellets Eq. to Diclofenec
sodium…………100mg
Pharmaceuticals
23. 084364 Eyzo 20mg Capsule 2x7’s Rs.119/- M-267
Esomeprazole (as Magnesium 2017
trihydrate) Enteric Coated pellets
……..20mg
Pharmaceuticals
24. 084365 Eyzo 40mg Capsule 14’s Rs.198/- M-267
Esomeprazole (as Magnesium 2017
trihydrate) Enteric Coated pellets
………..…..40mg
Pharmaceuticals
25. 090235 Derbina 250mg Tablet 1x10’s Rs.500/- M-279
Each tablet contains: June, 2018
Terbinafine as
hydrochloride.…250mg
(USP specifications)
26. 090236 Derbina 125mg Tablet 10’s Rs.313/- M-279
Each tablet contains: June, 2018
Terbinafine as
hydrochloride…..125mg
(USP specifications)
27. 084278 Zvox 600mg Tablet 12’s Rs.2556/ M-264 The firm has
Each Tablet Contains: - May, 2017 now requested
Linezolid …..……..600mg to correct the
(As per *Innovator’s Specifications) dosage form as
film coated
tablet since it
is approved as
film coated
tablet by UK-
MHRA. The
claim of the
firm has been
verified.
28. 084279 Zvox 400mg Tablet 12’s M-264 The firm has
Each Tablet Contains: May, 2017 now requested
Linezolid ………400mg Rs.1460/ to correct the
(As per *Innovator’s Specifications) - dosage form as
film coated
tablet since it
is approved as
film coated
tablet by UK-
MHRA. The
claim of the
firm has been
verified.
29. 084280 Regapen 50mg Capsule 14’s Rs.202/- M-264
Each Capsule Contains: May, 2017
Pregabalin…..…50mg
Pregabalin…..….75mg
Pregabalin..…….100mg
(As per Innovator’s Specifications)
32. 084283 MyFlox 400mg Tablet 5’s M-264 The firm has
Each Tablet Contains: May, 2017 now requested
Moxifloxacin as HCL ……..400mg Rs.475/- to correct the
(As per *Innovator’s Specifications) dosage form as
film coated
tablet since it
is approved as
film coated
tablet by UK-
MHRA. The
claim of the
firm has been
verified.
33. 084284 Syfate 1000mg Suspension 60ml Rs.50/- M-264
Each 5ml Contains: May, 2017
Sucralfate …..…1000mg
34. 084285 Co-Deeprex Plus 6mg / 25mg 14’s Rs.218/- M-264
Capsule May, 2017
Each Capsule Contains:
Olanzapine …….6mg
Fluoxetine as HCl …….. 25 mg
35. 084286 Co-Deeprex 3mg / 25mg Capsule 14’s Rs.130/- M-264
Each Capsule Contains: 30’s Rs.257/- May, 2017
Olanzapine ……...3 mg
Fluoxetine as HCl …… 25mg
36. 087719 Cloneepam 0.5mg Tablet 30’s Rs.118/- M-275
Each tablet contains: February,
Clonazepam……0.5mg 2018
37. 087720 Cloneepam 2mg Tablet 30’s Rs.145/- M-275
Each tablet contains: February,
Clonazepam………2mg 2018
38. 087721 Zolly 10mg Tablet 20’s Rs.250/- M-275
Each film coated tablet contains: February,
Zolpidem tartrate………..10mg 2018
39. 087722 Fe-betone 30mg Tablet 100’s Rs.40/- M-275
Each tablet contains: 60's Rs.24/- February,
Phenobarbitone……30mg 2018
40. 082343 Picam 20mg Capsule 10’s Rs.71/- M-270
Each capsule contains: September,
Piroxicam…20mg 2017
41. 082344 Bylium 5mg/5ml Suspension 120ml Rs.84/- M-270
Each 5ml contains: 60ml Rs.42/- September,
Domperidone …5mg 2017
42. 082345 Bymac DM Syrup 60ml Rs.26/- M-270
Dextromethorphan hydrobromide 2017
……10 mg
Pseudoephedrine hydrochloride
……30mg
43. 082346 Bydin 200mg/5ml Suspension 60ml Rs.32/- M-270
Metronidazole benzoate … 320 mg 2017
eq. to Metronidazole ……200mg
(BP Specifications)
44. 089657 Ryospan 40mg Tablet 20’s Rs.40/- M-277
Drotaverine hydrochloride…40mg
( As per *innovator’s specifications)
45. 089658 Ryospan Plus 80mg Tablet 20’s Rs.60/- M-277
Drotaverine hydrochloride…80mg
( As per *innovator’s specifications)
The firm has provided following documents for this purpose: -
i. Application dossier (form-5).
ii. Fee of Rs.20,000/- for each product.
iii. Copies of registration letters.
iv. NOC for CRF clearance valid till 31-12-2018.
v. Copy of approval of new name/title from CLB.
vi. Undertaking that the formulation, API source and specifications,
manufacturing process, analytical test methods, release and shelf life
specifications have not been changed.
Decision: Registration Board approved the change of registration status of the
products mentioned above in the new title of the firm i.e. M/s Arreta
Pharmaceuticals (Pvt) Ltd., Plot No. 13, Street No. N-5, RCCI, Industrial
Estate Rawalpindi. The Registration Board also approved the correction
in dosage form of the products at S. No. 27, 28 & 32 from tablet to “film
coated tablet”.
Case No. 75: Correction in registration letter of M/s Davis Pharmaceuticals, Islamabad
M/s. Davis Pharmaceuticals, Islamabad has requested for correction in composition in
Registration letter for following product.
S. Reg. Existing Name of Drug(s) & Desired corrections
No No. Composition
1. 089593 Mobil-N gel Mobil-N gel
Each gm contains: Each gm contains:
Diclofenac diethylammonium, 11.6mg Diclofenac diethylammonium, 11.6mg
equivalent to diclofenac equivalent to diclofenac
sodium…………. 1mg (1% w/w) sodium…………. 10mg (1% w/w)
(As per *Innovator’s Specification) (As per *Innovator’s Specification)
i. Copy of initial registration letter dated 09-05-2018
ii. Renewal due: 08-05-2023
iii. Fee of Rs.5000/-
iv. NOC for CRF clearance
It is submitted that the above product is approved by UK-MHRA in the same strength as
desired by the firm.
Decision taken in 14th meeting of PRVC:-
Chairman Registration Board, upon recommendation(s) of Committee referred the product to
Registration Board.
Decision: Registration Board approved the request of M/s Davis Pharmaceuticals,

Islamabad for correction in composition of above product.
Case No.76: Correction in registration letter of M/s Bio-Labs, Islamabad

M/s Bio-Labs, Islamabad have requested for correction in pack and MRP of their
following registered product with details below.
S. Reg. Existing Name of drug(s) with Existing Demand Remarks
No. No. formulation Pack & pack &
MRP MRP
I II III IV V VI
1. 090248 O-Zeetine 6/25mg capsules Rs.156/10’s Rs.156/10’s The approved
Each capsule contains: Rs.296/30’s Rs.430/30’s MRP for 30’s
Olanzapine………………………6mg pack size of the
Fluoxetine as hydrochloride formulation is
……25mg Rs.430/30’s.
(USP specification)

i. Copy of registration letter dated 25-06-2018
iii. The demanded pack size and MRP by the firm is 10’s, 30’s, As per PRC.
Registration Board.
Decision: Registration Board approved the request of M/s Bio-Labs, Islamabad for
correction in Pack and MRP of above product i.e. Rs.156/10’s &
Rs.430/30’s.
Case No.77: Correction in registration letter of M/s Jupiter Pharma, Rawat.
Dy. No. 579 DD (R-III) dated 29-05-2018

M/s Jupiter Pharma, Rawat have requested (Page 288/C) for correction in pack
and MRP of their following registered product with details below.
S. Reg. Existing Name of drug(s) with
Existing Demand Remarks
No. No. formulation Pack & pack &
MRP MRP
I II III IV V VI
1. 081941 Judep Plus capsules Rs.218/20’s Rs.296/20’s The approved
Each capsule contains: MRP for 14’s
Olanzapine………………………6mg pack size of the
Fluoxetine as hydrochloride formulation is
……25mg Rs.218 while for
(USP specification) 20’s, the MRP is
Rs.296. The firm
has requested for
pack size of 20’s.
i. Copy of registration letter dated 26-10-2016 (pages 293-299/C)
iii. NOC for CRF clearance valid till 31-12-2018.
iv. The demanded pack size and MRP by the firm is 2x10’s, As per DPC.

Registration Board.
Decision: Registration Board approved the request of M/s Jupiter Pharma, Rawat
for correction in Pack and MRP of above product i.e. Rs.296/20’s.
Case No. 78: Change / amendment in composition/dosage form.
M/s. Webros Pharmaceuticals, Islamabad have requested for change in

composition/dosage form in Registration letter for following product.
I II III IV V
S. Reg. Existing Name of Drug(s) & Desired changes Initial registration
No No. Composition letter and renewal
status
1. 072053 Fusid-H Cream Fusid-H Cream Date of registration:
Each gm contains: Each gm contains: 28-06-2011
Sodium Fucidic acid…………20mg Renewal due:
fusidate…………20mg Hydrocortisone 27-06-2016
Hydrocortisone acetate……..10mg Renewal applied:
acetate….10mg (BP Specification) 14-06-2016
(BP Specification)
2. 035698 Maltose complex tablets Maltose complex tablets Date of registration:
Each tablet contains: Each chewable tablet 31-12-2004
Iron III hydroxide polymaltose contains: Last Renewal due:
complex eq. to elemental Iron Iron III hydroxide 30-12-2014
……..100mg polymaltose complex eq. to Last Renewal
elemental Iron ……..100mg applied: 01-12-2014
i. Copy of initial registration letters and renewal status
ii. Fee of Rs.5000/- for each product dated 16-11-2016
iii. NOC for CRF clearance valid till 31-12-2018
For product at S. No. 1, it is submitted that the product is approved by UK-MHRA (Fucidin
H Cream) with same composition as desired by the firm. Sodium fusidate is a salt of a
medicine called fusidic acid. Me-too of desired composition is also available (Fusimed-H of
M/s Medera).
For product at S. No. 2, it is submitted that product is not approved by reference regulatory
authorities but me-too are available in chewable dosage forms.
Decision: Registration Board approved the request of M/s. Webros

Pharmaceuticals, Islamabad for correction in composition/dosage form of
above products as mentioned in column IV above.
Registration-IV Section
Case No.79: Permission for transfer of contract manufacturing drug along with
extension.
M/s. Swat Pharmaceuticals applied for transfer of contract manufacturing permission from
M/s. Welwrd Pharmaceuticals to M/s. EG Pharmaceuticals Islamabad along with extension in
contract manufacturing for the following drugs:-
S.No Reg. No. Name of Drug (s) & Composition Contract manufacturer
1 029879 Sanex Injections I.V. M/s. Welwrd
Each vial contains:- Pharmaceuticals Hattar.
Ceftriaxone Sodium
≡ Ceftriaxone ..…………….1gm
(USP Specification)
2 029880 Sanex Injection IM -do-
Ceftriaxone Sodium
≡ Ceftriaxone …………….250mg
(USP Specification)
3 029881 Sanex 500 Injections IM -do-
Ceftriaxone Sodium
≡ Ceftriaxone ……………….500mg
(USP Specification)
Firm was granted extension in contract manufacturing permission in 250th Meeting of Drug
Registration Board which is valid till 30-06-2020.
In this regard firm has submitted following documents: -

i) Application Form.
ii) Fee of Rs.50,000/- for each products vide Challan No.0726140 (Sanex
250mg), 0726139 (Sanex 1gm) and 0726141 (Sanex 500mg).
iii) Copy of Registration letter (250th Meeting).
iv) NOC for CRF Clearance.
v) Photocopy of Agreement between M/s. Sawat Pharmaceuticals and M/s. EG
Pharmaceuticals.
vi) GMP inspection report of M/s. EG Pharmaceuticals (Valid Till 03.09.2019).
Moreover, the brand name which was granted to this firm (i.e. Sanex) resembles with already
registered brand name Xanax (Reg.No.009822) of M/s. Kurram Chemical Company Kahuta
Road, Islamabad.
Decision: Registration Board deferred the case for capacity assessment of M/s EG
Case No.80: Registration letter of M/s. Saydon Pharmaceuticals, Peshawar.

M/s. Saydon Pharmaceutical Peshawar informed that their Drug Esildon 1mg Tablet
(Estazolam…1mg) was approved in the 227th Drug Registration Board meeting. Details are
as under: -
S. Name of Name of Drugs Demanded Approved MRP Decision/ Current Status
No Manufactu with composition. pack size & with reference of Remarks
rers Price meeting
1. M/s Esildon 1mg Rs.2.51 Rs.56.00/20’s Approved Rs.56.00/20’s
Saydon Tablets per tablet S.R.O.905(I)/ S.R.O. 905(I)/2017
Pharmaceut Each tablet 2017 The product is US
icals contains:- The case was FDA approved
Industries Estazolam then referred to Prosom for
Ltd., ……..1mg Now the Pricing Specifications M/s. Abbott
77/A, (Saydon firm has Division for of formulation Laboratories which
Hayatabad, Specification) revised price fixation. needs to be was discontinued
Industrial their changed to “As but not because of
Estate, demand of per Innovator’s safety reasons.
Peshawar. pack size Specifications” Product is available
and price in accordance as Estazolam for
to as with the M/s. Watson Lab
available in decision taken till date.
approved by the Board in
SRO. its 269th
meeting.
At that time registration letter could not be issued as the case was referred to pricing division
for price fixation. Moreover, the balance/differential fee of PKR=12000/- paid on 16th May
2018 vide Bank Challan No.0721590. Furthermore, the firm has also produced a letter from
Licensing Division bearing No.F.6-1/2009-Lic dated 17th March 2009 which shows that the
previously approved Tablet Quinolone Section has been converted into Tablet Psychotropic
Section. The price of said product generic was fixed in SRO.905 dated 07-09-2017.
Decision: Registration Board decided to approve the registration of above-

referred product.
Case No.81: Pending Registration letter of M/s. Wnsfeild Pharmaceuticals, Hattar.

M/s. Wnsfeild Pharmaceutical, Hattar has informed that they had applied for the registration
of their drugs with the brand name “Wnsbalta” (Duloxetine) 20mg, 30mg & 60mg
Capsules which were brought before the board by the section and approved by the
Registration Board in its 227th meeting, but mistakenly name of manufacturers for their
products at S.No.122-124 was mentioned as M/s. Welmark Pharmaceuticals, Hattar while
actually their products with the same salt (Dulxetine) with brand name “Dulotin” were also
included in that agenda at S.No. 134-136. The two products of M/s. Wnsfeild i.e. Wnsbalta
30mg and 60mg Capsules were granted registration but product Wnsbalta 20mg could not be
granted registration because of unavailability of price. Further details are as under: -
S. Name of Name of Drugs with Demanded Approved Decision/ Current Status
No. Manufact composition. pack size & MRP with Remarks
urers Price reference of
meeting
1. M/s. Wnsbalta 20mg 10’s - Approved Rs.447.00/14’s

Wnsfeild Capsules As Per ten S.R.O.170 (I)/2016
Pharmaceut Each capsule SRO molecules
ical, Hattar contains:- per section Choice of firm with
Duloxetine HCl as per respect to pack size
(enteric Coated policy. was to be confirmed
pelelts)…..20mg because the price of
(Anti-depressant) demanded packs was
not available.
Now the price of above mentioned strength is approved by the pricing division vide
SRO.170(I)/2016, hence the firm has requested for the grant of registration letter with respect
to the pending product.
Firm submitted following documents as an evidence: -
i. Copy of the-then submitted application for registration of “Wnsbalta“ 20,30
&60mg Capsule duly endorsed by statistical officer exhibiting the submission of
fee Rs.8000 x03=24000/- dated 13th November, 2009.
ii. Copy of the-then submitted application for Pellet Fee duly endorsed by statistical
officer exhibiting the submission of fee (Rs.7000x03=21000/-) dated 09-05-2011.
iii. Copy of the then issued registration letter (Duloxetine HCl 30mg and 60mg)
dated:18.03.2013.
S.No. Name of Name of Drugs /label Claim Demande Demand Date Remarks
Firms d Pack ed Price
size
1 M/s. Wnsbalta 20mg Capsules 10’s As Per 13-11- Approved ten
Welmark Each capsule contains:- SRO 2009 molecules per
Pharmaceutic Duloxetine HCl (enteric section as per
als, Hattar Coated pelelts)……20mg policy.
(Anti-depressant)
2 -do- Wnsbalta 30mg Capsules 10’s As Per -do- -do-
Each capsule contains:- SRO
Duloxetine HCl (enteric
Coated
pellets)…………30mg
(Anti-depressant)
3 -do- Wnsbalta 60mg Capsules 10’s As Per -do- -do-
coated pellets)…………60mg
(Anti-depressant)
4 M/s. Dulotin 20mg Capsules 10’s As per 24-11- Approved ten
Welmark Each capsule contains:- SRO 2009 molecules per
Pharmaceutic Duloxetine HCl (enteric section as per
als, Hattar coated pellets)……….20mg policy.
(Anti-depressant)
5 -do- Dulotin 30mg Capsules 10’s As per -do- -do-
coated pellets)…….30mg
(Anti-depressant)
6 -do- Dulotin 60mg Capsules 10’s As per -do- -do-
coated pellets)…….60mg
(Anti-depressant)
Decision: Registration Board deferred the case for confirmation of facts from
Receipt and Issuance (R & I) Section.
Registration -V
Case No.82: Registration of M/S. Shrooq Pharma, Lahore.
Following drugs were deferred of M/S. Shrooq Pharma, Lahore. in 277th meetings as
per below mentioned decision of the Registration Board.
Sr.No Name of Drug with Decision of Registration Remarks
composition th
Board in 277 Meeting
1. Misoprost Tablet Approved in USFDA
Each tablet contains:- Deferred products for with boxed
Misoprostol……….100 mcg clarification of
formulation regarding Differential fee Rs
dispersion with HPMC. 12000/- submitted on
12th March, 2013
2. Misoprost tablet -do- Approved in USFDA
Each tablet contains:- with boxed
Misoprostol…………...200mcg Differential fee Rs
12000/- submitted on
12th March, 2013
Firm has submitted master formulation and certificate of analysis wherein Misoprostol is
mentioned as 1% w/w dispersion in HPMC.
Decision: Registration Board approved above mentioned products of M/s Shrooq
pharma, Lahore.
Correction in minutes for the product of M/s. Magns Pharmaceutical, Faisalabad.

Registration Board in its 264th meeting approved the following product of M/s. Magns
Pharmaceuticals, Faisalabad as per detailed below:-
Sr.No Name of Drug with composition Remarks
1. SIGNUS 4mg TABLETS Registration letter was pending due to
clarification of formulation, applied formulation
Each film coated tablet contains: has been verified from original dosseir which
Montelukast sodium equivalent to was chewable tablet of Montelukast (as
Montelukast…4mg sodium) instead of film coated formulation
Correction in minutes solicited for above mentioned formulation.

Decision: Registration Board noted the above mentioned correction in minutes.
Case No.83: Correction in MRP for the product of M/s. Saffron Pharmaceuticals (Pvt)
Ltd Faisalabad.
M/s. Saffron Pharmaceuticals (Pvt) Ltd Faisalabad has requested for corrigendum of below
mentioned registered product which was deferred in PRVC meetings as per detailed below:-
Sr. Reg. No Name of Drug(s) & Existing Proposed Dy no.and date/ Remarks
No Composition MRP and MRP and Pack
Pack size size
1. 081383 Episaf Tablet 250mg Rs.40/30’s Rs. 787/30’s Dy No.14909
Each film coated tablet Dated 13.09.2017
contains:- As per doft copy of
Levetiracetam………250mg Minutes of 258th
(USP Specification) meeting(Whereby approval
was granted) Rs.40/30’s is
the demanded price.
The firm has submitted the following documents.
 Application for corrigendum .
 Copy of registration letter dated 27-07-2016.
Decision 5th PRVC:-
PRVC deferred the case with the advice to confirm demanded price from original dossier
submitted by the firm at the time of application.
The original dossier has been obtained from PEC wherein demanded MRP & Pack size
written as Rs. 1050/30’s in Annexure V whereas as per data available in CD, demanded MRP
and pack size mentioned in Aneexure V as Rs 350/20x10’s.
Decision in 12th PRVC.

The committee evaluated and recommended the case in light of SOP’s approved by
Registration Board, accordingly Chairman Registration Board deferred request of firm for
consideration by Registration Board.
Decision: Registration Board acceded to request of firm for issuing corrigendum

with correct MRP as per demanded MRP/Pack size as mentioned in CD
since demanded MRP mentioned in CD is lower than MRP mentioned in
dosseir.
Case No.84: Correction in pack size for the products of M/s. Medpharm Research
Labs, Lahore.
Chairman Registration Board in 12th PRVC referred the request of M/s. Medpharm
Research Labs, Lahore for correction in pack size of following products as per details below:-
S.N Reg No. Existing Brand Name Existing Proposed Remarks
o MRP/pack size correction in
as per MRP/ pack
registration size
letter
1. 090580 Med-Z Tablet 250mg Rs. Rs. MRP not avaiable
Each film coated tablet contains: 150.00/2x5’s 150.00/1x6’ for 2x5’s pack size.
Azithromycin (as s Pack size was
dihydrate)………….250mg mistakenly
(USP Specifications) mentioned as 2x5’s.
2. 090581 Med-Z Tablet 500mg Rs.275.00/6’s, 1x6’s MRP not avaiable
Each film coated tablet contains: 10’s for 10’s pack size.
Azithromycin (as Pack size was
dihydrate)………….500mg mistakenly
(USP Specifications) mentioned as 10’s.
Firm has submitted following documents
i. Application for correction in specification without fee.
ii. Copy of Registration letter dated 13th June 2018.

with correct pack sizes.
Case No.85: Grant of Registration in the name of M/s. Pharmasol (Private) Limited,
Lahore.
M/s. Pharmasol Private Limited, Lahore has requested for grant of registeration of following
registered products from M/s. Selmore Pharmaceuticals (Pvt) Ltd, Lahore to their name as
per detailed below:-
Sr. No. Reg. No. Brand Name &Composition Remarks
1. 055284 Breathmore Syrup 2mg/5ml MHRA Approved
Each 5ml contains: Renewal valid
Salbutamol as Sulphate ….. 2mg
(BP Specification)
2. 069046 Depin Tablets 20mg USFDA Approved
Each tablet contains: Renewal valid
Paroxetine as Hydrochloride … 20mg
(USP Specification)
3. 069047 Diclosel-P Tablets 50mg MHRA Approved
Each Film coated tablet contains: Renewal valid
Diclofenac Potassium ….50mg
(USP Specification)
4. 064728 Diclosel-S Tablets 50mg MHRA Approved
Each Enteric coated tablet contains: Renewal valid
Diclofenac Sodium ….50mg
(USP Specification)
5. 064737 Drotarin Tablets 40mg Approved by 3 EMA
Each tablet contains: member states i.e. Poland,
Drotaverine Hydrochloride ….40mg Hungary, Latvia.
(Pharmsol Specification) To be approved with
innovator’s specification
Renewal valid
6. 064720 Floxate Tablets 200mg MHRA Approved
Each film coated tablet contains: Renewal valid
Flavoxate Hydrochloride ….......200mg
(USP Specification)
7. 065647 Gamibiotic Tablets 320mg USFDA Approved
Each tablet contains: To be approved with
Gamifloxacin as Mesylate …… 320mg innovator’s specification
(Pharmasol Specification) Renewal valid
8. 055290 Meloxsel Tablets 15mg USFDA Approved
Each tablet contains: Renewal valid
Meloxicam ……........................15mg
(USP Specification)
9. 064733 Selclar Tablets 250mg USFDA Approved
Each film coated tablets contains: Renewal valid
Clarithromycin ……..250mg
10. 064732 Selclar Tablets 500mg USFDA Approved
Each film coated tablets contains: Renewal valid
Clarithromycin ……..500mg
11. 055267 Selprofen Suspension 100mg/5ml MHRA Approved
Each 5ml contains: Renewal valid
Ibuprofen ………………100mg
(USP Specification)
12. 055288 Typhoxin Tablets 200mg USFDA Approved
Each film coated tablet contains: Renewal valid
Ofloxacin ……200mg
(USP Specification)
The firm has submitted following documents.
i. Application with fee of Rs.20,000/- for each product for this purpose.
ii. Form-5
iii. NOC from M/s. Selmore Pharmaceuticals (Pvt) Ltd, Lahore (dated 18th August
2018)
iv. Section approval by CLB
v. GMP inspection report dated 3.10.2017

a. Cancellation of registration of above mentioned products from the name
of M/s. Selmore Pharmaceuticals (Pvt) Ltd, Lahore
b. Approved registration of above mentioned products in the name of M/s.
Pharmasol Private Limited, Lahore.
c. Reference will be sent to Cost and Pricing division for confirmation of
Case No.86: Correction in formulation for the product of M/s. Highnoon Laboratories
Ltd, Lahore .
Chairman Registration in 13th PRVC referred the request of firm M/s. Highnonn
Laboratories Ltd. Lahore has requested for correction in formulation of following product as
per details below:-
S.N Reg No. Existing Brand Name Proposed Correction in Remarks
o Formulations
1. 004584 Skilax Drops Skilax Drops Sulfolax is proprietary
Each ml contains:- Each ml contains:- name of product of
Sulfolax…………….7.5mg Sodium Picosulfate Almirall prodes
(Sulfolax)….7.5mg pharma(Sodium
Picosulfate 7.5mg/ml)
2. 021595 Skilax 5mg tablet Skilax 5mg tablet -Do-
Each tablet contains:- Each tablet contains:-
Sulfolax…………….5.0mg Sodium Picosulfate
(Sulfolax )….5.0mg
i. Application for correction in formulation with fee Rs.5000/-
ii. Copy of Registration letter.

with generic name i.e Sodium Picosulfate instead of proprietary name i.e
Sulfolax
Case No.87: Correction in formulation for the product of M/s. Bio-Mark

Pharmaceuticals, Lahore .
Chairman Registration in its 13th PRVC referred the request of M/s. Bio-Mark
Pharmaceuticals, Lahore has requested for correction in specification of following product as
per details below:-
S. Reg No. Existing Brand Name Proposed Correction in Remarks
No Formulations
1. 087548 Ignis 20mg Sachet Ignis 20mg Sachet
Each sachet contains:- Each sachet contains:- Pellets mistakenly
Enteric coated pellets of Esomeprazole magesnium mentioned in
Esomeprazole magesnium trihydrate eq to minutes whereas
trihydrate eq to: Esomeprazole……….20mg firm applied powder
Esomeprazole……….20mg form (as per Form 5)
2. 087549 Ignis 40mg Sachet Ignis 40mg Sachet -do-
Each sachet contains:- Each sachet contains:-
Enteric coated pellets of Esomeprazole magesnium
Esomeprazole magesnium trihydrate eq to
trihydrate eq to Esomeprazole……….40mg
Esomeprazole……….40mg
i. Application for correction in formulation with fee Rs.5000/- .
ii. Copy of Registration letter. .
Decision: Registration Board did not aceede to request of firm since approved
formulation is according to as approved by RRA i.e gastro resistant
pellets.
Case No.88: Contract manufacturing permission to M/s Lahore chemical and

Pharmaceutical Works (Pvt) Ltd. Lahore
The request of M/s Lahore chemical and pharmaceutical works (pvt) Ltd was deferred in
283rd meeting for contract manufacturing of below mentioned product from M/s.
Novamed Pharmaceuticals (Pvt) Ltd, Lahore as per detailed below:-
Reg. No Name of product & formulation Reason/justification
021686 Cimonil Capsule Due to non availability of cephalosporin
Each capsule contains:- section firm intends to manufacture product by
Cefixime……………….400mg M/s Novamed, Lahore on contract
manufacture basis
Remarks: applied formulation exist in JP.
Decision: Registration Board deferred the request of firm for confirmation of renewal
status of the product.
Now the firm has submitted evidence of renewal fee submission i.e Rs. 10,000/- on dated
02.05.2018 of above mentioned product .
Decision: Registration Board acceded to request of firm for contract manufacturing

of above mentioned product by M/s. Novamed Pharmaceuticals (Pvt) Ltd,
Lahore
Case No.89: Registration for the products of M/s. Radiant Pharma (Pvt) Ltd. Lahore.
Registration Board in 237th and 283rd meetings considered the products of M/s. Radiant
Pharma (Pvt) Ltd. Lahore as per detailed below:-
Sr. Name of firm Name of product and Demanded Demanded Remarks
No composition pack size MRP
1. M/s.Radiant Pharma Ramodine Suspension 60ml Rs.45/- FDA approved
(Pvt) Ltd, 43-E Each 5ml contains:- formulation is
Sundar Industrial Famotidine…10mg 40mg/5ml
Estate, Sundar (Antacid) Confirmation in SRA
Raiwind Road, required
Lahore.
2. -do- Ferfolic Tablets 10’s As per Firm clarified
Each tablet contains:- SRO formulation as:
Iron polymaltose Each chewable tablet
…..100mg contain:
Folic acid ….0.35mg Iron polymaltose
(haematinic) Complex...100mg.
Folic
acid.........0.35mg.
Submitted Rs 5000/-
Above mentioned
formulation may be
standardized as Iron
(III) hydroxide
polymaltose complex
eq. to elemental
iron...100mg
3. -do- Radibron Dry Syrup 120ml As per FDA approved
Each 5ml contains:- SRO formulation
Erythromycin…..200mg Erythromycin ethyl
(macrolide) succinate oral
granules for
suspension
Firm Clarified
formulation as
Erythromycin ethyl
succinate eq. to
Erythromycin 200mg
Submitted fee
Rs.5000/-
4. -do- Radmol Liquid Syrup 60ml -do- MHRA approved
Each 5ml contains:-
Paracetamol….120mg
5. -do- Radimether Dry Syrup 60ml -do- WHO approved
Each 5ml contains:-
Artemether….15mg
Lumefantrine…90mg
6. -do- Ramocine Capsule 10’s -do- HPRA (Ireland)
Each capsule contains:- approved
Diclofenac
sodium….50mg
7. -do- Ramocine SR Capsule 10’s -do- MHRA approved
Each capsule contains:-
Diclofenac
sodium….100mg
8. -do- Radiflox Dry Syrup 60ml As per MHRA approved
Each 5ml contains:- 120ml SRO Firm clarified
Ciprofloxacin ….250mg formulation Radiflox
Dry Suspension
Each 5ml contains:
ciprofloxacin HCl eq.
to ciprofloxacin
250mg
Firm submitted fee

Rs 5000/-
Source of granules is
Neutro pharma,
Lahore (permission
granted for semi
basic mfg dated
28.03.2018
9. -do- Radiflox Dry Syrup 60ml -do- Approved by
Each 5ml contains:- Registration Board in
Ciprofloxacin….125mg 269th meeting
Firm clarified
formulation Radiflox
Dry Suspension
Each 5ml contains:
ciprofloxacin HCl eq.
to ciprofloxacin
125mg
Firm submitted fee
Rs 5000/-.
Source of granules is
Neutro pharma,
Lahore (permission
granted for semi
basic mfg dated
28.03.2018
Decision: Registration Board deferred the request of firm for latest GMP inspection report
within 1 year period.
Now the firm has submitted latest GMP inspection report conducted on dated 31.07.2018
(firm operating at satisfactory level of GMP compliance) and requested for registration of
above mentioned products.
a) Approved products at Sr. no. 4,5,6 and 7
b) Approved products at Sr. no. 2,3,8 and 9 with corrected formulation as stated in
the last column
c) Deferred products at Sr. no. 1 for confirmation of approval status in RRA
Case No.90: Change of Packing due to resemblance with products of M/s. GSK Pakistan
Limited, Karachi.
Chairman Registration Board 3rd PRVC (held on 18 January 2018) considered the request of
M/s. GSK Pakistan Limited, Karachi about resemblance of packging design and color scheme
with products of M/s. BJ Pharma Lahore and M/s. Jawa Pharma, Lahore Since the
packing design and color scheme were granted to M/s. GSK Pakistan Limited, Karachi prior
hence M/s. BJ Pharmaceutical, Lahore and M/s. Jawa Pharmaceutical where advised to
change packing design and color scheme due to resemblance (dated 12th Feb, 2018). Since
firm did not provided alternate packging design and color scheme hence Reminder-I also
written to both firms (dated 09th May, 2018) but both firms have not responded yet.
S. Regn. Product name Initial registration with Name of firm and Packaging
# No. renewal resembling appearance
1. 000817 Panadol Tablet 15-Aug-1976 Bemol Tablet of M/s. Color scheme

Last renewal 12.07.2013 BJ Pharmaceutical, appearance and
Reg.No. 074353 approved beacon
logo.
2. 021527 Voltral Emulgel 23-May-1998 Jfenec Gel of M/s. Color scheme
1% Prodcut transfer to GSK Jawa Pharmaceutical, appearance and
on 20th april 2017. Reg.No. 071460 approved beacon
logo.
Decision: Registration Board decided to issue show cause to above mentioned firms
since they have not applied alternate packings despite of intimation as
well as reminder.
Case No.91: Registration for the products of M/s. News Pharma . Lahore.
Registration Board in 237th meeting considered the products of M/s. News Pharma . Lahore.
as per detailed below:-
Sr.No Name of firm Name and Demanded Decision Remarks
composition pack size/
M RP
1. M/s News Pharma Nemether Injection 6 x1ml Approved WHO approved
Lahore. Each 1ml Contains:- 100 x1ml subject to formulation
Artemether…80mg Rs. 600/- 10 products
Rs.10,000/- per section
Firm has submitted following documents:-

i. Application for this purpose.
ii. Copy of inspection report conducted on 26.04.2018 (Panel
recommends the renewal of DML of liquid injectible section).
iii. Copy of NOC for CRF valid till 31.12.2018.
Now the firm is requesting for issuance of registration letter for above mentioned product.
Decision: Registration Board approved above mentioned product.
Case No. 92: Registration of M/s. Medipak Pharma Lahore.

The Registration Board has deferred following products of M/s Medipak, Lahore in
rd
243 meetings for Product specific inspection by panel comprising of Director DTL, Lahore
& area FID, Lahore .
S. Name of Drug(s) with formulation Demanxded Remarks
No. MRP/Pack size
1. Voluven Infusion Solution. Rs.521.70/500ml Approval status in SRA not
Each 1000ml Contains:- confirmed
Poly(O-2-Hydroxyethyl) starch
(Hydroxyethyl starch
130/0.4)………60.0gm
Sodium Chloride……..9.0gm
2. Moxidex Eye Drops Rs.400.00/5ml vial Approval status in SRA not
Each ml contains:- confirm
Moxifloxacin HCl eq. to
Moxifloxacin…….5mg
Dexamethasone sodium phosphate eq. to
Dexamethasone phosphate…..1mg
3. Medisol ½+5% Infusion. 500ml Baxter Health care Limited
Each 1000ml contains:- As per SRO (UK)
Dextrose Monohyrate….. .55gm.
Sodium Chloride….4.5gm.
4. Napro Tablet As per SRO USFDA approved
Each tablet contains:- formulation contains
Naproxen (as sodium)……….550mg Naproxen sodium 550mg
5. IPM-F Chewable Tablet Rs.300.00/1X10’S Formulation to be written as
Each tablet contains:- per standard formulation as:
Iron (III) Hydroxide Polymaltose Iron (III) Hydroxide
Complex…..100mg Polymaltose Complex eq, to
Folic Acid……0.35mg elemental iron…..100mg
(Iron preparation(Haematonic)
6. IPM Chewable tablet Rs.350.00/1X10’S Formulation to be written as
Each tablet contains:- per standard formulation as:
Iron (III) Hydroxide Polymaltose Iron (III) Hydroxide
complex…..100mg Polymaltose Complex eq, to
(Iron preparation(Haematonic) elemental iron…..100mg
Minutes for 286 Meeting of Registration Board , DRAP (14 – 16 November, 2018)
th th
| 671
7. L-Citrazine Tablet 150.00/1X10’S MHRA approved
Levocetrizine Dihydrochloride…..5mg
8. Cefezim Capsule As per SRO USFDA approved
Each capsule contains:- Evidence of cephalosporin
Cefixime (as Trihydrate) …..200mg section not provided by firm.
9. Napro Tablet As per SRO USFDA approved
Each tablet contains:- formulation contains
Naproxen (as sodium)……..275mg Naproxen sodium 275mg
10. Medi-Oflox 200mg Tablet As per SRO MHRA approved
Ofloxacin ….............200mg
11. Noltren-P 75mg tablet As per SRO Approval status in SRA not
Each tablet contains:- confirm
Diclofenac Postassium ….75mg
12. Cefezim 200mg/5ml suspension As per SRO USFDA approved

Each 5ml contains:- Evidence of cephalosporin
Cefixime (as Trihydrate) 200mg section not provided by firm.
13. Cefezim 100mg suspension As per SRO USFDA approved

Each 5ml contains:-
Cefixime (as Trihydrate).........100mg Evidence of cephalosporin
section not provided by firm.
14. Medi-Oflox 400mg Tablet As per SRO MHRA approved
Ofloxacin ....….400mg
15. Medi-Oflox 200mg I.V Infusion As per SRO MHRA approved
Each ml contains:- Formulation approved in
Ofloxacin ……...........200mg MHRA as 2mg/ml
16. Cefezim 400mg Capsule As per SRO USFDA approved
Each capsule contains:- Evidence of cephalosporin
Cefixime (as Trihydrate) ….400mg section not provided by firm.
The firm is requesting for approval of above mentioned products for registration.
Firm has submitted following documents:

a) Latest GMP inspection report dated 17.10.2017
b) Evidence of fee submission (Rs 12000/-) for each product.

a) Approved products at Sr. no. 3,5,6 ,7,10 and 14.
b) Deferred products at Sr. no. 1,2,4,9,11 and 15 for confirmation of approval
status in RRA
c) Rejected applications for products at Sr.no.8, 12, 13 and 16 due to non
availability of cephalasporin section, approved by CLB.
Case No. 93: Contract Manufacturing permission for the register products of M/s.
Lahore Chemicals and Pharmaceuticals Works, Lahore.
M/s. Lahore Chemicals and Pharmaceuticals Works, Lahore has requested for
contract manufacturing permission for already registered product from M/s.MedPharm,
Lahore as per detailed below:-
S. No. Reg.No. Name of Drug(s) with formulation Remarks
1. 028131 Ceftacin Injection 250mg Rs. 50000/- dated 17.09.2018
Ceftazidime pentahydrate USP eq to: Last renewal submitted on dated 06.06.2017
Ceftazidime…………………..250mg Renewal valid
2. 028132 Ceftacin Injection 500mg Rs. 50000/- dated 17.09.2018
Ceftazidime…………………..500mg Renewal valid
3. 028133 Ceftacin Injection 1g Rs. 50000/- dated 17.09.2018
Ceftazidime…………………..1g Renewal valid
4 026243 Libor 250mg Injection Rs. 50000/- dated 17.09.2018
Ceftriazone sodium eq to Last renewal submitted on dated 19.08.2015
Ceftriaxone base……………..250mg Renewal valid
5. 026244 Libor 1gm Injection Rs. 50000/- dated 17.09.2018
Each vial contains:- Rs. 50000/- dated 17.09.2018
Ceftriazone sodium eq to Last renewal submitted on dated 19.08.2015
Ceftriaxone base……………..1gm Renewal valid
6. 027577 Libor 500mg Injection Rs. 50000/- dated 17.09.2018
Each vial contains:- Last renewal submitted on dated 26.04.2017
Ceftriazone sodium eq to Renewal valid
Ceftriaxone base……………500mg
Due to unavailability of cephalosporin section firm requested grant contract manufacturing

permission for above mentioned products.

i. Application for this purpose with fee Rs.50000/- for each product.
ii. Copy of registration letter alongwith valid renewal status
iii. Copy of NOC for CRF.
iv. Copy of DML
v. Copy of GMP inspection report of M/s. LCPW, Lahore conducted on
26.06.2018.
vi. Contract agreement between M/s. M/s. Lahore Chemicals and
Pharmaceuticals Works, Lahore and Med Pharm, Lahore on dated
15.09.2018.
Decision: Registration Board acceded to request of firm for contract manufacturing

of above mentioned products by M/s.MedPharm, Lahore
Case No.94: Registration for the products of M/s. CSH Pharmaceuticals (Pvt) Ltd,
Lahore.
Registration Board in its 234th meeting approved the following products of M/s. CSH
Pharmaceuticals (Pvt) Ltd, Lahore as per detailed below:-
S .No Name of the drugs with composition Pack Proposed Remarks
Size Price
1. Sulmox 500mg Tablets 1x6’s -do- Approval
Each tablet contains:- status in SRA
Sulbactam…..250mg not confirm
Amoxicillin……250mg
2. Sulmox 250mg Suspension 60ml -do- Approval
Each 5ml contains:- status in SRA
Sulbactam……125mg not confirm
Amoxicillin (as trihydrate)….125mg
(Broad spectrum penicillin)
3. Amicloxin 250mg Suspension 60ml -do- Approval
Each 5ml contains:- 90ml status in SRA
Ampicillin (as trihydrate)….125mg not confirm
Cloxacillin micronized….125mg
4. Sulmox 1000mg DS Tablets 1x6’s -do- Approval
Each tablet contains:- status in SRA
Sulbactam…..500mg not confirm
Amoxicillin……500mg
Now the firm has requested for registration letter of above mentioned products.
Decision: Registration Board deferred above mentioned products for confirmation

of approval status in RRA.
Case No.95: Registration for the products of M/s. Venus Pharma, Lahore.
Registration Board in its 238th meeting deferred the following products of M/s. Venus
Pharma, Lahore as per detailed below:-
S .No Name of the drugs with composition Pack Size Proposed Decision
Price
1. Viodol Infusion Per Vial Rs.90.00 Deferred for product
Each 100ml contains:- specific inspection by
Paracetamol……..1gm DDG E&M Lahore, area
FID and area ADC.
2. Ciproflox Infusion Per vial Rs.275.00 -Do-
Each 100ml contains:-
Ciprofloxacin……….200mg
3. Clarithrovin-250 Tablets 1x10 Rs.298.00 -Do-
Clarithromycin…………250mg
4. Vioflox-500 Tablets 1x10 Rs.292.00 -Do-
Levofloxcin………500mg
Now the firm has requested for registration letter of above mentioned products. Firm has
submitted inspection report conducted on 5th September 2016 for verification of
manufacturing facility of above mentioned products wherein panel recommends the grant of
registration for above mentioned products. Last GMP inspection conducted on 9th July, 2018.
Decision: Registration Board approved above mentioned products of M/s. Venus
Pharma, Lahore.
Case No.96: Grant of Registration of M/s. Horizon Healthcare (Pvt) Limited, Lahore
(Formerly M/s. Wellness Pharmaceuticals Pvt Ltd Lahore) at New
Manufacturer Title.
M/s. Horizon healthcare (Pvt) Limited, Lahore (Formerly M/s. Wellness Pharmaceuticals Pvt
Ltd Lahore) has requested for grant of registration of below mentioned products at new
manufacturer title i.e. M/s. Horizon healthcare (Pvt) Limited, Lahore as per detailed below:-
Sr. No Reg. No. COMPOSITIONS Reg. Date
1 089958 Dits-S Capsule 40/1100mg 14th May -2018
Omeprazole……………………….40mg
Sodium bicarbonate………………..1100mg
(As per innovator’s specification)
2 089956 Serratol 20mg capsule 14th May -2018
FLuoxetine (as hydrochloride)……….20mg
Firm has submitted following documents:-
i. Form-5
ii. Application with fee of Rs.20000/- for each product for this purpose.
iii. Copy of registration letter.
iv. Copy of NOC for CRF valid till dated 31.12.2018.
v. Approval letter from CLB for new manufacturer title and change of
management (21st June 2018).
Decision: Registration Board approved above mentioned products with new title of
firm i.e M/s. Horizon healthcare (Pvt) Limited, Lahore (Formerly M/s.
Wellness Pharmaceuticals Pvt Ltd Lahore)
Case No.97: Registration for the products of M/s. Tagma Pharma (Pvt) Ltd, Lahore
Registration Board in 283rd meetings considered following product of M/s. Tagma Pharma
(Pvt) Ltd, Lahore as per detailed below:-
Sr. Name of firm Name of product and Demanded Remarks
No composition MRP/ pack
size
1. M/s.Tagma Celesta Tablets 10’s MHRA approved
Pharma Lahore Each tablet contains:- As Per SRO formulation is
Zolpidem Hemitartrate….10mg Zolpidem tartrate

i. Application with differential fee of Rs.12000/- for each product this purpose.
ii. Form-5
iii. Psychotropic section approval dated 14th June, 2018 (New section)
Decision: Registration Board deferred the product for clarification of applied salt w.r.t
Formulation approved in reference country.
Now the firm has clarified that zolpidem tartrate is also known as zolpidem hemitartrate
which is actual form of compound, a salt containing 2 drug molecules and one tartaric acid
molecule zolpidem is commercially available as its hemitartrate salt of formula 2 having a
2:1 ratio of zolpidem base to l-(+) tartaric acid. The hemitartrate salt of zolpidem.
Source: HealthTap, https://www.healthtap.com/user_questions/1090598-what-is-the-

difference-between-zolpidem-tartrate-and-zolpidem-hemitartrate
Decision: Registration Board was apprised that firm has re-submitted formulation
with corrected salt form of Zolpidem i.e. Zolpidem tartrate, as per
refrence product approved by USFDA. Hence Registration Board
approved the formulation as per following details:
“Celesta Tablets
Zolpidem tartrate….10mg”
Case No.98: Registration of M/S. Soma Laboratories , Lahore.

Following product of M/S. Soma Laboratories, Lahore was approved in 265th
meeting as per below mentioned decision of the Registration Board.
Sr.No Name of product and composition Demanded Decision
MRP/pack size
1. Dicophen 75 Tablet As Per SRO Approved with Brand name of
Each enteric coated tablet contains:- 2x10’s “Dicophen 50”
Diclofenac potassium…..50mg 100’s Jar
(USP Specification)
Registration letter was pending due to clarification of applied formulation i.e 50mg or 75mg.
Now the firm has clarified that applied formulation was Diclofenac sodium 50mg instead of
75mg. Firm has submitted copy of Form-5 as well as undertaking in this regards. Moreover
firm requested for correction in coating i.e film coating instead of enteric coating (also
submitted fee of Rs 5000/-)
Decision: Registration Board deferred request of firm for confirmation from R&I
section for initially applied formulation.
Case No.99: Export Registration of M/s. Friends Pharma (Pvt) Ltd, Lahore .
The request of M/s. Friends Pharma (Pvt) Ltd, Lahore was referred to Registration
Board in 12th PRVC for export registration of following product as per details below:-
S .No Name of the drugs with Me too status/International Fee
composition Reference Dy No. & Date
1. Tatio-Cee Not available Rs.20000 Dated 23.04.2018
Each ml contains:- Approval in reference country Rs.30000 Dated 31.07.2018
Ascorbic Acid………..250mg not confirm Page No.201/cor.
Formulation found approved in Dy. No. 14889
importing country i.e dated 23.04.2018
Philippines (FDA).
Purchase order also provided by
the firm.
The firm has submitted the following documents as per SOP.
Application with fee of Rs. 20000/- for this As mentioned in above para
purpose
Form-5/Form 5D. Provided
Copy of GMP inspection Conducted on 06.10.2016
Approval of section by CLB Provided
Undertaking for export only purpose. Provided
Decision: The committee evaluated and recommended the case in light of SOP’s approved by
Registration Board, accordingly Chairman Registration Board referred the request
of firm for consideration by Registration Board.
Decision: - Registration Board approved above mentioned product with following
conditions:
 Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No objection certificate from concerned DRAP office.
 Manufacturer will also furnish export documents endorsed from
custom authorities (if required for any query) in order to ensure the
export of the product.
Case No.100: Correction in minutes for the product of M/s. Jaens Pharmaceuticals
Industries (Pvt) Ltd, Lahore.
M/s. Jaens Pharmaceuticals Industries (Pvt) Ltd, Lahore has requested for correction
in formulation of following registered product as per details below:-
S. Reg Existing Formulation Proposed Correction in Remarks
No No. Formulations
1. 091865 Redoquine Cream Redoquine Cream Registration letter was
Each gram contains: Each gram contains: issued as per formulation
Hydroquinone…0.01% w/w Hydroquinone….…4% w/w approved in minutes of
Fluocinolone Fluocinolone 282nd meeting .
Acetonide…4%w/w Acetonide..0.01%w/w Whereas firm has submitted
Tretinoin……..0.05%w/w Tretinoin……..0.05%w/w evidence wherein applied
(As per innovator’s (As per innovator’s formulation was
Specification) Specification) Hydroquinone.…4% w/w
Fluocinolone
Acetonide..0.01%w/w
Tretinoin……..0.05%w/w
Applied formulation is as
per USFDA.

i. Application for correction in formulation without fee.
ii. Copy of Registration letter issued dated 25.09.2018.
Above mentioned formulation to be corrected in minutes (282nd meeting) and corrigendum

may be issued accordingly.
Decision: Registration Board acceded to request of firm for correction in

formulation.
Case No.101: Correction in formulation for the product of M/s. Shrooq

Pharmaceuticals (Pvt) Ltd, Lahore.
M/s. Shrooq Pharmaceuticals (Pvt) Ltd, Lahore has requested for correction in
formulation of following registered product as per details below:-
S. Reg Existing Brand Name Proposed Correction in Remarks
No No. Formulations
1. 040843 Metical-V Cream Metical-V Gel Last Renewal dated 13th
Contains:- Contains:- July,2015.
Metronidazole…0.75% Metronidazole……………0.75%
USFDA approved
formulation is
Metronidazole vaginal gel.
same formulation exist in
BP.
 Application for correction in formulation without fee.
 Copy of Registration letter issued dated 15.07.2005
 Evidence for applied formulation (dated 28.04.2005) i.e Gel instead of cream.
Decision: Registration Board acceded to request of firm for correction in formulation.
Case No.102: Registration for the products of M/s. Pacific Pharmaceuticals Ltd,
Lahore.
Registration Board different meeting approved the following products of M/s. Pacific
Pharmaceuticals Ltd, Lahore per details below:-
Sr. Name of Product name and Demanded Demanded Decision/
firm composition pack size MRP remarks
1. M/s. Pacific Azcort Tablets. 20’s ---- Approved* for
Pharma Each Tablet Contains;- 30’s clarification and
Lahore Deflazoacrt….6mg. confirmation of
formulation/ section. (M-
212)
Hormonal section
approved by CLB in 257th
meeting
USFDA approved
2. -do- Azcort Tablets. 20’s ---- -do-
Each Tablet Contains;-
Deflazacort…….30mg. USFDA approved
3. -do- Femidol + Capsules 20’s Rs.90.00 Approved as per policy.
Each capsule contains:- 10’s Rs.380.00 (M-225)
Paracetamol Capsule (Psychotropic/
BP...500mg Narcotic) Section
Caffeine BP…..30mg approved by CLB in 257th
Codeine Phosphate BP meeting
…..8mg MHRA approved
4. -do- Femidol + Soluble 20’s Rs.66.00 Approved as per policy.
Tablet 100’s Rs.300.00 (M-225)
Each soluble tablet Tablet (Psychotropic/
contains:- Paracetamol Narcotic) Section
BP …….500mg approved by CLB in 257th
Codeine Phosphate BP meeting
……8mg
Approval status in RRA
not confirmed in Soluble
form.
5. -do- Femidol Migraine 10 x 10’s Rs.475.00 Approved (M-226)
Tablet
Each tablet contains:- Tablet (Psychotropic/
Ibuprofen….. 200mg Narcotic) Section
Codeine Phosphate approved by CLB in 257th
Hemihydrate …12.8mg meeting
MHRA approved
6. -do- Femidol Max Tablets 10 x 10’s Rs.280.00 Approved (M-226)
Each tablet contains:- Tablet (Psychotropic/
Paracetamol . 500mg Narcotic) Section
Codiene Phosphate approved by CLB in 257th
Hemihydrate.12.8mg meeting
MHRA approved
i. Application for issuance of registration letter.
ii. Copy of section approval letter from CLB.
iii. Last GMP inspection report dated 22.02.2018, at GOOD level of GMP
compliance
a) Approved products at Sr. no. 1,2,3,5 and 6.
b) Deferred products at Sr. no. 4 for confirmation of approval status in RRA
Case No.103: Registration for the products of M/s. Himont Pharmaceuticals (Pvt) Ltd,
Lahore .
Registration Board in its 237th meeting approved the following products of M/s.
Himont Pharmaceuticals (Pvt) Ltd, Lahore per details below:-
Sr. Name of product and Demanded Demanded Fee Details Remarks
No composition Pack size MRP
1. Diocid SR Tablets 20’s Rs.316.00 22-5-2012 Comparative dissolution
Each tablet contains:- Fee.8000 profile.
Gliclazide…..60mg Fast track
(Antidiabetic agent/ submission Duplicate dossier.
sulfonylurea) Fee.52000 MHRA approved
formulation as modified
release tablet
2. Diocid SR Tablets 20’s Rs.190.00 22-5-2012 -do-
Each tablet contains:- Fee.8000 MHRA approved
Gliclazide…..30mg Fast track formulation as modified
(Antidiabetic agent/ submission release tablet
sulfonylurea) Fee.52000

i. Application for issuance of registration letter.
ii. Comparative dissolution profile Gliclazide Tablet 30mg & 60mg.
Decision: Registration Board approved above mentioned products. Reference will

be sent to Budget & Accounts Division, DRAP for verification of challan
of Rs.52,000/- and the Board also authorized the Chairman, Registration
Board for issuance of registration letter.
Case No.104: Registration of M/s. Derma Techno, Lahore,
Registration Board in its 234th Meeting approved following drugs of M/s. Derma
Techno, Lahore, as per detailed below:-
Sr. Name of firm Product name and composition Demande Demanded Decision /remarks
No. d pack MRP
size
1. M/s. Derma Arid 150mg Tablet 1x10’s Rs.8.82 Approved
Techno, Lahore, Each film coated tablet contains:-
Ranitidine as HCl….150mg USFDA approved
(H2 Blocker)
2. -do- Alpzole 30mg Capsule 2 x 7’s Rs.10.00/ Approved
Each capsule contains: per capsule
Lansoprzole (eteric coated Source of pellets
pellets) 30mg not provided
(proton inhibitor)
3. -do- Sildiazine Cream 25gm Rs.78.99 Approved
Each gram contains:- 50gm Rs.152.39
Silversulphadiazine ……10mg 250gm Rs.439.39 USFDA approved
(antibacterial)
4. -do- Mupical Cream 10gm Rs.75.00 Approved
Each gram contains:- Approval status in
Mupirocin calcium…..43mg RRA not confirmed
Last GMP inspection report has been submitted by firm dated 21.05.2018 and 05.07.2018
(GMP compliant), firm has been requesting for issuance of Registration letters.
Differential fee Rs 12000/- each product submitted on 05.01.2017.

a) Approved products at Sr. no. 1 and 3.
b) Deferred product at Sr. no. 2 for source of pellets
c) Deferred product at Sr. no. 4 for approval status in RRA.
Case No.105: Registration of M/s. Derma Techno, Lahore.

Registration Board in its 234th Meeting deferred following drugs of M/s. Derma
Techno, Lahore, as per detailed below:-
S. Name of Drugs & Demanded Approved Decision Remarks if any
No. Composition MRP & MRP by
Pack Size Pricing
1. Rubonal –S 50mg 1’s/ Rs.4.65 20’s/ Approved Subject to Firm has clarified that
Tablets Rs.60.00 confirmation of they will formulate
Each enteric coated source, GMP and product at their own
tablet contains:- stability of dosage site as they have
Diclofenac sodium form in sustained facility of enteric
…..50mg release/Enteric coating .
(Phenylacetic acid) coated dosage form.
MHRA approved
2. Eprazid- 40 mg 2 x 7’s/ Rs.323/14s Approved Subject to Source of pellets M/s
Capsules Rs.16.42/ (Rs. confirmation of Spansules
Each capsule contains: cap 23/Cap) source, GMP and formulations GMP
Esomeprazole usp (as Demanded stability of dosage dated 05.07.2017)
enteric coated pellets) price less form in sustained
40mg then release/Enteric coated
(proton inhibitor) approved dosage form. USFDA approved
price
3. Dermolimus Cream 5gm/ Rs. Approved Approval status not
Each gram contains:- Rs.150.00 137.00/10 confirmed
Tacrolimus ….0.3mg gm
Last GMP inspection report has been submitted by firm dated 21.05.2018 and 05.07.2018, Firm
has been requesting for issuance of Registration letters.
Differential fee Rs 12000/- each product submitted on 05.01.2017.

a) Approved products at Sr. no. 1 and 2.
b) Deferred product at Sr. no. 3 for approval status in RRA.
Case No.106: Correction in formulation/specification for the product of M/s. Jawa
Pharmaceuticals (Pvt) Ltd, Lahore .
The request of M/s. Jawa Pharmaceuticals (Pvt) Ltd, Lahore was referred to
Registration Board in 14th PRVC for correction in formulation/specification of following
registered product as per details below:-
No Formulations
1. 004230 Paracetamol Elixir Paracetamol Syrup Formulation exist in
Each 5ml contains:- Each 5ml contains:- BP as Paracetamol
Paracetamol…….120mg Paracetamol…….120mg Suspension. Innovator
(B.P Specification) brand Calpol in
suspension form
(by Mcneil)
MHRA approved.
i. Application for correction in formulation with fee Rs.5000/- for each
product.
ii. Copy of Registration letter and renewal status (last renewal dated
17.05.2018).
Decision: Registration Board deferred request of firm for approval status of proposed
formulation i.e Syrup in RRA.
Case No.107: Change in specification for the product of M/s. Pharmasol (Pvt) Ltd,
Lahore.
The request of M/s. Pharmasol (Pvt) Ltd, Lahore was referred to Registration Board in 14 th
PRVC for change in specification of following product registered for export purpose as per
details below:-
No Formulations
1. 089881 Zithrocin Capsule 250mg Zithrocin Capsule 250mg Firm want to change
Each capsule contains:- Each capsule contains:- finshed product
Azithromycin (as dihydrate)……250mg Azithromycin (as specification
(USP Specification) dihydrate)……250mg because in USP
(B.P Specification) assay method
Amperometric
Electrochemical
detector is use which
is very costly in
contrast in UV
detector which is use
in BP method.
2. 090406 Zithrocin Suspension Zithrocin Suspension -do-
Each 5ml (after reconstitution) contains:- Each 5ml (after
Azithromycin (as dehydrate)……200mg reconstitution) contains:-
(USP Specification) Azithromycin (as
dehydrate)……200mg
(B.P Specification)
i. Application for change in specification with fee of Rs.5000/-.
ii. Copy of Registration letter.
Decision:- The committee evaluated the case in light of SOPs approved by Registration
Board and on recommendations of the committee, Chairman Registration
Board referred the case to Registration Board.
Decision: Registration Board acceded to request of firm for change in specification.
Case No.108: Allocation Of Quota For Control Substances Ephedrine HCl for the year
2017 to M/s. Sharex Laboratories, Sadiqabad.
The case of M/s. Sharex Laboratories, Sadiqabad was considered in 275th meeting of
Registration Board as per detailed below:-
Letter received from Assistant Director (CD) (Dated 21st Sep, 2017) wherein it has been
stated that M/s Sharex Laboratories, sadiqabad applied for quota allocation of product
“Tracodil syrup (Reg. 003158). The case was presented before 43rd meeting of committee on
allocation of controlled drug held on 26th July, 2017, the comittee deferred the case for
issuance of show cause by DRAP for manufacturing of Tracodil syrup (Reg. 003158) 60ml,
400ml pack without approval.
It was requested to verify the status of product registration of Tracodil syrup (Reg. 003158)
400ml pack size.
The approved pack sizes of product “Tracodil Syrup” (Reg no. 003158) have been verified as
per available record i.e 120ml, 450ml (National Formulary 1981) and 60ml (dated 27th
October 1988).
Decision: Registration decided to call M/s Sharex Laboratories, Sadiqabad for personal
hearing and for deliberating above mentioned matter before the Registration
Board
Now the firm has been called for personal hearing for deliberating the matter.
Mr. Muhammad Ishfaq, production pharmacist, appeared before Registration Board and
apologized on behalf of the firm for applying quota of 400ml pack size of
product “Tracodil syrup (Reg.003158) without approval.
Decision: Registration Board referred the case to Legal Affair division for legal opinion.
Case No.109: Grant of Registration to M/s.Wellness Pharmaceuticals (Pvt) Ltd,

Lahore from M/s. Wnsfeild Pharmaceuticals, Hattar
The request of M/s. Horizon Healthcare (Pvt) Limited (Formerly M/s. Wellness
Pharmaceuticals (Pvt) Ltd, Lahore) was deferred in 275th and 284th meeting for transfer of
following registered products of M/s. Wnsfeild Pharmaceuticals, Hattar to their name :-
Sr. Reg. No Name of product & formulation Remarks
No
1. 083140 Ridomide 50mg Tablet Renewal valid (brand name changed
Each film coated tablet contains:- dated 18th oct, 2017)
Lacosamide…………………….50mg USFDA approved
2. 083142 Ridomide DS 100mg Tablet Renewal valid (brand name changed
Lacosamide…………………….100mg USFDA approved
3. 084220 Profitam 250mg Tablet Renewal valid (brand name changed
Levetiracetam………………….250mg
(USP Specification) USFDA approved
4. 084221 Profitam 500mg Tablet Renewal valid (brand name changed
Levetiracetam………………….500mg
5. 084227 Delpoflex 4mg tablet Renewal valid (brand name changed
Each tablet contains:- dated 18th oct, 2017)
Tizanidine as HCl…………………..4mg
6. 064337 Endtron Injection Last Renewal dated 31 july, 2015.
Each 4ml contains:-
Ondansetron (as HCl)…………8mg MHRA approved
(USP Specification)
7. 064338 Respivant 1mg Tablet Last Renewal dated 31 july, 2015.
Each tablet contains:- Firm demanded brand name
Risperidone…………………….1mg Mytodone
8. 064339 Respivant 2mg Tablet Last Renewal dated 31 july, 2015.
Risperidone…………………….2mg Mytodone
9. 064340 Moxofin 400mg Tablet Last Renewal dated 31 july, 2015.
Moxifloxacin (as HCL)…………….50mg Moxofin
USFDA approved
10. 080877 Moxofin 400mg Infusion Renewal valid (brand name changed
Each 250ml vial contains:- dated 18th oct, 2017)
Moxifloxacin HCl eq to:- Firm demanded brand name
Moxifloxacin………………..400mg Moxofin
USFDA approved
11. 087031 Mytodone 4mg Tablet Renewal valid.
Each film coated tablet contains:- USFDA approved
Risperidone…………………….4mg
(USP Specification)
12. 046813 Delpoflex Tablet Renewal valid (brand name changed
Each tablet contains:- dated 18th oct, 2017)
Tizanidine as HCl………………..2mg USFDA approved
13. 060052 Lewdes 5mg tablet Last renewal dated 22nd July, 2014
Each tablet contains:- USFDA approved
Desloratadine……………………..5mg
14. 075596 Endtron 8mg tablet Last renewal dated 28.03.2018.
Ondansetron (as HCl dihydrate) ….8mg USFDA approved
(USP Specification)
15. 075577 Zolfenac 50mg tablet Last renewal dated 16.03.2018
Each coated tablet contains:-
Diclofenac Sodium………………..50mg USFDA approved formulation is
Misoprostol…………………………200 µg delayed release
(USP specification)
16. 080244 Olaway tablet 8mg Renewal valid (brand name changed
Lornoxicam………………………..8mg USFDA approved
Transfer of registeration of above mentioned products are subject to contract manufacturing:
 M/s wellness pharmaceutical, Lahore (contract giver)
 M/s wnsfeild pharmaceuticals, Hattar (contract acceptor).

i. Application with fee of Rs.50000/- for each product for this purpose.
ii. Form-5.
iii. Agreement for Transfer of Registration subject to Toll manufacturing (dated
13th Feb, 2018)
iv. Agreement for contract manufacturing (dated 05.04.2018) between M/s
wellness pharmaceutical, Lahore (contract giver) and Wnsfeild (contract
acceptor).
v. Copy of Registration letters with renewal status.
vi. Last GMP inspection report of Wnsfeild dated 18.01.2018.
The case was discussed in 281st meeting and decided as follows:
Decision: Registration Board deferred the request of M/s. Wellness Pharmaceuticals (Pvt)
Ltd, Lahore for confirmation of total number of sections and products already
registered on contract manufacturing basis.
M/s wellness has submitted detail regarding sections approved by CLB i.e 4 sections, Tablet
(General), Capsule (General), oral liquid (General) and external preparation. Moreover there
is no any product registered on contract manufacturing basis.
The case was discussed in 284th meeting and decided as follows:
Decision: Since title of firm has been changed from M/s. Wellness Pharmaceuticals Pvt Ltd
Lahore to M/s. Horizon healthcare (Pvt) Limited, Lahore hence Registeration
Board deferredthe request of firm for submission of revised documents., fee etc.
Now the firm has submitted Rs.5000/- dated 01.10.2018 for each product and revised
documents.
Decision: Registration Board deferred the request of firm for submission of differential
fee of Rs 45000/- each product
Case No.110: Grant of Registration to M/s.Wellness Pharmaceuticals (Pvt) Ltd,

Lahore in to new title i.e M/s. Horizon Healthcare (Pvt) Limited, Lahore
The request of M/s. Horizon Healthcare (Pvt) Limited (Formerly M/s. Wellness
Pharmaceuticals (Pvt) Ltd, Lahore) has requested to issued below mentioned product into
new title as per detailed below:
Sr. No Name of product & formulation Remarks
1. FLUVIR Capsule 75mg Approved in 283rd meeting
Oseltamivir as phosphate……75mg
2. LETZ Tablets 2.5mg Approved in 283rd meeting
Letrozole USP…….2.5mg
3. TELBINESS Tablets 600mg Approved in 283rd meeting
Diary No:15768, 27-04-2018 , Rs: 20,000/-
Telbivudine…..600mg
Now the firm has submitted Rs.20000/- dated 06.09.2018 for each product and requested for
issuance of Registration letter at their new manufacturer title i.e M/s. Horizon Healthcare
(Pvt) Limited, Lahore .
Decision: Registration Board approved above mentioned products at new title of

manufacturer i.e M/s Horizon Healthcare (Pvt) Ltd, Lahore (Formerly M/s.
Wellness Pharmaceuticals (Pvt) Ltd, Lahore).
Case No.111: Change of formulation for the product of M/s. Jassh Pharma, 19-km
Ferozpure Road, Lahore
M/s. Jassh Pharma, Lahore has requested for change in formulation for below mentioned
registered product as per detailed below:-
S. No Reg. No. Name of drug (s) & Composition Proposed correction
1. 044699 Carbosol Haemodialysis Sodium……………………80-110 m.mol
Concentrate. Potassium………………….0-3 m.mol
Each 1000ml contains:- Calcium……………………0-2 m.mol
Na……………138.00 m.mol Magnesium……………… 0-1.2 m.mol
K……………..2.00 m. mol Chloride………………… 90-120 m.mol
Ca…………….1.25m.mol Acetic Acid……………… 2.5-10 m.mol
Mg……………0.50m. mol Glucose…………………….0-12gm
Cl……………..109.0m. mol
CH3COO……..3.00m. mol Part-B (Sodium bicarbonate powder)
HCO3…………32.0 m.mol Sodium (Not more than 45 m.mol)
Glucose………..1.00gm. Bicarbonate (Not more than 45 m.mol)
Applied formulation found approved in Health
Canada

i. Application with fee of Rs.20000/- for each product for this purpose.
ii. Form-5.
iii. Copy of registration letter dated 02.11.2006 renewal dated 16.05.2016.
iv. Last GMP inspection report dated 07.01.2015.
Decision: Registration Board referred to MD&MC Division for their opinion about
above products as drugs or Medical devices.
RRR SECTION
Case No: 112: Amendments in SOP’s for renewal of registered drugs approved in 276 th
meeting of Registration Board
Following amendments are proposed:

I II III IV
S. Form 5-B Rule 26 (3A) Documents required to be submitted with Proposed amendment
No. Form 5B
1. I/We…………………….of a. Covering letter on applicant‟s letter head for The point (f) may be
………….hereby apply for renewal of registered drug along with Form deleted as the same
renewal of registration of 5-B and prescribed fee (endorsed by does not come under
the drug, namely DRAP‟s Budget & Accounts Division). This the scope of renewal of
…………………….details will be submitted in DRAP‟s R&I Division. drugs.
of which are enclosed. Date b. Signature on the covering letter and
…………Signed ………… undertaking on Form 5-B should be from
Place ... ………… Chief Executive Officer/ Managing Director
/ Director / Authorized Officer not below the
manager level.
c. An undertaking that the applied products has
never been de-registered.
d. An undertaking that submitted documents
are true copy of the originals and that, if at
any stage any discrepancy / misinformation
is detected / observed the firm/company will
be held responsible as per relevant laws.
e. Authority letter shall be submitted along
with application. f. Copy of NOC of Central
Research Fund (CRF) as required by Budget
& Accounts Division
f. Copy of NOC of Central Research Fund
(CRF) as required by Budget & Accounts
Division
2. Brand (Proprietary) name a. Also attach attested copy of registration Attach attested copy of
of the drug. letter for confirmation of brand name. registration letter and
b. Attested copy of change in brand name letter change in brand name
(if any). letter (if any).
3. Strength of active a. Furnish information of approved strength as
ingredient(s) per valid registration letter
4. Name and address of the In addition, following to submit: The information
manufacturer a. Attested copy of valid Drug Manufacturing regarding point (a) and
License (for locally manufactured drugs) (c) shall be obtained
b. Attested copy of valid Drug Sale License from Licensing
(for imported drugs) Division and for point
c. Attested copy of last inspection report (c) form the QA & LT
conducted by DRAP (for locally Division instead of
manufactured products). manufacturer.
d. Approval of the section / manufacturing The point (f) may be
facility (by Central Licensing Board) or last deleted as the same is
DML renewal inspection report. covered in the provided
e. Legalized CoPP as per WHO’s format or CoPP or GMP.
legalized free sale certificate and GMP
certificate (for imported products).
f. Inspection report by regulatory authority of
country of manufacture.
5. Name and address of the a. Furnish information if any
agent or indenter in case of
imported drug
6. Whether the drug is As per registration letter status
registered for local a. Brief report of last manufactured batch (for
manufacture or import. locally manufactured drugs).
b. DRAP’s attested import invoice (for
imported products).
7. Patent number in Pakistan a. Furnish information if any.
& its expiry date.
8. Name of the registered a. Attested copy of last submitted renewal
drug with its registration application along with fee or renewal
number and date of initial certificate (if any).
registration and last
renewal.
9. Changes, if any, in Any post registration variation since grant of
information furnished at the registration including but not limited to
time of initial registration following
or last renewal. i) Change of brand name
ii) Change of manufacturing site (local as well
as manufacturer abroad)
iii) Change of manufacturer name/title (local as
well as manufacturer abroad)
iv) Registration from contract manufacturing to
their own facility.
v) Change in official specification
(Pharmacopeial specification if available)
vi) Change in prescribed information leaflet.
vii) Any other change relevant to finished
pharmaceutical product (Container Closure
System etc.)
10. If withdrawn from the a. Document confirming status (withdrawal) of The Point (a) & (b)
market anywhere: product by reference regulatory authorities. may be deleted as same
(i) The name of the b. If not withdrawn from the market, the same data may verified and
country; and should be asked from the firm along with compiled by DRAP
(ii) The reasons thereof. undertaking that the product was not instead of asking from
withdrawn/never withdrawn. manufacturer/Importer.
11. UNDERTAKING a. Attested copy of DRAP’s approval for The information
I/We hereby undertake that Production Manager and Quality Control regarding Point (a) &
the above given Manager. (b) may be obtained
information is true and b. Attested copy of application submitted in from Licensing
correct to the best of our DRAP for approval of Production Manager Division.
knowledge and belief. and Quality Control Manager (if above
Production Manager……… document is not available).
Quality Control Manager
…………………………..
The RRR section was also advised to segregate the above SOP for imported and locally
manufactured drugs. The revised SOP are detailed as under:
REVISED SOP FOR RENEWAL OF REGISTERED DRUGS

i. Locally manufactured drugs
S. Form 5-B Rule 26 (3A) Documents required to be submitted with Form 5B
No.
1. I / We……….of a. Covering letter on applicant‟s letter head for renewal of registered
………….hereby apply for drug along with Form 5-B and prescribed fee (endorsed by DRAP’s
renewal of registration of the Budget & Accounts Division). This will be submitted in DRAP’s
drug, namely R&I Section.
…………….details of which b. Signature on the covering letter and undertaking on Form 5-B
are enclosed. Date should be from Chief Executive Officer/ Managing Director /
…………Signed …………. Director / Authorized Officer not below the manager level.
th
| 687
Place ... ………… c. An undertaking that the applied products has never been de-
registered.
d. An undertaking that submitted documents are true copy of the
originals and that, if at any stage any discrepancy / misinformation
is detected / observed the firm/company will be held responsible as
per relevant laws.
e. Authority letter shall be submitted along with application. f. Copy
of NOC of Central Research Fund (CRF) as required by Budget &
Accounts Division
2. Brand (Proprietary) name of Attach attested copy of registration letter and change in brand name
the drug. letter (if any).
3. Strength of active Furnish information of approved strength as per valid registration letter
ingredient(s)
4. Name and address of the As per Drug Manufacturing License (DML)
manufacturer
5. Name and address of the Furnish information if any
agent or indenter in case of
imported drug
6. Whether the drug is Brief report of last manufactured batch.
registered for local
manufacture or import.
7. Patent number in Pakistan & Furnish information if any.
its expiry date.
8. Name of the registered drug Attested copy of last submitted renewal application along with fee or
with its registration number renewal certificate (if any).
and date of initial registration
and last renewal
9. Changes, if any, in Any post registration variation since grant of registration including but
information furnished at the not limited to following
time of initial registration or i) Change of brand name
last renewal. ii) Change of manufacturing site (local as well as manufacturer abroad)
iii) Change of manufacturer name/title (local as well as manufacturer
abroad)
iv) Registration from contract manufacturing to their own facility.
v) Change in official specification (Pharmacopeial specification if
available)
vii) Any other change relevant to finished pharmaceutical product
(Container closure system etc.)
10. If withdrawn from the market Furnish information if any.
anywhere:
(i) The name of the
country; and
(ii) The reasons thereof.
11. UNDERTAKING
I/We………………….hereby
undertake that the above
given information is true and
correct to the best of our
knowledge and belief.
Production Manager…….…
Quality Control Manager ......
ii. Imported Drugs
S. Form 5-B Rule 26 (3A) Documents required to be submitted with Form 5B

No.
1. I/We…………..…….of a. Covering letter on applicant‟s letter head for renewal of registered
………….hereby apply drug along with Form 5-B and prescribed fee (endorsed by DRAP‟s
for renewal of registration Budget & Accounts Division). This will be submitted in DRAP‟s R&I
of the drug, namely Division.
…………….details of
b. Signature on the covering letter and undertaking on Form 5-B should
which are enclosed. be from Chief Executive Officer/ Managing Director / Director /
Date………….………… Authorized Officer not below the manager level.
Signed…………………. c. An undertaking that the applied products has never been de-registered.
Place………...................d. An undertaking that submitted documents are true copy of the
originals and that, if at any stage any discrepancy / misinformation is
detected / observed the firm/company will be held responsible as per
relevant laws.
e. Authority letter shall be submitted along with application. f. Copy of
NOC of Central Research Fund (CRF) as required by Budget &
Accounts Division.
2. Brand (Proprietary) name Attach attested copy of registration letter and change in brand name letter
of the drug. (if any).
3. Strength of active Furnish information of approved strength as per valid registration letter
ingredient(s)
4. Name and address of the a. Attested copy of valid Drug Sale License (for imported drugs)
manufacturer b. Legalized CoPP as per WHO‟s format or legalized free sale certificate
and GMP certificate (for imported products).
5. Name and address of the Furnish information if any
agent or indenter in case
of imported drug
6. Whether the drug is DRAP‟s attested import invoice.
registered for local
manufacture or import.
7. Patent number in Pakistan Furnish information if any.
& its expiry date.
8. Name of the registered Attested copy of last submitted renewal application along with fee or
drug with its registration renewal certificate (if any).
number and date of initial
registration and last
renewal
9. Changes, if any, in Any post registration variation since grant of registration including but not
information furnished at limited to following
the time of initial i) Change of brand name
registration or last ii) Change of manufacturing site (local as well as manufacturer
renewal. abroad)
iii) Change of manufacturer name/title (local as well as manufacturer
abroad)
iv) Registration from contract manufacturing to their own facility.
v) Change in official specification (Pharmacopeial specification if
available)
vii) Any other change relevant to finished pharmaceutical product
(Container closure system etc.)
10. If withdrawn from the Furnish information if any.
market anywhere:
(i) The name of the
country; and
(ii) The reasons thereof.
11. UNDERTAKING
I/We……………..hereby
undertake that the above
given information is true
and correct to the best of
our knowledge and belief.
Production Manager……
Quality Control Manager
…………………………..
Decision: Registration Board approved the above SOP’s for onward processing the
renewal application. The same may be uploaded on DRAP website and
will be communicated to concerned quarters for compliance.
Case No.113: Finished Product Specifications

It is observed that finished product specifications are not mentioned on
registration letters most of which were issued before establishment of Drug Regulatory
Authority of Pakistan. Registration Board decided that pharmacopeial specifications shall be
mentioned on the registration letter if available in any of the reference pharmacopeia and
Innovator Specification shall be granted to all those formulations which are not available in
reference pharmacopeia.
Therefore, in such case we may ask the firms to provide the reference of
pharmacopeial specifications for all those case approved by the board before issuance of
renewal letter and if such formulation are not available in pharmacopeia, Innovator specs may
be incorporated in the letter.
The above matter was discussed in the 284th meeting of Registration Board wherein it
was deferred for deliberations in forthcoming meeting.
Decision: Registration Board deferred the case for further deliberation in
forthcoming meeting.
Case No:114: Non available registered formulations in reference drug agencies.

It is submitted that Registration Board in its various meetings approved the
reference drugs agencies regarding the registration of generic drug products in the country.
The formulations which are approved in the said agencies are only considered by the Board
for grant of marketing authorization and the applications of those formulations which are not
approved in reference agencies are being rejected by the Board.
It has been observed while scrutinizing the applications of renewal of registered drugs
that number of previously registered formulations are not approved in the reference drug
agencies. Therefore the guidance is required from the Board regarding the disposal of such
registered drugs.
Decision: The task to identify such molecules which are not approved in the
reference regulatory agencies is assigned to Pharmaceutical Evaluation
Cell (PEC) and Renewal Section will work in line with PEC. Cases will be
kept pending till the decision of Board in such matters.
Case No.115: Renewal applications of local manufacturers (human) evaluated as per
SOP approved by Registration Board.
Date of
Brand Name, Composition Initial date of application
Sr. No Reg. No. Renewal validity Validity
& Specification Registration (R&I)
Fee submitted
i. M/s Faas Pharmaceuticals Pvt Limited, F-748L S.I.T.E., Karachi
1. 073840 Airy 5mg Tablet 27-3-2013 Dy. No. 26-3-2023 w.e.f. 27-03-2018
Each chewable tablet 10531 dated to 26-03-2023.
contains: Change of 21-3-2018
Montelukast brand name: 10000/-
Sodium……5mg 09-01-2018
(Manufacturer’s
Specification)
2. 073841 Airy 10mg Tablet 27-3-2013 Dy. No. 26-3-2023 w.e.f. 27-03-2018
Montelukast brand name: 10000
Sodium……10mg 09-01-2018
(Manufacturer’s
Specification)
3. 073842 Des-OD 5mg Tablet 27-3-2013 Dy. No. 26-3-2023 w.e.f. 27-03-2018
Each film coated tablet 10531 dated to 26-03-2023.
Desloratadine…5mg brand name: 10000
(Manufacturer’s 09-12-2014
Specification)
4. 073843 Winloxine 400mg 27-3-2013 Dy. No. 26-3-2023 w.e.f. 27-03-2018
Tablet 10531 dated to 26-03-2023.
Each film coated tablet Change of 21-3-2018
contains: brand name: 10000
Moxifloxacin as 09-12-2014
HCl…….400mg
(Manufacturer’s
Specification)
5. 073844 Fasofenac 100mg Tablet 27-3-2013 Dy. No. 26-3-2023 w.e.f. 27-03-2018
contains: 21-3-2018
Moxifloxacin as 10000
HCl…….400mg
(Manufacturer’s
Specification)
6. 073845 Fastcure 150mg Capsule 27-3-2013 Dy. No. 26-3-2023 w.e.f. 27-03-2018
contains: 21-3-2018
Iron Polymaltose 10000
Complex eq. to
elemental Iron...150mg
(Manufacturer’s
Specification)
7. 073840 Airy Sachet 4mg 27-3-2013 Dy. No. 26-3-2023 w.e.f. 27-03-2018
Montelukast as brand name: 10000/-
Sodium……5mg 13-02-2018
(Manufacturer’s
Specification)
ii. M/s Martin Dow Marker Limited (Formerly Merck Pvt Limited), 7-Jail Road, Quetta
8. 047230 Glioptim 1mg Tablet 19-11-2007 Dy. No. 02-04-2023 w.e.f. 03-04-
Each tablet contains: Change of 10816 2018 to 02-04-
Glimepiride……1mg brand name dated 22-3- 2023
(Manufacturer dated: 31-12- 2018
Specification) 2007 10000/-
Transfer of
Registration
Dated:
03-04-2008
9. 047231 Glioptim 2mg Tablet 19-11-2007 Dy. No. 02-04-2023 w.e.f. 03-04-2018
Each tablet contains: 10817 to 02-04-2023
Glimepiride……2mg Change of dated 22-3-
(Manufacturer brand name 2018
Specification) dated: 31-12- 10000/-
2007
Transfer of
Registration
Dated:
03-04-2008
Each tablet contains: 10818 to
Glimepiride……3mg Change of dated 22-3- 02-04-2023
(Manufacturer brand name 2018
Specification) dated: 31-12- 10000/-
2007
Transfer of
Registration
Dated:
03-04-2008
Each tablet contains: Change of 10819 to
Glimepiride……4mg brand name dated 22-3- 02-04-2023
(Manufacturer dated: 31-12- 2018
Specification) 2007 10000/-
Transfer of
Registration
Dated:
03-04-2008
12. 047222 Tizorel 2mg tablet 17-11-2007 Dy. No. 02-04-2023 w.e.f. 03-04-2018
Each tablet contains: Transfer of 10820 dated to
Tizanidine (as Registration 22-3-2018 02-04-2023
hydrochloride)…2mg Dated: 10000/-
Specification)
13. 047223 Tizorel 4mg tablet 17-11-2007 Dy. No. 02-04-2023 w.e.f. 03-04-2018
Tizanidine (as Registration 22-3-2018 02-04-2023
hydrochloride)…4mg Dated: 10000/-
Specification)
14. 047317 Fopsec Tablet 10mg 5-12-2007 Dy. No. 02-04-2023 w.e.f. 03-04-2018
Atorvastatin ( as Registration 22-3-2018 02-04-2023
calcium Dated: 10000/-
trihydrate)….10mg 03-04-2008
(Manufacturer’s
Specification)
(Manufacturer’s
Specification)
(Manufacturer’s
Specification)
17. 075959 Laxoberon Drops 30-05-2013 Dy. No. 29-05-2023 w.e.f. 30-05-2018
Each ml contains: 14425 dated to 29-05-2023
Sodium picosulphate 18-4-2018
monohydrate
BP….7.5mg
(BP Specification)
18. 050360 Pailet Tablets 04-08-2008 Dy. No. 03-08-2023 w.e.f. 04-08-2018
Each film coated tablet 14420 dated to 03-08-2023
contains: 18-4-2018
Clopidogrel (as
bisulfate) USP
Specification
19. 048579 Psyper Tablets 3mg 03-05-2008 Dy. No. 02-05-2023 w.e.f. 03-05-2018
Each tablet contains: 14427 dated to 02-05-2023
Risperidone ……3mg 18-4-2018
(Manufacturer specs)
22. 075906 Cosome DA Cough 08-05-2008 Dy. No. Deferred for the
Syrup 14422 dated approval status in
Each 5ml contains: 18-4-2018 reference
Acefylline regulatory agencies
piperazine…..45mg
Diphenhydramine
Hydrochloride……8mg
(Manufacturer
specification)
iii. M/s Nabiqasim Industries (Private) Limited, 17/24 Korangi Industrial Area, Karachi
23. 075863 Fanart DS Suspension 18-4-2013 Dy. No. 17-04-2023 w.e.f. 18-04-2018
Each 5ml contains: 11437 dated to 17-04-2013
Artemether……30mg 28-3-2018
Lumefantrine…180mg 10000/-
(Manufacturer
Specification)
24. 075864 Savol Syrup 18-4-2013 Dy. No. 17-04-2023 w.e.f. 18-04-2018
Carbocisteine….100mg 28-3-2018
(Mfg. Specification) 10000/-
25. 075865 Vicomid 200mg Tablets 18-4-2013 Dy. No. 17-04-2023 w.e.f. 18-04-2018
contains: 28-3-2018
Lacosamide ….200mg 10000/-
(Manufacturer
Specification)
contains: 28-3-2018
(Manufacturer
Specification)
contains: 28-3-2018
(Manufacturer
Specification)
contains: 28-3-2018
(Manufacturer
Specification)
29. 000922 Lumether Tablet 29-4-2008 Dy. No. 28-04-2023 w.e.f 29-04-2018
-EX Each Tablet contains: 11437 dated to 28-04-2023
Lumefantrine….120mg 10000/-
NQ’s Specs.
iv. M/s Nawan Laboratories Pvt Limited, 136 Sector 15, KIA Karachi
30. 030020 Nafradin Injection 1gm 12-3-2003 Dy. No. 8596 11-03-2023 w.e.f 12-03-2018
Each vial contains: dated 07-3- to 11-03-2023
Cephradine (as sterile 2018
Cephradine ) USP…1g 10000/-
Arginine sterile..0.600g
31. 030019 Nafradin Injection 12-3-2003 Dy. No. 8596 11-03-2023 w.e.f 12-03-2018
500gm dated 07-3- to 11-03-2023
Each vial contains: 2018
Cephradine (as sterile 10000/-
Cephradine) USP
………….500mg
Arginine sterile
………..300mg
32. 030018 Nafradin Injection 12-3-2003 Dy. No. 8596 11-03-2023 w.e.f 12-03-2018
250mg dated 07-3- to 11-03-2023
Cephradine (as sterile 10000/-
Cephradine )
USP……250mg
Arginine sterile
………..150mg
v. M/s Pharmatec Pakistan (Private) Limited, D-86/A, S.I.T.E., Karachi
33. 004097 Duplazin Syrup 04-04-2013 Dy. No. 03-04-2023 w.e.f 04-04-2018
-EX Each 5ml contains: 11058 dated to 03-04-2023
Salbutamol (as 26-03-2018
sulphate)…….1mg 10000/-
Bromhexine HCl….2mg
Guaiphenesin….50mg
34. 004098 Fludol Capsule 04-04-2013 Dy. No. 03-04-2023 w.e.f 04-04-2018
-EX Each capsule contains: 11058 dated to 03-04-2023
Paracetamol…..300mg 26-03-2018
Phenylephrine HCl 10000/-
……5mg
Chlorpheniramine
Maleate …….4mg
Caffeine anhydrous
….30mg
35. 004099 Fludol P+ Syrup 04-04-2013 Dy. No. 03-04-2023 w.e.f 04-04-2018
Phenylephrine HCl 10000/-
……5mg
Chlorpheniramine
Maleate …….1mg
vi. M/s Atco Laboratories Limited, B-18 S.I.T.E., Karachi
36. 075947 Atcomid 50mg Tablet 30-5-2013 Dy. No. 29-05-2023 w.e.f 30-05-2018
Each film coated tablet 14738 dated: to 29-05-2023
contains: 20-4-2018
Lacosamide…..50mg
(Manufacturer
specification)
contains: 20-4-2018
Lacosamide…..100mg
(Manufacturer
specification)
Each film coated tablet 14738 to 29-05-2023
contains: dated:20-4-
Lacosamide….150mg 2018
(Manufacturer
specification)
contains: 20-4-2018
Lacosamide….200mg
(Manufacturer
specification)
40. 048591 Phenobarb Injection 6-5-2008 Dy. No. 05-05-2023 w.e.f 06-05-2018
Each ml contains: 14738 to 05-05-2023
Phenobarbital…130mg dated:20-4-
(USP) 2018
41. 048590 Addfer Syrup 6-5-2008 Dy. No. 05-05-2023 w.e.f 06-05-2018
Each 5ml contains: 14739 dated: to 05-05-2023
Elemental Iron (as Iron 20-4-2018
III Hydroxide
Polymaltose Complex)
……50mg
(USP Specification)
42. 021669 Clobederm NN 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018
Ointment contains: 14739 dated: to 19-05-2023
Clobetasol 20-4-2018
Propionate..0.05% w/w
Neomycin
Sulphate….0.5% w/w
Nystatin Micronized
…100,000Units
43. 021670 Clobederm E Cream 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018
contains: 14739 to 19-05-2023
Clobetasol Propionate dated:20-4-
…..0.05% w/w 2018
44. 021670 Clobederm Ointment 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018
contains: 14739 dated: to 19-05-2023
Clobetasol Propionate 20-4-2018
…..0.05% w/w
45. 000897 Clobetsonate Ointment 3-4-2008 Dy. No. 02-04-2023 w.e.f 03-04-2018
-EX Ointment contains: 14739 dated: to 02-04-2023
Clobetasol Propionate 28-3-2018
BP………0.05%
46. 000900 Zincviet Dry Suspension 3-4-2008 Dy. No. 02-04-2023 Deferred for
-EX Each 5ml contains: 14739 dated: clarification of
Elemental Zinc (as zinc 28-3-2018 formulation by the
sulphate monohydrate firm.
USP)……….10mg
47. 000893 Atcobeta S Ointment 3-4-2008 Dy. No. 02-04-2023 w.e.f 03-04-2018
-EX Each 100gm contains: 14739 dated: to 02-04-2023
Betamethasone as 28-3-2018
dipropionate
………0.05% w/w
Salicylic acid
…….….3.00 w/w %
48. 000894 Atcobeta N Ointment 3-4-2008 Dy. No. 02-04-2023 w.e.f 03-04-2018
-EX Each 100gm contains: 14739 dated: to 02-04-2023
Betamethasone 17 28-3-2018
Valerate…0.122gm
Miconazole Nitrate
USP………2gm
Neomycin sulphate
BP…….0.5gm
49. 000894 Atcobeta N Drops 3-4-2008 Dy. No. 02-04-2023 w.e.f 03-04-2018
-EX Each 100ml contains: 14739 dated: to 02-04-2023
Betamethasone sodium 28-3-2018
Phosphate….0.1w/v %
Neomycin sulphate
BP…….0.5gm
vii. M/s LINZ Pharmaceuticals (Pvt) Limited, Plot No. 31-G/H , Sector 15, Korangi Industrial
Area, Karachi
50. 050621 Lizobal 500mcg Tablet 12-9-2008 Dy. No. 11-9-2023 w.e.f 12-09-2018
Each tablet contains: 12214 dated to 11-09-2023 with
Mecobalamin..500mcg 03-04-2018 correction of
(Manufacturer’s 10000/- description as per
Specification) formulation
approved in
reference agencies.
51. 053426 Osolinz Tablet 23-12-2008 Dy. No. Deferred for
Each tablet contains: 12214 dated submission of
Alfacalcidol….0.5mcg 03-04-2018 manufacturing
(BP Specification) 10000/- process by firm.
52. 053428 Vocit 5mg Tablet 23-12-2008 Dy.No.12214 22-12-2023 w.e.f 23-12-2018
Each tablet contains: 03-04-2018 to 22-12-2023.
Levocetirizine HCl..5mg 10000/-
53. 053429 Surid 1mg Tablet 23-12-2008 Dy. No. 22-12-2023 w.e.f 23-12-2018
Each tablet contains: 12214 dated to 22-12-2023.
Glimepiride……..1mg 03-04-2018
10000/-
10000/-
10000/-
10000/-
viii. M/s PharmEvo (Private) Limited, A-29 North Western Industrial Zone, Port Qasim
Karachi
57. 004056 Trixafin 250mg IM 12-3-2013 Dy. No. 7932 11-03-2023 w.e.f 12-03-2018
-EX Injection dated to 11-03-2023
Each vial contains: 01-03-2018
Ceftriaxone
Sodium……250mg
58. 004057 Trixafin 500mg IM 12-3-2013 Dy. No. 7932 11-03-2023 w.e.f 12-03-2018
-EX Injection dated 01-03- to 11-03-2023
Ceftriaxone
Sodium……500mg
59. 004058 Trixafin 1g IM Injection 12-3-2013 Dy. No. 7932 11-03-2023 w.e.f 12-03-2018
-EX Each vial contains: dated 01-03- to 11-03-2023
Ceftriaxone 2018
Sodium……1g
60. 004059 Trixafin 250mg IV 12-3-2013 Dy. No. 7932 11-03-2023 w.e.f 12-03-2018
Ceftriaxone
Sodium……250mg
61. 004060 Trixafin 500mg IV 12-3-2013 Dy. No. 7932 11-03-2023 w.e.f 12-03-2018
Ceftriaxone
Sodium……500mg
62. 004061 Trixafin 1g IV Injection 12-3-2013 Dy. No. 7932 11-03-2023 w.e.f 12-03-2018
-EX Each vial contains: dated 01-03- to 11-03-2023
Ceftriaxone 2018
Sodium……1g
ix. M/s S.J. & G. Fazul Ellahie (Pvt) Limited, E/46 S.I.T.E Karachi
63. 021706 Dinofac Injection 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018
Each 3ml contains: Change of 14019 dated to 19-05-2023
Diclofenac brand name 13-4-18
sodium……75mg 22-4-1999
64. 021708 Rexaphenicol Eye 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018
Drops 14019 dated to 19-05-2023
Each 100ml contains: 13-4-18
Chloramphenicol..0.5g
65. 021709 Rexaphenicol Ear Drops 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018
Chloramphenicol…..1 13-4-18
66. 021710 Tamycin Eye/ Ear Drops 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018
Gentamycin as 13-4-18
sulphate….0.3gm
67. 000962 Hepeta Tablet 10-5-2008 Dy. No. 09-05-2023 w.e.f 10-05-2018
-EX Each tablet contains: 15278 dated to 09-05-2023
Adefovir Dipivoxil.10mg 24-4-2018
68. 000963 Korel Syrup 10-5-2008 Dy. No. 09-05-2023 w.e.f 10-05-2018
Iron (III) Hydroxide 24-4-2018
Polymaltose Complex
eq. to elemental Iron
….50mg
x. M/s Uni-Tech Pharmaceuticals Pvt Limited Plot No. 4/ 116, Sector 21, Korangi Industrial
Area Karachi
69. 000961 U-Viagra Tablet 100mg 10-5-2008 Dy. No. Deferred for
-Ex Each tablet contains: 15922 dated confirmation of
Sildenafil as 27-4-2018 registration status
citrarte………100mg 10000/- by the concerned
section.
xi. M/s ZAFA Pharmaceutical Laboratories (Private) Limited Karachi
70. 004138 Hydralazine HCl 02-07-2013 Dy. No. 01-07-2023 w.e.f 02-07-2018
-EX Tablets 15277 dated to 01-07-2023
Each tablet contains: 24-4-2018
Hydralazine HCl
USP……..50mg
xii. M/s. P.D.H. Pharmaceuticals (Pvt) Ltd., 19-K.m, Ferozepur Road, Lahore.
71. 029334 Myclar Tablet 500mg 03-03-2003 02-03-2018 02-03-2023 w.e.f 03-03-2018 to
Each tablet contains:- Dy. No. 7937 02-03-2023 with
Clarithromycin … dated 01-03- correction of
500mg 2018 description of
formulation as per
10000/- reference agencies
72. 029335 Myclar Suspension Do Do Do Deferred for
125mg clarification of pellets
Each 5ml contains:- source by the firm.
Clarithromycin..125mg
73. 029336 Myclar XL Tablet Do Do Do Deferred for
500mg clarification of
Each tablet contains:- formulation in
Clarithromycin..500mg reference agencies.
xiii. M/s. Saffron Pharmaceuticals (Pvt.) Ltd., 19-Km, Sheikhupura Road, Faisalabad.
74. 074400 Rostor 20mg Tablet 02-04-2013 01-04-2018 01-04-2023 w.e.f 02-04-2018 to
Each tablet contains:- Dy. No. 8057 01-04-2023
Rosuvastatin as 02-03-2018
Calcium … 20mg 10000/-
75. 074401 Doxolin Syrup 02-04-2013 01-04-2018 01-04-2023 w.e.f 02-04-2018 to
Each 5ml contains:- Dy. No. 8057 01-04-2023
Doxofylline … 100mg 02-3-2018
10000/-
76. 074402 Doxolin 400mg Tablet 02-04-2013 01-04-2018 01-04-2023 w.e.f 02-04-2018 to
Doxofylline … 400mg 02-03-2018
10000/-
77. 074403 Safart Tablet 02-04-2013 01-04-2018 01-04-2023 w.e.f 02-04-2018 to
Artemether … 80mg 02-03-2018
78. 074404 Safart Tablet 02-04-2013 01-04-2018 01-04-2023 w.e.f 02-04-2018 to
Artemether … 40mg dated 02-03-
Lumefantrine… 2018
240mg 10000/-
th
| 698
79. 074405 Safart Suspension 02-04-2013 01-04-2018 01-04-2023 w.e.f 02-04-2018 to
80. 074406 Safart Suspension 02-04-2013 01-04-2018 01-04-2023 w.e.f 02-04-2018 to
Lumefantrine … 90mg 10000/-
xiv. M/s. Himont Pharmaceuticals (Pvt) Ltd., 17-K.m Ferozpur Road, Lahore.
81. 021714 HI-Cobal Tablet 20-05-1998 19-05-2018 19-05-2023 w.e.f 20-05-2018 to
Mecobalamine … 01-03-2018
500mcg 10000/-
82. 049038 Hizac Syrup 05-03-2008 04-03-2018 04-03-2023 w.e.f 05-03-2018 to
Fluoxetine (as HCl) … 01-03-2018
20mg 10000/-
(USP)
83. 049087 Montelair Chewable 18-03-2008 17-03-2023 17-03-2023 w.e.f 18-03-2018 to
Tablet Dy. No. 7938 17-03-2023
Each chewable tablet dated 01-03-
contains:- 2018
Montelukast as
Sodium … 5mg 10000/-
(Himont’s Specs)
84. 049159 Faxon Tablet 50mg 15-04-2008 14-04-2018 14-04-2023 w.e.f 15-04-2018 to
Venlafaxine (as HCl) dated 01-03-
… 50mg 2018
(BP) 10000/-
85. 030499 Pamaryl Tablet 1mg 19-05-2003 18-05-2018 18-05-2023 w.e.f 19-05-2018 to
Glimepiride … 1mg 01-03-2018
10000/-
86. 030500 Pamaryl Tablet 2mg Do Do Do w.e.f 19-05-2018 to
Each tablet contains:- 18-05-2023
Glimepiride … 2mg
Glimepiride … 3mg
Glimepiride … 4mg
89. 019152 Sefoban Injection 1gm 24-04-1996 26-05-2018 26-05-2023 w.e.f 27-05-2018 to
Each vial contains:- Change of Dy. No. 7938 26-05-2023
Cefotaxime Sodium … brand name dated 01-03-
1gm USP dated 2018
11-07-1996
Transfer of 10000/-
Reg. dated
27-05-2003
90. 019153 Sefoban Injection Do Do Do w.e.f 27-05-2018 to
500mg 26-05-2023
Cefotaxime Sodium …
0.5gm USP
91. 015858 Sefoban Injection Transfer of Do Do w.e.f 27-05-2018 to
250mg Reg. dated 26-05-2023
Each vial contains:- 27-05-2003
Cefotaxime Sodium …
.025g
92. 019154 Novosef Injection I.V. 24-04-1996 26-05-2018 26-05-2023 w.e.f 27-05-2018 to
500mg Transfer of Dy. No. 7938 26-05-2023
Each vial contains:- Reg. dated dated 01-03-
Ceftriaxone Sodium … 27-05-2003 2018
500mg USP 10000/-
93. 019155 Novosef Injection I.M. Do Do Do w.e.f 27-05-2018 to
500mg 26-05-2023
Ceftriaxone Sodium …
500mg USP
94. 019156 Novosef Injection I.V. Do Do Do w.e.f 27-05-2018 to
1gm 26-05-2023
Ceftriaxone Sodium …
1gm USP
95. 019157 Novosef Injection I.M. Do Do Do w.e.f 27-05-2018 to
1gm 26-05-2023
Ceftriaxone Sodium..1g
96. 021699 Novosef 250mg I.M 20-05-1998 Do Do w.e.f 27-05-2018 to
Injection Transfer of 26-05-2023
Each vial contains:- Reg. dated
Ceftriaxone Sodium 27-05-2003
eq. to Ceftriaxone …
250mg
97. 021700 Novosef 250mg I.V Do Do Do w.e.f 27-05-2018 to
Injection 26-05-2023
Ceftriaxone Sodium
eq. to Ceftriaxone …
250mg
98. 076852 Viferol Ampoules 21-05-2013 20-05-2018 20-05-2023 w.e.f 21-05-2018 to
Each ml contains:- Dy. No. 7938 20-05-2023
Vitamin D3 … 5MG dated 01-03-
(Cholecalciferol- 2018
200,000 I.U.)
(Himont’s Specs) 10000/-
99. 076853 Antiprosis Sachets Do Do Do w.e.f 21-05-2018 to
Each sachet contains:- 20-05-2023
Strontium Ranelate …
2g
(Himont’s Specs)
100. 076854 Cardiosil Plus Tablet 21-05-2013 Do Do w.e.f 21-05-2018 to
5mg/160mg Change of 20-05-2023
Each film coated tablet brand name
contains:- dated
Amlodipine … 5mg 22-07-2015
Valsartan … 160mg
(Himont’s Specs)
101. 076855 Cardiosil Plus Tablet Do Do Do w.e.f 21-05-2018 to
5mg/80mg 20-05-2023
Each film coated tablet
contains:-
Amlodipine … 5mg
Valsartan … 80mg
(Himont’s Specs)
102. 076856 Cardiosil Plus Tab Do Do Do w.e.f 21-05-2018 to
10mg/160mg 20-05-2023
contains:-
Amlodipine … 10mg
Valsartan … 160mg
(Himont’s Specs)
103. 076857 Gliptin Tablet 50mg 21-05-2013 Do Do w.e.f 21-05-2018 to
Sitagliptin Phosphate
Monohydrate eq. to
Sitagliptin … 50mg
(Himont’s Specs)
104. 076858 Gliptin Tablet 100mg Do Do Do w.e.f 21-05-2018 to
Monohydrate eq. to
(Himont’s Specs)
105. 076859 Gliptin Tablet 25mg Do Do Do w.e.f 21-05-2018 to
Monohydrate eq. to
(Himont’s Specs)
106. 076860 Gliptin Plus Tablet Do Do Do w.e.f 21-05-2018 to
Monohydrate eq. to
Metformin HCl …
500mg
(Himont’s Specs)
107. 076861 Gliptin Plus Tablet Do Do Do w.e.f 21-05-2018 to
Monohydrate eq. to
Metformin HCl …
1000mg
(Himont’s Specs)
108. 076862 Rosocard Tablet Do Do Do w.e.f 21-05-2018 to
Rosuvastatin (as
Calcium) … 40mg
(Himont’s Specs)
Rosuvastatin (as
Calcium) … 10mg
(Himont’s Specs)
Rosuvastatin (as
Calcium) … 20mg
(Himont’s Specs)
Rosuvastatin (as
Calcium) … 5mg
(Himont’s Specs)
112. 076866 Hiconate Tab 150mg Do Do Do w.e.f 21-05-2018 to
Ibandronic Acid (as
Ibandronate Sodium)
… 150mg
(Himont’s Specs)
113. 076876 Rozilin Capsule 30-05-2013 29-05-2018 29-05-2023 w.e.f 30-05-2018 to
Each capsule Dy. No. 7938 29-05-2023
contains:- dated 01-03-
Cefprozil … 500mg 2018
(Himont’s Specs) 10000/-
114. 076877 Rozilin Capsule Do Do Do w.e.f 30-05-2018 to
Each capsule 29-05-2023
contains:-
Cefprozil … 250mg
(Himont’s Specs)
115. 076878 Loxadril Capsule Do Do Do w.e.f 30-05-2018 to
contains:-
Cefadroxil (as
Monohydrate)...500mg
(USP Specs)
116. 076879 Loxadril Capsule Do Do Do w.e.f 30-05-2018 to
contains:-
Cefadroxil (as
Monohydrate)..1000mg
(USP Specs)
117. 076880 Xesafin Dry Do Do Do w.e.f 30-05-2018 to
Suspension 29-05-2023
Each 5ml contains:-
Cephalexin (as
Monohydrate)…250mg
(USP Specs)
118. 076881 Rozilin Suspension Do Do Do w.e.f 30-05-2018 to
Each 5ml contains:- 29-05-2023
Cefprozil … 250mg
(USP Specs)
119. 076882 Loxadril Suspension Do Do Do w.e.f 30-05-2018 to
Cefadroxil (as
(USP Specs)
120. 076883 Rozilin Suspension Do Do Do w.e.f 30-05-2018 to
Cefprozil … 125mg
(USP Specs)
121. 076884 Loxadril Drops Do Do Do Deferred for approval
Each 10ml contains:- status in reference
Cefadroxil (as regulatory agencies.
Monohydrate)..100mg
(Himont’s Specs)
122. 076885 Loxadril Suspension Do Do Do w.e.f 30-05-2018 to
250mg/5ml 29-05-2023
Each 5ml contains:-
Cefadroxil as
Monohydrate…250mg
(USP Specs)
123. 076886 Xesafin Capsule Do Do Do w.e.f 30-05-2018 to
contains:-
Cephalexin (as
(Himont’s Specs)
124. 076887 Xesafin Capsule Do Do Do w.e.f 30-05-2018 to
contains:-
Cephalexin (as
(Himont’s Specs)
125. 076888 Xesafin Drops Do Do Do Deferred for approval
Each 10ml contains:- status in reference
Cephalexin (as regulatory agencies.
(Himont’s Specs)
126. 076889 Xesafin Suspension Do Do Do w.e.f 30-05-2018 to
Cephalexin (as
(USP Specs)
xv. M/s. Paradise Pharma, 23-K.m Sheikhupura Road, Lahore.
127. 074319 Tincture Iodine 11-03-2013 10-03-2018 10-03-2023 Deferred for approval
External Preparation Dy. No. 8451 status in reference
Each 100ml contains:- dated 06-03- agencies.
Iodine … 2.5mg 2018
Potassium Iodide
………..2.5mg 10000/-
Deionised water..2.5ml
Ethanol 90% QS …
100ml
(Paradise’s Specs)
128. 074320 Hydrogen Peroxide Do Do Do w.e.f 11-03-2018 to
External Preparation 10-03-2023.
Each contains:-
Hydrogen peroxide …
20 volumes (6% w/v)
(Paradise’s Specs)
129. 074321 Glycerol Suppositories Do Do Do Deferred for approval
Each contains:- status in reference
Glycerin … 70% w/v agencies.
(USP Specs)
xvi. M/s. Benson Pharmaceuticals, Plot No. 119, Street No. 8, Sector, I-10/3, Industrial Area,
Islamabad.
130. 021569 Bepsin Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Each tablet contains:- Dy. No. 10813 DML from Licensing
Famotidine … 20mg 22-03-2018 Division
10000/-
131. 021570 Bepsin Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Famotidine … 40mg 22-03-2018 Division
10000/-
132. 021571 Bentoril-100 Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Captopril … 25mg 22-03-2018 Division
10000/-
133. 021576 Keygesic Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Diclofenac Potassium 22-03-2018 Division
… 50mg 10000/-
134. 021577 Keygesic Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Diclofenac Potassium 22-03-2018 Division
… 75mg 10000/-
135. 021584 Unitrate-20 Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Isosorbide mononitrate 22-03-2018 Division
… 20mg 10000/-
136. 021587 Cardi 50 Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Atenolol … 50mg 22-03-2018 Division
10000/-
137. 021591 Domotin Tablet 02-05-1998 01-05-2018 01-05-2023 Deferred for status of
Domperidone … 10mg 22-03-2018 Division
10000/-
138. 030458 Benicef Capsule 250mg 11-06-2003 10-06-2018 10-06-2023 Deferred for status of
Each capsule Dy. No. 10808 DML from Licensing
contains:- 22-03-2018 Division
Cephradine … 250mg 10000/-
139. 030459 Benicef Capsule 500mg 11-06-2003 10-06-2018 10-06-2023 Deferred for status of
140. 030460 Benicef Suspension 11-06-2003 10-06-2018 10-06-2023 Deferred for status of
125mg Dy. No. 10806 DML from Licensing
Each 5ml contains:- 22-03-2018 Division
141. 030461 Benicef Suspension 11-06-2003 10-06-2018 10-06-2023 Deferred for status of
250mg Dy. No. 10802 DML from Licensing
Each 5ml contains:- 22-03-2018 Division
142. 030462 Benifix Capsule 11-06-2003 10-06-2018 10-06-2023 Deferred for status of
Cefixime … 400mg 10000/-
143. 030463 Benifix Suspension 11-06-2003 10-06-2018 10-06-2023 Deferred for status of
Each 5ml contains:- Dy. No. 10827 DML from Licensing
Cefixime … 100mg 22-03-2018 Division
10000/-
xvii. M/s. Tagma Pharma (Pvt) Ltd., 12.5 K.m, Raiwind Road, Lahore.
144. 029867 Tagacit Tablet 12-03-2003 11-03-2018 11-03-2023 w.e.f 12-03-2018 to
Each tablet contains:- Dy. No. 8449 11-03-2023.
Cimetidine … 400mg 06-03-2018
10000/-
xviii. M/s. Biogen Pharma, 8 K.m, Chakbeli Road, Rawat.
145. 075323 Bidon 2mg Tablet 08-04-2013 07-04-2018 07-04-2023 w.e.f 08-04-2018 to
Each tablet contains:- Dy. No. 11672 07-04-2023.
Risperidone … 2mg 30-03-2018
(USP Specs) 10000/-
146. 075324 Bidon 3mg Tablet Do Do Do w.e.f 08-04-2018 to
Each tablet contains:- 07-04-2023 with
Risperidone … 3mg correction of
(USP Specs) description of
formulation as
approved in reference
agencies.
xix. M/s. Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi Industrial Area, Karachi
147. 048438 Normisar Plus Tablet 04-02-2008 03-02-2018 03-02-2023 w.e.f 04-02-2018 to
Each film coated tablet Dy. No. 3383 03-02-2023.
Telmisartan … 40mg 2018
Hydrochlorothiazide
… 12.5mg 10000/-
(Manufacturer’s Specs)
148. 000838- Rengat 250mg Tablet 22-02-2008 21-02-2018 21-02-2023 w.e.f 22-02-2018 to
EX Each film coated tablet Dy. No. 3383 21-02-2023
contains:- 25-01-2018
Clarithromycin … 10000/-
250mg
149. 000839- Rengat 125mg/5ml Do Do Do Deferred for
EX Suspension confirmation of
Each 5ml reconstituted source of granules by
suspension contains:- the firms.
Clarithromycin..125mg
150. 000840- Renapime 10mg Tablet Do Do Do w.e.f 22-02-2018 to
EX Each film coated tablet 21-02-2023
contains:-
Simvastatin … 10mg
xx. M/s. Ferozsons Laboratories Limited, Amangarh, Nowshera, Khyber Pakhtunkhwa.
151. 076805 Xolox Tablet 04-04-2013 03-04-2018 03-04-2023 w.e.f 04-04-2018 to
Each film coated tablet Dy. No. 10797 03-04-2023
contains:- 22-03-2018
Ribavirin …. 400mg 10000/-
xxi. M/s. Platinum Pharmaceuticals (Pvt) Ltd., A-20, North Western Industrial Zone, Bin
Qasim, Karachi.
152. 023028 Oligyn Vaginal Tablet 14-05-1999 01-05-2018 01-05-2023 w.e.f 02-05-2018 to
Each tablet contains:- Change of Dy. No. 14677 01-05-2023
Clotrimazole … brand name 19-04-2018
100mg 02-05-2003 10000/-
153. 023029 Oligyn-1 Vaginal Do Do Do w.e.f 02-05-2018 to
Tablet 500mg 01-05-2023
Clotrimazole… 500mg
154. 027690 Oligyn Vaginal Cream 19-07-2002 02-05-2018 02-05-2023 w.e.f 02-05-2018 to
Contains:- Change of Dy. No. 14677 01-05-2023
Clotrimazole … 2% brand name 19-04-2018
dated 10000/-
02-05-2003
155. 048586 Acelish 100mg Tablet 05-05-2008 04-05-2018 04-05-2023 w.e.f 05-05-2018 to
Each film coated tablet Dy. No. 14677 04-05-2023
Aceclofenac … 100mg 2018
(BP Specs) 10000/-
156. 048587 Alvigo 5mg Tablet Do Do Do w.e.f 05-05-2018 to
contains:-
Levocetirizine
Dihydrochloride eq. to
Levocetirizine … 5mg
157. 048588 Arbimox 400mg Do Do Do w.e.f 05-05-2018 to
Tablet 04-05-2023
contains:-
Moxifloxacin HCl eq.
to Moxifloxacin …
400mg
158. 021618 Fastaid Tablet 20-05-1998 19-05-2018 19-05-2023 w.e.f 20-05-2018 to
Each enteric coated Dy. No. 14677 19-05-2023
tablet contains:- 19-04-2018
Diclofenac Sodium …
75mg 10000/-
159. 021614 Prozyn 20mg Capsule Do Do Do w.e.f 20-05-2018 to
contains:-
Fluoxetine 22.36mg
eq. to Fluoxetine …
20mg
160. 022052 Hi-Paradent Do Do Do Deferred for approval
Toothpaste status of formulation
Contains:- in reference agencies.
Permethol … 0.25%
xxii. M/s. Aries Pharmaceuticals (Pvt) Ltd., 1-W, Industrial Estate Hayatabad, Peshawar
161. 076890 Omec 40mg Capsule 15-05-2013 14-05-2018 14-05-2023 w.e.f 15-05-2018 to
Each capsule delayed Dy. No. 10743 14-05-2023
release contains:- dated 22-03-
Omeprazole eneteric 2018
coated pellets eq. to
Omeprazole … 40mg 10000/-
Sourece of Pellets:
M/s. Vision
Pharmaceuticals Street
# 1, Plot # 224, I-10/3
Industrial Area,
Islamabad.
xxiii. M/s Zantock Pharmaceutical Laboratories, F/5, S.I.T.E., Hyderabad.
162. 076484 Zancpal Extra Tablet 06-06-2013 Dy. No. Deferred for the
Correction 14388 dated confirmation of GMP
Each tablet contains: in 17-4-2018 status for QA&LT
Paracetamol….500mg Registration Division.
Caffeine………..65mg No. dated: 20000/-
(Manufacturer 06-08-2014
Specification)
xxiv. M/s Pharmatec Pakistan (Private) Limited, D-86/A, S.I.T.E., Karachi
163. 021374 Harten 50 Tablets 20-5-1998 Dy. No. w.e.f 20- w.e.f 20-05-2018 to
Each tablet contains: 11058 dated 05-2018 to 19-05-2023
Atenolol………50mg 26-03-2018 19-05-2023
164. 021375 Harten 100 Tablets 20-5-1998 Dy. No. w.e.f 20- w.e.f 20-05-2018 to
Each tablet contains: 11058 dated 05-2018 to 19-05-2023
Atenolol………100mg 26-03-2018 19-05-2023
165. 075813 Leflotec 250mg Tablets 3-4-2013 Dy. No. 02-04-2023 w.e.f 03-04-2018 to
Each film coated tablet 11058 dated 02-04-2023
contains: 26-03-2018
Levofloxacin as 10000/-
hemihydrate…..250mg
166. 075814 Leflotec 500mg Tablets 3-4-2013 Dy. No. 02-04-2023 w.e.f 03-04-2018 to
Each film coated tablet 11058 dated 02-04-2023
Levofloxacin as 10000/-
hemihydrate…..500mg
(Manufacturer Specs)
167. 075815 Leflotec 500mg/ 100ml 3-4-2013 Dy. No. Deferred for
Infusion 11058 dated confirmation of
Each 100ml contains: 26-03-2018 approval of
Levofloxacin as 10000/- manufacturing facility
hemihydrate…500mg from Licensing
(Manufacturer Specs) Division as firm
informed that
manufacturing facility
is not available for the
said product.
168. 021379 Lonac 75 Tablets 20-05-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018 to
Each tablet contains: 11058 dated 19-05-2023
Diclofenac 26-03-2018
sodium………75mg 10000/-
169. 021376 Metbic 200mg Tablets 20-05-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018 to
Metronidazole 26-03-2018
…….200mg 10000/-
170. 021377 Metbic 400mg Tablets 20-05-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018 to
Metronidazole 26-03-2018
…….400mg 10000/-
171. 021378 Metbic Suspension 20-05-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018 to
Each 5ml contains: 11058 dated 19-05-2023
Metronidazole as 26-03-2018
benzoate …….200mg 10000/-
172. 075937 Namentec 10mg tablets 29-5-2013 Dy. No. 28-05-2023 w.e.f 29-05-2018 to
Memantine HCl...10mg 26-03-2018
(Manufacturer Specs) 10000/-
173. 004097 Duplazin Syrup 04-04-2013 Dy. No. 03-04-2023 w.e.f 04-04-2018 to
-EX Each 5ml contains: 11058 dated 03-04-2023
Salbutamol (as 26-03-2018
sulphate)…….1mg 10000/-
Bromhexine HCl..2mg
Guaiphenesin….50mg
174. 004098 Fludol Capsule 04-04-2013 Dy. No. 03-04-2023 w.e.f 04-04-2018 to
-EX Each capsule contains: 11058 dated 03-04-2023
Phenylephrine 10000/-
HCl……5mg
Chlorpheniramine
Maleate…….4mg
Caffeine
anhydrous….30mg
175. 004099 Fludol P+ Syrup 04-04-2013 Dy. No. 03-04-2023 w.e.f 04-04-2018 to
-EX Each 5ml contains: 11058 dated 03-04-2023
Phenylephrine 10000/-
HCl……5mg
Chlorpheniramine
Maleate…….1mg
xxv. M/s ZAFA Pharmaceutical Laboratories (Private) Limited Karachi
176. 006777 Debridate Tablets 20-6-1983 Dy. No. 19-06-2023 w.e.f 20-06-2018 to
Trimebutine 30-3-2018
Maleate……100mg
xxvi. M/s Sami Pharmaceuticals Pvt Limited, F-95, S.I.T.E., Karachi
177. 009743 Dicloran SR-100 08-05-1988 Dy. No. Deferred for
Tablets 11442 dated clarification of
Each sustained release Change of 28-3-2018 following:
tablet contains: brand name 10000/- a. Approval of
Diclofenac dated: 10- change of address
Sodium……100mg 01-1989 from concerned
section.
b. Submission of
differential fee for
regularization of
renewal of 2014.
c. Submission of
renewal
application in
2018 instead in
2019.
d. Approval of
blister packaging
and BP specs
from concerned
section.
178. 009744 Dicloran 50mg Tablets 08-05-1988 Dy. No. -do-
Each enteric coated Change of 11442 dated
tablet contains: brand name 28-3-2018
Diclofenac dated: 10- 10000/-
Sodium……50mg 01-1989
179. 009748 Dicloran 75mg 08-05-1988 Dy. No. Deferred for
Injection 11442 dated clarification of
Each 3ml contains: Change of 28-3-2018 following:
Diclofenac brand name 10000/- a. Approval of
Sodium……75mg dated: 10- change of address
01-1989 from concerned
section.
b. Submission of
differential fee for
regularization of
renewal of 2014.
c. Submission of
renewal
application in
2018 instead of
2019.
180. 009749 Pencit Injection 250mg 08-05-1988 Dy. No. Deregistered as
Each vial contains: 11442 dated requested by the firm.
Sterile Ampicillin 28-3-2018
Sodium BP equivalent 10000/-
to Anhydrous
Ampicillin…125mg
Sterile Cloxacillin
Sodium B.P. equivalent
to Anhydrous
Cloxacillin….125mg
181. 09778 Moxypen 250mg 08-05-1988 Dy. No. Deregistered as
Injection Change of 11442 dated requested by the firm.
Each vial contains: brand name 28-3-2018
Sterile Amoxicillin 10-01-1989 10000/-
Sodium equivalent to
Amoxicillin…..250mg
182. 021386 Pulsate 50mg 16-5-1998 Dy. No. Deferred for approval
Dispersible Pediatric 11442 dated of formulation in
Tablets 28-3-2018 reference drug
Each tablet contains: 10000/- agencies.
Roxithromycin
Ph.Eur……50mg
183. 021387 Samerol-N Tablets 16-5-1998 Dy. No. 15-05-2023 w.e.f 16-05-2018 to
Each tablet contains: 11442 dated 15-05-2023.
Orphenadrine 10000/-
citrate………..35mg
xxvii. M/s Nabiqasim Industries (Private) Limited, 17/24 Korangi Industrial Area, Karachi
184. 075863 Fanart DS Suspension 18-4-2013 Dy. No. 17-04-2023 w.e.f 18-04-2018 to
Each 5ml contains: 11437 dated 17-04-2023.
(Manufacturer
Specification)
185. 075864 Savol Syrup 18-4-2013 Dy. No. 17-04-2023 w.e.f 18-04-2018 to
Each 5ml contains: 11437 dated 17-04-2023.
Carbocisteine….100mg 28-3-2018
(Manufacturer 10000/-
Specification)
186. 075865 Vicomid 200mg Tablets 18-4-2013 Dy. No. 17-04-2023 w.e.f 18-04-2018 to
Each film coated tablet 11437 dated 17-04-2023.
contains: 28-3-2018
(Manufacturer
Specification)
contains: 28-3-2018
(Manufacturer
Specification)
contains: 28-3-2018
(Manufacturer
Specification)
189. 075847 Vicomid 150mg 18-4-2013 Dy. No. 17-04-2023 w.e.f 18-04-2018 to
Tablets 11437 dated 17-04-2023.
contains: 10000/-
Lacosamide ….150mg
(Manufacturer
Specification)
190. 000922 Lumether Tablet 29-4-2008 Dy. No. 28-04-2023 w.e.f 29-04-2018 to
-EX Each Tablet contains: 11437 dated 28-04-2023.
Lumefantrine….120mg 10000/-
NQ’s Specs.
191. 075866 Piquin Capsules 18-4-2013 Dy. No. 17-04-2023 w.e.f 18-04-2018 to
Each capsule contains: 11437 dated 17-04-2023.
Dihydroartemisinin 28-3-2018
…40mg 10000/-
Piperaquine
phosphate….320mg
(Manufacturer
Specification)
192. 075867 Piquin Sachet 18-4-2013 Dy. No. 17-04-2023 w.e.f 18-04-2018 to
Each Sachet contains: 11437 dated 17-04-2023.
Dihydroartemisinin 28-3-2018
…15mg 10000/-
Piperaquine phosphate
….120mg
(Manufacturer
Specification)
xxviii. M/s GlaxoSmithKline Pakistan Limited, F/268 S.I.T.E., Karachi
193. 048644 Actilix-CTZ Tablets 21-6-2008 Dy. No. 20-06-2023 w.e.f 21-06-2018 to
Each tablet contains: 15276 dated 20-06-2023.
Cetirizine 24-4-2018
dihydrochloride..10mg
(BP Specs)
xxix. M/s Wilson’s Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad
194. 029094 Cycloprin Suspension 19-02-2003 Dy. No. 4900 18-02-2023 w.e.f 19-02-2018 to
Each 5ml contains: 09-02-2018 18-02-2023
Cyclosporin….100mg 10000/-
195. 029097 Onderon SR Tablets 19-2-2003 Dy. No. 4901 18-02-2023 w.e.f 19-02-2018 to
Each tablet contains: 09-02-2018 18-02-2023
Ondansetron 10000/-
HCl….4mg
196. 029097 Carbine SR Capsules 19-2-2003 Dy. No. 4902 18-02-2023 w.e.f 19-02-2018 to
Each capsule contains: 09-02-2018 18-02-2023
Carbamazepine (as
carbamazepine 10000/-
pellets)….200mg
197. 029097 Carbine SR Capsules 19-2-2003 Dy. No. 4906 18-02-2023 w.e.f 19-02-2018 to
Each capsule contains: 09-02-2018 18-02-2023
Carbamazepine (as
carbamazepine 10000/-
pellets)….400mg
xxx. M/s Abbott Laboratories (Pakistan) Limited, Landhi Karachi
198. 021398 Acyclovir Injection 16-5-1998 Dy. No. 15-05-2023 w.e.f 16-05-2018 to
Each vial contains: 13419 dated 05-05-2023
Acyclovir sodium eq. to 11-4-18
Acyclovir……1gm
199. 021397 Acyclovir Injection 16-5-1998 Dy. No. 15-05-2023 w.e.f 16-05-2018 to
Each vial contains: 13419 dated 05-05-2023
Acyclovir sodium eq. to 11-4-18
Acyclovir……500mg
200. 021592 Isoptin 40mg Tablet 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018 to
Each film coated tablet Transfer of 13419 dated 19-05-2023.
contains: registration 11-4-18
Verapamil HCl….40mg 19-07-2002
201. 021593 Isoptin 80mg Tablet 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018 to
Each film coated tablet Transfer of 13419 dated 19-05-2023.
contains: registration 11-4-18
Verapamil HCl….80mg dated: 19-
07-2002
202. 021594 Isoptin SR 240mg 20-5-1998 Dy. No. 19-05-2023 w.e.f 20-05-2018 to
Tablet Transfer of 13419 dated 19-05-2023.
Each film coated tablet registration 11-4-18
contains: dated: 19-
Verapamil 07-2002 and
HCl…….240mg dated : 02-
11-2006
xxxi. M/s Medisure Laboratories Pakistan (Pvt) Limited, A-115, S.I.T.E., Super Highway Karachi.
203. 047315 Xonboc Capsule 04-12-2007 Dy. No. Deferred for
Each capsule contains: 24889 dated submission of
Sibutramine (as 18-12-2017 differential fee as
HCl)……10mg application was
(Manufacturer Specs) submitted after due
date but within sixty
days and confirmation
of registration status
from reference
regulatory agencies.
204. 047316 Xonboc Capsule 04-12-2007 Dy. No. -do-
Each capsule contains: 24889 dated
Sibutramine (as 18-12-2017
HCl)……15mg
205. 073517 Amesure Infusion 12-12-2012 Dy. No. -do-
Each 100ml contains: 24889 dated
Ciprofloxacin as 18-12-2017
lactate……200mg
206. 073518 Evaxosure Infusion 12-12-2012 Dy. No. -do-
Levofloxacin 18-12-2017
hemihydrate eq. to
Levofloxacin….500mg
207. 073519 Mezole Infusion 12-12-2012 Dy. No. -do-
Each ml contains: 24889 dated
Metronidazole ….5mg 18-12-2017
208. 073520 Zoxam Infusion 12-12-2012 Dy. No. -do-
Ofloxacin HCL eq. to 18-12-2017
Ofloxacin….200mg
209. 073521 Biofloxacin Infusion 12-12-2012 Dy. No. -do-
Moxifloxacin as HCl 18-12-2017
……..400mg
210. 073522 Fero-D Ampoule 12-12-2012 Dy. No. -do-
Each ml ampoule 24889 dated
Cholecalciferol…5mg
xxxii. M/s CSH Pharmaceuticals Lahore.
211. 074328 Oximox 1000mg Tablet 04-04-2013 Due date 03-04-2023 w.e.f. 04-04-2018 to
Each film coated tablet 03-04-2018 03-04-2023
contains: Application
Amoxicillin (as received
Trihydrate)…..1000mg 29-01-2018
212. 076957 Oximox 500mg Tablet 19-09-2013 Due date 18-09-2023 w.e.f.19-09-2018 to
Each film coated tablet 18-09-2018 18-09-2023
contains: Application
Amoxicillin (as received
Trihydrate) …..500mg 29-06-2018
xxxiii. M/s Martin Dow Marker Limited (Formerly Merck Pvt Limited), 7-Jail Road, Quetta
213. 010194 Concor Tablets 5 mg 05-12-1989 Dy. No. Deferred for further
Each film-coated tablet 6522/2018 evaluation.
contains: - Dated
Bisoprolol Hemi 21-02-2018
fumarate … 5 mg 10000/-
(USP Specification)
214. 026855 Lodopin Tablets 10 mg 12-05-2001 Dy. No. -do-
Each tablet contains: - 6557/2018
Amlodipine Besilate, Change of
equivalent to brand name Dated
Amlodipine.… 10 mg dated: 22-01- 21-02-2018
(USP Specification) 2002 10000/-
215. 026853 Lodopin Tablets 2.5 mg 12-05-2001 Dy. No. -do-

Each tablet contains: - Change of 6558/2018
Amlodipine Besilate, brand name Dated
equivalent to dated: 22-01- 21-02-2018
Amlodipine.…2.5 mg 2002 10000/-
(USP Specification)
216. 026854 Lodopin Tablets 5 mg 12-05-2001 Dy. No. -do-
Each tablet contains: - 6559/2018
Amlodipine Besilate, Change of Dated
equivalent to brand name 21-02-2018
Amlodipine….… 5 mg dated: 22-01- 10000/-
(USP Specification) 2002
217. 027807 Lidocaine 1% Injection 07-05-2002 Dy. No. -do-
Each ml contains: 6560/2018
Lidocaine HCl, USP Dated
……1% 21-02-2018
(As per Innovator’s 10000/-
Specification)
218. 037634 Mercip Tablets 750 mg 07-03-2005 Dy. No. -do-
Each Film coated 6563/2018
Tablet contains: Dated
Ciprofloxacin 21-02-2018
Hydrochloride, USP 10000/-
equivalent to
Ciprofloxacin…750mg
(USP Specification)
219. 004158 Multibionta for 11-06-1978 Dy. No. -do-
Infusion 6569/2018
Each 10 ml contains: Dated
Vitamin A 21-02-2018
(Palmitate)...10,000 IU 10000/-
Vitamin B1 (Thiamine
Hydrochloride).. 50mg
Riboflavin 5’-
Phosphate Sodium
............. 10mg
Vitamin B6
(Pyridoxine
Hydrochloride).. 15 mg
Nicotinamide.. 100mg
Dexpanthenol..... 25mg
Vitamin C (Ascorbic
Acid) ....... 500 mg
Vitamin E (dl-Alpha
Tocopheryl Acetate)
….... 5 mg
(As per Innovator’s
Specification)
220. 020242 Multibionta M Syrup 14-10-1997 Dy. No. -do-
Each 5 ml contains:- 6568/2018
Vitamin A Dated
(Palmitate)...3000 I.U. 21-02-2018
Vitamin D 10000/-
(Cholecalciferol)
………..400 I.U.
Hydrochloride).1.5 mg,
Riboflavin 5’-
Phosphate Sodium,
….1.2 mg,
Vitamin B6
(Pyridoxine
Hydrochloride) ...1mg,
Vitamin B12
(Cyanocobalmin),
……….3mcg,
Vitamin C (Ascorbic
Acid)….50 mg,
Nicotinamide…..10mg,
Dexpanthenol ….5mg,
Iron (as ferrous
gluconate) ….3mg,
Iodine (as potassium
Iodide)….75 mcg,
Calcium (as Calcium
Lactate)…. 40 mg,
Phosphorous (as
Hypophosphoric acid)
….43 mg,
Manganese (as
Manganese gluconate)
…. 0.5 mg,
Magnesium (as
Magnesium gluconate)
…. 3 mg,
Zinc (as Zinc
Gluconate)…0.5mg,
Choline (as Choline
Bitartrate)… 5 mg,
Inositol ………. 5 mg
Specification)
221. 027809 Merstatin Tablets 20mg 07-05-2002 Dy. No. -do-
Each Tablet contains: 6581/2018
Simvastatin.…20 mg 21-02-2018
(USP Specification) 10000/-
222. 010193 Neurofenac Capsules 05-12-1989 Dy. No. -do-
50 mg 6585/2018
Each capsule contains: Dated
Diclofenac Sodium, 21-02-2018
USP…… 50 mg 10000/-
(Source of pellets:
Inventia Healthcare
Pvt. Ltd., Maharashtra
state, India)
Specification)
223. 018032 Optifam Tablets 20 mg 05-10-1995 Dy. No. -do-
Each film- coated tablet Change of 6596/2018
contains: - brand name Dated
Famotidine.… 20 mg dated: 04-03- 21-02-2018
224. 018033 Optifam Tablets 40 mg 05-10-1995 Dy. No. -do-
Each film- coated tablet Change of 6597/2018
contains: - brand name Dated
Famotidine … 40 mg dated: 04-03- 21-02-2018
225. 018718 Pcam Gel 0.5% 13-05-1997 Dy. No. -do-
Pcam gel contains: 6601 / 2018
Piroxicam.... 0.5% w/w 21-02-2018
(BP Specification) 10000/-
226. 017582 Pcam Capsules 10 mg 13-05-1997 Dy. No. -do-
6599/2018
Piroxicam ........ 10 mg 21-02-2018
227. 018040 Pcam Capsules 20 mg 13-05-1997 Dy. No. -do-
6600/2018
Piroxicam .........20 mg 21-02-2018
228. 018048 Pcam Injection 13-05-1997 Dy. No. -do-
Each 1 ml contains: 6604/2018
Piroxicam ......20 mg Dated
(As per Innovator’s 21-02-2018
Specification) 10000/-
229. 000723 Polybion Forte 30-11-1976 Dy. No. -do-
Injection 6606/2018
Each 2 ml contains:
Hydrochloride), Dated
USP…..10 mg, 21-02-2018
Riboflavin 5’-
Phosphate Sodium, 10000/-
USP….4 mg,
Vitamin B6
(Pyridoxine
Hydrochloride), USP
…… 4 mg,
Vitamin B12
(Cyanocobalmin),
USP…..8 mcg,
Nicotinamide, USP
…..40 mg,
Dexpanthenol,
USP….6 mg,
Specification)
230. 025485 Ranulcid Tablets 300 17-11-1999 Dy. No. -do-
mg 6613/2018
Each film-coated tablet Dated
Ranitidine brand name 10000/-
Hydrochloride dated: 15-02-
equivalent to 2000
Ranitidine … 300 mg
(BP Specification)
231. 025486 Ranulcid Tablets 150mg 17-11-1999 Dy. No. -do-
Each film-coated tablet 6612/2018
contains: Dated
Ranitidine Change of 21-02-2018
Hydrochloride brand name 10000/-
equivalent to dated: 15-02-
Ranitidine …. 150 mg 2000
(BP Specification)
232. 014785 Refobacin Injection 10 20-09-1995 Dy. No. -do-
mg 6614/2018
Gentamicin sulfate 21-02-2018
USP equivalent to 10000/-
Gentamicin…….10 mg
Specification)
mg 6615/2018
Specification)
mg 6616/2018
Specification)

mg 6617/2018
Specification)
236. 007434 Sangobion Syrup 27-05-1984 Dy. No. -do-
Each 5ml contains: 6619/2018
Ferrous Dated
Gluconate,USP....129.5 21-02-2018
mg
Hydrochloride), USP.... 10000/-
1 mg
Vitamin B2
(Riboflavin),
USP...............1 mg
Vitamin B6
(Pyridoxine
Hydrochloride),
USP…..1.5 mg
Nicotinamide,
USP............. 15 mg
Biotin, USP.......0.3 mg
Specification)
237. 006475 Sistalgin Tablets 11-07-1982 Dy. No. -do-
Each Tablet contains: 6622/2018
Pramiverine Dated
Hydrochloride.. 2 mg 21-02-2018
238. 018039 Teril Tablets 200 mg 05-10-1995 Dy. No. -do-
Each tablet contains: 6625/2018
Carbamazepine USP Dated
….. 200 mg 21-02-2018
239. 044472 Vitabion Capsules 30-12-2006 Dy. No. -do-
Each soft gelatin 6627 / 2018
capsule contains:
Vitamin A (Palmitate), Dated
USP.... 5000 I.U. 21-02-2018
Mononitrate), USP 10000/-
......5 mg,
Vitamin B2
(Riboflavin),
USP..........3 mg,
Vitamin B6
(Pyridoxine HCl),
USP.... 5 mg,
Vitamin B12
(Cyanocobalamin),
USP....3 mcg,
Nicotinamide
USP........... 25 mg,
Calcium D-
Pantothenate , USP......
10 mg
Biotin, USP ….50 mcg,

Procaine HCL, USP…..
55mg,
Folic Acid USP…..
0.4mg,
Inositol USP…. 30mg,
Orotic Acid Ext. Pharm
…… 30 mg,
Vitamin C (Ascorbic
Acid) USP.........60 mg,
Vitamin D
(Cholecalciferol), USP
..... 400 I.U.,
Vitamin E (dl-Alpha
Tocopherol Acetate),
USP...10 mg,
Ethyl Linolate, USP …

28 mg,
Lecithin from soya
beans, USP……60 mg,
Choline Hydrogen
Tartrate, MDM..50mg,
L-Lysine Monochloride
……25 mg,
Hematoporphyrin
………..1 mg,
Adenosine…. 0.75 mg,
Intrinsic factor 20U/g
…..6.22 mg,
Magnesium
glycerophosphate
……… 40 mg,
Dehydrated Calcium
hydrogen Phosphate…
35 mg,
Potassium (as
Potassium sulfate), BP
….. 8 mg,
Dehydrated Ferrous (II)
sulfate… 10 mg,
Dehydrated Cupric (II)
sulfate… 0.5mg,
Dehydrated Mangnous
(II) sulfate ….. 0.5mg,
Dehydrated
Cobaltous (II) Sulfate
….. 0.1mg,
Dehydrated Sodium
Molybdate…80 mcg,
Zinc Oxide…. 0.5 mg
Specification)
240. 07483 Sangobion Fe Injection 04-06-2013 Dy. No. -do-
Each 5 ml contains: - 14423/2018
Iron Sucrose Complex Dated
Equivalent to 18-04-2018
elemental Iron 10000/-
………..… 100 mg
(USP Specification)
Decision: Registration Board considered the request of firms and decided as
mentioned against each in last column.
Case No.116: Renewal applications of local manufacturers (Veterinary) evaluated as

per SOP approved by Registration Board.
Date of
Brand Name,
Sr. Initial date of application Renewal
Reg. No. Composition & Validity
No Registration (R&I) validity
Specification
Fee submitted
i. M/s Nawan Laboratories Pvt Limited, 136 Sector 15, KIA Karachi
241. 014106 Albazol Suspension 1-8-1993 Dy. No. 8596 30-3-2023 w.e.f 31-03-2018
Each 100ml contains: Transfer of dated 07-3- to 30-03-2023.
Albendazole registration 2018
…….12.5gm dated: 31st 10000/-
March 1998
242. 021306 L.S. Minerals Powder 11-5-1998 Dy. No. 8596 10-05-2023 w.e.f 11-5-2018
Each kg contains: dated 07-3- to 10-5-2023
Calcium…….155gm 2018
Phosphorous …....135gm 10000/-
Magnesium..55gm
Sodium……45gm
Iron (as Ferrous) ….1gm
Zinc……….3gm
Manganese….2gm
Copper……0.6gm
Cobalt……0.01gm
Iodine….0.04gm
Selenium…0.003gm
243. 014105 Albazol-C Bolus 1-8-1993 Dy. No. 8596 30-3-2023 w.e.f 31-03-2018
Each bolus contains: Transfer of dated 07-3- to 30-03-2023.
Albendazole…..600mg registration 2018
31-3-1998 10000/-
244. 021307 Nawamax Drench 11-5-1998 Dy. No. 8764 10-05-2023 w.e.f 11-5-2018
Solution dated 8-3- to 10-5-2023
Each 100 ml contains: 2018
Oxfendazole B.P 10000/-
……….2.265gm
245. 021303 Nawacin-100 Injection 11-5-1998 Dy. No. 8759 10-05-2023 w.e.f 11-5-2018
Each 100ml contains: dated 8-3- to 10-5-2023
Oxytetracycline dihydrate 2018
eq. to 10gm of 10000/-
oxytetracycline base
246. 021304 Gentawan-10 Injection 11-5-1998 Dy. No. 8762 10-05-2023 w.e.f 11-5-2018
Each 100ml contains: dated 8-3- to 10-5-2023
Gentamycin sulphate 2018
…10gm 10000/-
247. 017130 Trimodin Bolus 28-5-1995 Dy. No. 8761 30-3-2023 w.e.f 31-03-2018
Each bolus contains: Transfer of dated 8-3- to 30-03-2023.
Trimethoprim….200mg registration 2018
Sulphadiazine….1.0gm 31-3-1998 10000/-
248. 074019 Doximax Oral 12-3-2013 Dy. No. 11-3-2023 w.e.f 12-3-2018
Suspension 13363 dated to 11-3-2023
Each litre contains: 10-4-2018
Doxycycline HCl
BP……10kg 20000/-
Tylosin tartrate BP
…….5Kg
Colistin sulphate BP
…..0.125Kg
Bromhexine
Hydrochloride
BP…….0.1Kg
ii. M/s. Biogen Pharma, 8 K.m, Chakbeli Road, Rawat.
249. 057035 Phenylogen Oral Liquid 03-04-2009 17-04-2018 17-04-2023 w.e.f 18-4-2018
Each 100ml contains:- Change of Dy. No. to 17-4-2023
Tylosin Tartrate … 10gm brand name 11671 dated
Doxycycline HCI … dated 30-03-2018
20gm 18-04-2013
Phenylbutazone … 1.5gm 10000/-
Bromhexin HCI….0.5gm
250. 049727 Sulphadiadin Plus Oral 26-09-2008 Do Do w.e.f 18-4-2018
Powder Change of to 17-4-2023
Each kg contains:- brand name
Sulphaquinoxaline dated
Sodium … 200gm 18-04-2013
Sulphadimidine Sodium
… 82.5gm
Diaverdine … 50gm
Vitamin A … 2.5M.I.U
Vitamin K3 … 2000mg
Vitamin E … 500mg
251. 049725 Ampsul-K Oral Powder 02-10-2009 Do Do w.e.f 18-4-2018
Each 100gm contains:- Change of to 17-4-2023
Sulphaquinoxaline as brand name
Sodium … 20gm dated
Amprolium HCl … 30gm 18-04-2013
252. 049717 Enrogen 200 Oral Liquid 26-09-2008 Do Do w.e.f 18-4-2018
Each ml contains:- Change of to 17-4-2023
Enrofloxacin … 200mg brand name
18-04-2013
253. 049718 Dylogen Oral Liquid Do Do Do w.e.f 18-4-2018
Each 100ml contains:- to 17-4-2023
Tylosin Tartrate … 10gm
Doxycycline HCl …
20gm
254. 048227 Coxygen Oral Powder 17-07-2008 Do Do w.e.f 18-4-2018
Colistin Sulphate … brand name
20,000,000IU dated
Doxycycline HCl…10gm 18-04-2013
255. 048229 Brodogen Super Oral Do Do Do w.e.f 18-4-2018
Powder to 17-4-2023
Tylosine Tartrate..10gm
Doxycycline HCl..20gm
Bromhexin HCl…250mg
256. 049721 Hexatox Oral Powder 26-09-2008 Do Do w.e.f 18-4-2018
Methenamine … 95gm brand name
Vitamin B1 … 800mg dated
Vitamin B2 … 920mg 18-04-2013
257. 048236 Wormycid Oral Liquid 17-07-2008 Do Do w.e.f 18-4-2018
Levamisole HCI (Vet) … brand name
15g dated
Oxyclozanide (Vet) … 18-04-2013
30mg
Selenium … 3.5mg
Cobalt … 3.8mg
258. 048238 Bioalba Plus Oral Liquid Do Do Do w.e.f 18-4-2018
Each 100ml contains:- to 17-4-2023
Albendazole … 12.5gm
Cobalt Sulphate …
0.382gm
Sodium Selenite …
0.035gm
259. 048239 Oxfendagen SC Do Do Do w.e.f 18-4-2018
Suspension to 17-4-2023
Oxfendazole … 2.265%
Cobalt … 0.02%
Selenium … 0.05%
260. 048243 Neo Bronco CTC Oral 18-07-2008 Do Do w.e.f 18-4-2018
Powder Change of to 17-4-2023
Each kg contains:- brand name
Bromhexin HCl … 5gm dated
Chlortetracycline HCl … 18-04-2013
80gm
Colistin Sulphate … 4gm
Neomycin Sulphate …
70gm
261. 049719 Enco-Super Liquid 26-09-2008 Do Do w.e.f 18-4-2018
Enrofloxacin … 100mg brand name
Colistin Sulphate … dated
48MIU 18-04-2013
262. 071020 Macrocin Plus Oral 28-06-2011 24-04-2018 24-04-2023 w.e.f 25-4-2018
Liquid Change of Dy. No. to 24-4-2023
Each 100ml contains:- brand name 11670 dated
Tylosin Tartrate … 10gm dated 30-03-2018
Doxycycline HCl.. 20gm 25-04-2013
Colistin Sulphate … 3gm 10000/-
Bromehexine HCl..1gm
263. 075612 Maxi-Flor Liquid 27-05-2013 26-05-2018 26-05-2023 w.e.f 27-5-2018
Each ml contains:- Dy.No.11670 to 26-5-2023.
Florfenicol … 100mg 30-03-2018
10000/-
264. 075613 Tri-Star Injection Do Do Do w.e.f 27-5-2018
Each ml contains:- to 26-5-2023.
Trimethoprim … 8%
Sulphadiazine … 40%
265. 075614 Tylo-200 Injection Do Do Do w.e.f 27-5-2018
Tylosin Tartrate…200mg
266. 075622 Eco-Man Liquid Do Do Do w.e.f 27-5-2018
Each 100ml contains:- to 26-5-2023.
Enrofloxacin … 10%
Colistin Sulphate… 3.5%
Amantadine HCl … 3.5%
267. 075623 Mectogen Injection Do Do Do w.e.f 27-5-2018
Ivermectin … 1.2%
268. 075625 Flunil Oral Powder Do Do Do w.e.f 27-5-2018
Each 100gm contains:- to 26-5-2023.
Enrofloxacin … 10gm
Colistin Sulphate … 4gm
Amantadine HCl … 4gm
iii. M/s Nawan Laboratories Pvt Limited, 136 Sector 15, KIA Karachi
269. 014103 Utavet Uterine 1-8-1993 Dy. No. 8596 Deferred for
Pessaries dated 07-3- confirmation of
Each pessary contains: Transfer of 2018 penicillin section from
Sulphathiazole.1750mg registration 10000/- Licensing Division.
Penicillin G dated: 31-
……100000IU 3-1998
Streptomycin (as
sulphate)…50mg
Ethinyloestradiol
…..0.5mg
270. 021302 Predivet Injection 11-5-1998 Dy. No. 8760 Deferred for
Each 100ml contains: dated 8-3- confirmation of steroidal
Prednisolone 2018 section from Licensing
acetate……2.5gm 10000/- Division.
271. 021305 Amovet L.A. Injection 11-5-1998 Dy. No. 8761 Deferred for
Each 100ml contains: dated 8-3- confirmation of
Amoxicillin trihydrate 2018 penicillin section from
eq. to 15gm 10000/- Licensing Division.
Amoxicillin base
272. 013715 Trimodin Forte Oral 19-1-1993 Dy. No. 8768 30-3-2023 w.e.f 31-3-2018 to 30-3-
Suspension Transfer of dated 8-3- 2023
Each liter contains: registration 2018
Trimethoprim…80gm dated 31-3- 10000/-
Sulphadiazine…400gm 1998
273. 017922 Enrocin Solution 27-7-1995 Dy. No. 8763 30-3-2023 w.e.f 31-3-2018 to 30-3-
Each 100ml contains: Transfer of dated 8-3- 2023
Enrofloxacin…..10gm registration 2018
31-3-1998 10000/-
Decision: Registration Board acceded the request of firms and decided to grant the
renewal mentioned in last column.
Case No.117: Finished Import Human

Sr. Reg. Manufacturer Brand Name, Initial date of Date of application (R&I)
No No. Composition & Registration Fee submitted
Specification
1. M/s Eli Lilly Pakistan Pvt Limited, 605, Business Avenue, P.E.C.H.S., Block-6 Main Shah-e-
Faisal Karachi.
274. 043071 M/s Lilly Strattera 25mg 12-9-2006 Dy. No. 16147 dated 30-4-2018
S.A. Avda. Capsules
De la Each capsule Change of 20000/-
Industria, 30 contains: source of
Alcobendas Atomoxetine supply of Legalized CoPP vide No. 2017/ 03253
(Madrid) HCl eq. to finished dated 19-12-2017
Spain. 25mg product dated:
Atomoxetine 09-05-2008
Decision: Registration Board acceded to the request of firm for the renewal of
registration subject to correction/confirmation of address by the
concerned section. Address will be corrected by concerned section.
Case No.118: Cases received in accordance with SRO 1005(I) 2017
i. Locally Manufactured Drugs (Human)

Sr. Name of the Reg.no. Decision
Brand Name Date of Reg. Fee along with date
No. Firm
1. Amson 025848 Aceta INH Tablet 22-05-2000 (Due Date: Deferred the
Vaccines & Thiacetazone Transfer of 06-07-2015) case for the
Pharma (Pvt.) …50mg registration 30,000/- approval status
Ltd., INH…100 mg dated 30-11-2017 in Reference
Islamabad 07-07-2005 Firm submitted Regulatory
30,000/- for Agencies.
regularization of
renewal of year
2010 on 17-08-
2018
2. Amson 019652 Albendal 07-08-1996 (Due Date: Regularize the
Vaccines & Suspension Transfer of 21-09-2016) renewal of year
Pharma (Pvt.) Each 5ml contains registration 30,000/- 2011 till 21-09-
Ltd., Albendazole dated 30-11-2017 2016 and
Islamabad USP… 100 mg 22-09-2006 Firm submitted acceded the
30,000/- for renewal of year
regularization of 2016 w.e.f. 22-
renewal of year 09-2016 to 21-
2011 on 17-08- 09-2021
2018
3. Amson 019651 Albendal Tablets 07-08-1996 (Due Date: Regularize the
Vaccines & Albendazole Transfer of 21-09-2016) renewal of year
Pharma (Pvt.) USP…. 200 mg registration 30,000/- 2011 till 21-09-
Ltd., dated 30-11-2017 2016 and
Islamabad 22-09-2006 Firm submitted acceded the
2011 on 17-08- 09-2021
2018
4. Amson 038532 Aller-Eze Syrup 08-06-2005 (Due Date: Deferred the
Vaccines & Each 5ml contains 07-06-2015) case for the
Pharma (Pvt.) Clemastine 30,000/- approval status
Ltd., Hydrogen 30-11-2017 in Reference
Islamabad Fumarate USP eq Firm submitted Regulatory
to Clemastine 30,000/- for Agencies.
USP….0.25mg regularization of
renewal of year
2010 on 17-08-
2018
5. Amson 025581 Amchoram - 4 08-03-2000 (Due Date: Deferred the
Vaccines & Tablet Transfer of 08-06-2015) case for the
Pharma (Pvt.) Each tablet registration 30,000/- approval status
Ltd., contains: dated 30-11-2017 in Reference
Islamabad Chlorpheniramine 09-06-2005 Firm submitted Regulatory
Maleate BP…. 4 30,000/- for Agencies.
mg regularization of
renewal of year
2010 on 17-8-
2018
6. Amson 017353 Amfen Tablets 200 27-06-1995 (Due Date: Regularize the
Vaccines & mg Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) Each tablet registration 30,000/- 2010 till 06-07-
Ltd., contains: dated 30-11-2017 2015 and
Islamabad Ibuprofen BP…. 07-07-2005 Firm submitted acceded the
200 mg 30,000/- for renewal of year
year 2010 on 07-2015 to 06-
17-08-2018 07-2020
7. Amson 017354 Amfen Tablets 400 27-06-1995 (Due Date: Regularize the
Vaccines & mg Transfer of 06-07-2015) renewal of year
Islamabad Ibuprofen BP …. 07-07-2005 Firm submitted acceded the
400 mg 30,000/- for renewal of year
year 2010 on 07-2015 to 06-
17-08-2018 07-2020
8. Amson 030388 Amflu 200 mg 30-05-2003 (Due Date: Regularize the
Vaccines & Capsule Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) Each capsule registration 30,000/- 2010 till 06-07-
Islamabad Fluconazole 07-07-2005 Firm submitted acceded the
……..200 mg 30,000/- for renewal of year
2010 on 17-08- 07-2020
2018
9. Amson 030386 Amflu 50 mg 30-05-2003 (Due Date: Regularize the
Vaccines & Capsule Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) Each capsule registration 30,000/- 2010 till 06-07-
Islamabad Fluconazole …..50 07-07-2005 Firm submitted acceded the
mg 30,000/- for renewal of year
2010 on 17-08- 07-2020
2018
10. Amson 030389 Amflu Infusion 30-05-2003 (Due Date: Regularize the
Vaccines & Each ml contains Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) Fluconazole…. registration 30,000/- 2010 till 06-07-
Ltd., 2 mg dated 30-11-2017 2015 and
2010 on 17-08- 07-2020
2018
11. Amson 030385 Amflu Suspension 30-05-2003 (Due Date: Regularize the
Vaccines & Each 5ml contains Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) Fluconazole…..50 registration 30,000/- 2010 till 06-07-
Ltd., mg dated 30-11-2017 2015 and
2010 on 17-08- 07-2020
2018
12. Amson 025439 Amsoprin Tablet 23-11-1999 (Due Date: Regularize the
Vaccines & Each tablet Transfer of 08-06-2015) renewal of year
Pharma (Pvt.) contains: registration 30,000/- 2010 till 08-06-
Ltd., Acetyl Salicylic dated 30-11-2017 2015 and
Islamabad Acid …300 mg 09-06-2005 Firm submitted acceded the
2010 on 17-08- 06-2020
2018
13. Amson 024290 Amsoton Capsule 12-03-2002 (Due Date: Deferred for the
Vaccines & Each capsule Transfer of 09-07-2017) approval status
Pharma (Pvt.) contains: registration 30,000/- in Reference
Ltd., Mefenamic Acid dated 30-11-2017 Regulatory
Islamabad BP…..250 mg 10-07-2007 Firm submitted Agencies
30,000/- for
regularization of
renewal of year
2012 on 17-08-
2018
14. Amson 025849 Amsozid Tablet 22-05-2000 (Due Date: Regularize the
Ltd., INH….300 mg dated 30-11-2017 2015 and
2010 on 17-08- 07-2020
2018
15. Amson 025435 Amsozide - 100 23-11-1999 (Due Date: Regularize the
Vaccines & Tablet Transfer of 08-06-2015) renewal of year
Pharma (Pvt.) Isoniazid BP…… registration 30,000/- 2010 till 08-06-
Ltd., 100 mg dated 30-11-2017 2015 and
2010 on 17-08- 06-2020
2018
16. Amson 018089 Amspar Syrup 24-09-1995 (Due Date: Deferred the
Vaccines & Each 5ml contains Transfer of 30-10-2015) case for the
Pharma (Pvt.) Piperazine Citrate registration 30,000/- approval status
Ltd., BP …. 937.5 mg dated 30-11-2017 in Reference
Islamabad eq to 31-10-2005 Firm submitted Regulatory
Piperazine 30,000/- for Agencies.
Hydrate….. 500 regularization of
mg renewal of year
2010 on 17-08-
2018
17. Amson 018088 Amspar Tablet 24-09-1995 (Due Date: Deferred the
Vaccines & Piperazine Citrate Transfer of 30-10-2015) case for the
Pharma (Pvt.) BP eq to registration 30,000/- approval status
Ltd., Piperazine Hydrate dated 30-11-2017 in Reference
Islamabad ….100 mg 31-10-2005 Firm submitted Regulatory
regularization of
renewal of year
2010 on 17-08-
2018
18. Amson 040693 Calciglu 08-07-2005 (Due Date: Deferred the
Vaccines & Effervescent 07-07-2015) case for the
Pharma (Pvt.) Tablets 30,000/- approval status
Ltd., Each Tablet 30-11-2017 in Reference
Islamabad Contains Firm submitted Regulatory
Calcium Lactate 30,000/- for Agencies.
Pentahydrate BP regularization of
eq. to Calcium renewal of year
Lactate …..422mg 2010 on 17-08-
Calcium D 2018
Gluconate
Monohydrate BP
eq. to Calcium-D
Gluconate....578m
g
Calcium Carbonate
BP..........327mg
Vitamin C BP
.........500mg
19. Amson 017375 Coenza Capsules 27-06-1995 (Due Date: Deferred for the
Vaccines & Each capsule Transfer of 06-07-2015) approval status
Pharma (Pvt.) contains: registration 30,000/- in Reference
Ltd., Ubidecarenone…. dated 30-11-2017 Regulatory
Islamabad 50 mg 07-07-2005 Firm submitted Agencies
30,000/- for
regularization of
renewal for year
2010
20. Amson 017347 Damex Cough 27-06-1995 (Due Date: Regularize the
Vaccines & Syrup Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) Each 5 ml registration 30,000/- 2010 till 06-07-
Ltd., contains:- dated 30-11-2017 2015 and
Islamabad Aminophylline 07-07-2005 Firm submitted acceded the
BP… 32 mg 30,000/- for renewal of year
Diphenhydramine regularisation of 2015 w.e.f. 07-
BP… 8 mg year 2010 on 07-2015 to 06-
Ammonium 17-08-2018 07-2020
Chloride
BP…30mg
Menthol…. 0.98
mg
21. Amson 017356 Epiphen Capsules 27-06-1995
(Due Date: Regularize the
Vaccines & Each Capsule Transfer of
06-07-2015) renewal of year
Pharma (Pvt.) Contains registration
30,000/- 2010 till 06-07-
Ltd., Phenytoin Sodium dated 07-07-
30-11-2017 2015 and
Islamabad BP…. ..100 mg 2005 Firm submitted acceded the
regularisation of 2015 w.e.f. 07-
year 2010 on 07-2015 to 06-
17-08-2018 07-2020
22. Amson 025846 Ethrifid - P Tablet 22-05-2000 (Due Date: Deferred the
Vaccines & Rifampicin…120 Transfer of 06-07-2015) case for the
Pharma (Pvt.) mg registration 30,000/- approval status
Ltd., Ethambutol HCl…. dated 30-11-2017 in Reference
Islamabad 225 mg 07-07-2005 Firm submitted Regulatory
INH….60 mg 30,000/- for Agencies.
Pyrazinamide…. regularization of
300 mg renewal of year
2010 on 17-8-
2018
23. Amson 042604 Flugon Capsules 25-02-2006 (Due Date: Regularize the
Vaccines & 75mg 24-02-2016) renewal of year
Pharma (Pvt.) Each Capsule 30,000/- 2011 till 24-02-
Ltd., contains: 30-11-2017 2016 and
Islamabad Oseltamivir Firm submitted acceded the
Phosphate eq. to 30,000/- for renewal of year
Oseltamivir regularization of 2016 w.e.f. 25-
…..75mg renewal of year 02-2016 to 24-
2011 on 17-08- 02-2021
2018
24. Amson 042605 Flugon Suspension 25-02-2006 (Due Date: Regularize the
Vaccines & Each 5ml contains: 24-02-2016) renewal of year
Pharma (Pvt.) Oseltamivir 30,000/- 2011 till 24-02-
Ltd., Phosphate eq. to 30-11-2017 2016 and
Islamabad Oseltamivir Firm submitted acceded the
……60mg 30,000/- for renewal of year
2011 on 17-08- 02-2021
2018
25. Amson 017357 Gliclasol Tablet 27-06-1995 (Due Date: Regularize the
Vaccines & Gliclazide BP…. Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) 80 mg registration 30,000/- 2010 till 06-07-
Ltd., dated 30-11-2017 2015 and
regularisation of 2015 w.e.f. 07-
2010 on 07-2020
17-08-2018
26. Amson 042900 Glimer Tablets 18-03-2006 (Due Date: Regularize the
Pharma (Pvt.) Each Tablet 30,000/- 2011 till 17-03-
Ltd., contains 30-11-2017 2016 and
Islamabad Glimepiride…1mg Firm submitted acceded the
2011 on 17-08- 03-2021
2018
Islamabad Glimepiride..2mg Firm submitted acceded the
2011 on 17-08- 03-2021
2018
28. Amson 042902 Glimer Tablets 18-03-2006 (Due Date: Do Regularize
Vaccines & 3mg 17-03-2016) the renewal of
Pharma (Pvt.) Each Tablet 30,000/- year 2011 till
Ltd., contains 30-11-2017 17-03-2016 and
2011 on 17-8- 03-2021
2018
2011 on 17-08- 03-2021
2018
30. Amson 019671 Hemofer Tablet 07-08-1996 (Due Date: Regularize the
Ltd., Ferrous Sulphate dated 30-11-2017 2016 and
Islamabad BP …150 mg 22-09-2006 Firm submitted acceded the
Folic Acid BP…. 30,000/- for renewal of year
0.5 mg regularization of 2016 w.e.f. 22-
2011 on 17-08- 09-2021
2018
31. Amson 019663 Hypril 4 Tablets 07-08-1996 (Due Date: Regularize the
Ltd., Perindopril dated 30-11-2017 2016 and
Islamabad INN…..4 mg 22-09-2006 Firm submitted acceded the
2011 on 17-08- 09-2021.
2018
32. Amson 019650 Levam 40 mg 07-08-1996 (Due Date: Deferred the
Vaccines & tablets Transfer of 21-09-2016) case for the
Pharma (Pvt.) Each tablet registration 30,000/- approval status
Ltd., contains: dated 30-11-2017 in Reference
Islamabad Levamisole USP 22-09-2006 Firm submitted Regulatory
(As HCl) ….40 mg 30,000/- for Agencies.
regularization of
renewal of year
2011 on 17-08-
2018
33. Amson 017377 Metro 200 mg 27-06-1995 (Due Date: Regularize the
Islamabad Metronidazole 07-07-2005 Firm submitted acceded the
BP….200mg 30,000/- for renewal of year
2010 on 17-8-2017 07-2020
34. Amson 017378 Metro 400 mg 27-06-1995 (Due Date: Regularize the
Islamabad Metronidazole BP 07-07-2005 Firm submitted acceded the
400mg 30,000/- for renewal of year
2010 on 17-08- 07-2020
2018
35. Amson 017379 Metro Suspension 27-06-1995 (Due Date: Regularize the
Vaccines & Each 5ml contains: Transfer of 06-07-2015) renewal of year
Pharma (Pvt.) Metronidazole registration 30,000/- 2010 till 06-07-
Ltd., Benzoate 200 mg dated 30-11-2017 2015 and
2010 on 17-08- 07-2020
2018
36. Amson 025844 M-Pcin Capsule 22-05-2000 (Due Date: Regularize the
Vaccines & Each capsule Transfer of 30-10-2015) renewal of year
Ltd., Rifampicin BP dated: 30-11-2017 2015 and
Islamabad 150 mg 31-10-2005 Firm submitted acceded the
2010 on 17-08- 10-2020
2018
37. Amson 025845 M-Pcin Capsule 22-05-2000 (Due Date: Regularize the
Vaccines & Each capsule Transfer of 30-10-2015) renewal of year
Ltd., Rifampicin BP dated: 30-11-2017 2015 and
Islamabad 300 mg 31-10-2005 Firm submitted acceded the
2010 on 17-08- 10-2020
2018
38. Amson 018087 Pyraquin Syrup 24-09-1995 (Due Date: Deferred the
Vaccines & Each 5ml contains Transfer of 30-10-2015) case for the
Pharma (Pvt.) Chloroquine registration 30,000/- approval status
Ltd., Phosphate…. 84 dated 30-11-2017 in Reference
Islamabad mg 31-10-2005 Firm submitted Regulatory
eq. to 30,000/- for Agencies.
Chloroquine….50 regularization of
mg renewal of year
2010 on 17-08-
2018
39. Amson 018086 Pyraquin Tablets 24-09-1995 (Due Date: Deferred the
Vaccines & Each contains Transfer of 30-10-2015) case for the
Pharma (Pvt.) (Film/Sugar) registration 30,000/- approval status
Ltd., contains dated 30-11-2017 in Reference
Islamabad Chloroquine 31-10-2005 Firm submitted Regulatory
Phosphate...242.5 30,000/- for Agencies.
mg regularization of
eq. to Chloroquine renewal of year
……..150 mg 2010 on 17-08-
2018
40. Amson 040698 Resonate Tablets 08-07-2005 (Due Date: Regularize the
Islamabad Risedronate Firm submitted acceded the
Sodium…. 35mg 30,000/- for renewal of year
2010 on 17-8-2018 07-2020
41. Amson 040697 Resonate Tablets 08-07-2005 (Due Date: Regularize the
Islamabad Risedronate Firm submitted acceded the
Sodium…. 5mg 30,000/- for renewal of year
2010 on 17-08- 07-2020
2018
42. Amson 027542 Rhoza Tablet 04-05-2002 (Due Date: Regularize the
Vaccines & Rifampicin BP Transfer of 09-07-2017) renewal of year
Pharma (Pvt.) …150 mg Registration 30,000/- 2012 till 09-07-
Ltd., Isoniazid BP….75 dated: 30-11-2017 2017 and
Islamabad mg 10-07-2007 Firm submitted acceded the
Pyrazinamide 30,000/- for renewal of year
BP… 400 mg regularization of 2017 w.e.f. 10-
2012 on 17-08- 07-2022
2018
43. Amson 027539 Ripazin Tablet 04-05-2002 (Due Date: Regularize the
Pharma (Pvt.) contains: Registration 30,000/- 2012 till 09-07-
Ltd., Rifampicin dated 30-11-2017 2017 and
Islamabad BP….150 mg 10-07-2007 Firm submitted acceded the
Isoniazid 30,000/- for renewal of year
BP….150 mg regularization of 2017 w.e.f. 10-
Pyrazinamide renewal of year 07-2017 to 09-
BP…. 500 mg 2012 on 17-08- 07-2022
2018
44. Amson 019669 Thiaben Tablet 07-08-1996 (Due Date: Deferred the
Vaccines & Each tablet Transfer of 21-09-2016) case for the
Pharma (Pvt.) contains: registration 30,000 approval status
Ltd., Thiabendazole dated 30-11-2017 in Reference
Islamabad BP….. 500 mg 22-09-2006 Firm submitted Regulatory
regularization of
renewal of year
2011 on 17-08-
2018
45. Amson 025436 Vitam Tablet 23-11-1999 (Due Date: Deferred the
Vaccines & Vitamin B1 B.P Transfer of 08-06-2015) case for the
Pharma (Pvt.) 15 mg Registration 30,000 approval status
Ltd., Vitamin B2 B.P dated 30-11-2017 in Reference
Islamabad 10mg 09-06-2005 Firm submitted Regulatory
Vitamin B6 B.P 30,000/- for Agencies.
……….5mg regularization of
Vitamin B12 B.P renewal of year
4mcg 2010 on 17-08-
Niacinamide B.P 2018
100mg
Calcium
Pantothenate BP
…….20mg
Vitamin C B.P
500 mg
46. Amson 019648 Worex Tablet 07-08-1996 (Due Date: Regularize the
Pharma (Pvt.) contains: registration 30,000 2011 till 21-09-
Ltd., Mebendazole USP dated 30-11-2017 2016 and
Islamabad ….. 100 mg 22-09-2006 Firm submitted acceded the
2011 on 17-08- 09-2021
2018
47. Amson 019649 Worex Tablet 07-08-1996 (Due Date: Deferred the
Vaccines & Each tablet Transfer of 21-09-2016) case for the
Pharma (Pvt.) contains: registration 30,000 approval status
Ltd., Mebendazole dated 30-11-2017 in Reference
Islamabad USP….. 500 mg 22-09-2006 Firm submitted Regulatory
regularization of
renewal of year
2011 on 17-08-
2018
48. Amson 042904 Zolimat 2.5mg 18-03-2006 (Due Date: Regularize the
Vaccines & Tablets 17-03-2016) renewal of year
Pharma (Pvt.) Each Tablet 30,000 2011 till 17-03-
Islamabad Zolmitriptan Firm submitted acceded the
…2.5mg 30,000/- for renewal of year
2011 on 17-08- 03-2021
2018
49. Opal 002528- Relix Capsules 17-08-2010 (Due Date: 16-8- Acceded the
Laboratories, Ex 20mg 2015) renewal of year
Karachi Each capsule Rs.20,000/- 2015 w.e.f.
contains: 09/11/2017 17-08-2015 to
Esomeprazole as Rs.40,000/- 16-08-2020
Magnesium… 12-12-2017
20mg
Source of Pellets:
M/s. Vision
Pharmaceuticals,
Plot No. 22-23,
Industrial Triangle,
Kahuta Road,
Islamabad.
50. Opal 002529- Relix Capsules 40mg 17-08-2010 (Due Date: 16-08- Acceded the
Laboratories, Ex Each capsule 2015) renewal of year
Karachi contains: Rs.20,000/- 2015 w.e.f.
Esomeprazole as 09/11/2017 17-08-2015 to
Magnesium..40mg Rs.40,000/- 16-08-2020
Source of Pellets: 12-12-2017
M/s. Vision
Pharmaceuticals,
Plot No. 22-23,
Industrial Triangle,
Kahuta Road,
Islamabad.
Decision: Registration Board considered the request of firms and decision is
mentioned against each in column VII.
ii. Finished Drugs for Import (Human)
I II III IV V VI
S
Firm Name Reg. No. Brand Name Date of Reg. Validity
No.
51. M/s. Galaxy 039811 IVF C injection 5000IU 03-06-2005 Grant the renewal of year
Pharma Pvt. Ltd., Each vial contains 2015 w.e.f. 03-06-2015 to
Karachi Human Chorionic 02-06-2020 with the advice to
Gonadotropin handover the record to
(hCG) 5000IU Biological Division for
Manufactured by M/s. onward processing the case at
LG Life Sciences, Ltd., their end.
Korea
52. M/s. Galaxy 039812 IVF C Injection 1000IU 03-06-2005 Grant the renewal of year
Karachi Human Chorionic 02-06-2020 with the advice to
Gonadotropin handover the record to
(hCG) 1000IU Biological Division for
Manufactured by M/s. onward processing the case at
LG Life Sciences, Ltd., their end.
Korea
53. M/s. Galaxy 039813 IVF-M Injection 75 IU 03-06-2005 Grant the renewal of year
Karachi Menotropin (hMG) 75 02-06-2020 with the advice to
IU handover the record to
Manufactured by M/s. Biological Division for
LG Life Sciences, Ltd., onward processing the case at
Korea their end.
54. M/s. Galaxy 039814 IVF M Injection 150 IU 03-06-2005 Grant the renewal of year
Karachi Menotropin (hcG) 150 02-06-2020 with the advice to
IU handover the record to
Manufactured by M/s. Biological Division for
LG Life Sciences, Ltd., onward processing the case at
Korea their end.
55. M/s. Galaxy 039815 Solvent for Follimon 03-06-2005 Grant the renewal of year
Pharma Pvt. Ltd., IVF-C 5000IU, IVF-C 2015 w.e.f.
Karachi 1000 IUm IVF-M 75 IU 03-06-2015 to
& IVF M 150 IU 02-06-2020 with the advice to
Injection handover the record to
Each solvent vial Biological Division for
contains:- onward processing the case at
Isotonic Sodium their end.
Chloride injection for
reconstitution 1ml
Manufactured by M/s.
LG Life Sciences, Ltd.,
Korea
56. M/s. Galaxy 052258 Aromek Film coated 13-11-2008 Grant the renewal of year
Pharma Pvt. Ltd., tablet 2013 w.e.f. 13-11-2013 to 12-
Karachi Each tablet contains 11-2018
Letrozole … 2.5mg
Manufactured by M/s.
Celon Pharma,
Pharma,Poland
Decision: Registration Board acceded the request of firms and decided to grant the
renewal mentioned against each in column VI. Renewal is confirm subject
to prevailing import policy for the Manufacturer Abroad.
Case No.119: Correction in Typographical Errors
Following typographical errors need to be corrected considered in 262nd, 276th and 279th
meeting
Sr. Date of Typographical
Firm Name Reg. No. Brand Name Decision of the Board
No. Reg. Error
1. M/s. Well & 042848 Omreplus Capsule 19-08- Registration Board Registration
Well Each capsule 2011 acceded to request No. is corrected
Pharmaceutical contain:- of the firm and as 072848 and
s Islamabad. Omeprazole….20 mg decided to grant the Brand name &
Sodium bicarbonate renewal of above composition of
….1100 mg products till 18th the product is
August, 2021. corrected as
Omrel plus
Capsule
Each capsule
contain:-
Omeprazole …
40 mg
Sodium
bicarbonate …
1100 mg
2. Genetic 072529 Xavidon Tablet 40mg 21-11- Registration Board Composition of
Pharmaceutical, Each Tablet 2011 acceded to request the product is
Lahore contains:- of the firm and corrected as
Ziprasidone Mesylate decided to grant the Ziprasidone
…40mg renewal of above Hydrochloride
(Imported from M/s. products till 20-11- …40mg
Chongqing 2021 subject to
Shenghuaxi prevailing import
Pharmaceutical Co, policy for finished
Ltd, China.) drugs.
Lahore conatins:- of the firm and corrected as
Ltd, China.) drugs.
Lahore contains:- of the firm and corrected as
Ltd, China.) drugs.
5. Meditech 036894 Medralka Syrup 31-01- Registration Board Composition is
Pharmaceutical, Each 5ml contains: 2005 acceded to request corrected as
Peshawar. Silymarin … 100mg of the firm and Sodium Acid
decided to grant the Citrate …
renewal of product 1.25mg
w.e.f. 31-01-2015
till 30-01-2020
Decision: Registration Board noted the information.
Case No.120: Cases received after expiry, for consideration under SRO 1005(I)/2017.
i. M/s. Morgan Technologies Services Karachi

Registration Board in its 279th meeting deferred the case of M/s. Morgan Technologies
Services, Karachi, 2017 for opinion of Legal Affair Division. The case is related to avail the
opportunity provided in the third proviso of SRO 1005(I)/ 2017, the amended Rule 27 of
Drug (Licensing, Registering& Advertising) Rule 1976 as under
“27. Duration of certificate of registration: - A certificate of registration under this

chapter, shall unless earlier suspended or cancelled, be in force for a period of five years
from the date of registration of the drugs and may thereafter be renewed for periods not
exceeding 5 years and a certificate to this effects shall be issued within one month at a time.
Provided that an application shall be made within sixty dates after the expiry of the
registration and when an application has been aforesaid the registration shall subject to the
orders passed on the application for the renewal continue in force for the next period of five
years and a certificate to this effect shall be issued within one month.
Provided further that one-time opportunity shall be given to those firms who have not
complied with the first proviso since 1st January, 2010 till the issuance of this notification
and those within sixty days after issuance of this notification shall deposit three times of
their applicable renewal fee for their registration to continue to be valid until explicit
orders are passed on the request by the Registration Board. After expiry of sixty days of
issuance of this notification, the registration of the products shall be considered as
cancelled and any manufacturing shall be penalized under the provision of the Act.
Provided also that those firms who do not fulfil the first proviso, an additional fee shall be
charged equivalent to applicable renewal fee for each month till one year of the expiry of
registration and one year the registration shall be cancelled.
Provided further that in case of an imported drug, the renewal may be granted and a
renewal certificate shall be issued, if in the opinion of the Registration Board it is necessary
to do so in the public interest.
M/s. Morgan Technologies Services, Karachi avail the opportunity given in 3rd proviso of
Rule 27 (L R&A) for the regularization of renewal of year 2017 regarding the following
products: -
Sr. Reg. No. Product Name Along with Initial Reg. Date Application Receiving Date
No. Composition
1 045729 Avizole Injection 26-07-2007 (Due Date: 25-07-2017)
Contains: Rs.120,000/- 21-12-2017
Omeprazole sodium … 42.6mg Renewal Application of year 2017
eq. to 40mg Omeprazole is submitted 5 month late.
Imported from M/s. Yangzhou Rs.40,000/- is paid as prescribed fee
AosalKang Pharmaceuticals Co. for the period of within 60 days.
Ltd., China. Rs.80,000/- is paid for 3 month
renewal fee.
2 045728 Toprazole Injection (Pantoprazole 26-07-2007 (Due Date: 25-07-2017)
Sodium Freeze Dried Lyophilized Renewal Application of year 2017
Powder for Injection) is submitted 5 month late.
Each vial contains: Rs.40,000/- is paid as prescribed fee
Pantoprazole Sodium …….40mg for the period of within 60 days.
Imported from M/s. Yangzhou Rs.60,000/- is paid for 3 month
AosalKang Pharmaceuticals Co. renewal fee.
Ltd., China.
The opinion of Legal Affair is narrated as under:
The following three scenarios could be possible in the light of said circumstances:-
(i) If the firm could not submit renewal application due on 25.07.2012,it had
opportunity to file application for renewal with three times of applicable renewal
fee under first proviso of amended rule 27 till 04.12.2017
(ii) Similarly, if the firm got renewal of registration on 25.07.2012 and could not
submit application for renewal due on 25.07.2017 ,it had opportunity to file
application for renewal with three times of applicable renewal fee under first
proviso of amended rule 27 till 04.12.2017
(iii) If the firm could not submit renewal application due on 25.07.2012 or on
25.07.2017 and did not avail the one time opportunity provided under first proviso
of amended rule 27 till 04.12.2017, it may submit renewal application under third
proviso with applicable fee + an additional fee equivalent to applicable renewal
fee for each month till 25.07.2018, provided the products were renewed on
25.07.2012.
It seems that the case of M/s. Morgan Technologies Services, Karachi falls under point
(iii).In case the above products were renewed on 25.07.2012, the renewal application
submitted on 25.07.2012, the renewal application submitted on 21.12.2017 may be
considered under third proviso of amended rule 27 with applicable fee + five time fee as the
application is five month’s late from due date. In case the products were not renewed not
renewed on 25.07.2012, the firm cannot avail third proviso of amended rule 27.
It is for the information of respected board that the renewal of year of 2012 of
abovementioned product has been regularized vide SRO 1005(I)/ 2017 in 278th meeting of
Registration Board.
Decision: Registration Board acceded to the request of firm and decided to grant the
renewal w.e.f. 26-07-2017 to 25-07-2022 subject to prevailing import
policy for the Manufacturer Abroad.
ii. M/s.UM Enterprises, Karachi

M/s.UM Enterprises, Karachi avail the opportunity given in 3rd proviso of Rule 27 (L R&A)
for the regularization of renewal of year 2018 regarding the following imported veterinary
products:
Sr. Reg. No. Product Name Along with Initial Reg. Due Date along application
No. Composition Date receiving Date
1 014166 Avitryl Oral Solution 01-08-1993 (Due Date:31-07-2018)
Each 100cc contains: Firm submitted the renewal
Enrofloxacin…..10gm application of year 2018 three
Manufactured by M/s. Arab month late after expiry of
Veterinary Industrial Co. Registration i.e. 12-10-2018
Amman,Jordan along with fee of Rs.60, 000/-.
2 014164 Colimycin Powder -do- -do-
Erythromycin
Thiocyanate…11.5mg(active)
Colistin Sulphate…..40,000,000 IU
Manufactured by M/s. Arab
Veterinary Industrial Co.
Amman,Jordan
3 014165 Aviquil Plus Powder -do- -do-
Flumequine….10gm
Colistin Sulphate…..40,000,000 IU
Manufactured by M/s. Arab
Veterinary Industrial Co.
Amman,Jordan
renewal w.e.f.01-08-2018 to 31-07-2023 subject to prevailing import policy
for the Manufacturer Abroad.
iii. M/s. Roche Pakistan Limited 37-C,Block 6 P.E.C.H.S, Karachi

Registration Board in its 261st meeting considered the renewal application of M/s.
Roche Pakistan Limited for the following products and decided to grant the validity till 21-
07-2018 which need correction as the correct validity is 01-07-2018.
Case is placed before the Board for the regularization of Renewal of year 2018 as the firm
has submitted renewal application on 08-11-2018 with prescribed fee as per SRO 1005
(I)/2017 narrated below:
Provided also that those firms who do not fulfil the first proviso, an additional fee
shall be charged equivalent to applicable renewal fee for each month till one year of
the expiry of registration and one year the registration shall be cancelled.
Sr. Reg.no. Product Name along Initial Reg. Date Due Date Remarks
no. with composition
1. O43001 Tarceva 25mg Tablets 22-03-2006 01-07-2013 Firm did not submit the
Each film coated (P-28-29/corr.) renewal application of
tablets contains : Change of year 2013
Erlotinib manufacturing site However the firm
hydrochloride 02-07-2008 representative informed
corresponding to (P-35/corr.) that they have submitted
25mg of Erlotinib application for
Deregistration to the
concerned section.
2. 043002 Tarceva 100mg 22-03-2006 01-07-2018
i- Application received on
Tablets Change of ii- 08-11-2018 along with
Each film coated manufacturing site fee of Rs.100,000/-
tablets contains : 02-07-2008
Erlotinib Change of
hydrochloride manufacturing site
corresponding to 21-11-2013
100mg of Erlotinib Change of
Manufactured by Source/Manufacturer
M/s.F. Hoffmann-La of Drug
Roche Ltd. 14-12-2016
Grenzacherstrasse
124, CH-4070 Basel,
Switzerland
3. 043003 Tarceva 150mg -do- -do- -do-
Tablets
Each film coated
tablets contains :
Erlotinib
hydrochloride
corresponding to
150mg of Erlotinib
Manufactured by
M/s.F. Hoffmann-La
Roche Ltd.
Grenzacherstrasse
124, CH-4070 Basel,
Switzerland
Decision: Registration Board decided to refer the product at sr.no. 1to R-I section for
further processing & grant the renewal of products at sr.no. 2& 3 w.e.f. 02-
07-2018 to 01-07-2023 subject to prevailing import policy for the
manufacturer abroad.
Case No.121: M/s. Global Pharmaceuticals (Pvt) Ltd., Islamabad.

M/s. Global Pharmaceuticals (Pvt.) Ltd., Islamabad has applied for the renewal of registration
of following products.
Sr. Initial date of
Reg. No. Product Name Application Receiving date
No. Registration
1. 047992 Vellive Tablets 02-01-2008 Due date (01-01-2018)
Each tablet contains: Fee of Rs.10,000/- deposited on
Valsartan….160mg 20-02-2018.As application received
within 60 days after expiry of Reg.
So remaining Fee of Rs.10,000/-
deposited on 22-03-2018.
2. 047996 Di-Vellive Tablet 02-01-2008 Due date (01-01-2018)
Each tablet contains: Fee of Rs.10,000/- deposited on
Valsartan….160mg 20-02-2018.As application received
Hydrochlorothiazide….25mg within 60 days after expiry of Reg.
So remaining Fee of Rs.10,000/-
It is submitted that above products contain Valsartan in their formulation and currently
active substance valsartan supplied by Zhejiang Huahai Pharmaceuticals is under review.
Firm did not informed about the supplier of active substance valsartan and stated that they
have not manufactured any batch of above mentioned products till 28-09-2018.
Decision: Registration Board acceded to the request of firm and decided to grant
the renewal w.e.f. 02-01-2018 to 01-01-2023.
Case No.122: M/s. GlaxoSmithKline (GSK) Pakistan Limited (DML 000248) Plot No. 5,
Sector 21, Korangi Industrial Area, Karachi.
Case is referred by Pricing Division for the confirmation of renewal status of following
products;
Application
Sr. Reg.
Product Name Initial date of Registration Due Date Receiving
No. No.
Date
1. 006221 Zinacef 250mg Injection 03-02-1982 09-09-2018 04-09-2018
Each vial contains:- Transfer of reg. dated
Cefuroxime Sodium eq. 10-09-2003
to Cefuroxime….250mg Transfer of reg. dated
22-12-2010
Case No. 123: M/s. GlaxoSmithKline (GSK) Pakistan Limited (DML 000233) F-268,
S.I.T.E., Karachi.
Case is referred by Pricing Division for the confirmation of renewal status of following
products;
I II III IV V
Sr. Reg. Initial date of
Product Name Validity
No. No. Registration
1. 009264 Augmentin Syrup 16-03-1988 w.e.f.
Each 5ml contains:- Transfer of reg. 30-08-2018 to
Amoxycillin trihydrate eq. to Amoxycillin … 125mg dated 29-08-2023
Potassium Clavunate eq. to Clavulanic 30-08-2003
Acid…31.25mg
2. 018360 Augmentin DS Syrup 18-10-1995 w.e.f.

Each 5ml contains:- Transfer of reg. 30-08-2018 to
Potassium Clavunate eq. to Clavulanic Acid..62.50mg 30-08-2003
3. 006747 Augmentin Tablet 375mg 01-04-1985 w.e.f.
Each tablet contains:- Transfer of reg. 30-08-2018 to
Potassium Clavunate eq. to Clavulanic Acid… 125mg 30-08-2003
4. 017297 Augmentin Tablet 625mg 11-06-1995 w.e.f.
5. 022244 Augmentin BD Tablet 29-08-1998 w.e.f.
the renewal mentioned against each in column V.
Case No. 124: M/s. Otsuka Pakistan Limited, Karachi.

M/s. Otsuka Pakistan Limited, Karachi has applied for renewal of registration of their
products. Detail of which is as under;
Product Name Application Receiving date
1. 045744 Abilify Tablet 26-07-2007 Due date (25-07-2017)
Each tablet contains:- Application is received after approx. 8 month
Aripiprazole … 10mg of expiry of registration on 22-03-2018.
Renewal of year 2012 has also not submitted.
2. 045745 Abilify Tablet Do Do
Aripiprazole … 15mg
In Form 5-B, firm has stated that initial registration had been given in July 2007, but due to
price fixation matter they have not marketed their product. That is why they are applying for
renewal for the first time. However, initial registration letter issued vide letter no. F.3-3/2007-
Reg-I (M-206) dated 26-07-2007 bears the price of Rs.250.00/3x10’s and Rs.300.00/3x10’s
for above mentioned products. Registration Board in its 283rd meeting deferred the case for
further deliberation.
Submitted for consideration of Board please.
Decision: Registration Board decided to adopt the cancellation procedure as per
Section 42 of drug act 1976 as of the opinion of Legal Affair Division.
Case No.125: Applications Received with Shortcomings.
This section apprised the Board that Directorate of (PE&R) is dealing with
number of applications submitted for renewal of drugs which are incomplete or have
shortcoming especially with reference to the submitted prescribed renewal fees.
The following applications for renewal of drugs are submitted on Form 5-B after the
expiry of validity of the certificate of registration but within sixty days after validity of
certificate of registration. The applications for renewal are incomplete with reference to
renewal application fee or having some other deficiency.
RULE 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of
certificate of registration). A certificate of registration under this chapter, [shall unless
earlier suspended or cancelled, be in force for a period of five years from the date of
[Registration of the drug] and may thereafter be renewed for period not exceeding five years
and a certificate to this effect shall be issued within one month] at a time.
Provided that an application for the renewal of registration shall not be entertained unless it
has been made within sixty days after the expiry of the registration and when an application
has been made aforesaid the registration shall subject to the orders passed on the application
for the renewal continue in force for the next period of five years and a certificate to this
effect shall be issued within one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal
certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so
in the public interest
Following cases are placed below for the consideration of Registration Board.
i) With Prescribed Fee
a) M/s. Well & Well Pharmaceuticals Islamabad.
I II III IV V VI
Sr. Reg. Initial date of Validity
1. 070068 H-Trax 250mg Capsule 15-04-2011 Due date (14-04-2016) w.e.f. 15-04-2016
Each capsule contains:- Received within 60 days to 14-04-2021
Tranexamic Acid … 250mg after expiry of Reg. with fee
of Rs.20,000/- deposited on
18-04-2016.
2. 070071 Citrovel Sachet Do Do w.e.f. 15-04-2016
Each sachet contains:- to 14-04-2021
Citric Acid … 0.702gm
Sodium Bicarbonate …
1.716gm
Sodium Citrate … 0.613gm
Tartaric Acid … 0.858gm
3. 065121 Nothrox 275mg Tablet 22-07-2010 Due date (21-07-2015) w.e.f. 22-07-2015
Each tablet contains:- Received within 60 days to 21-07-2020
Naproxen Sodium … after expiry of Reg. with fee
550mg of Rs.20,000/- deposited on
24-08-2015.
4. 065122 Nothrox 550mg Tablet Do Do w.e.f. 22-07-2015
Each tablet contains:- to 21-07-2020
Naproxen Sodium …
550mg
the renewal mentioned in column VI.
b) M/s. AG&C Pharma, Karachi.
Case is referred by R-I section for confirmation of renewal status with the copies of registration
letter and post registration variation of following products registered in the name of M/s.
AG&C, Karachi for transfer of registration to M/s. Novartis Pharma (Pakistan) Limited,
Karachi.
Initial date
Sr. Reg.
Product Name of Application Receiving date
No. No.
Registration
1. 008249 Tobrex Ophthalmic 0.3% Solution 07-11-1985 Due date (02-09-2015)
Each ml contains:- Change of Received within 60 days after expiry
Tobramycin … 3mg source dated of Reg. with fee of Rs.40,000/-
Benzalkonium Chloride … 0.1mg 03-09-2005 deposited on 07-9-2015.
Imported from M/s. Alcon Belgium.
2. 028401 Travatan Sterile Ophthalmic Solution 12-08-2002 Due date (02-09-2015)
Travoprost … 0.004% Change of Received within 60 days after expiry
Imported from M/s. Alcon Belgium. source dated of Reg. with fee of Rs.40,000/-
03-09-2005 deposited on 07-9-2015.
the renewal w.e.f. 03-09-2015 to 02-09-2020 subject to prevailing import
policy for the manufacturer abroad.
c) M/s. Fresenius Medical Care Pakistan (Pvt) Ltd., Lahore.

Case is referred by R-I section.
Sr. Reg. Initial date of Application Validity
Product Name
No. No. Registration Receiving date
1. 039884 CAPD/DPCA 2 stay safe Peritoneal 09-09-2005 Due date (08- w.e.f.
Dialysis Solution Change of 09-2015) 09-09-2015 to
Each litre contains:- brand name & Received 08-09-2020
Sodium Chloride … 5.786gm manufacturer within 60 days
Sodium Lactate … 3.925gm
Calcium Chloride … 0.2573gm dated after expiry of
Magnesium Chloride … 0.1017gm 30-05-2011 Reg. with fee
Glucose monohydrate … 16.5gm of Rs.40,000/-
Anhydrous glucose … 15gm deposited on
Manufactured by: M/s. Fresenius 12-10-2015.
Medical Care Deutschland GmbH, St.
Wendel, Germany.
2. 039886 CAPD/DPCA 3 stay safe Peritoneal Do Do Do
Dialysis Solution
Each litre contains:-
Sodium Chloride … 5.786gm
Calcium Chloride … 0.2573gm
Magnesium Chloride … 0.1017gm
Glucose monohydrate … 46.75gm
Anhydrous glucose … 42.5gm
Manufactured by: M/s. Fresenius
Wendel, Germany.
3. 039887 CAPD/DPCA 4 stay safe Peritoneal Do Do Do
Dialysis Solution
Each litre contains:-
Sodium Chloride … 5.786gm
Calcium Chloride … 0.2573gm
Magnesium Chloride … 0.1017gm
Glucose monohydrate … 46.75gm
Anhydrous glucose … 22.73gm
Manufactured by: M/s. Fresenius
Wendel, Germany.
the renewal w.e.f. 09-09-2015 to 08-09-2020 subject to prevailing import
policy for the manufacturer abroad.
ii) With Differential Fee

a) M/s. Well & Well Pharmaceuticals Islamabad.
1. 070066 Malavel Suspension 15-04-2011 Due date (14-04-2016)
Each 5ml contains:- Fee of Rs.10,000/- deposited on 18-04-2016.
Artemether … 15mg As application received within 60 days after
Lumefantrine … 90mg expiry of Reg. Remaining Fee of Rs.10,000/-
2. 070067 Cipnolone 250mg Do Do
Suspension
Each 5ml contains:-
Ciprofloxacin (as HCl) …
250mg
Decision: Registration Board acceded to request of the firm and decided to grant
renewal w.e.f 15-04-2016 to 14-04-2021
b) M/s. ISIS Pharmaceuticals Karachi.

Case is referred by Controlled Drugs Division.
1. 061695 Pram 0.5mg Tablet 14-07-2010 Due date (13-07-2015)
Each tablet contains:- Fee of Rs.10,000/- deposited on 28-07-
Alprazolam … 0.5mg 2015. As application received within 60
days after expiry of Reg. Remaining Fee of
Rs.10,000/- deposited on 08-11-2016.
the renewal w.e.f. 14-07-2015 to13-07-2020.
c) M/s. Amros Pharmaceuticals Karachi.

Case is referred by R-II section.
2. 070526 Megacip Infusion 28-04-2011 Due date (27-04-2016)
Each 100ml contains:- Fee of Rs.10,000/- deposited on 28-04-
Ciprofloxacin … 200mg 2016. As application received within 60
days after expiry of Reg. Remaining Fee
of Rs.10,000/- deposited on 19-07-2018.
3. 070527 Levocin Infusion Do Do
Levofloxacin … 500mg
d) M/s. Martin Dow Limited, Karachi.
Case is referred by R-II section for confirmation of renewal status of products
registered in the name of M/s. Martin Dow Limited, Karachi for change of post registration
variation. During evaluation it was observed that these products were transferred from M/s.
Rosch Pakistan Ltd., Karachi to M/s. Martin Dow Pharmaceuticals (Pakistan) Limited,
Karachi. While the DML attached in the file bears the name of firm M/s. Martin Dow
Pharmaceuticals Limited, Karachi. This anomaly needs to be addressed for considering the
renewal application.
I II III IV V VI
Sr. Reg. Initial date of Validity
1. 001049 Rivotril Tablet 15-08-1976 Due date (28-06-2015) w.e.f. 29-06-2015
0.5mg Transfer of Fee of Rs.10,000/- deposited on to 28-06-2020
Each tablet Registration 16-06-2015. As it is bulk import
contains:- dated and locally repacked product
Clonazepam … 29-06-2010 from M/s Rosch Farm, SA,
0.5mg Leganes, Spain. So remaining
Fee of Rs.10,000/- deposited on
18-09-2018.
2. 003626 Rivotril Tablet 2mg 05-01-1978 Do w.e.f. 29-06-2015
Each tablet Transfer of to 28-06-2020
contains:- Registration
Clonazepam … 2mg dated
29-06-2010
3. 022988 Dilatrend Tablet 30-01-1999 Due date (28-06-2015) w.e.f. 29-06-2015
6.25mg Change of Fee of Rs.10,000/- deposited on to 28-06-2020
Each tablet brand name 16-06-2015. As it is bulk import
Carvedilol … 03-01-2006 from M/s Rosch S.pA. Segrate,
6.25mg Transfer of Italy. So remaining Fee of
Registration Rs.10,000/- deposited on 18-09-
dated 2018.
29-06-2010
4. 022989 Dilatrend Tablet Do Do w.e.f. 29-06-2015
12.5mg to 28-06-2020
Carvedilol….12.5mg
5. 014929 Dormicum Ampoule 24-02-1994 Due date (28-06-2015) w.e.f. 29-06-2015
Each ml contains:- Transfer of Fee of Rs.10,000/- deposited on to 28-06-2020
Midazolam … 1mg Registration 16-06-2015. As it is bulk import
dated and locally repacked product
29-06-2010 from M/s Cenexi Sas,
Fontenary, Sous Bios, France.
So remaining Fee of
Rs.10,000/- deposited on 18-09-
2018.
6. 001047 Rivotril Drop 0.25% 15-08-1976 Due date (28-06-2015). Fee of w.e.f. 29-06-2015
Each ml contains:- Transfer of Rs.10,000/- deposited on 16-06- to 28-06-2020
Clonazepam … Registration 2015. As it is bulk import and
2.5mg dated locally repacked product from
29-06-2010 M/s Rosch S.pA. Segrate, MI-
Italy. So remaining Fee of
2018.
7. 008433 Rocephin Injection 10-07-1985 Due date (28-06-2015) w.e.f. 29-06-2015
IV 250mg Transfer of Fee of Rs.10,000/- deposited on to 28-06-2020
Each vial contains:- Registration 16-06-2015. As it is bulk import
Ceftriaxone … dated and locally repacked product
250mg 29-06-2010 from M/s F. Hoffman
LaRosche, Basle, Switzerland.
So remaining Fee of
2018.
8. 008432 Rocephin Injection Do Do w.e.f. 29-06-2015
IM 250mg to 28-06-2020
Ceftriaxone …
250mg
IV 500mg to 28-06-2020
Ceftriaxone …
500mg
IM 500mg to 28-06-2020
Ceftriaxone ..500mg
11. 007014 Rocephin Injection 18-04-1985 Do w.e.f. 29-06-2015
IV 1gm Transfer of to 28-06-2020
Each vial contains:- Registration
Ceftriaxone … 1gm dated
29-06-2010
12. 008436 Rocephin Injection 10-07-1985 Do w.e.f. 29-06-2015
IM 1gm Transfer of to 28-06-2020
Each vial contains:- Registration
Ceftriaxone … 1gm dated
29-06-2010
13. 000584 Valium Ampoule 15-08-1976 Due date (28-06-2015) w.e.f. 29-06-2015
10mg/2ml Transfer of Fee of Rs.10,000/- deposited on to 28-06-2020
Each ampoule Registration 16-06-2015. As it is bulk import
Diazepam … 10mg 29-06-2010 from M/s Cenexi Sas,
Fontenary, Sous Bios, France.
So remaining Fee of
2018.
14. 017005 Dilatrend Tablet 15-06-1995 Due date (25-10-2015) w.e.f. 26-10-2015
25mg Change of Fee of Rs.10,000/- deposited on to 25-10-2020
Each tablet brand name 16-06-2015. As it is bulk import
Carvedilol … 25mg 03-01-2006 from M/s Rosch S.pA. Segrate,
Transfer of Italy. So remaining Fee of
Registration Rs.10,000/- deposited on 18-09-
dated 2018.
26-10-2010
renewal mentioned in column VI.
e) M/s. Trigon Pharmaceuticals (Pvt) Ltd., Lahore.
1. 047757 Pantagon Injection IM/IV 25-10-2007 Due date (24-10-2017)
Each 1ml contains:- Fee of Rs.10,000/- deposited on 25-10-
Pentazocine (as Lactate) … 2017. As application received within 60
30mg days after expiry of Reg. Remaining Fee of
Rs.10,000/- deposited on 23-04-2018.
2. 047758 Bubrifen Injection Do Do
Each ml contains:-
Buprenorphen (as HCl) …
0.3mg
Decision: Registration Board deferred the case for the confirmation of status of License
from Licensing Division
M/s AGP Limited, Karachi.

Case is referred by R-II Section.
Sr. Initial date of
No. Registration
1. 050357 AxidNeo 40mg Capsules 04-08-2008 Due date (01-03-2014)
Each capsule contains: Change of Fee of Rs.10,000/- deposited on 17-02-2014.
Esomeprazole enteric source of As these are imported pellets from M/s. Titan
coated pellets (as pellets dated Laboratories (Pvt.) Ltd., India Plot No.E-
Magnesium 02-03-2009 27/1&E-27/MIDC MAHAD, Village JITE
Trihydrate)…40mg District Raigad Maharashtra India. Remaining
fee of Rs10,000/- is deposited on 24-09-2018.
2. 050356 AxidNeo 20mg Capsules 04-08-2008 Due date (01-03-2014). Fee of Rs.10,000/-
Each capsule contains: Change of deposited on 17-02-2014. As these are
Esomeprazole enteric source of imported pellets from M/s. Titan Laboratories
coated pellets (as pellets dated (Pvt.) Ltd., India Plot No.E-27/1&E-27/MIDC
Magnesium 02-03-2009 MAHAD, Village JITE District Raigad
Trihydrate)….20mg Maharashtra India. Remaining fee of
Rs10,000/- is deposited on 24-09-2018.
f) M/s. Getz Pharma (Pvt.) Limited, Karachi.
Case is referred by R-II Division.
Sr. Initial date of
No. Registration
1 050392 Tamsolin 0.4mg Capsule 06-08-2008 Due date (05-08-2013)
Each modified release capsule Change of name Fee of Rs.10,000/- deposited on 28-
contains: of bulk import 05-2013 (Photocopy, processed in
Tamsulosin HCl…..0.4mg source the light of decision of 264th meeting
(as modified release pellets) 05-05-2009 of Registration Board). As these are
imported pellets from M/S RA Chem
Pharma Limited. clinical Research
and Bio Science India (Pvt.) Ltd. So,
remaining fee of Rs.10,000/- is
deposited on 7-12-2017.(Photocopy).
Furthermore Renewal application of
year 2018 was received on 27-06-
2018 i.e. within time.
Decision: Registration Board acceded to the request of firm and decided to
regularize the renewal of year 2013 till 05-08-2018.Further grant the
renewal of year 2018 w.e.f. 06-08-2018 to 05-08-2023.
g) M/s. Opal Laboratories (Pvt.) Ltd. Karachi.
It is submitted that a letter received from R-II Section, wherein they have stated that the firm
has applied for change of source of pellets of following products. So they requested to
confirm the renewal status of products. It is pertinent to mentioned here that the concerned
section did not inform about the previous source of pellets and same is not mentioned in the
renewal dossiers submitted by the firm.
I II III IV V VI
Sr. Initial date of Validity
No. Registration
1. 003734- Enon Capsule 20mg 04-10-2012 Due date (03-10-2017) w.e.f. 04-10-2017 to
EX Each capsule contains: Firm applied for renewal of 03-10-2022
Esomeprazole (as year 2017 on 06-09-2017
Magnesium along with fee of Rs.20,000/-
Trihydrate)… 20mg
2. 000768- Enon Capsule 40mg 06-11-2007 Due Date (05-11-2017) w.e.f. 06-11-2017 to
EX Each capsule contains: Firm applied for renewal of 05-11-2022
Esomeprazole (as year 2017 on 01-11-2017
Magnesium along with fee of Rs.20,000/-
Trihydrate)… 40mg Further firm submitted
renewal of year 2012 along
with fee of Rs.10,000/-
renewal mentioned in column VI.
h) M/s. Asian Continental (Pvt.) Ltd., Karachi.
Case is referred by R-II Division.
1 058553 Kolac Syrup 03-10-2009 Due date (02-10-2014)
Each 5ml contains: As these are imported in bulk from M/s.
Lactulose……….3.35gm Fresenius Kabi, Austria, GMBH,
M/s. Fresenius Kabi, Austria, Estermannstrasse 17,4020 Linz, Austria
GMBH, Estermannstrasse ,so firm submitted renewal application
17,4020 Linz, Austria along with fee of Rs.20,000/- deposited
on 03-09-2014 (Photocopy, processed in
the light of decision of 264th meeting of
Registration Board).
Case No: 126: M/s. Geofman Pharmaceuticals Karachi.

It is submitted that M/s. Geofman Pharmaceuticals Karachi requested for issuance of
Renewal letter vide letter no. nil dated 7th September, 2018 for their following products.
According to the letter firm exporting the subject products to Myanmar and for exporting
purpose they applied for Certificate of Pharmaceutical Product (CoPP) in DRAP Karachi
office. But the concerned office of DRAP required confirmation of renewal status of below
mentioned products:
Sr. Reg.no. Product Name along with Initial Date of Due Date Validity
no. composition Registration
1. 005268 Nuramine Forte Tablet 29-03-1980 28-03-2015 w.e.f. 29-03-2015 till
Each tablet contains: Change of brand 28-03-2020
Thiamine Mononitrate….100mg name dated Product is registered
Cyanocobalamin ……..200mcg 05-04-1982 on the address of 19
Pyridoxine HCl...200mg West Wharf, Karachi
2. 004402 Nuramine Forte Injection 22-11-1978 21-11-2018 w.e.f. 22-11-2018 till
Each 3ml contains: 21-11-2023
Thiamine HCl….100mg Product is registered
Pyridoxine HCl….100mg on the address of 19
Cyanocobalamin.1000mcg West Wharf, Karachi
Decision: Registration Board acceded to the request of firm for the renewal of
registration and grant the renewal validity given in the last column
subject to correction/confirmation of address by the concerned section.
Case No: 127: M/s Moreno Iglisias Research Laboratories Pvt Limited, Lahore.
M/s Moreno Iglisias Research Laboratories (Pvt) Ltd., Lahore for the
confirmation of renewal status of following products. Detail of which is as under: -
S. Reg. No. Product Name Initial Reg. Due Date Application Remarks Validity
No. Date Receiving
Date
1 058763 Levasole 24-07-2009 23-07-2014 16-07-2014 Renewal w.e.f 24-7-
Suspension application 2014 to 23-
received within 7-2019
time
2 058764 Lincospen -do- -do- -do- -do- -do-
Liquid
3 058765 Triclasheph -do- -do- -do- -do- -do-
Drench 8.75
4 058766 Triclasheph -do- -do- -do- -do- -do-
Drench 12.50
5 058767 Werminid -do- -do- -do- -do- -do-
Drench
6 058768 Werminid Plus 24-09-2009 23-09-2014 16-07-2014 -do- w.e.f. 24-9-
Drench 2014 to 23-
9-2019
7 058769 Devermer -do- -do- -do- -do- -do-
Drench 10%
8 058770 Imesantal -do- -do- -do- -do- -do-
Drench
9 058771 Fenbendasheph -do- -do- -do- -do- -do-
Drench
10 058772 Multifleece -do- -do- -do- -do- -do-
Liquid
11 062101 Enrosheph 10 07-05-2010 06-05-2015 03-06-2015 Application was w.e.f 07-
Oral Solution submitted after due 05-2015 to
date but within sixty 06-05-2020
days with 20000/-
fee
12 62102 Toltrasheph -do- -do- -do- -do- -do-
5% Oral
Solution
13 62103 Fenzonid -do- -do- -do- -do- -do-
Drench
14 62104 Albasheph -do- -do- -do- -do- -do-
Drench
15 62105 Zentanid -do- -do- -do- -do- -do-
Drench
16 62106 Refonid -do- -do- -do- -do- -do-
Drench
17 62107 Alzanid Drench -do- -do- -do- -do- -do-

18 62108 Refobenide -do- -do- -do- -do- -do-
Drench
19 69618 Lincosheph 14-04-2011 13-04-2016 11-05-2016 Application was w.e.f
Plus Liquid submitted after due 14-04-2016
date but within sixty to
days with 10000/- 13-04-2021
fee. Differential fee
10000 is submitted
by the firm.
20 69619 OXA Plus -do- -do- -do- -do- -do-
Drench
21 69620 Albasheph 10 -do- -do- -do- -do- -do-
Drench
Decision: Registration Board granted the renewal as mentioned against each in the
last column.
Export Facilitation Desk
Introduction:
An Export Facilitation Desk has been established by DRAP to assist exporters
of therapeutic goods & to facilitate the applicants for priority disposal of various task i.e
Certificate of Pharmaceutical Product (CoPP), Registration of therapeutic goods for export
purpose, Good Manufacturing Practices (GMP) Certificates, etc.
Case No.128: Cases Referred by Post Registration Variation Committee.

a) Registration of Drugs of M/s. Getz Pharma Pvt Ltd. Karachi for Export purpose.
M/s. Getz Pharma Pvt Ltd. Karachi has applied for registration of drug (s) exclusively for
export purpose as per following details:
Sr. No. Name of Drug(s) Generic/RRA Status Diary No. Fee with date
I II III IV
1. Linapta Tablets 5mg Tradjenta tablets 5mg by Dy No.38-PE&R-(EFD)
Each film coated tablet contains: M/s Boehringer, USA 23.10.2018
Linagliptin……5mg Rs.50,000/-
b) Registration of Drugs of M/s Searle Company Limited, Karachi for Export

purpose.
Firm has applied for registration of drug(s) only for export purpose as per following details:
Sr.# Name of Drug(s) Generic/RRA Status Diary No. Date with Fee
I II III IV
01. DIALIN 5MG TABLET USFDA Approved Dy No.43-PE&R-(EFD)
Each film coated tablet contains: Tradjenta Tablet 5mg 29.10.2018
Linagliptin……….5mg Rs.50,000/-
02. DIALIN-M 2.5MG+850MG USFDA Approved Dy No.44-PE&R-(EFD)
TABLET Jentadueto Tablet 29.10.2018
Each film coated tablet contains: Rs.50,000/-
Linagliptin……….2.5mg Approved with Boxed warning by
Metformin HCI…….850mg RRAs.
03. DIALIN-M 2.5MG+1000MG USFDA Approved Dy No.46-PE&R-(EFD)
Metformin HCI….1000mg RRAs.
04. DIALIN M 2.5MG+500MG USFDA Approved Dy No.45-PE&R-(EFD)
Metformin HCI…….500mg RRAs.
Decision: Registration Board deferred the case for further deliberation in the light
of views/comments furnished by IPO Pakistan.
Case No.129: Issuance of CoPP To M/s. Indus Pharma (Pvt.) Ltd, Karachi.
Additional Director DRAP, Karachi has forward a letter wherein he has informed that M/s.
Indus Pharma (Pvt.) Ltd, Plot No. 65, Sector 27, Korangi Industrial Area, Karachi has
requested to issue them CoPP for following product for export purpose to Turkmenistan
which is registered for export purpose only.
S.No. Name of Drug(s) Reg.No./ Initial Date of Registration
1. Nasogin Injection 000496-EX
Metamizol Sodium …… 500mg
Pitofenone HCl ………… 2mg
Fenpiverinium Bromide …. 0.02mg
However, in the light of decision taken vide 196th meeting of Drugs Registration Board, the
registration of all formulations containing “Metamizole” either alone or in fixed dose
combinations was cancelled/ withdrawn vide letter No.f.3-1/2006-Reg.II-S (M-196) dated 21-
03-2006.
The Additional Director, DRAP, Karachi has requested to confirm the registration
status of the above product. Accordingly, the case was referred to RRR section and as per
information provided by that section, the renewal application is received on 28-06-2016 i.e.,
within time, under Rule 27 of Drugs Licensing, Registering & Advertising Rule, however,
could not be entertained due to cancellation/ withdrawal of formulation. Furthermore, they
have stated that RRR section, under Rule 27, confirms the renewal of drugs for a period of
five years unless earlier suspended/ cancelled.
The case has been placed for deliberation w.r.t issuance of CoPP and fate of all those
products already registered exclusively for export purpose, containing
formulations/molecules which have been withdrawn/cancelled/suspended by the Drugs
Registration Board.
Decision: Registration Board acceded to request of the firm regarding issuance of

CoPP of Nasogin Injection, registered for export purpose exclusively.
Furthermore, in order to facilitate exports, it was decided that all such
matters/ cases w.r.t formulation/molecules which have been
withdrawn/cancelled/suspended by the Registration Board, shall be
processed keeping in view the demand and requirement of importing
country.
Case No.130: Registration of Drug “Beplam” of M/s. Bloom Pharmaceuticals, Hattar

for Export purpose.
M/s Bloom Pharmaceuticals, Hattar has applied for registration of drug (s)
exclusively for export purpose as per following details.
S. Name of Drug(s) Me-Too/SRA Status Diary No. & Date/ Remarks
No.
I II III V
1. Beplam 75mg Tablet The applied strength Dy.No.40/
Each Film Coated could not be 20-04-2018 & 704/24-07-2018
Tablet Contains: - confirmed in any
Diclofenac RRA. However, Decision of M-258 of Registration Board:
Potassium….75mg Ke-Nac Care Tablets Diclofenac Potassium is not registered in any
(006452-EX) of M/s. reference country in dose more than 50mg, thus
Wnsfeild Registration Board decided to issue show cause
Pharmaceuticals, notices to manufacturers of Diclofenac Potassium (75
Hattar is registered and 100mg) for de-registration of these products.
for export purpose.
Details of requirements as per SOP (approved by Registration Board in its M- 283 meeting)
and the documents submitted by the firm are as under:-
S. Requirements As Per SOP Submitted documents
No.
a. Application on form- 5 / Form 5D/ Form 5F (CTD) with Form-5 and Fee (Rs.20,000/-)
required fee as per relevant SRO (pages 95-101)
b. Copy of approved section from CLB or panel inspection Provided (Page No.103)
report for renewal of DML as evidence of approved sections
for DML before 2005.
c. Copy of Last GMP Inspection Report conducted by DRAP Approval of relevant section
within last 12 months. verified from panel inspection
report dated 18-01-2018. (Page.104)
d. An undertaking that applied registration is exclusively for Provided.
export purpose and will not be sold in Pakistan
e. Evidence of generic / approval status by the reference Not Provided.
regulatory authorities for applied formulation. In case where
the formations are neither generic nor approved by reference
regulatory authorities, applicant will provide evidence of
approval status of applied formulation by regulatory authority
of importing country.
f. Copy of DML along with its renewal status. Provided.
g An undertaking that the proposed name / label /colour scheme Provided.
do not resemble with already registered brands in importing
country. In case of resemblance similarity with already
registered product in importing country, the applicant could
be liable to change immediately.
It is submitted that after issuance of show cause notices to the local

manufacturers (in the light of above mentioned decision of the Board in its 258th meeting)
same formulation was registered, exclusively for export purpose (as mentioned vide Column
III of above table), on grounds of evidence of availability in importing country “Kenya” (i.e.,
K-Nac-75 Tablets manufactured by Universal Cooperation Ltd. Kenya), submitted by M/s
Wnsfeild, Hattar.
Furthermore, for all those formulations which have already been registered for
export purpose, the Registration Board has taken following decision vide its 262nd meeting:
“Registration Board deliberated the case and authorized Chairman for grant of registration
of finished drugs for export purpose in following categories:
 Generic version / me too drugs of already registered formulatuions.

 Formulations which have already been registered for export purposes.
 Formulations which are approved by reference regulatory authorities (as approved
by Registration Board) and yet not registered for local sale.”
In view of the position explained above, the case has been placed for deliberation regarding
registration status of Ke-Nac Care Tablets by M/s Wnsfeild, Hattar and for consideration of
current application of M/s Bloom Pharmaceuticals, Hattar as a generic/me too version of Ke-
Nac Care Tablets.
Decision: Keeping in view the requirements of importing country and already

granted approval of “Ke-Nac Care Tablet”, the Registration Board
decided to approve the grant of registration for “Beplam 75mg Tablet”,
exclusively for export purpose.
The Board further decided that the applications for export registration of
all those formulations/molecules which have been withdrawn/cancelled
/suspended by the Drugs Registration Board, shall be processed keeping
in view the demand and requirement of importing country.
Item No. V: Division of Biological Evaluation & Research
Item Details of application No. of

No. Cases
I. Imported Human Biologicals from Reference Countries 1
II. Imported Human Biologicals from non- Reference Countries 1
III. Imported Veterinary Biologicals from Non-Reference Countries 9
IV. Miscellaneous/ Deferred cases 72

V. Additional Agenda 21
Total 104
Sr. No. Assistant Director Designated No. No. of Cases

a. Mr. Khurram Khalid AD-I 30
b. Mr. M. Sarfraz Nawaz AD-II 35
c. Mr. M. Zubair Masood AD-III 39
Item No. I: Imported Human Biologicals from reference countries.
1. Name and addressof M/s Novartis Pharma (Pakistan) Limited 15, west
Importer wharf, Karachi
Detail of DSL Copy of DSL No. 0488 valid till 26-11-2019
Name and address of Product License Holder:
Manufacturer M/s Novartis Pharma AG,
Lichtstrasse 35, CH-4056 Basel, Switzerland.
Manufacturer:
M/s Amgen Manufacturing Limited, Carr 31, Km 24 6
Juncos, Puerto Rico 00777 USA.
Brand Name +Dosage Form + Aerinex 70mg
Strength Solution for Injection
Diary No. Date of R& I & fee Dy No. 21550/2018(R&I) Date: 19-06-2018.
Rs. 50,000/- dated 19-06-2018
Composition Each prefilled syringe(1ml) contains:
Erenumab…70mg
Pharmacological Group Monoclonal Antibody
Type of Form Form-5A
Finished Product Specification Innovator Spec’s
Shelf Life 2Years at 2-80C
Document Details Valid Legalize CoPP no. Z9UH-SX8E from USA
expiration date June 11, 2020.
Valid Legalized CoPP issued by EMA no. 04/18/124011
dated 11.9.2018
Pack size & Demanded Price 1’s PFS
International Availability USA, Ireland
Products already registered in Not available
Pakistan
Remarks of the evaluator Provided Sole agency agreement with M/s Novartis
Switzerland, whereas it is neither manufacturer nor
marketing authorization holder, in response to that firm
submit a legalized USA document which showed that
manufacturer of applied product is M/s Amgen
Manufacturing Limited, Carr 31, Km 24 6 Juncos, Puerto
Rico 00777 USA and worldwide License Partner for
Distribution and Marketing is M/s Novartis Pharma AG,
Switzerland. As per Form-5A drug would be imported
from Switzerland.
As per USA CoPP product is not available in exporting
country. Now the firm have submitted a new CoPP issued
by EMA which showed that product is available in
exporting country in which manufacturer is M/s Amgen
Manufacturing Limited, Carr 31, Km 24 6 Juncos, Puerto
Rico 00777 USA which is same as USA CoPP but
Marketing Authorization Holder is Novartis Europharm
Limited, Vista Building, Elm Park, Merrion Road, Dublin
4, Ireland.
Registration Board in its 256th meeting decided as follows:
“if an imported drug is not on free sale in its respective
country of origin / manufacture, suchproduct will be
registered in Pakistan if the product manufactured in the
applied facility is
approved by any of the regulatory authorities from
USFDA, EMA, PMDA Japan, AustraliaTGA, Health
Canada, Switzerland or any of regulatory authority of
former erstwhile Western Europe (United Kingdom,
Germany, France,Switzerland, Netherlands, Austria,
Belgium,Denmark, Finland, Sweden, Italy, Ireland,
Luxemburg, Norway, Scotland and Spain) or
threestringent regulatory bodies of former erstwhile
Eastern Europe. However, referencescountries regarding
availability of drug / molecule / formulation shall remain
the same as specified in 249th meeting of Registration
Board.”
Decision: Keeping in view valid legalized CoPP, approval of USFDA (Reference
Regulatory Authority) and decision of 256th meeting; Registration Board approved the
product subject to compliance of current Import Policy for Finished Drugs.
Item No. II: Imported Human Biologicals from non-reference countries.
1. Name of Importer M/s. 3A Diagnostics

12-F-1, Mehmood Chowk, Main Johar Town, Lahore
DSL details Copy of valid DSL no. 25-A/Ait/11/2014 valid upto 11-
08-2018
Name of Manufacturer Yuxi Walvax Biotechnology Co., Ltd 83, South
Dongfeng Road, High & new Technology Industries
Development Zone, Yuxi, Yunnan Province, P.R. China
Brand Name +Dosage Form + SALBEKSON
Strength Diphtheria, Tetanus and Acellular Pertussis Combined
Vaccine, adsorbed, for injection.
0.5mL vial
Composition Each 0.5mL vial contains:
Acellular pertussis…….. not less than 4IU
Diphtheria toxoid..…….. not less than 30IU
Tetanus toxoid……...….. not less than 40IU
Finished product specifications European Pharmacopeia
Pharmacological Group Human vaccine
International Availability of this China
product
Similar Product already registered Diphtheria tetanus and pertussis vaccine adsorbed by M
in Pakistan & M Pharma Lahore.
Dy No & Date of application, Dy.No.23591 dated 09-07-2018
Fee submitted Rs.100,000/- dated 29-06-2018.
Demanded Price/ Pack size PKR 1330/vial
General documentation 1. Legalized Free Sale Certificate issued No.2017-42

by Yunnan Food and Drug Administration, China
dated 31-07-2017.
2. Legalized Certificate of Pharmaceutical Product
issued No.2017-047 by Yunnan Food and Drug
Administration, China dated 31-07-2017.
3. Legalized GMP Certificate issued No.CN20150168
by China Food and Drug Administration dated 30-
10-2015.
4. Original Letter of Authorization dated 6-06-2017.
Pharmaceutical Product (CoPP) issued on 17-05-
2017.
Remarks of Evaluator 1. Stability data
(Khurram Khalid AD) i. Three Trial batches: The firm has submitted
a. long term stability data (36 Months)
b. accelerated stability data (6 Months)
c. Stress stability data (28 days)
ii. Three Commercial batches: The firm has
submitted
a. Long term stability data (12 Months).
b. Accelerated stability study data not provided
It is submitted that the firm has also submitted
Undertaking regarding long term stability test
completion for next 12 months in July 2019 for
commercial batches. Accelerated stability study
data not provided.
2. Clinical Trial data
Safety: Safety test in 20 individuals before conducting
phase III clinical trials.
Efficacy: Random, Blind, Single center Phase III
clinical trials conducted in 600 individuals. Compared
with vaccine manufactured by Wuhan institute of
Biological products.
Decision: Registration Board deferred the application for clarification of following by the
firm:
a. Only 20 individuals are used for efficacy studies which is very low number of
subjects.
b. Efficacy studies are single centered instead of multi-center.
Item No. III: Imported Veterinary Biologicals from non-reference countries.
1. Name of Importer M/s Hivet Animal Health Business, Lahore

DSL details License to sell drug as Distributor renewed upto: 09-02-
2019
Name of Manufacturer M/s Beijing sinder-vet technology co., ltd. Address:
No. 118, shunyu road, Beijing Tianzhu airport
economic development zone, shunyi district Beijing
Brand Name +Dosage Form + SINVAC ND+H9
Strength Emulsion
Composition Each dose contains:
Newcastle disease antigen inactivated (La Sota strain)
(before inactivated virus content ≥ 108.0EID50/0.1ml)
Avian influenza antigen inactivated (H9 subtype, SS
strain) (before inactivated virus content ≥
107.4EID50/0.2ml)
Finished product specifications As per innovator specification.
Pharmacological Group Poultry vaccine
Shelf life 18 months at 2-80C
International availability China
Products already registered in ME FLUVAC H9+ND of M/s Bromed animal health,
Pakistan Lahore
Type of Form Form 5-A,
Dy No & Date of application, Dy. No. 21702(R&I) Date: 21-06-2018
Fee submitted Rs. 100,000/- Date: 21-06-2018
Demanded Price / Pack size Decontrolled/ 500ml/Bottle
General documentation Valid legalized GMP valid 04/01/2016-3/1/2021
Original Valid legalized FSC dated 12-09-2018
Remarks of Evaluator Firm submit accelerated Stability data of applied product
at room temperature for 2 days and for 6 months at 100C.
Decision: Registration Board deferred the application for clarification on
submission of 2 days accelerated stability studies.
2. Name of Importer M/s Mustafa Brothers situated at P-186-D PEOPLE
COLONY NO.01, DISTRICT FAISALABAD
DSL details License to sell drug as Distributor License No: 06-331-
0168-031770D valid upto 21-Jun-2020
Name of Manufacturer M/s TIANJIN Speerie Challenge Biotechnology Co., Ltd
Address: No. 16 Huiyuan RD, Zhangjiawo Industry Area,
Xiqing District, Tianjin China
Brand Name +Dosage Form + Enhanced IGY-Yolk antibody
Strength
Composition Triple purified yolk antibodies
Each ml contains:
Specific antibody against IBD agar diffusion antibody
≥1:32
Specific antibody against ND HIAb≥9log2
Specific antibody H9 HIAb≥9log2
Finished product specifications Chinese veterinary pharmacopeia
Pharmacological Group Poultry vaccine
Products already registered in Nil
Pakistan
Demanded Price / Pack size Decontrolled 100ml/Bottle, 250ml/Bottle 500ml/Bottle
General documentation Valid legalized GMP No. 02005 valid till 19/8/2020
Valid legalized FSC No. 2017004 dated 25-09-2017
Decision: Registration Board deferred the application for confirmation of status of
applied formulation in reference regulatory authorities.
3. Name of Importer M/s. Forward Solutions Pakistan Plot No.19-B. Qazalbash
Chowk Abdul Sattar Edhi Road, District Lahore.
Name of Manufacturer M/s FATRO S.P.A
Via Molino Emili, 2 – 25030 Maclodio (BS) – Italy
M/s FATRO S.P.A
Via Emilia, 285 – 40064 Ozzano Emilia (Bologna) Italy
Brand Name +Dosage Form + IBA-VAC
Strength Freeze-dried vaccine for oral suspension
Composition Each dose (0.3mL/bird) contains;
Live attenuated virus of infectious bursal disease I-65PV
strain Titre: not less than 103EID50
Finished product specifications B.P
Pharmacological Group Veterinary
Shelf life 18 Months
Similar Product already Bio Gumboro Vaccine (Live Freeze Dried I/65/Pv Vaccine
registered in Pakistan Against IBD) by Khyber Poultry Enterprises Faisalabad.
Dy No & Date of application, R&I Dy.No. 24240 dated 16-07-2018
Fee submitted AD Bio Dy. No. 906 dated 16-07-2018.
Rs.100,000/- dated 20-6-2017(the fee was submitted for 2500
doses which was not processed upon firm’s request and it
was further requested to consider the said fee for 5000 doses)
Demanded Price/ Pack size Decontrolled/ Pack of 5000 doses
General documentation Legalized Certificate of Pharmaceutical Product (CoPP)
having Certificate No.86/2018/C issued by Ministry of
Health, Directorate General for Animal Health and Veterinary
Medicinal Products, Italy.
Remarks of Evaluator 1. As per documents submitted by the firm the vaccine will
(Khurram Khalid AD) be diluted by water and volumes of water required for
vaccination is as under;
Age of Chicken (weeks). Quantity of water (litres)
0-2 35-50
3-5 50-100
6-12 100-300
More than 12 250- 300
2. Accelerated stability study data has been provided for 6
months with a gap of 0, 3 and 6 months. Test for required
titer (as per initial composition Titre should not less than
103EID50) qualifies in initial 0 months (3.7 at 0 month).
While in upcoming months it falls as compare to initial
value (2.5 in 3rd month & 1.8 in 6th month).
Decision: Registration Board deferred the application for clarification regarding the
difference in volume of water required for dilution of vaccine according to the age and
submitted dose i.e. 0.3ml/bird.
4 Name of Importer M/s. Gallimune International 131-B Lahore Canal Bank
Co-operative Housing Society Thokar Niaz Baig Lahore.
Details of DSL Copy of valid DSL no. 133-A/AIT/11/2016 valid up to 06-09-
2016. (Expired)
Name of Manufacturer M/s Yebio Bioengineering Co Ltd of Qingdao
Address 1. No.21 AO DONG NAN ROAD, HONGDAO
STREET, ECONOMY ZONE OF HONGDAO, QINGDAO.
Address 2. No. 21, HE YUAN ROAD, ECONOMY ZONE
OF HONGDAO, QINGDAO.
Brand Name +Dosage Form + Yevac NBE
Strength Triple vaccine of ND, IB and EDS, Inactivated
Strength of Active Ingredient(s) per Dose(0.5ml):
The active ingredient in each dose is more than 108.5EID50 for
inactivated Newcastle Disease virus (La Sota
strain);107.0EID50 inactivated Infectious Bronchitis virus (M41
strain) and HA titer for Egg Drop Syndrome virus (NE4
strain) is more than 1:8192
Composition Each 0.5ml dose contains:
Inactivated LaSota Strain Newcastle Disease Virus…. more
than 108.5EID50
Inactivated M41 strain Infectious Bronchitis virus….
107.0EID50
Inactivated Egg Drop Syndrome (NE4 strain)…. HA titer
more than 1:8192 virus
Finished product specifications Not provided as per decision of Registration Board made in
its 267th meeting.
Pharmacological Group Veterinary Vaccine
Shelf life 24 Months at 20–80C
International Availability of China, Egypt, Indonesia, Myanmar
this product
Similar Product already ARRIAH ND IB EDS 76 by M/s Mustafa Brothers,
registered in Pakistan Faisalabad
Type of Form Form-5A dated 16-10-2018
Dy No & Date of application, R&I Dy.No.23276 dated 06-12-2017.
Demanded Price/ Pack size Decontrolled/ 500mL bottle
General documentation 1. Legalized GMP Certificate No. 219 dated 11-04-2016
valid till 15-10-2019.
2. Legalized Fee Sale Certificate dated 26-07-20117 valid for
3 years.
3. Legalized certificate of composition.
Remarks of Evaluator 1. Composition is not mentioned in FSC and separate
(Khurram Khalid AD) Legalized certificate of composition has been provided.
2. Two addresses are mentioned in GMP and one on Free
Sale Certificate which is different as per following
details;
Addresses mention in Addresses Addresses
GMP mention in mentioned in
FSc Distribution
Agreement
Address 1.No.21 Ao Address Address
Dong Nan Road, 1.No.21 1.No.21
Hongdao street, Aodong Nan Aodong Nan
Economy Zone of Road, Road,
Hongdao, Qingdao. Hongdao, Hongdao
Address 2. No. 21, Qingdao. Economy
Heyuan road, Economy China. Zone
Zone of Hongdao, Qingdao.
Qingdao.
3. Validity of DSL is expired.
4. Address of the importer is different in distribution
agreement and DSL as per following details;
Addresses mention in Addresses mention
distribution agreement on DSL
52-D-2, Behind Hockey Stadium 131-B Lahore Canal
Johar Town, Lahore – Pakistan Bank Co-operative
Housing Society
Thokar Niaz Baig
Lahore.
5. Specifications of the product have not been provided as
per decision made by Registration Board in its 267th
meeting.
6. Provided long term stability study data starts from 15
months and data for the first 15 months is not provided.
th
| 755
Moreover, provided stability data is of laboratory batches
and not commercial batches
Decision: Registration Board deferred the application for submission of following by the
firm:
a. Clarification of two (02) manufacturing addresses mentioned on GMP certificate.
b. Valid legalized FSC indicating composition of product.
c. Clarification of difference in address of importer on sole agency agreement and Drug
Sale License.
d. Drug product specifications in light of decision of 267th meeting of Registration Board.
e. Long term stability data of three (03) commercial batches for appropriate time points
as per vICH guidelines.
5. Name of Importer M/s. Gallimune International 131-B Lahore Canal Bank

2016. (Expired)
Brand Name +Dosage Form + Yevac ND+H9
Strength Binary Inactivated Vaccine of ND+AI(H9)
inactivated Newcastle Diosease virus(La Sota strain);
107.5EID50 for inactivated Avian Influenza virus (H9 subtype,
F strain)
Composition Each Dose (0.5ml):
Inactivated LaSota Strain Newcastle Disease Virus… more
than 108.5EID50
Inactivated Avian Influenza virus (H9 subtype, F strain) …..
107.5EID50
its 267th meeting.
Shelf life 24 Months at 20-80C
International Availability of China, Egypt
this product
Similar Product already New Castle Disease and Avian Influenza (H9N2 Subtype)
registered in Pakistan Vaccine, Inactivated by M/s Vet Line International Lahore.
Type of Form Form-5A dated 16-10-2018.
Demanded Price/ Pack size Decontrolled/ 500 mL bottle
2. Legalized Fee Sale Certificate dated 26-07-20117 valid
for 3 years.
details:
Addresses mention in GMP Addresses Addresses
mention in mentioned in
FSc Distribution
Agreement
Address 1.No.21 Ao Dong Address Address
Nan Road, Hongdao street, 1.No.21 1.No.21
Economy Zone of Hongdao, Aodong Aodong Nan
Qingdao. Nan Road, Road, Hongdao
Hongdao, Economy Zone
Address 2. No. 21, Heyuan Qingdao. Qingdao.
road, Economy Zone of China.
Hongdao, Qingdao.
Addresses mention in Addresses mention on
distribution agreement DSL
52-D-2, Behind Hockey 131-B Lahore Canal
Stadium Johar Town, Lahore – Bank Co-operative
Pakistan Housing Society Thokar
Niaz Baig Lahore.
5. Specifications of the product has not been provided as per
decision made by Registration Board in its 267th meeting.
months and data for the first year is not provided.
and not commercial batches.
firm:
Sale License.
6. Name of Importer M/s. Gallimune International 131-B Lahore Canal Bank
2016. (Expired)
Brand Name +Dosage Form + Yemune NGH9
Strength Triple Inactivated Vaccine of ND+AI(H9)+IBD
inactivated Newcastle Disease virus(La Sota strain);
107.5EID50 for inactivated Avian Influenza virus(H9 subtype,
YBF003 strain) and IBD VP2 protein AGP titer is more than
1:64
Inactivated LaSota Strain Newcastle Disease Virus…..more
than 108.5EID50
Inactivated YBF003 strain H9 subtype Avian Influenza
virus….107.5EID50
IBD VP2 Protein.…………… more than 1:64
Finished product specificationsNot provided as per decision of Registration Board made in
its 267th meeting.
Pharmacological Group Veterinary vaccine
Shelf life 24 Months at 20-80C
International Availability of China, Egypt
this product
Similar Product already China, Egypt
registered in Pakistan
Dy No & Date of application, R&I Dy.No.23273 dated 06-12-2017
for 3 years.
details:
FSc Distribution
Agreement

Economy Zone of Hongdao, Aodong Aodong Nan
Qingdao. Nan Road, Road, Hongdao
Address 2. No. 21, Heyuan Hongdao, Economy Zone
road, Economy Zone of Qingdao. Qingdao.
Hongdao, Qingdao. China.
Niaz Baig Lahore.
meeting.
firm:
Sale License.
7. Name of Importer M/s. Gallimune International 131-B Lahore Canal Bank Co-
operative Housing Society Thokar Niaz Baig Lahore.
2016. (Expired)
Brand Name +Dosage Form + Yemune NBG
Strength Triple Inactivated Vaccine of ND+IB+IBD
inactivated Newcastle Disease virus(La Sota strain);
106.5EID50 inactivated Infectious Bronchitis virus(M41 strain)
and IBD VP2 protein) and IBD VP2 protein AGP titer is more
than 1:64
Inactivated LaSota Strain Newcastle Disease Virus(La Sota
strain),…. 108.5EID50
Inactivated M41 strain Infectious Bronchitis virus (M41
strain)…. 106.5EID50
IBD VP2 protein AGP ……… more than 1:64
its 267th meeting
International Availability of China, Egypt, Indonesia, Myanmar.
this product
Similar Product already GPVAC ND+IB+IBD Injection By M/s Grand Pharma Pvt
registered in Pakistan Ltd
Islamabad
Type of Form Form-5A dated 16-10-2018

for 3 years.
details:
FSc Distribution
Agreement

Economy Zone of Hongdao, Aodong Nan Aodong Nan
Qingdao. Road, Road,
Address 2. No. 21, Heyuan Hongdao, Hongdao
road, Economy Zone of Qingdao. Economy
Hongdao, Qingdao. China. Zone Qingdao.
Niaz Baig Lahore.
meeting.
firm:
Sale License.
2016. (Expired)
Brand Name +Dosage Form + Yemune G7
Strength Inactivated Vaccine of Recombinant Newcastle Disease Virus
inactivated recombinant Newcastle Disease Virus (A-VII
strain).
Inactivated recombinant Newcastle Disease Virus (A-VII
strain)………….…....……………..... more than 108.0EID50
its 267th meeting.
International Availability of China, Egypt, Indonesia, Myanmar.
this product
Similar Product already JOVAC NDV B1 Vaccine by M/s Eros Pharmaceuticals Pvt.
registered in Pakistan LtdKarachi.
for 3 years.
3. Legalized certificate of composition
details:
FSc Distribution
Agreement
Address 1.No.21 Ao Dong Address Address 1.No.21

Nan Road, Hongdao street, 1.No.21 Aodong Nan
Economy Zone of Hongdao, Aodong Road, Hongdao
Qingdao. Nan Road, Economy Zone
Address 2. No. 21, Heyuan Hongdao, Qingdao.
road, Economy Zone of Qingdao.
Niaz Baig Lahore.
meeting.
6. Provided long term stability study data do not conform
with ICH guidelines i.e. for first year, studies at intervals
of 3, 6, 9 and 12 are required. Moreover, data provided is
of laboratory batches and not commercial batches.
Furthermore, accelerated stability data is not provided
firm:
Sale License.
2016. (Expired)
Address 1. NO.21 AO DONG NAN ROAD, HONGDAO
ADDRESS 2. NO. 21, HE YUAN ROAD, ECONOMY
ZONE OF HONGDAO, QINGDAO.
Brand Name +Dosage Form + Yemune REO 4plus
Strength Quadruple Inactivated Vaccine of ND+IB+IBD+REO
Newcastle Disease Virus (La Sota strain), 106.5EID50
inactivated infectious Bronchitis virus(M41 strain), IBD VP2
protein AGP titer is more than 1:64 and 106.7EID50 inactivated
REOvirus (AV2311 strain)
Inactivated La Sota Strain Newcastle Disease Virus (La Sota
strain) …. more than 108.0EID50.
Inactivated Infectious Bronchitis virus (M41 strain)….
106.5EID50
IBD VP2 protein AGP titer……. more than 1:64
Inactivated REO virus (AV2311 strain) ...…… 106.7EID50
Finished product specificationsNot provided as per decision of Registration Board made in

its 267th meeting.
Shelf life 20–80C
International Availability of China
this product
Similar Product already WINVAC IV (ND+IB+IBD+REO) VACCINE by M/s
registered in Pakistan KHYBER POULTRY ENTERPRISES,FAISALABAD.
for 3 years.
3. Legalized certificate of composition
details:
FSc Distribution
Agreement
Nan Road, Hongdao street, 1.No.21 1.No.21 Aodong
Economy Zone of Hongdao, Aodong Nan Road,
Qingdao. Nan Road, Hongdao
Address 2. No. 21, Heyuan Hongdao, Economy Zone
road, Economy Zone of Qingdao. Qingdao.
Niaz Baig Lahore.
5. Specifications of the product has not been provided as per
decision made by Registration Board in its 267th meeting.
6. Provided long term stability study data do not conform
with ICH guidelines i.e. for first year, studies at intervals
of 3, 6, 9 and 12 are required. Moreover, data provided is
of laboratory batches and not commercial batches.
Furthermore, accelerated stability data is not provided.
firm:
Sale License.
Item No. IV: Miscellaneous/ Deferred Cases
1. Registration of veterinary vaccines from one importer to another importer applied by

M/s Hipra Pakistan Limited, Lahore
M/s. Hipra Pakistan (Private) Limited, Lahore request for registration of following
registered imported veterinary drugs from the name of previous importer M/s. Marush (Pvt) Limited,
K-123, Model Town, Lahore to their name. The details are submitted as under:-
Sr. Reg. Brand Name & composition as per Brand Name & composition as Initial Date of
No. No. CoPP per Initial Reg. letter Registrati Last
on Date Renewal
Submissi
on
1. 0208 HIPRAGUMBORO – CH/80 HIPRAGUMBORO – 20-1- 03-03-
05 Oral freeze-dried tablet CH/80 vaccine 1998 2015
(Monovalent live freeze-
Composition per dose (0.03ml): dried vaccine)
Live attenuated Infectious Bursal Contains:
Disease Virus, clone IBDV CH/80…103.6TCID60
CH/80…………………10 - 3.5
106.5TCID50*
*50% infectious dose in tissue
culture
2. 0481 BRONIPRA-ND/IBD BRONIPAR-ND/IBD 03-03- 03-03-
34 Injectable Emulsion Each 0.5ml dose contains: 2008 2015
Composition per dose (0.5ml) Inactivated Infectious
Inactivated Newcastle disease Bronchitis
virus, strain La Sota…….IHA virus, strain
1/16-1/1024(*) H52…≥106EID50
Live infectious Bronchitis virus, Inactivated Newcastle
strain H52….…SN:2.4-16(**) Disease virus strain La
Inactivated infectious bursal Sota…≥108EID50
disease virus, strain Inactivated Infectious Bursal
W2512…………….ELISA: 357- Disease Virus, strain
13500(***) W2512…≥10 DICT50
5
(*)IHA: Antibody titre obtained

by hemagglutination inhibition.
(**)SN: Titre of antibodies
against IBV in seroneutralizing
units.
(***) ELISA = Titre of
antibodies against IBDV in
ELISA units
3. 0332 HIPRAVIAR-TRT HIPRAVIAR-TRT Vaccine 11-11- 03-03-
03 Injectable Emulsion 2004 2015
Composition per dose (0.5ml) Each 0.5ml dose contains:
Inactivated Turkey Rhinotracheitis Inactivated Turkey
Virus, strain Rhinotracheitis Virus, strain
1062…..……..ELISA≥196(*) 1062…...≥106 TCID50
* ELISA = Titer of antibodies
expressed in ELISA units TRTV
4. 0818 HIPRAVIAR-B1/H120 HIPRAVIAR-B1/H120 03-11- 02-11-
13 Freeze-dried tablet and solvent (Freeze-dried tablet) 2016 2021
for suspension
Each dose (0.03ml) contains:
Composition per dose (0.03ml) Live Newcastle disease virus
Live Newcastle disease virus attenuated B1 strain
attenuated B1 strain ….106.5 – 107.8 EID50
….10 – 10 EID50
6.5 7.8
Live Infectious Bronchitis
Live Infectious Bronchitis virus, virus, attenuated H120 strain
attenuated H120 strain ..103 – 105 DIE50
..10 – 10 DIE50
3 5
*50% infective dose in
*50% infective dose in chicken chicken embryo
embryo
5. 0804 AVISAN MULTI AVISAN MULTI vaccine 22-03- 21-03-
24 Injectable emulsion Injectable 2016 2021
Per dose (0.5ml): Each 0.5ml of dose contains:

Inactivated Infectious Bronchitis Inactivated Infectious
Virus, Strain H52……....HAI1:26- Bronchitis Virus, Strain
28 H52……....HAI1 :26-28
Inactivated Newcastle Disease Inactivated Newcastle
Virus, Strain La Sota….HAI2:24-26 Disease Virus, Strain La
Inactivated Swollen Head Sota…. HAI2:24-26
Syndrome, Adenovirus strain Inactivated Swollen Head
127……………...…….HAI1:27-29 Syndrome, Adenovirus strain
1
Mean titre of haemagglutination 127…..…….HAI1:27-29
1
inhibition after inoculation of one Mean titre of
dose of vaccine to SPF pullets. haemagglutination inhibition
2
Mean titre of haemagglutination after inoculation of one dose
inhibition after inoculation of 1/50 of vaccine to SPF pullets.
2
dose of vaccine to SPF pullets. Mean titre of
haemagglutination inhibition
after inoculation of 1/50 dose
of vaccine to SPF pullets.
6. 0274 HIPRAVIAR-S HIPRAVIAR-S VACCINE 12-06- 03-03-
85 Oral freeze-dried tablet 2002 2015
(Live Newcastle virus La
Composition per dose (0.03ml): Sota Strain)
Virus live attenuated Newcastle
disease, La Sota strain……106.5 –
108.5EID50*
*50% infective dose in chicken
embryos
7. 0814 CORIPRAVAC Brand name & composition 28-09- 27-09-
41 Suspension Injectable As per Form-5A 2016 2021
Per dose (0.5ml): CORIPRAVAC

Avibacterium paragallinarum Suspension Injectable
inactivated serotype A, strain
17756…...8-32 MAT* Per dose (0.5ml):
Avibacterium paragallinarum Inactivated Avibacterium
inactivated serotype B, strain paragallinarum serotype A,
0222……..8-32 MAT* (Strain 1753)5x 109
Avibacterium paragallinarum microorganisms
inactivated serotype C, strain Inactivated Avibacterium
Modesto 8-32 MAT* paragallinarum serotype B,
(Strain 1755)5x 109
*MAT: Mean titre obtained by the microorganisms
plate agglutination test after Inactivated Avibacterium
inoculation of the vaccine in paragallinarum serotype C,
chickens. (Strain 1756)5x 109
microorganisms
8. 0818 TOXIPRA-S7 TOXIPRA-S7 03-11- 02-11-

16 Injectable Suspension Injectable Suspension 2016 2021
Composition per dose (2 ml): Composition per dose (2 ml):

ß toxoid of type B, C and D ß toxoid of type B, C and D
Clostridium perfringens…...≥10 Clostridium
IU of ß antitoxin/ml of serum* perfringens………………….
ɛ toxoid of type B, C and D ..≥10 IU of ß antitoxin/ml of
Clostridium perfringens……≥5 IU serum*
of ɛ antitoxin/ml of serum* ɛ toxoid of type B, C and D
ɑ toxoid of type B Clostridium Clostridium
novyi……..≥3.5 IU of ɑ perfringens…………………
antitoxin/ml of serum* …≥5 IU of ɛ antitoxin/ml of
Toxoid ɑ of Clostridium septicum serum*
≥ 2.5 IU antitoxin ɑ / ml of serum* ɑ toxoid of type B
Anaculture of Clostridium Clostridium
chauvoei 100% protection in novyi………………………
guinea pig** …..≥3.5 IU of ɑ antitoxin/ml
Anaculture of Clostridium of serum*
sordellii 100% protection in Toxoid ɑ of Clostridium
guinea pig** septicum ≥ 2.5 IU antitoxin ɑ
/ ml of serum*
*International Units (antitoxin
per ml of serum)
**Protection level in guinea pig
(According to European
Pharmacopoeia)
9. 0804 AVISAN SECURE AVISAN SECURE 13-05- 12-05-
27 Injectable emulsion Injectable emulsion 2016 2021
Per dose: Per dose:

Inactivated Salmonella enteritidis Inactivated Salmonella
PT4……..…….MAT≥1/13* enterididis
Inactivated Salmonella PT4.…….MAT≥1/13*
typhimurium Inactivated Salmonella
DT104………...MAT≥1/40* typhimurium
*Titre obtained with the DT104……MAT≥1/40*
Microagglutination in plate assay *Titre obtained with the
alter the inoculation of the vaccine Microagglutination in plate
in SPF chickens. assay alter the inoculation of
the vaccine in SPF chickens.
10.0481 HIPRAVIAR-TRT4 HIPRAVIAR-TRT4 03-03- 03-03-
38 Injectable Emulsion Each 0.5ml dose contains: 2008 2015
Composition per dose (1ml): Inactivated Newcastle
Inactivated Newcastle Disease Disease Virus strain LA Sota
Virus, strain 918UHA
LaSota……..IHA≥1/16(*) Inactivated Infectious
Inactivated Bronchitis Infectious Bronchitis strain
Virus, strain H52………..≥106EID50
H52………..SN≥2,4(**) Inactivated
Inactivated Bursal Disease GumboroDisease Virus,
Virus, strain strain
W2512…………….ELISA≥357( w2512….≥105.5TEID50
***)
Inactivated Turkey
Rhinotracheitis Virus, strain
1062…..ELISA≥196(****)
(*) IHA = Titre of antibodies

obtained by hemoagglutination
inhibition.
(**)SN = Titre of antibodies
expressed in seroneutralizing units
IBV.
(***)ELISA = Titre of antibodies
expressed in ELISA units IBDV.
(****)ELISA = Titre of antibodies
expressed in ELISA units TRTV
11.0814 HIPRAVIAR-BPL2 HIPRAVIAR-BPL2 28-09- 27-09-
40 Injectable Emulsion Injectable Emulsion 2016 2021
Per dose: Each Dose contains:
Inactivated Newcastle Disease Inactivated Newcastle
virus, strain Disease virus, strain
LaSota………IHA≥1/16* LaSota………IHA≥1/16*
(*)IHA: Antibody titre obtained by (*)IHA: Antibody titre

hemagglutination inhibition obtained by hemagglutination
inhibition
12.0481 BRONIPRA-1 BRONIPRA-1 03-03- 26-02-
36 Oral freeze-dried tablet 2008 2015
Composition per dose (0.03ml): Each dose 0.03ml contains:
Live attenuated Infectious Live Infectious Bronchitis
Bronchitis virus, strain virus, strain
H120……….103 – 105.4 EID50 H120……….103EID50
*Infective dose 50% in chicken
embryo
13.0481 BRONIPRA-ND Bronipra-ND 03-03- 26-02-
37 Injectable emulsion 2008 2015
Each dose 0.5ml contains: -
Composition per dose (0.5ml): - Inactivated Newcastle
Inactivated Newcastle disease disease virus strain La-
virus strain La-Sota…IHA: 1/16- Sota…≥108EID50
1/1024(*) Inactivated Infectious
Inactivated Infectious Bronchitis Bronchitis Virus, strain
Virus, strain H52…….SN: 2.4- H52…….≥106EID50
16(**)
(*)IHA: Antibody titre
obtained by hemagglutination
inhibition.
(**)SN: Titre of antibodies
against IBV in seroneutralizing
units.
14.0285 HIPRAVIAR-CLON HIPRAVIAR-CLON 21-08- 03-03-
51 Oral freeze-dried tablet Vaccine 2002 2015
Composition per dose (0.03ml): (Live cloned vaccine against

Virus live attenuades Newcastle Newcastle Disease, clone
Disease, clone CL/79)
CL/79…………106,5 – 107,7 EID50
* 50% infective dose in chicken
embryos
15.0818 HIPRABOVIS-4 HIPRABOVIS-4 03-11- 02-11-
15 Lyophilisate and solvent for Lyophilisate for suspension 2016 2021
Injectable suspension for injection
Composition per dose (3ml):
Inactivated Infectious Bovine Each dose (3ml) contains:
Rinotracheitis Virus, strain Live Bovine Respiratory
LA……ELISA≥50 Syncytial Virus, strain Lym-
Inactivated Parainfluenza-3 56……………..≥104TCID50
virus, strain
SF4…………………………….I
HA≥1/16
Inactivated Bovine Viral
Diarrhoea Virus, strain
NADL………………ELISA≥50
Live Bovine Respiratory Syncytial
Virus, strain Lym-
56……………..≥104TCID
*ELISA: Antibody titre
determined by ELISA in
vaccinated rabbits.
**IHA: Antibody titre determined
by hemagglutination inhibition in
vaccinated rabbits.
***CCID50: Cellular culture
infective dose 50%
16.0818 HIPRAVIAR-SHS HIPRAVIAR-SHS 03-11- 02-11-
12 Lyophilisate for suspension (Freeze dried tablet for 2016 2021
suspension)
Composition per dose(0.03ml): Each dose(0.03ml) contains:
Rhinotracheitis virus of turykey, Rhinotracheitis virus of
live attenuated, strain turkey, live attenuated, strain
1062………..102.4 – 104.4 CCID50 1062………..102.4 – 104.4
*50% infectious dose in cell CCID50
culture *50% infectious dose in cell
culture
17.0637 HIPRAGUMBORO-GM97 HIPRAGUMBORO-GM97 19-08- 03-03-
26 Oral freeze-dried tablet vaccine 2010 2015
Each dose of vaccine
Per dose: contains:
Live Infectious Bursal Disease Live Infectious Bursal
Virus, strain GM97…………..102 Disease (IBD) Virus, strain
– 103EID50 GM97……..102 EID50
(embryo infective dose 50%)
18.0804 HIPRAVIAR-ILT Brand name & composition 13-05- 12-05-
28 Lyophilisate for suspension as per Form-5A 2016 2021
Per dose: HIPRAVIAR-ILT

Live attenuated Lyophilisate for suspension
Infectious
Laryngotracheitis, strain
Each dose contains:
CHP50………103 – 103.5EID50 Live avian infectious
*50% infective dose in chickenLaryngotracheitis virus,
embryos strain CHP50………103 –
103.5EID50
*50% infective dose in
chicken embryos
19.0775 HIPRAGUMBORO-BPL2 HIPRAGUMBORO-BPL2 30-12- 29-12-
31 Injectable emulsion Each dose of 0.5ml contains: 2014 2019
Composition per dose(0.5ml): Inactivated infectious
Inactivated Newcastle disease Bursal Disease Virus,
Virus, strain Strain W2512…≥105TCID50
LaSota………….IHA≥1/16(*) Inactivated Newcastle
Inactivated Gumboro Disease disease Virus, strain La
Virus, strain Sota….≥108EID50
W2512…….ELISA≥357(**)
(*) IHA: Antibody titer obtained
by hemagglutination inhibition.
(**) ELISA: Titre of antibodies
expressed in ELISA units IBDV,
assay determined by enzyme-
linked immunosorbent.
20.0775 HIPRAVIAR-ND BROILERS HIPRAVIAR-ND 30-12- 29-12-
42 Emulsion for injection BROILERS 2014 2019
Active ingredient(s) and amount Each per dose (0.2ml)

(s) per unit dose including contains:
excipients: Inactivated Newcastle
DCI o DOE: Disease Virus strain La
Inactivated NDV, strain La Sota: Sota…>108EID50 Adjuvant
>/= 10exp.8 EID 50
Product is not available in
exporting countries
21.0481 HIPRAVIAR-S/H120 HIPRAVIAR-S/H120 03-03- 03-03-
35 Oral Lyophilisate Live vaccine against 2008 2015
Active ingredient(s) and amount(s) Newcastle Disease LaSota
per unit dose including excipients: strain and Infectious
Live Newcastle Disease Virus, Bronchitis, strain H120
strain LaSota >= 10exp.6.5 EID50
Live Infectious Bronchitis, strain
H120 >= 10exp.3.0 EID50
Not available in country of
origin
22.0818 EVALON EVALON 03-11- 02-11-
14 Oral solution Oral solution 2016 2021
Each dose contains:
Each dose contains: Eimeriaacervulina, strain
Eimeriaacervulina, strain 003.. 003.. 332-450 sporulated
332-450 sporulated oocytes oocytes
Eimeria maxima, strain 013……. Eimeria maxima, strain
196-265 sporulated oocytes 013……. 196-265 sporulated
Eimerianecatrix, strain 033….340- oocytes
460 sporulated oocytes Eimerianecatrix, strain
Eimeriabrunetti, strain 034… 033….340-460 sporulated
.213-288 sporulated oocytes oocytes
Eimeriatenella, strain Eimeriabrunetti, strain 034…
004…….276-374 sporulated .213-288 sporulated oocytes
oocytes Eimeriatenella, strain
004…….276-374 sporulated
oocytes
The firm has submitted the following documents:

1. Application on Form-5A
2. Fee Challan of Rs. 100000/- for each product.
3. Copy of Initial registration letter and last renewal submission.
4. Termination letter in name of M/s Marush Private Limited, Lahore.
5. Sole Agency Letter in name of M/s Hipra Pakistan Limited, Lahore.
6. NOC from existing registration holder in the name of M/s Hipra Spain with-out date.
Case History:
M/s Hipra Pakistan Limited, Lahore applied for the transfer of registration of already
approved veterinary vaccines in their name from M/s Marush Private Limited, Lahore.
M/s Marush (Pvt.) Limited Lahore has already filed a suit vide no. 3629/18 in the Court of
Senior Civil Judge Lahore regarding the transfer of registration from their name to M/s Hipra
Pakistan (Private) Limited Lahore. The case was sent to Legal Affair Division for opinion
which is reproduced as under:
“After perusal of the case, I am of the opinion that DRAP and the Registration Board
should proceed with the applications for transfer of registration under the law as the courts
have refused to grant interim injunction/stay order to Marush private Ltd.
Furthermore, nominated counsel in the suit no. 3629/18 has intimated that he has also filed
an application before the Addl. District Judge for dismissal of both the suit no. 3629/18 and
also appeal against the order dated 25-01-2018 filed by Marush Private Ltd.”
After legal opinion case of two products were considered in 283rd meeting of Registration
Board and Board decided as under:
Decision of 283rd meeting of Registration Board

“Registration Board advised DBER to issue a show cause notice to M/s Marush
Private Limited, Lahore to explain why not the registrations/ permission of Hipragumboro-
CH/80and Bronipar-ND-IBD are withdrawn as their sole agency agreement has been
terminated by M/s Laboratorios Hipra, S.A. (Hipra), Av. De La Selva, 135, in Amer (Girona),
Spain. The Board further advised to ask the firm that if they desire to be heard in person they
may inform accordingly”
The decision of 283rd meeting of Registration Board was communicated to the firms and
Show cause Notice also issued as per decision of Registration Board to M/s Marush Private
Limited, Lahore on 28-09-2018 in reply of that M/s Marush Private Limited, Lahore request
for personal hearing and a letter with date and time for personal hearing also communicated
to M/s Marush Private Limited, Lahore on 02-11-2018.
Rest of the products of M/s Hipra Pakistan Limited, Lahore considered in 285th meeting of
Registration Board for transfer of registration of veterinary vaccines from the name of M/s.
Marush (pvt) Ltd, Lahore to their own name and Board decided to issue show cause notices
to M/s. Marush Private Limited, Lahore to explain why not the registrations of all registered
products manufactured / authorized by M/s Laboratorios Hipra, S.A. (Hipra), Av. De La
Selva, 135, in Amer (Girona), Spain be cancelled as sole agency agreement has been
terminated. Accordingly show cause notice has been issued to M/s. Marush (pvt) Ltd, Lahore
to submit their reply within five (05) days and if desired to be heard in person, they may
come in 286th meeting of Registration Board.
Furthermore, the NOC submitted by M/s Hipra Pakistan (Private) Limited Lahore without
date and as per decision of 283rd meeting of Registration Board “Document confirming NOC
(issued within last 6 Months) from existing registration holder permitting for registration of
product to another importer.
A letter from M/s Marush Private Limited, Lahore received in which states that “undersigned
has never issued any NOC for transfer in the name of any other agent/company”
Evaluator Remarks:
Product at sr. 20 & 21 are not available in country of origin and CoPP submitted for Product
at sr. no. 22 i.e. EVALON Oral solution is not legalized, further firm not provided the
accelerated stability data for above mentioned products.
In response to accelerated stability data firm submit reply as under:
The European Pharmacopoeia 9.5 in its general monograph 0062 “Vaccines for veterinary
use” defines that the stability should be evaluated under recommended storage conditions. As
the storage condition of vaccines is 2-8°C, the European Pharmacopoeia requires to perform
the stability studies only at 2-8°C.
“Stability: Evidence of stability is obtained to justify the proposed period of validity.
This evidence takes the form of the results of virus titrations, bacterial counts or potency tests
carried out at regular intervals until 3 months beyond the end of the shelf life on not fewer
than 3 representative consecutive batches of vaccine kept under recommended storage
conditions together with results from studies of moisture content (for freeze-dried products),
physical tests on the adjuvant, chemical tests on substances such as the adjuvant constituents
and preservatives, and pH, as appropriate.
Where applicable, studies on the stability of the reconstituted vaccine are carried out, using
the product reconstituted in accordance with the proposed recommendations.
The variations in the results obtained during the stability study are taken into account when
defining appropriate formulation and release specifications to ensure the conformity of the
product for the claimed shelf life”
Also, the European Directive 2001/82/EC, in its second title in which the requirements for
immunological veterinary products are described, states that the stability study shall always
be real-time studies: meaning that the studies have to be done at real conditions. In the case of
vaccines is 2-8°C. The European Directive does not require to perform accelerated stability
studies for vaccines.
Title II of European Directive:
“Stability Tests: A description shall be given of the tests undertaken to support
the shelf life proposed by the applicant. These tests shall always be real-time studies; they
shall be carried out on a sufficient number of batches produced according to the described
production process and on products stored in the final container(s): these tests include
biological and physico-chemical stability tests.
The conclusions shall contain the results of analysis, justifying the proposed shelf-life under
all proposed storage conditions.
In the case of products administered in the feed, information shall also be given as necessary
on the shelf-life of the product, at the different stages of mixing, when mixed in accordance
with the recommended instructions.
Where a finished product requires reconstitution prior to administration, details of the
proposed shelf-life are required for the product reconstituted as recommended. Data in
support of the proposed shelf-life for the reconstituted product shall be submitted”
Additionally, the Guideline on requirements for the production and control of immunological
veterinary medicinal products (EMA/CVMP/IWP/206555/2010) supports the reasons given
above as on its chapter 4 points out that the stability testing shall be carried out as specified in
the Directive 2001/82/EC and in the Ph. Eur. 0062 Vaccines for veterinary use.
Finally, there is no VICH Guideline that covers immunological products as the Guideline
GL17: Stability testing of biotechnological / veterinary medicinal products on its scope
excludes the conventional vaccine; meaning that this guideline is not applicable for vaccines.
II. Scope of the annex (2)
The guidance stated in this annex applies to the products composed of well-characterized
proteins and polypeptides, and their derivatives which are isolated from tissues, body fluids,
cell cultures, or produced using r-DNA technology. Thus, the document covers the generation
and submission of stability data for products such as cytokines, growth hormones and growth
factors, insulins, monoclonal antibodies, and those vaccines which consists of well-
characterized proteins or polypeptides even when chemically synthesized. This document
does not cover antibiotics, heparins, vitamins, cell metabolites, DNA products, allergenic
extracts, conventional vaccines, cells, whole blood, and cellular blood components.
Accelerated and Stress Conditions (6.3)
As previously noted, the expiration dated should be based on real-time/real-temperature
data. However, it is strongly suggested that studies be conducted on the drug substance and
drug product under accelerated and stress conditions. Studies under accelerated conditions
may provide useful support data for establishing the expiration date, provide product
stability information for future product development (e.g., preliminary assessment of
proposed manufacturing changes such as change in formulation, scale-up), assist in
validation of analytical methods for the stabi9lity program, or generate information that may
help elucidate the degradation profile of the drug substance or drug product.
Studies under stress conditions may be useful in determining whether accidental exposures to
conditions other than those proposed (e.g., during transportation) are deleterious to the
product and also for evaluating which specific test parameters may be the best indicators of
product stability. Studies of the exposure of the drug substance or drug product to extreme
conditions may help to reveal patterns of degradation; if so, such changes should be
monitored under proposed storage conditions. Although the tripartite guideline on stability
describes the conditions of the accelerated and stress study, the applicant should note that
those conditions may not be appropriate for biotechnological/ biological products.
Conditions should be carefully selected on case-by-case basis”
Therefore, for all the above reasons, the current stability regulatory framework in Europe do
not request to perform the accelerate stability study for vaccine. Only stability studies at the
real storage conditions (2-8°C for the vaccines) are required.
Discussion:
The Board was informed that, in response to show cause and personal hearing notices,
1. M/s. Marush (Pvt) Ltd, Lahore responded as follow;

“… it is submitted that there is need to see and consult the relavent record for
preparation and submission of reply. M/s. Marush Pvt Ltd has to consult with lawyer in this
regard because litigation is also pending adjudication before courts of law at Lahore with
regard to registration and termination of Distribution agreement, details of which can only
be given after getting information from lawyer who is not available due to his illness.
Therefore, reasonable time period at least one month may kindly be given to M/s. Marush Pvt
Ltd for submission of reply and to plead its case before the Drug Registration Board.”
2. M/s Laboratorios Hipra, S.A., Spain

Mr. Carlos Montane’s Managing Director & Member of the Board and Ms. Elia
Torroella Research and Development and Registration Division Worldwide from M/s
Laboratorios Hipra, S.A., Spain attended the meeting and informed the Board that M/s
Laboratorios Hipra, S.A., Spain appointed M/s Marush Private Limited, Lahore as their
authorized agent in 2010 and done the business with them for over 07 years. They had some
payment issues with M/s Marush Private Limited, Lahore and came to know about the legal
troubles of M/s Marush Private Limited, Lahore in May, 2017. Hence, they terminated the
sole agent authorization of M/s Marush Private Limited, Lahore and appointed M/s Hipra
Pakistan (Private) Limited, Lahore as their sole agent for above products. They also
submitted the legalized termination letter in name of M/s Marush Private Limited, Lahore and
legalized authorization letter in name of M/s Hipra Pakistan (Private) Limited, Lahore.
3. The Legal Affair Division of DRAP was of the view that DRAP and the Registration
Board should proceed with the applications for change/transfer of registration under the law
as the courts have refused to grant interim injunction/stay order to Marush private Ltd. and
termination of distribution agreement of M/s Marush Private Limited, Lahore from M/s
Laboratorios Hipra, S.A., Spain.
4. On the opinion of Veterinary Expert, Registration Board considered the query on

stability studies of veterinary vaccines by the manufacturers and advised the DBER for
adoption of following guidelines.
Guidelines on Stability Studies of Veterinary Vaccines
The Registration Board after discussion decided to adopt the European framework for
stability testing of vaccines for veterinary use. The European Pharmacopoeia 9.5 (General
monograph (0062) “Vaccines for Veterinary Use” defines that the stability should be
evaluated under the recommended storage conditions. As the storage conditions of vaccines
is 2-80C (unless otherwise stated), the European Pharmacopoeia requires to perform the
stability studies only at 2-80C. Moreover, the European Directive 2001/82/EC (II-Title) does
not require performing accelerated stability studies for vaccines. Accordingly, evidence of
stability is obtained to justify the proposed period of validity (recommended shelf life).
a. Evidence indicated above is the form of the results of virus titrations, bacterial counts
of potency tests carried out at regular intervals until 3 months beyond the end of the
shelf life on not fewer than 3 representative consecutive batches of vaccine kept under
recommended storage conditions together with results from studies of moister content
(for freeze dried products), physical tests on the adjuvants, chemical tests on
substances such as the adjuvant constituents and preservatives, and pH as appropriate.
b. Where applicable studies on the stability of the reconstituted vaccine are carried out
using the product reconstituted in accordance with the proposed recommendations.
c. The variations in the results obtained during the stability study are taken into account
when defining appropriate formulation and release specification to ensure the
conformity of the product for the claimed shelf life.
Decision: Keeping in view the facts stated above including termination of
distribution agreement by M/s. Laboratorios Hipra SA, Spain in favour of
M/s. Marush Pvt Ltd, Lahore for the above mentioned products, the
Registration Board decided as follow:
a. Approved the cancellation of registration of products at Sr.No.1-22 (of
above table) from the name of M/s. Marush (Pvt) Ltd, Lahore.
b. Approved the registration of products at Sr.No.1-19 in the name of
M/s. Hipra Pakistan (Private) Limited, Lahore as per valid legalized
CoPPs, Current Import Policy for Finished Drugs and advised the
DBER to adopted the above Guidelines on Stability Studies of
Veterinary Vaccines developed in the light of European
Pharmacopoeia 9.5 (General Monograph (0062) and European
Directive 2001/82/EC (II-Title) for all veterinary vaccines.
Registration letters shall be issued after confirmation of cold storage
facility of M/s Hipra Pakistan (Pvt) Limited, Lahore by the area FID.
c. For products at sr. no. 20 & 21, Registration Board referred the case
to Expert Working Group on Veterinary drugs regarding their
opinion on non-availability in country of origin.
d. For product at sr. no. 22, Registration Board deferred the case for
submission of valid legalized CoPP by the firm.
2. Change in address of importer.

M/s Galaxy Pharma (Private) Limited Karachi has submitted an application for
transfer of registration letter on new address (without Change of Proprietor)of importer as per
DSL of below mentioned registered Biological products.
Details of the products provided by the firm are given below:
Sr. Reg. No. Brand name & Composition Initial Reg. Last Renewal
No. date Date
1. 069577 Follitrope 300IU 12-04-2011 04-04-2016
Each Pre-filled Syringe Injection contains:
Recombinant Human Follicle Stimulating
Hormone….300IU
2. 069576 Follitrope 225IU 12-04-2011 04-04-2016
Hormone…...225IU
3. 069575 Follitrope 150IU 12-04-2011 04-04-2016
Hormone…..150IU
4. 069574 Follitrope 75IU 12-04-2011 04-04-2016
Hormone…..75IU
Address as per registration letter and new submitted DSL

Registration letter New applied address as per DSL
M/s Galaxy Pharma (Pvt.) Ltd., B-102, Block- M/s Galaxy Pharma (Pvt.) Ltd., D-180, Roihan
6, Gulshan-e-Iqbal, Karachi Street Block-5, Clifton, Karachi
The firm has submitted following documents: -

(i) Application with Fee of Rs.5, 000 /- for each product.
(ii) Copy of registration letter and last renewal status.
(iii) Copy of DSL.
(iv) Firm submit renewal in time.
Decision: Keeping in view the valid Drug Sale License, Registration Board
approved the change in address of importer of above products from M/s
Galaxy Pharma (Pvt.) Ltd., B-102, Block-6, Gulshan-e-Iqbal, Karachi to
M/s Galaxy Pharma (Pvt.) Ltd., D-180, Roihan Street Block-5, Clifton,
Karachi subject to storage facility verification of new address.
3. Product applied by M/s Huzaifa International, Sargodhaapproved in 282th
meeting of Registration Board for exemption of foreign inspection of
imported finished products from Turkey.
It is submitted that following products of M/s Huzaifa International, Sargodha approved in
282th meeting of Registration Board as per following details:
Sr Manufacturer Brand Name & Composition Decision of 282th
No meeting of RB
1. M/s VETAL Hayvan Sagligi PESTVAC K Keeping in view the
Urunleri A.S. (Vetal Animal Live freeze-dried vaccine valid legalized CoPP;
Health Products Co.) Registration Board
Golbasi Karayolu Uzeri 7. Each 1 ml dose of lyophilized vaccine approved the
Km ADIYAMAN/TURKEY contains: product subject to
Freeze dried Modified Peste Des Petits compliance of current
Ruminant virus strain Nig 75/1 not less Import Policy for
than 102.5TCID/50 Finished Drugs.
Diluent
Diluent for Pestvac K
Each 1L contains:
NaCl………..……8.0g
KCl………………0.2g
Na2HPO4…….….1.15g
KH2PO4…………0.2g
Distilled water……upto 1000mL
(As per innovator specifications) *
As per above decision of Registration Board, the inspection of same manufacturing facility was
carried out by panel of inspectors (Mr. Asim Rauf, Additional Director (E&M), DRAP Lahore
& Mr. Abdullah, Additional Director (PE&R) on dated 24th&26th September 2018 in which
panel “RECOMMENDED” the facility and rating GOOD (Inspection report Attached). As
per decision of 270th meeting of Registration Board Chairman authorized for inspection
exemption. Chairman approved the inspection exemption of above-mentioned product. The
product will be import in combo pack and same have applied by the firm on form-5A
accordingly registration letter was issued to the firm.
Decision: Registration Board acknowledged the above information.
4. Conditions of Registration letter for Government supply

(i) This biological drug shall be imported, stored and sold in compliance with the
provision(s) of the Drugs Act, 1976, the DRAP Act, 2012 and rules framed there
under.
(ii) The label of a container of every drug intended for the supply to any Government
agency including an autonomous body or a semi-Government agency shall be in
“Pakistan Green” colored labels and packing, Government logo printed prominently
on it. The following words shall be printed prominently in red color in English and
Urdu, Namely: - “Government Supply” “Not for Sale” as provided in Labelling and
Packing Rules 1986.
(iii) This biological drug shall be imported in sufficient quantity so as to ensure its regular
and adequate supply till validity under rules, until & unless earlier suspended by
competent Authority under the Act.
(iv) The importer shall not, without the prior approval of the Registration Board,
discontinue the import which may result in its shortage.
(v) Color scheme of the labels/cartons and packaging material shall not resemble with any
of the other drugs, which has/have already been registered.
(vi) The name shall be changed in case it has resemblance with already registered drugs.
(vii) The registered drugs shall conform to the specifications of pharmacopoeial reference
as provided in Drug (Specifications) Rules, 1978. Any change in the formulation or
the manufacturing process or the quality control testing procedures or any change in
the posology, safety profile, prescribing information, clinical indications or any new
condition imposed by the regulatory authorities of the country of origin, shall be
communicated to DBER and shall require fresh approval.
(viii) Quality Control test procedures or reference standard or any technical assistance if
required by any Government Laboratory designated to test biological drugs shall be
furnished through the Division of Biological Evaluation and Research. Proper record
of each live pathogen if imported for test purpose shall be documented in this
Division for further follow up under Pakistan Bio-safety Rules, 2005 (notificationvide
SRO 336 (I)/2005) and other related requirement of Bio-safety.
(ix) One copy of the complete method of testing of the finished drug(s) containing full
details of all minor and major steps and protocols along with specifications (low and
upper limits) shall be submitted to the following institutions within a period of one
month:
(a) Chief, Drugs Control & Research Division, National Institute of Health,
Islamabad.
(b) Director, Central Drug Laboratory, Building No.4 S.M.C.H.S.,
Karachi.
(c) Director, Drugs Testing Laboratory, 1-Bird Wood Road, Lahore.
(d) Director, Drugs Testing Laboratory, Government of Sindh, Karachi.
(e) Director, Drugs Testing Laboratory, Government of KPK, Peshawar.
(f) Director, National Control Laboratory for Biologicals, Islamabad.
(x) One copy of the Master Formula(s), containing the name of active and
inactive materials along with the quantities shall be furnished, to the concerned
Assistant Drugs Controller, within a period of one month for which a receipt shall
also be obtained.
(xi) The Drugs (Labeling and Packing) Rules, 1986 shall be complied with in letter and
spirit.
(xii) Registration/Market Authorization will be withdrawn by default if any one of the
reference countries withdraws approval. Report the situation within a week to DRAP.
Written approval of continuation will be issued by DRAP on review of information
and satisfaction.
(xiii) Importer and registration holder will be bound to keep themselves educated about
GMP compliance of facility and transportation etc., in any case where violation is
recorded by any regulating agency; the same will be brought into the notice of DRAP
within a week time.
(xiv) The products mentioned above are highly technical which should be dispensed strictly
in accordance with dispensing instructions as per CoPP and product label.
(xv) Failure to comply with any one of the conditions mentioned on the registration letter
shall be reported to the Registration Board for review of the registration.
(xvi) If any of the conditions not fulfilled or public health risk reported at any stage, the
drug registration shall stand cancelled with immediate effect.
Discussion: Registration Board discussed that conditions of Registration are already

defined in The Drugs (Licensing, Registration & Advertising) Rules, 1976 and the labeling
requirements for government supplies are the purview of procuring agency.
Decision: Registration Board deferred the case for further deliberation in next meeting.
5. Product applied by M/s Immunonet Pharma (Pvt.) Ltd Lahore deferred in 285 th
meeting of Registration Board.
Following human Biological applied by M/s Immunonet Pharma (Pvt.) Ltd Lahore deferred
in 285th meeting of Registration Board as per following details:
1. Name of Importer M/s Immunonet Pharma (Pvt.) Ltd.,
12-F-1, Mahmood Chowk, Johar Town, Lahore, Pakistan
DSL details License No: 05-352-0066-034495D valid upto 05-July-2020
Name of Manufacturer M/s Xi’an Huitian Blood Products Co., Ltd Add: No.2369
the 2ndBaiiu Road, Modern Textile industrial Park, China
Brand Name +Dosage Form + Human Immunoglobulin (pH4) for Intravenous Injection
Strength
Composition Each mL contains:
Human immunoglobulin-G (active ingredient) ….50mg
Maltose (Stabilizer) …………………………...….90-110mg
Finished product specifications B.P Specs
Pharmacological Group Plasma derivative product

Approval status in Reference Flebogamma DIF 50 mg/ml solution for infusion
countries

Products already registered in Human Immunoglobulin (PH4) For Intravenous Injection. of
Pakistan M/s 3a Diagnostics, Lahore
Demanded Price / Pack size Rs. 38000Pkr. / 50ml vial
General documentation Valid legalized GMP Certificate No. CN20160017 valid until
22/02/2021
Valid legalized FSC Certificate No. 2017-S001 Issuing date
05-07-2017 valid for two years.
Remarks of Evaluator Accelerated Stability data of applied product is not submitted
by the firm. Firm submitted a document in which they
highlighted the Heat stability test which shows that “No
gelation at 570C for 4 hours.
“Registration Board deferred the case for submission of data of accelerated stability studies for
three (03) batches”
Now the firm has submitted the accelerated stability data.
Decision: Registration Board deferred the application and advised DBER to
summarize the data in next Board meeting.
6. Shelf Life inclusion in initial registration letters of veterinary vaccines applied by

M/s Hilton Pharma (Pvt.) Ltd., Karachi.
M/s Hilton Pharma (Pvt.) Ltd., Karachi applied for the inclusion of shelf life in
registration letters of their already registered vaccines. The details of the vaccines are as
follows:
Sr. Reg. Brand Name & Composition Date of Date of Last Demanded
No. No. Initial Renewal shelf life
Registration
1 039940 Medivac IB H-52 Vaccine 05-07-2005 30-03-2015 24 months
Each dose contains:
Freeze-dried live IB viruses of H-52
Massachusetts strain ≥ 103.5 EID50
2 039942 Medivac Gumboro B Vaccine 05-07-2005 30-03-2015 24 months
Each dose contains:
Freeze-dried live Gumboro viruses
of D22 strain ≥ 103.5 TCID50

i. Fee Challans of Rs. 5000/- for each product
ii. Copies of initial registration letters
iii. Copies of last renewal submissions for each product
iv. Real time stability data of 3 batches for each product
v. Valid legalized CoPP for each product issued by Ministry of Agriculture, Directorate
General of Livestock and Animal Health Services, Indonesia indicating claimed shelf
lives of aforementioned vaccines.
In this context, it is submitted that original renewal applications were not received and only
photocopy of evidence of renewal application submission is received from RRR section. The
renewal applications were processed in light of decision of 264th meeting and applications
were referred to R&I and Budget & Accounts. The R&I verified the renewal submissions
while Budget & Accounts did not verify the submission of fee challan. The firm then
submitted the photocopies of attested yellow copy of ABL fee challan.
Decision: Registration Board advised to adopt procedure for verification of fee as

approved in 284th meeting.
7. Imported Human Biologicals applied by M/s Timax Life Sciences Private
Limited, Karachi approved in 282nd meeting of Registration Board.
Following products of M/s Timax Private Life Sciences Private Limited, Karachi
were approved in 282nd meeting of Registration Board as per following details:
Sr. Name of Brand Name & Document Decision of RB in 282nd
No. Manufacturer Composition Details Meeting
1. M/s Octanate 50IU/ml Valid legalized Keeping in view valid legalized
Octapharma Powder and solvent CoPP No. 5.8.1- CoPP and approval of Medical
AB, for solution for 2017-340 dated Products Agency, Sweden
112 75 injection 16-10-2017 (Reference Regulatory
Stockholm, After reconstitution issued by Authority); Registration Board
Sweden each ml contains: Medical Products approved the product subject to
Coagulation factor Agency, Sweden price fixation by the Federal
VIII……….50 IU indicating Government and compliance of
Solvent: water for availability of the current Import Policy for
injection 5ml product in Finished Drugs.
country of origin.
2. Octanate LV 100 Valid legalized Keeping in view valid legalized
IU/mL CoPP No. 5.8.1- CoPP and approval of Medical
Powder and solvent 2017-340 dated Products Agency, Sweden
for solution for 16-10-2017 (Reference Regulatory
injection issued by Authority); Registration Board
After reconstitution Medical Products approved the product subject to
each ml contains: Agency, Sweden price fixation by the Federal
Coagulation factor indicating Government and compliance of
VIII……….100IU availability of the current Import Policy for
Solvent: water for product in Finished Drugs.
injection 5ml country of origin.
3. M/s. Octanine F 50 IU/mL Valid legalized Keeping in view valid legalized
Octapharma Powder and solvent CoPP No. CoPP and approval of Federal
Pharmazeutika for solution for 10374507 dated Office for Safety in Health
Produktionsges. injection 19-10-2017 Care, Austria (Reference
m.b.H, issued by Federal Regulatory Authority);
Oberlaaerstraβe Each ml contains: Office for Safety Registration Board
235 1100 Wien, Human Coagulation in Health Care, approved the product subject to
Austria Factor IX……….50 Austria indicating price fixation by the Federal
IU availability of the Government and compliance
Solvent: water for product in of current Import Policy for
injection 5ml country of origin. Finished Drugs.
4. M/s Octanine F 100IU/mL Valid legalized Keeping in view valid legalized
Octapharma Powder and solvent CoPP No. CoPP and approval of Federal
Pharmazeutika for solution for 10374496 dated Office for Safety in Health
Produktionsges. injection 19-10-2017 Care, Austria (Reference
m.b.H, issued by Federal Regulatory Authority);
Oberlaaerstraβe Each ml contains: Office for Safety Registration Board
235 1100 Wien, Human Coagulation in Health Care, approved the product subject to
Austria Factor Austria indicating price fixation by the Federal
IX……….100IU availability of the Government and compliance
Solvent: water for product in of current Import Policy for
injection 5ml country of origin. Finished Drugs. Firm will select
one manufacturer and
packaging site for product and
Chairman shall authorize
issuance of registration letter.
In this context, it is submitted that during processing the case for storage facility verification
it was observed that the firm has applied for storage conditions of 2-250C for their
aforementioned products and provided the real time stability data at 2-80C and 250C.
Accordingly, the case was taken up in 282nd meeting with 2-250C storage conditions and
same was approved while as per the package leaflets available at official websites, the
products at sr. no. 1-3 should be stored at 2-80C and the product at sr. no. 4 should be stored
below 250C.
Decision: Keeping in view the package leaflets of above products available at official
websites of country of origin; Registration Board approved the storage
conditions as per following details:
Sr. No. Name of Product Storage Conditions
1. Octanate 50IU/ml 20C-80C
2. Octanate LV 100IU/ml 20C-80C
3. Octanine F 50IU/ml 20C-80C
4. Octanine F 100IU/ml ≥250C
8. WHO Prequalified Typbar TCV vaccine applied by M/s Sind Medical

Stores, Karachi approved in 284th meeting.
Following product of M/s Sind Medical Stores, Karachi was approved in 284th
meeting of Registration board as per following details:
Name of Brand Name & Document Details Decision of RB in 284th Meeting
Manufacturer Composition
M/s Bharat Typbar TCV Valid Legalized CoPP Keeping in view the WHO
Biotech 0.5ml Vial No. 2528/E(M)/TS/2018- Prequalification and valid legalized
International 32 CoPP indicating the availability of
Limited, Each dose of Date of Issue: 13-04-2018 product in country of origin; Registration
Genome Valley, 0.5ml contains: Validity: 14-03-2020 Board approved the product subject to
Shameerpet Purified Vi Certifying Authority price fixation by the Federal government
Mandal, Medchal Capsular DCA, Govt. of and compliance of current Import Policy
District-500078, Polysachharide of Telangana. for finished drugs. The firm will submit
Telangana State, Salmonella typhi new brand name along with NOC from
India Ty2 conjugate to manufacturer abroad and Chairman
Tetanus Registration Board is authorized for
Toxoid…25µg issuance of Registration letter.
In this context, it is submitted that DBER received a letter from M/s Vikor Enterprises,
Rawalpindi on 05-10-2018 stating that the manufacturer M/s Bharat Biotech International
Limited, India had contacted and awarded M/s Vikor Enterprises Pvt. Ltd., Karachi the
marketing authorization of Typbar and terminated from the name of M/s Sindh Medical
Stores, Karachi. The firm requested to hold all product registration activities related to
Typbar vaccine in favor of M/s Sind Medical stores, Karachi.
Moreover, M/s Sind Medical Stores, Karachi on 01-10-2018 informed that their principal
may have forwarded a copy of termination letter of Exclusive Authorization dated 02-12-213
issued to them on 14-09-2018 for following two under registration products:
Sr. No. Product Name Pack
1. Typbar TCV(Typhoid (Vi Capsular Polysaccharide) – 0.5ml Vial/ 1 Dose
Tetanus Toxoid Conjugate Vaccine
2. Typbar TCV(Typhoid (Vi Capsular Polysaccharide) – 0.5ml PFS/ 1 Dose
Tetanus Toxoid Conjugate Vaccine
The firm requested not to take any action on the said letter, if we received it and give them
some time to settle the issue as principal did not inform them earlier about their termination
for the exclusive authorization from the said products as well as the reasons for termination
and they are in discussion with the principal and trying to know and remove the reasons for
their said action.
Decision: Registration Board advised M/s Sind Medical Stores, Karachi to submit
updated Sole agency agreement within 30 days.
9. Nemovac Vaccine applied by M/s Saadat International, Lahore approved in 254 th
Following product of M/s Saadat International, Lahore was approved in 254th meeting
of Registration Board as per following details:
Name of Brand Name & Document Details Decision of RB in 284th
Manufacturer Composition Meeting
M/s Nemovac Vaccine CoPP No. CCLYUN Approved as per Import
Laboratoire Each dose of vaccine 2.05.11 10 Certificate Policy for Finished Drugs
Porte Des contains:- no. 10125 Firm will provide valid
Alpes, Saint Attenuated Swollen Dated 26-4-2011 COPP, confirmation of
Priest, France. Head Syndrome virus, Free sale certificate storage facility and
PL21 strain, at least 102.3 Confirming sale in Chairman,
CCID50 France. RB will permit issuance of
During processing the case it was observed that the name of manufacturer mentioned in
Form-5A was included in the agenda and same was recorded in the minutes of meeting. The
firm then submitted the new valid legalized Free Sale Certificate vide no. 16-163377 dated
17-10-2016 wherein the manufacturer was same as in initial FSC. The difference is recorded
as below:
Manufacturer as per minutes of meeting Manufacturer as per Initial & Newly submitted
FSC
M/s Laboratoire Porte Des Alpes, Saint M/s Merial Rue De L’ Aviation, 69800 ST Priest,
Priest, France France
Moreover, the composition, mentioned in Form-5A was included in the agenda and same was
recorded in the minutes, was slightly different from that of initially and newly submitted FSC
as per following details:
Brand name and composition as Brand name and composition as per Initially & Newly
per minutes of 254th meeting submitted free sale certificate
Nemovac Vaccine Nemovac Vaccine (Lyophilisate for suspension)
Each dose of vaccine contains:- Each dose contains:-
Attenuated Swollen Head Live pneumovirus, PL21 strain at least 2.3 log10 CCID50 (*)
Syndrome virus, PL21 strain, at CCID50 (*): 50% cell culture infective dose.
least 102.3 CCID50 (Biological
Products).
Chairman Registration Board then advised to take up the case in Registration Board meeting
as there is major difference in manufacturer therefore the firm was advised to submit revised
Form-5A with revised labeling and packaging information as per FSC. The firm has also
submitted fee challan of Rs. 100000/-
Decision: Keeping in view the valid legalized free sale certificate; Registration
Board approved the product as per following details:
Name of Manufacturer Brand Name & Composition Pack Size
Product License Holder: Nemovac 10 x 1000
M/s Merial, Lyophilisate for suspension doses
29 Avenue Tony Garnier, 69007 Each dose contains:-
Lyon, France Live pneumovirus, PL21 strain…..at
Manufacturer: least 2.3 log10 CCID50 (*)
M/s Merial, Rue De L’Aviation, (*)CCID50: 50% cell culture infective
69800 ST Priest, France dose.
10. Registration of Premarin Tablet 0.3mg to whole sale license on new Wyeth
Pakistan Limited Address along with change in packaging & release site
deferred in 285th meeting of Registration Board.
M/s Wyeth Pakistan Limited Karachi submitted an application that as a consequence
to Wyeth Pakistan Limited manufacturing site divestment located at S-33, Hawks Bay Road,
SITE, Karachi, Premarin 0.3mg Tablet packaging and release from current site shall be
discontinued. Therefore in order to ensure product supply continuity, arrangements have been
done and agreed between the companies. Hence, in future, Pfizer Pakistan Limited shall
perform packaging & release functions of Wyeth bulk product Premarin 0.3mg Tablet at its
manufacturing site located at B-2, S.I.T.E., Karachi registered under DML no. 000025. The
firm further submitted that following to the above mentioned change of registration status and
subsequent to manufacturing site divestment, Wyeth Pakistan Limited as an Importer &
Distributor shall discontinue packaging & release of bulk import product Premarin 0.3mg
Tablet from its current site i.e. S-33, Hawks bay Road, S.I.T.E., Karachi. Hence in order to
maintain supply continuity, contract arrangement services by M/s Pfizer Pakistan Limited for
Wyeth product packaging and release has been finalized and in place. As per agreement, m/s
Pfizer Pakistan Limited in future at its manufacturing site located at B-2, S.I.T.E., Karachi.
The case was considered in 284th meeting of Registration Board wherein the Board decided
as follows:
“Registration Board deferred the request of the firm for confirmation of nature of bulk
to be imported and packaging process performed locally.”
The firm then confirmed the nature of bulk imported and packaging process performed
locally as per following details:
Product Details Sites Responsibility/ Functions
Premarin Tablet 0.3mg Manufacturing Site: Manufacturing site functions includes:
Tablet M/s Pfizer Ireland Manufacturing, Coating of Compressed
(Conjugated Estrogen) Pharmaceuticals Tablets, assembly & Batch Analysis with
Pack Size: 3x10’s Newbridge County Release for Finished Product.
Reg. No. 039594 Kildare, Ireland
Import Status: Packaging Site & Release Primary & Secondary packaging along with
Compressed Coated Site: QC release.
Tablets in Bulk Form. M/s Pfizer Pakistan
Limited, B-2, Karachi
The case was taken up in 285th meeting wherein the Board decided as follows:
“Registration Board deferred the case and advised DBER to confirm all the documents along
with fee submitted by the firm.”
a. Application on Form-5A.
b. Fee Challans of Rs. 105000/- (Rs. 50000/- for change of importer, Rs. 5000/- for art
work change and Rs. 50000/- for contract manufacturing permission.)
c. Copy of Initial registration letter.
d. Copy of letter indicating the grant of renewal till 03-10-2020 dated 28-04-2017 issued
by DRAP.
e. NOC for CRF Clearance of M/s Wyeth Pakistan Limited valid till 31-05-2018.
f. Site Change approval of SECP
g. Copy of DSL dated 06-07-2018 valid till 21-06-2020
h. Valid notarized CoPP no. PP10149532 dated 19-05-2017 issued by MHRA valid
legalized CoPP dated 10-05-2017 issued by HPRA Ireland.
i. Existing and proposed Artwork
Decision: Registration Board approved the Registration of Premarin Tablet 0.3mg
(Reg. No. 039594) to M/s Wyeth Pakistan Ltd., B-2, S.I.T.E. Room No. 002
& 003, PGS Amin Block, 1st Floor, Karachi from M/s Wyeth Pakistan
Limited, S-33, Hawkes Bay Road, S.I.T.E., Karachi as per valid drug sale
license along with contract permission of primary & secondary packaging
and QC release at M/s. Pfizer Pakistan Karachi. Approval letter shall be
processed after storage facility verification report of new address / site.
11. Allotment of separate registration numbers for Epokine 2000IU/0.5mL PFS/ Vial
(023635)& 4000IU/0.4mL PFS/ Vial (023633) applied by M/s RG Pharmaceutica
(Pvt) Ltd., Karachi deferred in 283rdmeeting of Registration Board.
M/s RG Pharmaceutica (Pvt. Ltd., Karachi applied for the change in name of
manufacturer of Epokine 2000IU, 4000IU & Leukokine Injections and for separate
registration numbers for Epokine 2000IU PFS/Vial & 4000IU PFS/ Vial. The case was
considered in 262nd meeting of Registration Board wherein the Board decided as follows:
Name ofImporter/ Name of New Brands Fee Documentary details
Name ofExisting Manufacturer Name/ Composition status/
Manufacturer
M/s RG M/s CJ Epokine Total Fee Legalized and valid
Pharmaceutica (Pvt) HealthCare 2000Units/0.5mL deposited CoPP for Epokine vial
Ltd,Karachi. Corporation, Packing: PFS/Vial Rs.500,00 and PFS are submitted.
811,Deokpyeongr (Reg No.023635) 0/for Legalized and valid
M/s CJ o, allcases. CoPP for leukokine of
Cheilljedang Majangmyeon, Epokine dated 12-09-2014 is
Corporation, lcheon- 4000Units/0.4mL submitted.
Deokpyeongri, si,Gyeonggi- Packing: PFS/Vial
511, do,Korea. (Reg No. 023633) Letter from Ministry of
Majangmyeon, security and public
lcheon-city Leukokine Injection administration Korea
Kyeonggi-do, rhG-CSF)….300mcg/ that old and new
Korea. 1.2ml address identical and
(Reg. No 041140) legally valid.
“Registration board deferred the request of the firm for allotment separate registration
numbers for Epokine 2000IU/0.5mL PFS/ Vial (023635)& 4000IU/0.4mL PFS/ Vial (023633)
for discussion in next board meeting, however the board approved the change of name of
manufacturer from CJ Cheilljedang Corporation, Deokpyeong-ri, 511, Majang-myeon,
lcheon-city Kyeonggi-do, Korea to CJ HealthCare Corporation, 811, Deokpyeong-ro,
Majang-myeon, lcheon-si, Gyeonggi-do, Korea of Epokine 2000IU/0.5mL PFS/ Vial
(023635), 4000IU/0.4mL PFS/ Vial (023633) and Leukokine Injection (041140)”
Accordingly, approval letters for change of name of manufacturer were issued and the
case for separate registration numbers for Epokine 2000IU PFS/Vial & 4000IU PFS/ Vial
was taken up in 264th, 276thand then 283rd meeting of Registration board as per following
details:
“M/s RG Pharmaceutica (Pvt.) Ltd., Karachi applied for the allotment of separate registration
numbers for their already registered products Epokine 2000IU/0.5mL PFS/ Vial (023635)&
4000IU/0.4mL PFS/ Vial (023633). The firm submitted that at the time of registration of
Epokine 2000IU and 4000 IU vial and prefilled injection, the concerned section issued one
registration number for both products. The firm requested to issue separate additional
registration No. for Epokine 2000 &4000 IU vials. The firm further requested to issue that
along with the brand name generic/ composition as per CoPP may kindly be mentioned which
is not incorporated in initial registration letter. The case was initially discussed in the 264th
meeting of Registration Board wherein the board decided as under:
S.# Reg. Name of Brands Name Pack Size Documenta Decision of RB in
. No. Manufacturer &Composition & Price as ry details 264th meeting
per
Registrati
on Letter
1 02363 M/s CJ HealthCare Epokine Prefilled Valid Registration Board
5 Corporation, syringe/ Legalized
deferred request of
811,Deokpyeongro, Each dose Vial CoPP No.
the firm for
Majangmyeon,lche contains: Rs. 995/- 2014-A1-
allotment of
on-si, Recombinant 1583 dated
separate
Gyeonggi- Human 1 x 6’s 03-09-2014
registration
do,Korea. Erythropoietin Pre-filled for PFS.
numbers for
… syringes Epokine2000IU/0.5
...2000Units in Valid mL PFS/ Vial
cardboard Legalized (023635) &
box. CoPP No. 4000IU/0.4mL PFS/
Price not 2014-A1- Vial (023633) and
mentioned 1578 dated advised to provide
in letter. 03-09-2014 the current MRP
for Vial. along with import
2 02363 M/s CJ HealthCare Epokine Prefilled Valid status of aforesaid
3 Corporation, syringe/ Legalized products since
811,Deokpyeongro, Each dose Vial CoPP No. registration.
Majangmyeon,lche contains: Rs. 2000/- 2014-A1-
on-si, Recombinant 1576 dated
Gyeonggi- Human 1 x 6’s 03-09-2014
do,Korea. Erythropoietin Pre-filled for PFS.
… syringes/
...4000Units Vials in Valid
cardboard Legalized
box. CoPP No.
Price not 2014-A1-
mentioned 1579 dated
in letter. 03-09-2014
for Vial.
The firm has submitted required documents as per the decision of Registration Board and it
was observed that the firm was granted pack of 6’s while the pack of 10’s was not approved
to import. The case was again taken up in 276th meeting of registration board wherein the
Board decided as follows:
“Registration Board referred the case to QA & LT Division for their comments
regarding the import of pack size 10’s without registration.”
The response of QA&LT Division was received vide Dy. No. 353-DD/(QC) which includes a
letter vide No. F. 01-04/2018-DRAP(K) dated 24-05-2018 from DRAP office, Karachi. The
details of the letter are as follows:
“ The import of Epokine Vials 2000IU and 4000IU in pack of 1x10 by RG Pharmaceutica
and its release by our department is granted on following grounds:
i. That with each release the firm has submitted this office the initial registration letter and
amended note that showed that the firm possesses the registration of PFS and Vials under
one registration with approved MRP of individual unit along with pack size of 1x6 per
pack.
ii. That while clearing the case it was kept in mind that even after the pack size minor
variation, the MRP of single unit (Vial) would not be affected as per the condition of
iii. Upon that variation the firm replied that the same is being done keeping in view the
international availability in the same pack size, stability of drug and facilitation in
transportation of goods.
Based on the above facts it is the understanding of this office that as both the two put us of
Epokine Vial 2000IU and 4000IU are registered and lawfully approved by MOH vide its
letter dated 20th October 1999. The said letter includes the rectification note as well that due
to oversight the vials has not been mentioned in the registration letter dated 26-05-1999. It
further endorsed that the packing should have to be corrected accordingly. Rests of the
variance/ conditions were kept same. Secondly, the package inserts as available with each
imported pack mentioned the detail about presentation as follows:
Epokine Prefilled Injection
1000units/2000units/3000units/4000units/10000units carton of 6 syringes.
Epokine Injection Vial
2000units/4000units/10000units carton of 10 vials
And most important that MOH has awarded per unit price in registration letters irrespective
of pack size.
It is observed that the RG Pharmaceutica imported both drugs Epokine 2000IU and
Epokine 4000IU Vials after obtaining approval from MOH and as per presentation available
in country of origin i.e. prefilled syringes dosage form are available as 1x6’s pack only while
put ups of Epokine in Vial dosage forms as 1x10’s pack size only.
Therefore matter in question related to pack size (1x10’s) of Epokine 2000IU and
4000IU appears to be a typographical error or missing in the initial MoH letter and not a
violation against any of the provision of Drugs Act 1976 and Rules framed there under
because it doesn’t affect the quality, potency and MRP of the drug in question at any cost.
Therefore, it is recommended that DRAP may rectify the initial conditions of the registration
letter by granting the firm a separate registration for PFS and Vials along with proper pack
size for individual put ups.”
The board decided as follows:
“Registration Board advised the firm to Import Epokine injection 2000IU and 4000IU as per
registration letter and comply Drugs (Labelling and Packing) Rules, 1986. The Board
deferred firm’s request for allotment of separate registration numbers for Epokine
2000IU/0.5mL PFS/ Vial (023635)& 4000IU/0.4mL PFS/ Vial (023633) for further
deliberation.”
Accordingly, letter to the firm was issued and the case of separate registration numbers for
Epokine 2000IU/0.5mL PFS/ Vial (023635)& 4000IU/0.4mL PFS/ Vial (023633) was taken
up in 285th meeting of Registration Board wherein the Board decided as follows:
“Registration Board deferred the case for further deliberation in next meeting
regarding the requirement of panel inspection of manufacturer abroad for such
cases.”
Decision: Registration Board deferred the case and advised DBER to come up with
a list of all such cases where different packagings are registered against
one registration number.
12. Registration of NP-Poetin 2000IU (Reg. No. 077536) & 4000IU (Reg. No. 077537)
Inj. for market supply applied by M/s Nextar Pharma, Karachi.
Following products of M/s The Nextar Pharma, Karachi were registered only for trial
manufacturing and performance of biosimilarity studies in 244th meeting of Registration
Board as per following details:
S. Reg. Name of Brand name & Composition Pack Size
No. No. Manufacturer
1. 077536 M/s The Nextar NP-Poetin 2000 Inj. 1x1 PFS
Pharma, Plot No. E- Each Prefilled syringe contains:
58, North Western Erythropoietin……….2000IU(B.P./ml)
Industrial Zone, Port Shelf Life: 2 years (Store at 20C-80C)
2. 077537 Qasim, Karachi NP-Poetin 4000 Inj. 1x1 PFS
Each Prefilled syringe contains:
Erythropoietin……….4000IU(B.P./ml)
Shelf Life: 2 years (Store at 20C-80C)
Initially, the registration was granted for bulk import from M/s Pooyesh Darou, Tehran Iran
and then the firm applied for the change in bulk source to M/s Shangdong Kexing Bio-
Products Co., Ltd., China and accordingly the approval was granted on 17-02-2017. Now, the
firm has applied for the grant of Registration for market supplies and provided the data in
light of decision of 278th meeting of Registration Board as per following details:
Sr. Documents required as per 278th RB decision for Biological Drugs i. Remarks
No. (Concentrated Form/Ready to fill Form)
1. The firms shall provide legalized GMP certificate of biological drug Valid legalized copy of
substance manufacturer abroad (who will provide concentrate / ready to fill GMP certificate No.
bulk of biological drug to Pakistani manufacturers for further processing) CN20140140 dated 17-03-
as an evidence that the manufacturer is an authorized manufacturer of 2014 valid till 16-03-2019.
biological drug in the country of origin.
2. The firms shall provide legalized free sale certificate/CoPP either from Valid legalized FSC No.
country of origin or by any reference regulatory authority as adopted by 2017-007 dated 27-11-2017
Registration Board of finished product as evidence that the final product valid for two years.
has been manufactured by same concentrate/ready to fill bulk after
submission of data to the concerned regulatory authority.
3. The firm shall provide the complete Bio-similarity studies of the finished Provided and detailed
product of same source (bulk concentrate or ready to fill) manufactured below.
either from country of origin or by any reference regulatory authority as
adopted by Registration Board to 9demonstrate the bio-similarity.
4. The firm shall provide the lot release certificate of the finished product Not Applicable in China
manufactured by same bulk concentrate/ ready to fill from country of for Biotech products.
export (If applicable).
5. The firm shall provide the 6 months accelerated and real time stability Provided
studies for drug substance.
6. The local manufacturer shall manufacture three trial batches of the finished Provided
biological product to finalize the formulation and then perform analytical
studies(Physicochemical and biological) including protein content,
appearance, pH, Osmolarity, composition of key excipients including
stabilizers (if formulation is same), visible/subvisible particles, identity
testing to parent molecule, purity testing, in vitro biological activity,
sterility, Pyrogen content, safety, potency and toxicity with support of iso-
electro focusing data, gel electrophoresis, Western-Blot and other
analytical techniques). The firm shall submit the results for processing of
registration application.
7. The manufacturer shall perform all tests locally as detailed on Certificate Provided
of analysis.
8. The firm shall also provide the list of finished products being Provided
manufactured from same bulk concentrate or ready to fill form in any
country of the world (if available).
9. The firm shall provide the agreement with the source (of bulk Provided
concentrate/ready to fill) that if there shall be any critical change in
manufacturing process, biological systems used to manufacture, etc. the
firm shall inform DRAP immediately along with relevant documents.
10. Regular monitoring through pharmacovigilance reporting system shall be Pharmacovigilance Policy
observed through proper pharmacovigilance cell of the manufacturer and provided.
report will be forwarded to the National Pharmacovigilance Centre,
Division of Pharmacy Services and Biological Division of DRAP. In case
of any severe adverse event, immediate mandatory reporting procedure
shall be followed.
11. The firm shall inform DRAP if there shall be any adverse event or ADR Provided
reporting from the country of manufacture of concentrate/ready to fill bulk
and finished product as required vide Rules 30 of Drug (LR&A) Rule.
Bio-similarity studies of the finished product of same source (bulk concentrate or ready to fill)
manufactured from country of origin.
WHO Bio-similarity Data submitted by the firm
guidelines
Quality Comparison i. Primary sequence.
Physicochemical ii. Amino acid composition.
characterization iii. Terminal Analysis
a. N-terminal analysis.
b. C-terminal analysis.
iv. Peptide mapping.
v. Disulfide bond analysis.
vi. N-linked oligosaccharide analysis.
a. Sialic acid content
b. Sugar chain analysis
c. Neutral Sugar chain analysis by HPAEC-PAD
d. Isoform by capillary zone electrophoresis and isoelectric focusing.
vii. Secondary structure by Circular dichroism.
Biological Activity In-vivo activity by reticulocyte test.
In-vitro activity by research-cell diffusion analyses.
Immunochemical Immunoblotting.
properties
Impurities Impurity test by SDS-PAGE and immunoassay
Non-clinical Studies Repeat dose toxicity studies in Sprague-Dawley rats.
Clinical Studies Study to evaluate safety and efficacy of EPOSINO on anemic patients with CRF
and compare it with EPOGEN.
The case was considered in 285th meeting wherein the Board decided as follows:
“Registration Board deferred the case for further deliberation in next meeting.”
Decision: Keeping in view the GMP certificate of M/s The Nextar Pharma Private
Limited, Karachi and data submitted by the firm in light of decision of
278th meeting, Registration Board approved the above products for
market supply.
13. PESTDOLL-S vaccine applied by M/s Orion Group, Faisalabad approved in

269th meeting of Registration Board.
M/s Orion Group, Faisalabad submitted as per the submitted FSC, Form-5A, GMP
Certificate, Production Permit, Credential of Manufacturer and the Technical Dossier of
Pestdoll-S vaccine their manufacturer name is M/s Dollvet Veteriner Asi, Ilac, Biyolojik
Madde Uretimi Sanayi Ticaret A.S. The name of the manufacturer was not mentioned on the
received letter as well as in the minutes of 269th meeting. The firm has requested to mention
the company name.
In this context, it is submitted that the aforementioned product was approved in 269th meeting
of Registration Board as per following details:
Name of Brand Name & Document Details Decision of RB in 269th meeting
Manufacturer Composition
Organize PESTDOLL-S Copy of Valid Legalized GMP Registration Board approved the
SanayiBolgesi Each dose certificate No. GMP/TR/V/ product as per import policy for
8. Cadde No.3 contain: PPRV YI/S0034/2 015 dated 410-2016 finished drugs and as per valid
Sanliurfa/Tur Attenuatednijerya (Pages-193-194/corr.) legalized GMP and Free Sale
key INC. 75/1…103 Copy of Legalized Free Sale certificate.
TCID/Dose Certificate dated 04-10-2016
During agenda preparation, the name of manufacturer was inadvertently missed and only
address was mentioned. The same was recorded in the minutes.
Registration Board in its 262nd meeting authorized its Chairman for correction of
typographical errors in recording minutes. Therefore, it is proposed that we may refer the
case to Chairman Registration Board for approval of correction in minutes of 269th meeting
regarding name of manufacturer abroad i.e. M/s Dollvet Veteriner Asi, Ilac, Biyolojik Madde
Uretimi Sanayi Ticaret A.S. please. The Chairman Registration Board granted the approval
and the same was referred for correction in panel inspection letter.
14. Imported Veterinary Vaccines applied by M/s Vet Crown (Animal Health)
International, Lahore approved in 274th meeting of registration Board.
Following products of M/s Vet Crown (Animal Health) International, Lahore were
approved in 274th meeting of Registration Board as per following details:
Sr. Name of Brand Name & Composition Pack Documents Decision of RB
No. Manufacturer Size submitted in 274th
meeting
1. M/s S.C BIAROMVAC-PA 1’s Copy of valid Keeping in view
Romvac Infectious Bursal Disease Vial legalized CoPP the
Company S.A, (IBD) (2500 No. recommendation
Soseaua Each dose contains: doses) 930/3/28.09.2015 of veterinary
Centurii nr.7, Infectious Bursal Disease expert,
077190 virus- PA strain…….min. Registration
Voluntari, Jud. 103.5Eid50 – max. 105.5Eid50. Board approved
2. Ilfov- AVIPOX-GAL 1’s Copy of valid the products as
Romania. Lyophilized pellet Vial legalized CoPP per valid
Each dose contains: (1000 No. legalized CoPP
Avian pox virus- galinar doses) 930/7/28.09.2015 subject to
attenuated strain Gal- MP1 compliance of
……..min.102DIE50 -max. 105 current Import
DIE50 Policy for
finished drugs.
In this context, it is submitted that composition mentioned in minutes was as per

Form-5A which is almost same as mentioned in CoPP. However, registration letters were
issued as per composition mentioned in CoPP. The difference is recorded as under:
Name Composition as per minutes Composition as per CoPP
Biaromvac- Each dose contains Active substance: Each dose contains:
PA Live IBD virus attenuated strain (PA 43-94) Infectious Bursal Disease virus- PA
contain minimum 103.5 Eid 50 to maximum strain…….min.103.5EID50–max.
105.5 Eid 50. 105.5EID50
Avipox- Each vaccinal dose (0.01ml) contains: Each dose contains:
GAL The Avian pox virus-Galinar attenuated strain Avian pox virus- galinar attenuated
Gal-MP1with minimum titre 102 and strain Gal- MP1 ……..min.102DIE50 -
maximum titre 105 DIE50 / Vaccinal dose max. 105DIE50
15. Exemption of Urdu text, registration number & MRP on Shan TT (Adsorbed
Tetanus Vaccine) (Reg. No. 079273) and Import of product in standard export
packs applied by M/s Sanofi Aventis Pakistan Limited, Karachi deferred in 285 th
M/s Sanofi Aventis Pakistan Limited has requested for the exemption of Urdu Text,
Registration Number & MRP on packs of below mentioned human biological:
Reg. No. Name of Product Pack Size
079273 Shan TT 5ml/ 10 dose vial
(Adsorbed Tetanus Vaccine) (5ml x 30’s)
1. Copies of Initial registration letters.
2. SOPs for control of repacking operations.
3. An undertaking that we will print Registration Number on each pack of our vaccine
Shan TT (Reg. No. 079273) at our Karachi site bearing DML No. 000007, before
releasing the goods into the market.
The firm further informed that Tetanus vaccine is manufactured at a single source and
manufacturing site produces standard export packs in bulk to furnish the needs for different
countries. Therefore, it is not possible to follow the packaging and labeling rules of every
country at the time of export plus production, packaging, quality controls of these sterile and
temperature sensitive products require specialized methods and techniques of handling under
highly controlled environment. Repacking or overprinting is generally avoided so as not to
compromise on the cold chain process. However, in order to be compliant to the Pakistan
Drugs Labeling and Packaging rules once the vaccines are released by customs and come in
to their warehouse. They have given the under tacking that they will print name in Urdu Text
along with registration number and MRP on each pack under cold chain process before
The case was considered in 285th meeting of Registration Board wherein the Board decided
as follows:
“Registration Board deferred the case for submission of following by the firm:
a. Application processing fee
b. Duration of exemption”
The firm has now submitted the following documents:
a. Fee Challan of Rs. 5000/-
b. The firm submitted that they cannot restrict this request to certain time span.
Decision: Registration Board acceded to the request of the firm for import of
already registered Shan TT (Adsorbed Tetanus Vaccine) vide Reg. No.
079273 in Standard Export Packs. The Board advised the firm to locally
print MRP and Registration Number along with Urdu Text before sale of
drug at M/s Sanofi Aventis, Plot 23, sector 22, Korangi Industrial area,
Karachi to comply requirement as per Drugs (Labelling & Packing)
Rules, 1986. This permission shall be valid for two (02) years only.
16. Exemption of Urdu text, registration number & MRP on Shan 5 (Suspension for
Intramuscular Injection) (Reg. No. 090315) and Import of product in standard
export packs applied by M/s Sanofi Aventis Pakistan Limited, Karachi.
M/s Sanofi Aventis Pakistan Limited has requested for the exemption of Urdu
Text, Registration Number & MRP on packs of below mentioned human biological:
Reg. No. Name of Product Pack Size
090315 Shan 5 1’s Vial (0.5ml)
Suspension for Intramuscular Injection
1. Fee Challan of Rs. 5000/-
2. Copy of Initial registration letter dated 10-10-2018
3. SOPs for control of repacking operations.
4. An undertaking that we will print name in Urdu Text along with the Registration Number
& Maximum Retail Price (MRP) on each pack of our vaccine namely Shan 5 (Reg. No.
090315) at our Karachi site bearing DML No. 000007, before releasing the goods into the
market.
5. The firm submitted that they cannot restrict this request to certain time span.
The firm further informed that Shan 5 is manufactured at a single source and manufacturing
site produces standard export packs in bulk to furnish the needs for different countries.
Therefore, it is not possible to follow the packaging and labeling rules of every country at the
time of export plus production, packaging, quality controls of these sterile and temperature
sensitive products require specialized methods and techniques of handling under highly
controlled environment. Repacking or overprinting is generally avoided so as not to
compromise on the cold chain process. However, in order to be compliant to the Pakistan
Drugs Labeling and Packaging rules once the vaccines are released by customs and come in
to their warehouse. They have given the under tacking that they will print name in Urdu Text
along with registration number and MRP on each pack under cold chain process before
Decision: Registration Board acceded to the request of the firm for import of
already registered Shan 5 (Suspension for Intramuscular Injection) vide
Reg. No. 090315 in Standard Export Packs. The Board advised the firm to
locally print MRP and Registration Number along with Urdu Text before
sale of drug at M/s Sanofi Aventis, Plot 23, sector 22, Korangi Industrial
area, Karachi to comply requirement as per Drugs (Labelling & Packing)
Rules, 1986. This permission shall be valid for two (02) years only.
17. Registration of Dengue Vaccine applied by M/s Sanofi Aventis Pakistan Limited,
Karachi.
Following vaccines of M/s Sanofi Aventis Pakistan Limited, Karachi were approved
by the Registration Board in its 260th meeting held on 28th-29th June, 2016 on
recommendations of WHO Strategic Advisory Group of experts (SAGE) dated 12th-14th
April, 2016, expert from PMRC and representative of WHO in Pakistan:
Sr. No. Brand Name Composition
1. DENGVAXIA, powder and solvent for One dose (0.5 ml) contains:
suspension for Injection CYD dengue virus
Single dose. serotype1,2,3,4………….each 4.5-6.0 log10
CCID50/dose
2. DENGVAXIAMD, powder and solvent One dose (0.5 ml) contains:
for suspension for Injection CYD dengue virus
Multi dose. serotype1,2,3,4………….each 4.5-6.0 log10
CCID50/dose
Registration letters of above products were issued to M/s Sanofi Aventis Pakistan
Limited, Karachi in the light of decision of Registration Board in its 273rd meeting held on
28th-29th August, 2017 wherein it was decided to issue letters for govt. supplies only.
Meanwhile, it was noticed that Registration of Dengvaxia vaccine and Dengue

Immunisation programme was suspended by Philippines due to the new findings by M/s
Sanofi Pasteur, France that severe cases of dengue can occure in the longer term among those
vaccinated without prior infection. Accordingly, WHO on 22nd December, 2017 published its
interim position regarding the use of Dengvaxia vaccine which is reproduced as under:
“WHO acknowledges that in high seroprevalence settings, the vaccine can have significant
population-level benefits. However, until a full review has been conducted, WHO
recommends vaccination only in individuals with a documented past dengue infection, either
by a diagnostic test or by a documented medical history of past dengue illness.
Any further guidance, including a review by SAGE and update of the WHO position paper on
Dengvaxia®, will likely be available no earlier than April 2018 after a rigorous review of the
new data and additional activities, such as population based modelling, are undertaken.”
Keeping in view WHO interim position, Registration Board in its 277th meeting held
on 27th-29th December, 2017 decided that the vaccine is not indicated for a mass vaccination
program as Dengvaxia vaccineis indicated only in individuals with a documented past dengue
infection (seropositive persons), confirmed either by a diagnostic test or by a documented
medical history of past dengue illness. Moreover, in case of not using the vaccine, possibility
of mortality can be high as observed in previous years. It was furher decided that Registration
Board will review case further as soon as the decision of WHO Strategic Advisory Group of
Experts (SAGE) on immunization becomes available in April 2018.
On 19th April, 2018, WHO published “Revised SAGE recommendation on use of
Dengue vaccine” which is at Annex-I. Keeping in view revised SAGE recommendations,
Registration Board in its 283rd meeting held on 27th-29th June, 2018 decided to deliberate the
said matter in next Registration Board meeting withconcerned departments.
Moreover, European Medicine Agency (EMA) issued a press release on 19-10-2018
having following key points:
a. The European Medicines Agency's Committee for Medicinal Products for Human
Use (CHMP) has recommended granting a marketing authorisation for Dengvaxia
(dengue tetravalent vaccine (live, attenuated)), for the prevention of dengue caused by
dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old,
live in an endemic area and already had a prior dengue virus infection.
b. There are four types of dengue virus and people living in a dengue-endemic area can
have several dengue infections in their lifetime. No specific treatments for dengue
exist and prevention is mainly limited to the environmental management of
mosquitoes. There is currently no vaccine available for dengue in the EU.
c. The approved indication excludes the populations of the EU mainland and territories
outside tropical areas since dengue is not endemic in these regions. However, a
number of EU territories, mainly overseas, are situated in endemic areas, and these
territories could benefit from this vaccine.
d. In people who have never had dengue, there is an increased risk of clinically severe
dengue disease leading to hospitalisation when vaccinees are subsequently infected
with dengue virus. The CHMP therefore recommends limiting the use of the vaccine
to individuals with prior dengue virus infection, for whom laboratory confirmation of
the previous infection is available before vaccination.
e. Because there are no safety, immunogenicity or efficacy data to support vaccination
of individuals living in non-endemic areas and travelling to endemic areas,
vaccination of these individuals is not recommended.
f. The opinion adopted by the CHMP is an intermediary step on Dengvaxia’s path to
patient access. The CHMP opinion will now be sent to the European Commission for
the adoption of a decision on an EU-wide marketing authorisation.
Discussion:
Dr. Asaaf Deputy Director, Federal EPI and Mr. Massab Umair Sr. Scientific Officer,
NIH attended the meeting and submitted the following:
Dr. Asaaf Deputy Director, Federal EPI:
Exact disease burden of Dengue fever is yet unknown. In the absence of disease
burden data the age bracketing is not possible which is essential for primary health care
vaccines. Screening of seropositivity is very difficult as no assay will be 100%
specific.Moreover, once vaccinated the efficacy of vaccine for 2-3 years is established. What
will happen after that period is yet unknown. Further, dengue surveillance centers and proper
storage facilities for dengue vaccines should be established first. Therefore, until the exact
disease burden, seropositivity identification and safety data, the vaccine should not be
registered.
Mr. Massab Umair, Sr. Scientific Officer, NIH:
Sensitivity and specificity of dengue diagnostic test is a major hurdle.Therefore,
sampling time and type of diagnostic test should be assessed properly.Highly sensitive and
specific dengue diagnostic kits are available in NIH. NIH can provide technical support
regarding the development of diagnostic test facilities.
Decision: Registration Board considered the matter in light of comments by EPI
and NIH on disease burden data, cost and effectiveness of available
Dengue Diagnostic tests. Registration Board deferred the case for further
deliberation and advised DBER to come up with the current status of
Dengvaxia vaccine in neighboring and tropical countries in next
Registration Board meeting.
18. Change of Manufacturing Site of powder, Secondary Packaging site of powder
and diluent & QA Release Sites of powder and diluent of Nimenrix (Reg. No.
091876) applied by M/s Pfizer Pakistan Limited Karachi.
M/s Pfizer Pakistan Limited, Karachi applied for the Change of Manufacturing Site of
powder, Secondary Packaging site of powder and diluent & QA Release Sites of powder and
diluent of Nimenrix (Reg. No. 091876) as per following details:
Reg. No. Name of Product Approved Sites Newly Applied Sites
091876 NIMENRIX Manufacturer: Manufacturer:
Powder and M/s Glaxo smith Kline biologicals SA Rue M/s GlaxoSmithKline
solvent for dei I, Institut 89, B-1330 Rixensart, Belgium. Biologicals S.A., Parc de
solution for Secondary Packaging site of Powder and la Noire Epine, Rue
injection diluent: Fleming 20, 1300 Wavre,
(Meningococcal M/s GlaxoSmithKline Biologicals S.A., Parc Belgium.
group A,C,W-135 de la Noire Epine, Rue Fleming 20, 1300 Secondary Packaging
and Y Conjugate Wavre, Belgium. and QA Release sites of
Vaccine) QA Release site for powder and diluent: Powder and diluent:
M/s Glaxo smith Kline biologicals SA Rue M/s Pfizer Manufacturing
dei I, Institut 89, B-1330 Rixensart, Belgium. Belgium NV, Rijksweg
1202870 Puurs Belgium
a. Application on Form-5A
b. Fee Challan of Rs. 10000/-
c. Copy of Registration letter dated 19-09-2018
d. Valid legalized CoPP No. 03/18/116587 dated 30-01-2018 issued by EMA indicating
new manufacturing site.
e. An undertaking that all the provided information/ documents are true and correct to
the best of our knowledge.
In this context it is submitted that in the initial registration letter of Nimenrix only
manufacturing sites of powder & diluent were mentioned while now the firm has also applied
for the change in secondary packaging & QA release sites of powder and diluent which were
not indicated in initial registration letter. The application of the firm is evaluated as per SOPs
formulated in 283rd meeting of Registration Board and following deficiencies were observed:
a. Change in manufacturing site is considered as new application; therefore, full fee for
processing is required.
b. Clarification is required as the finished product specifications indicate Molecular size
distribution for Men C and Men Y as 75% while in stability studies Molecular size
distribution for Men C and Men Y is written as 70%.
Decision: Keeping in view the valid legalized CoPP and approval of EMA
(Reference regulatory authority); Registration Board approved the
Change of Manufacturing Site of powder, Secondary Packaging site of
powder and diluent & QA Release Sites of powder and diluent of
Nimenrix (Reg. No. 091876) as per following details:
Reg. No. Name of Product Alrady approved Sites Newly Approve Sites
091876 NIMENRIX Manufacturer: Manufacturer:
Powder and M/s Glaxo smith Kline biologicals SA Rue M/s GlaxoSmithKline
solvent for dei I, Institut 89, B-1330 Rixensart, Biologicals S.A., Parc de
solution for Belgium. la Noire Epine, Rue
injection Secondary Packaging site of Powder and Fleming 20, 1300 Wavre,
(Meningococcal diluent: Belgium.
group A,C,W-135 M/s GlaxoSmithKline Biologicals S.A., Secondary Packaging
and Y Conjugate Parc de la Noire Epine, Rue Fleming 20, and QA Release sites of
Vaccine) 1300 Wavre, Belgium. Powder and diluent:
QA Release site for powder and diluent: M/s Pfizer
M/s Glaxo smith Kline biologicals SA Rue Manufacturing Belgium
dei I, Institut 89, B-1330 Rixensart, NV, Rijksweg 1202870
Belgium. Puurs Belgium
19. Veterinary biological drugs applied by M/s Agriprom Pakistan (Pvt.) Ltd Lahore
deferred in 258th meeting of Registration board:
Following products of M/s Agriprom Pakistan (Pvt.) Ltd were discussed in various
meetings of Registration Board. Details are as under:
1. Name of Importer M/s Agriprom Pakistan (Pvt.) Ltd 1st Floor, Plot No.19-B,
Off Abdul Sattar Edhi Road, Near Qazalbash Chowk. District
Lahore.
DSL details Copy of valid DSL no. 05-352-0066-032258D valid upto 02-5-
2020
Name of Manufacturer M/s Laboratorios Vencofarma Do Brasil Ltda.
Travessa Dalva de Oliveira, 237,CEP 86030-370, Londrina,
Parana, Brazil
Brand Name +Dosage Form + Supravac 10 – Inactivated Vaccine
Strength
Composition Each dose of 5mL of the product contains:
Infectious Bovine Rhinotracheitis virus – IBR…103,4TCID50
Bovine Parainfluenza Type 3 – PI3…………….103,4TCID50
Bovine Respiratory Syncytial Virus - BRSV…..103TCID50
Inactivated Cytopathic sample Bovine Viral Diarrhea
BVD………………………………………..…..103TCID50
Inactivated Cytopathic sample Bovine Viral Diarrhea BVD
Type 2…………………………………………..103TCID50
Inactivated Non-Cytopathic sample Bovine Viral Diarrhea
BVD……………………………………………103FAID50
Bacterin of Leptospira canicola………………..106germs
Bacterin of Leptospria icterohaemorrhagiae…..106germs
Bacterin of Leptospira pomona………………..106germs
Bacterin of Leptospira grippothyphosa………..106germs
Bacterin of Leptospira hardjo…………………106germs
Bacterin of Leptospira wolffii…………………106germs
Bacterin of Pasteurella haemolytica..................104germs
Finished product As per innovator
specifications
Pharmacological Group Bovine vaccine
Shelf life 24 months (2-8oC)
International Availability of Brazil
this product
Similar Product already NA
Dy No & Date of application, Dy. No.136 dated 10-03-2016
Fee submitted Rs. 100000/-
09-03-2016
Demanded Price/ Pack size Decontrolled
General documentation Legalized GMP No.21034.012679/2017-19 dated 01-02-2018
Legalized Free Sale Certificate valid till 10-06-2023
Decision of Registration Deferred for submission of original legalized documents:
Board in 258th meeting. 1. CoPP/ FSC along with GMP.
2. Sole agency agreement
Decision of Registration Registration Board deferred the case for clarification regarding
Board in 285th meeting. the product becoming unsafe in very beginning months during
accelerated stability studies.
Remarks of Evaluator 1. The firm has submitted
(Khurram Khalid AD) a. Legalized GMP
b. Free Sale Certificate
c. Sole agency agreement
2. Accelerated stability data submitted by the firm shows that
at accelerated temperature the product is unsafe in very
beginning months. Now the firm has submitted additional
data of 90 days for accelerated study which shows that the
product is safe till 60th day and then become unsafe.
Decision: Keeping in view valid legalized GMP and FSC; Registration Board
approved the product subject to compliance of current Import Policy for Finished Drugs.
Lahore.
2020
Parana, Brazil
Brand Name +Dosage Form + Excell 10- vaccine
Strength
Composition Each dose of the product contains:
Clostridium chauvoei Bacterin……….at least 10-3 DL50/dose
Clostridium sordellii toxoid ɑ…….….at least 20 U.I/dose
Toxoid of Clostridium novyi Type B, toxoid ɑ......at least 20
U.I/dose
Toxoid of Clostridium septicum, toxoid ɑ.......at least 20
U.I/dose
Toxoid of Clostridium perfringens B, toxin ß and ɛ.......at least
10 U.I/dose
Toxoid of Clostridium perfringens C, toxin ß........at least 10
U.I/dose
Toxoid of Clostridium perfringens D, toxin ɛ.........at least 10
U.I/dose
Toxoid of Clostridium tetani..........at least 15 U.I/dose
Toxoid of Clostridium botulinum C……….at least 5 U.I/dose
Toxoid of Clostridium botulinum D……….at least 2000
U.I/dose
specifications
Shelf life 24 months (2-8oC)
International Availability of Brazil
this product
Similar Product already NA
Dy No & Date of application, Dy. No.137 dated 10-03-2016
Fee submitted Rs. 100,000/- 09-03-2016
Demanded Price/ Pack size Decontrolled
Free Sale Certificate No. 010/2017-PR validity 18-02-2028
c. Sole agency agreement
Lahore.
2020
Parana, Brazil
Brand Name +Dosage Form + Freeze-Dried Vaccine against Bovine Brucellosis- Brucella
Strength abortis live strain 19
Suspension
Composition Each dose of 2mL contains:
Brucella abortusculture strain B19 standardized….60 a 120 x
109 UFC.
Lyophilized Stabilization Solution:
Casein Digest…………………at least 2,5 x 10-5g
Sodium glutamate…………….at least 1 x 10-5g
Glucose……………………….at least 5 x 10-5g
Diluent:
Sterile buffered saline…q.s.f…2mL
specifications
Pharmacological Group Bovine vaccine
International Availability of Brazil and Paraguay
this product
Similar Product already BOVISHOT BRUCEL VACCINE by M/s TAROBINA
registered in Pakistan CORPORATION, LAHORE
Dy No & Date of application, R&I Dy. No.135 dated 10-03-2016.
Demanded Price/ Pack size Decontrolled/
Legalized Free Sale Certificate valid till 12-06-2021
Decision of Registration Registration Board deferred the case for clarification regarding
Board in 285th meeting. the product becoming unsafe in very beginning months during
accelerated stability studies.
c. Sole agency agreement.
2. Accelerated stability data submitted by the firm shows that
at accelerated temperature the product is unsafe in very
beginning months.
Now the firm has submitted additional data of 90 days for
accelerated study which shows that the product is safe till
75th day and then become unsafe.
20. Application for Change of Address of M/s Forward Solutions for already
registered products;
M/s Forward Solutions, Lahore has applied for change of address of their already
registered products and requested as under;
“We have changed our address from Plot No.66-West Wood Colony Thokar Niaz Baig,
Lahore to Plot No.19/B off Abdul Sattar Eidhi Road near Qazalbash Chowk, Lahore, Phone
No.042 35232901 against which we have received our Drug Sales license for products as
follows:
Sr. No. Product Name Registration No. Renewal
1. EDS OLVAC 077559 NA*
2. BIO-VAC LS H120 077560 NA
3. AI-OLVAC H9 077561 NA
4. BIO-VAC ND IB 084168 NA
5. BIO-VAC SGP 695 083351 NA
6. IBA VAC 084169 NA
7. BIO-VAC LASOTA 084167 NA
*Renewal application of above mentioned products is not applicable as the said duration (5 years) has
not been completed yet.
Address (Old DSL) Address (New DSL)

Plot No. 66-West Wood Colony, Thokar Niaz Plot No.19-B Off Abdul Sattar Edhi Road near
Baig, Lahore. Qazalbash Chowk, Lahore
The firm has submitted following documents;

i. Fee of Rs. 5000/- for each product.
ii. Copy of registration letter of above-mentioned products.
Decision: Keeping in view the valid Drug Sale License, Registration Board
approved the change in address of importer of above products from M/s
Forward Solutions, Plot No. 66-West Wood Colony, Thokar Niaz Baig,
Lahore to M/s Forward Solutions, Plot No.19-B Off Abdul Sattar Edhi
Road near Qazalbash Chowk, Lahore subject to storage facility
verification of new address.
21. Regulatory requirement for Enoxaparin for local manufacturers.

Registration Board in its 281st meeting held 11th to 13th April 2018 decided following
regulatory requirement regarding import applications of enoxaparin;
“Registration Board deliberated the matter in detail and decided that for registration of
Enoxaparins the applicants will provide following documents along with Form-5A:
i. The physical and chemical characteristics of enoxaparin.
ii. The nature of the heparin material and the chemical process used to break up heparin
chains into smaller pieces.
iii. The nature and arrangement of components that constitute enoxaparin.
iv. Certain laboratory measurements of the product’s anticoagulant activity.”
It is submitted that Registration Board in its 278th meeting has decided to adopt certain
guidelines as regulatory requirements for the registration of rDNA therapeutic proteins for
finished form importers as well as local manufacturer. While for enoxaparin, guidelines only
for finished importers were adopted. As biological drug division is receiving applications
from local manufacturer as well, so, in this regard the Registration Board is requested to set
guidelines as regulatory requirements for the registration for local manufacturer.
Decision: Registration Board referred the case to Expert working group on

Biological Drugs constituted in 273rd meeting of Registration Board.
22. Application for registration of Eritrogen (Erythropoietin) 2000IU PFS (M/s BF
Biosciences Ltd., Lahore)
Name of Brand Name, Type of Form, Dy. No & Documentary details (CoPP etc.)
Manufacturer Composition, date of application, Fee Reference agencies status,
Pharmacological group, status, Packing Me too
Shelf life &demanded MRP
M/s BF Eritrogen 2000IU Form-5 DML No. 000655 dated 30-01-
Biosciences Ltd., Each prefilled syringe 134/2014(R&I) 2014
5km- Sunder (1ml) contains: 09-05-2014 GMP certificate No. 20132021-
Raiwind Road, Recombinant Human Rs. 20000 000 013-18 dated 019-04-2018
Raiwind, Lahore Erythropoietin 07-05-2014 of M/s ZELLTEK S.A, Ruta
alpha........2000IU Pack of 6’s (PFS) Nacional No 168 S/N, Pasaje “EI
Price: Pozo’, ParqueTecologicoLitoral ,
Mitosis stimulating As per SRO of the Province of Santa Fe, of
factor & differentiating the Argentine Republic valid for
hormone 01 year.
Eprex of Janssen-Cilag Ltd., UK
Shelf Life: 24 months Sepo 2000IU/ml PFS by Al-
Karim Distributors, Karachi.
Eritrogen 4000IU Form-5 DML No. 000655 dated 30-01-
Each prefilled syringe 135/2014(R&I) 2014
(1ml) contains: 09-05-2014 GMP certificate No. 20132021-
Recombinant Human Rs. 20000 000 013-18 dated 019-04-2018
Erythropoietin 07-05-2014 of M/s ZELLTEK S.A, Ruta
alpha........4000IU Pack of 6’s (PFS) Nacional No 168 S/N, Pasaje “EI
hormone 01 year.
Shelf Life: 24 months Eprex of Janssen-Cilag Ltd., UK
Sepo 2000IU/ml PFS by Al-
Eritrogen 10000IU Form-5 ` DML No. 000655 dated 30-01-
Each prefilled syringe 136/2014(R&I) 2014
(1ml) contains: 09-05-2014 GMP certificate No. 20132021-
Recombinant Human Rs. 20000 000 013-18 dated 019-04-2018
Erythropoietin 07-05-2014 of M/s ZELLTEK S.A, Ruta
alpha.......10000IU Pack of 6’s (PFS) Nacional No 168 S/N, Pasaje “EI
hormone 01 year.
Eritrogen 10000IU Form-5 DML No. 000655 dated 30-01-
Each vial (1ml) 682/2014(R&I) 2014
contains: 13-06-2014 GMP certificate No. 20132021-
Recombinant Human Rs. 20000 11-06-2014 000 013-18 dated 019-04-2018
Erythropoietin Pack of 6’s (Vials) of M/s ZELLTEK S.A, Ruta
alpha.......10000IU Price: Nacional No 168 S/N, Pasaje “EI
As per SRO Pozo’, ParqueTecologicoLitoral ,
Mitosis stimulating of the Province of Santa Fe, of
hormone 01 year.
Case history:
The products were approved in 273rd meeting of Registration Board held on 28-29th August
2017. The data provided by the firm was in light of 246th meeting of Registration Board at
that time. The case was again taken in 276th meeting of Registration Board wherein the board
decided as under;
“Registration Board deferred the matter of issuance of registration letter till the
recommendations of working group for local manufacturing of Biological drugs”
Working group for local manufacturing ofBiological drugs recommended certain regulatory
requirements which were adoptedas guidelines for the registration of rDNA therapeutic
proteins by the Registration Board in its 278th meeting.
Now the firm has submitted data in light of decision made by the Registration Board in its
278th meeting. Detail is summarized as under;
The firm has submitted the documents/data in the light of regulatory guideline for biological products
approved in 278th meeting of Registration Board as per following details:
Documents required as per 278th ii. RB Documents submitted by firm

decision for Biological Drugs (Concentrated
Form/Ready to fill Form)
The firms shall provide legalized GMP Copy of GMP certificate No. 20132021-000 013-18 dated
certificate of biological drug substance 019-04-2018 of M/s ZELLTEK S.A, Ruta Nacional No 168
manufacturer abroad (who will provide S/N, Pasaje “EI Pozo’, ParqueTecologicoLitoral , of the
concentrate / ready to fill bulk of biological Province of Santa Fe, of the Argentine Republic valid for 01
drug to Pakistani manufacturers for further year.
processing) as an evidence that the (Not legalized)
manufacturer is an authorized manufacturer of
biological drug in the country of origin.
The firms shall provide legalized free sale Copy of Authorization Certificate by ANMAT (National
certificate/CoPP either from country of origin Administration of Medicines, Food and Medical
or by any reference regulatory authority as Technology) which include following products;
adopted by Registration Board of finished Eritrogen 2000IU, 4000IU & 10000 prefilled syringes.
product as evidence that the final product has i. The certificate do not show free sale of product in
been manufactured by same concentrate/ready country of origin.
to fill bulk after submission of data to the ii. Manufacturer site address is different
concerned regulatory authority. iii. Not legalized.
The firm shall provide the complete Bio- Details are included below
similarity studies of the finished product of
same source (bulk concentrate or ready to fill)
manufactured either from country of origin or
by any reference regulatory authority as
adopted by Registration Board to demonstrate
the bio-similarity.
The firm shall provide the lot release certificate Lot release certificate of the finished product manufactured
of the finished product manufactured by same by same bulk concentrate/ ready to fill from country of
bulk concentrate/ ready to fill from country of export (Not applicable).
export (If applicable).
The firm shall provide the 6 months Not provided
accelerated and real time stability studies for
drug substance.
The local manufacturer shall manufacture three The firm has submitted stability study data and CoA wherein
trial batches of the finished biological product the tests conducted are as under;
to finalize the formulation and then perform  Appearance
analytical studies(Physicochemical and  Leak test
biological) including protein content,  pH
appearance, pH, Osmolarity, composition of  Extractable volume
key excipients including stabilizers (if  Immuno characterization
formulation is same), visible/subvisible  Potency
particles, identity testing to parent molecule,  Sterility
purity testing, in vitro biological activity,  Bacterial endotoxins
sterility, Pyrogen content, safety, potency and  Particulate matter.
toxicity with support of iso-electro focusing  Sialic acid content
data, gel electrophoresis, Western-Blot and  Protein concentration
other analytical techniques). The firm shall
 Peptide mapping
submit the results for processing of registration
application.  Identification (by SDS page)
 Isoforms content
 Dimers and related proteins of higher molecular
mass
The manufacturer shall perform all tests locally Certificate of analysis of finished product is not provided
as detailed on Certificate of analysis. from country of origin. The firm has provided its own
certificate of analysis.
The firm shall also provide the list of finished The firm has submitted the list indicating following products
products being manufactured from same bulk from bulk of same source;
concentrate or ready to fill form in any country Hemastim: Mauritani, Ivory Cost, Ecuador, Gabon, Mali,
of the world (if available). Congo republic.
Alvoetin: Myanmar
Acromax: Ecuador
The firm shall provide the agreement with the Provided
source (of bulk concentrate/ready to fill) that if
there shall be any critical change in
manufacturing process, biological systems
used to manufacture, etc. the firm shall inform
DRAP immediately along with relevant
documents.
Regular monitoring through Post marketing surveillance system.
pharmacovigilance reporting system shall be Recall system
observed through proper pharmacovigilance
cell of the manufacturer and report will be
forwarded to the National Pharmacovigilance
Centre, Division of Pharmacy Services and
Biological Division of DRAP. In case of any
severe adverse event, immediate mandatory
reporting procedure shall be followed.
The firm shall inform DRAP if there shall be Provided the undertaking and agreement with manufacturer
any adverse event or ADR reporting from the of concentrate/ready to fill bulk.
country of manufacture of concentrate/ready to
fill bulk and finished product as required vide
Rules 30 of Drug (LR&A) Rule.
Bio-similarity studies of the finished product of same source (bulk concentrate or ready to fill)
manufactured from country of origin.
WHO Bio-similarity Data submitted by the firm
guidelines
Quality Comparison Under Eludication of structure of API, comparative analysis with 2 batches of
Physicochemical Procrit 4000IU of Janssen Products, LP is provided by M/s ZELLTEK S.A,
characterization Argentine Republic.
i. Mass of C-terminal peptide
ii. Mass of N-terminal peptide
iii. Molecular mass of native protein
iv. Identification by RP-HPLC
v. Content of EPO
vi. Determination of Impurities by Western Blot
vii. Bacterial Endotoxins
viii. Stability under stress conditions- Temperature
ix. Stability under stress conditions- pH
x. Determination of sequence of aminoacids
xi. Integrity of Disulfide Bond
xii. Percentual content of isoforms
xiii. Profile of native N-glycans
xiv. Occupation of the site of O-glycosylation
Biological Activity Biological activity in vivo
Immunochemical Immunoidentification (Western Blot)
properties
Impurities Determination of Impurities by Western Blot
Stability Studies Stability studies are provided.
Non-clinical Studies i. In Vivo primary Pharmacodynamic Study:
ii. In Vitro primary Pharmacodynamic Study:
iii. Pharmacokinetics in Wister rats
iv. Toxicity & immunogenicity and local tolerance after repeated dose in Wister
rats
Clinical Studies i. Reports of human pharmacokinetics and initial tolerability study.
ii. Reports of human pharmadynamics.
iii. Report of comparative pilot study between two recombinant human
erythropoitins, in the treatment of anemia associated to chronic kidney disease
in patients in chronic haemodylasis.
Remarks of i. Stability data of drug substance is not provided.
Evaluator: ii. CoA of finished products from country of origin is not provided.
iii. GMP is not legalized.
iv. Copy of Authorization Certificate by ANMAT (National Administration of
Medicines, Food and Medical Technology) which include following products;
Hemastim 2000IU, 4000IU & 10000 prefilled syringes.
a) The certificate do not show free sale of product in country of origin.
Not legalized.
Decision: Registration Board deferred the product for submission of following by the firm:
a. Valid legalized CoPP/ FSC.
b. Accelerated stability data of drug substance.
c. Certificate of Analysis (CoA) of Eritrogen 10000IU vial from country of origin.
23. Proposal for Amendment in Current Import Policy Order, 2016.

The current Import Policy Order, 2016 for import of vaccine from India is as under:
“Import of vaccines shall be allowed only from World Health Organization
(WHO) approved plants”
Biological division comments on current import policy order 2016 as under:
NRA of India is WHO prequalified for the last three years. Therefore, if the
product has lot released certificate of their designated laboratories the product
should be allowed. Further WHO prequalified products are only those which
the manufacturer wants to sell to UNDP projects, therefore the Import Policy
is to be revised.
In the light of above, it is proposed for the amendment of import policy to facilitate import of
vaccines & other lifesaving biologicals.

“Registration Board referred the case to Legal Affairs Division for their opinion on
the following:
 Vaccines imported from India which were registered before the import policy
order 2016 and are not WHO Prequalified.
 Does Import Policy Order bar the import of such vaccines from India or not?
 Can DRB reconsider registration of such vaccines for de-registration as the
circumstance in which the drug was registered no longer exists? “
Opinion of Legal Affairs Division:
“This division is opined that as per Import Policy Order, 2016, ‘Import of vaccines
shall be allowed only from World Health Organization (WHO) approved plants.” The import
of such vaccines in the instant case which are not prequalified from WHO shall not be
imported. The Import Policy Order, 2016 bars the import of such vaccine. If any vaccine
which was not prequalified from WHO and imported before the ibid policy, the same shall be
reconsidered by the DRB for de-registration according to section 7(11)(b) of the Drug Act,
1976 as the circumstance in which drug was registered no longer exists”
Decision: Registration Board deferred the case and advised DBER to come up with
complete data of registered vaccines imported from India which are not
WHO Pre qualified along with their alternate brands available in the
market.
24. Information cases of M/s Forward Solutions, Lahore.

Following products approved in 284th meeting show slight differences in composition as per
following details
Sr. Brand Name & Composition mentioned in Brand Name & Composition as per CoPP
No. Minutes of 284th meeting of RB
1. Clostrivax Clostrivax
(Suspension for Injection) (Suspension for Injection)
Each dose contains: Each 3mL dose contains:

Inactivated culture of Clostridium Inactivated culture of Clostridium
chauvoei…..not less than 30IU chauvoei…..not less than 30 I.U.
Inactivated culture of Clostridium novyi B Inactivated culture of Clostridium novyi B
…..not less than 7.5IU …..not less than 7.5 I.U.
Inactivated culture of Clostridium novyi Inactivated culture of Clostridium novyi
D…..not less than 7.5IU D…...not less than 7.5 I.U.
Toxoid of Clostridium novyi B: to induce a Toxoid of Clostridium novyi B: to induce a
serological response…..not less than 3.5IU per serological response …..not less than 3.5
millimeter of serum I.U per milliliter of serum
Toxoid of Clostridium novyi D: to induce a Toxoid of Clostridium novyi D: to induce a
serological response …..not less than 10 IU per serological response …..not less than 10 I.U
millimeter of serum per milliliter of serum
Toxoid β of Clostridium perfrigens: to induce a Toxoid β of Clostridium perfrigens: to
serological response …..not less than 10 IU per induce a serological response …..not less
millimeter of serum than 10 I.U per milliliter of serum
Toxoid ɛ of Clostridium perfrigens: to induce a Toxoid ɛ of Clostridium perfrigens: to
serological response …..not less than 10 IU per induce a serological response …..not less
millimeter of serum than 5 I.U per milliliter of serum
Toxoid of Clostridium septicum: to induce a Toxoid of Clostridium septicum: to induce a
serological response …..not less than 2.5 IU per serological response …..not less than 2.5
Toxoid of Clostridium tetani: to induce a Toxoid of Clostridium tetani: to induce a
serological response …..not less than 2.5 IU per serological response …..not less than 2.5
2. Bovax IBR Bovax IBR

(Injectable Suspension) (Injectable Suspension)
Each dose contains: Each 5mL dose contains:

Inactivated cultures of Infectious Bovine Inactivated cultures of Infectious Bovine
Rhinotracheitis (IBR)...2.107TCID50 Rhinotracheitis (IBR) virus...2.107 TCID50
To induce a medium serological neutralizing to induce a medium serological neutralizing
titre ≥ 10 in the cavy. titre ≥ 10 in the cavy.
25. Information cases of M/s Forward Solutions, Lahore
Following product of M/s Forward Solutions, Lahore was approved in 274th
Registration Board meeting held on 21-23rd September 2017;
Sr. Name of Brand Name & Pack Size Decision of 274th
No. manufacturer composition meeting of RB
1. Product License Set-Vac 1000 dose Registration Board
Holder: (Injectable Emulsion) bottle approved the product
M/s FATRO S.p.A, (500ml) as per valid legalized
Via Emilia, 285- Each dose contains: CoPP subject to
40064 Ozzano Emilia Inactivated culture of compliance of current
(Bologna) Italy. S.enteritidis…… Import Policy for
………….109CFU finished drugs.
Manufacturer: Inactivated culture of
M/s FATRO S.p.A, S.typhimurium...
in Via Molino Emili, …...........109CFU
2-25030
Maclodio(BS) Italy. Shelf Life: 24 months
During processing the case, it was observed that the approved pack size is not mentioned in
CoPP. For this, the firm was asked to clarify for which the firm replied anddemanded 10 x
250 ml polypropylene vial (5000 dose). Accordingly, registration letter has been issued
mentioning the latest desired pack size.
26. Information case of M/s Amson Vaccines and Pharma (Pvt.) Ltd;
Following product applied by M/s Amson Vaccines and Pharma (Pvt.) Ltd., Rawalpindi has
been approved in 284th meeting of Registration Board held on 31st July & 1st August
2018,and registration letter has been issued with name and composition as per CoPP. Detail is
as under;
Sr. Name and Composition as per Name and Composition as per CoPP
No approved minutes
1. Bivalent type 1 & 3 poliomyelitis Bivalent type 1 & 3 Oral Poliomyelitis
vaccine IP (boPV 1 & 3) Vaccine IP (boPV 1 & 3) (Live bivalent,
2mL (20 doses) vial MgCl2 stabilised)
Each dose of 2 drops (0.1ml) contains: Each dose of 2 drops (0.1mL) contains:
Poliovirus (Sabin) P.M.K.C.C: Poliovirus (Sabin) P.M.K.C.C:
Type 1……………106 CCID50 Type 1……………106 CCID50
Type 3……………105.8 CCID50 Type 3……………105.8 CCID50
27. Post registration variation of Basaglar Prefilled KwikPen applied by M/s Eli
Lilly Pakistan (Private) Limited Karachi:
M/s Eli Lilly Pakistan (Private) Limited Karachi has submitted document regarding post
registration variation for Basaglar 100IU/mL KwikPen and requested as under;
“The current Basaglar prefilled KwikPenallows the patient to inject a maximum dose of
60 units per single injection. By this letter we would like to inform you about a change in
the disposable prefilled KwikPen of above product which will allow the pen to deliver a
maximum of 80 units instead of 60 units. We confirm that there are no changes in the
drug substance/molecule and its quantity. We also confirm that there are no changes in
the formulation, specification and manufacturing process. The only change is the
mechanism of KwikPen to accommodate the additional 20 units, the Kwikpen remain
unchanged. The relevant updated technical modules are included.”
Post registration variation letter has been issued as per following details;
Reg. Name & Product Pack Size Existing upper limit Approved
No. Composition of maximum dose of upper limit of
measuring device maximum dose
of measuring
device
089813 Basaglar 5's x 3ml in 60 units 80 units
Solution for injection in prefilled
prefilled pen (Kwikpen) pen
(Kwikpens)
Each ml contains:
Insulin Glargine……100 units
USP Specifications
Annex-I
REVISED SAGE RECOMMENDATION ON USE OF DENGUE VACCINE
19 April 2018
WHO published the recommendations of the Strategic Advisory Group of Experts on Immunization
(SAGE) on the use of Dengvaxia® on 27 May 2016, and subsequently a WHO position paper on
dengue vaccine on 29 July 2016.
Following the disclosure of new data on Dengvaxia® by its manufacturer, Sanofi Pasteur, on 29
November 2017 (as described in more detail below), WHO`s Global Advisory Committee on Vaccine
Safety (GACVS) and the WHO Secretariat published interim statements on December 7, 2017 1, and
December 22, 20172, respectively. WHO initiated a process engaging independent external experts to
review the data in detail, and reconvened the SAGE working group on dengue vaccines. This process
has led to revised recommendations from SAGE on 18 April 2018. An updated WHO position paper
on dengue vaccine will be published in September 2018.
The purpose of this document is to supplement the WHO ”Question and Answer” document from
December December 22, 20172.
Dengue is the most frequent and rapidly spreading mosquito-borne virus. The first dengue vaccine,
CYD-TDV (Dengvaxia®) is currently licensed in twenty countries. The key findings from two large
Phase 3 trials involving over 30,000 participants aged 2 to 16 years included:
 Vaccine efficacy against virologically confirmed dengue, over a 25-month period from the
first dose of a three-dose immunization regimen among 9-16 year olds was 65.6% and in this
age-group, vaccination reduced severe dengue by 93% and dengue hospitalizations by 82%.
 An increased risk of hospitalized dengue was seen in the 2 to 5-year age group in Year 3 of
follow-up.
 At the time of SAGE April 2016 meeting, this increased risk was not observed in those aged 9
years and above.
Because of the higher efficacy of the vaccine against dengue and the absence of an observed increased
risk of hospitalized dengue observed in older children, licensure of the vaccine was sought in 2015
with an indication of 9 years and above. Mathematical modelling suggested that the public health
benefits of vaccination could be maximized if dengue seropositivity in the age group targeted for
vaccination was high.
WHO issued its position on the use of CYD-TDV in July 2016 based on recommendations provided
by SAGE in April 2016, principally, that countries interested in introducing the vaccine consider its
use only in those aged 9 years and above, and in areas with a seroprevalence of ≥70%, and not in
areas below 50%. SAGE noted that the evidence of the absence of a safety issue in seronegative
individuals aged 9 and above was based on the limited data set of 10%-20% of the trial population,
and highlighted the urgent need to better describe the long-term benefit-risk ratio of CYD-TDV in
seronegative individuals.
On 29 November 2017, Sanofi Pasteur announced the results of additional studies to better describe
the benefit-risk in seronegative individuals. This was made possible through the use of a newly
developed NS1-based antibody assay applied to blood samples taken 13 months after vaccination to
retrospectively infer dengue serostatus at time of first vaccination.
The new analyses from the long-term safety follow-up indicated that:
 Overall population level benefit of vaccination remains favorable, but the vaccine performs
differently in seropositive versus seronegative individuals.
 Vaccine efficacy (VE) against virologically confirmed symptomatic dengue was high among
inferred baseline seropositive participants ≥9 years of age: 76% (95%CI: 63.9, to 84.0), but
much lower among baseline seronegative participants: 38.8% (95%CI: –0.9 to 62.9%) in the
first 25 months after the first dose of vaccine.
 There is an increased risk of hospitalized and severe dengue in seronegative individuals
starting about 30 months after the first dose.
 In areas of 70% dengue seroprevalence, over a 5-year follow-up, for every 4 severe cases
prevented in seropositive, there would be one excess severe case in seronegative per 1,000
vaccinees; for every 13 hospitalizations prevented in seropositive vaccinees, there would be 1
excess hospitalization in seronegative vaccinees per 1,000 vaccinees.
In light of the new evidence on the long-term safety issue in seronegative individuals, balanced
against the documented efficacy and safety in seropositive individuals, SAGE carefully considered
two strategies: population seroprevalence criteria versus pre-vaccination screening. SAGE weighed up
the feasibility of population seroprevalence studies and individual pre-vaccination screening,
heterogeneity of seroprevalence between and within countries, potential vaccine coverage rates,
public confidence in national vaccination programmes, perceptions of ethical considerations with
regard to population level benefit versus individual level risk, and communication issues.
SAGE acknowledged that currently both “population seroprevalence criteria” and “pre-vaccination
screening” are programmatically difficult approaches for achieving high population protection from
dengue.
Updated SAGE recommendations on the use of CYD-TDV (Dengvaxia®)
For countries considering vaccination as part of their dengue control program, a “pre-vaccination
screening strategy” would be the preferred option, in which only dengue-seropositive persons are
vaccinated.
Conventional serological testing for dengue virus IgG (e.g. dengue IgG ELISA) could be used to
identify persons who have had previous dengue infections. Sensitivity and specificity of dengue IgG
ELISA should be assessed in a local context, and will depend on the prevalence of other flaviviruses,
and past use of flavivirus vaccines (such as Japanese encephalitis and yellow fever vaccines).
Currently available rapid diagnostic tests - despite their lower sensitivity and specificity to detect past
dengue infection compared with conventional dengue IgG ELISA - could be considered in high
transmission settings until better tests are available. In settings with high dengue transmission (high
numbers of seropositives), a test with lower specificity might be acceptable.
The pre-test probability of an individual being seropositive will be higher in settings with high
transmission. However, a pre-vaccination screening strategy may also be considered in low to
moderate transmission settings. In settings with low transmission (high numbers of seronegatives) a
test with high specificity is needed.
Given that no assay will be 100% specific, some truly seronegative individuals may be vaccinated due
to a false positive test result. Furthermore, although the efficacy against dengue infections in
seropositive individuals is high, it is still not complete. Hence, the limitations of CYD-TDV will need
to be clearly communicated to populations offered vaccination.
There is a continued need to adhere to other disease preventive measures and to seek prompt medical
care in the event of dengue-like symptoms, regardless of whether vaccinated or not. Vaccination
should be considered as part of an integrated dengue prevention and control strategy together with
well-executed and sustained vector control and the best evidence-based clinical care for all patients
with dengue.
Decisions about implementing a “pre-vaccination screening” strategy with the currently available tests
will require careful assessment at the country level, including consideration of the sensitivity and
specificity of available tests and of local priorities, dengue epidemiology, country-specific dengue
hospitalization rates, and affordability of both CYD-TDV and screening tests.
Age
Whether there are age-specific effects, independent of serostatus, is the subject of ongoing research.
Currently, the vaccine should be used within the indicated age range, which is typically 9 to 45 years
of age. The age to target for vaccination depends on the dengue transmission intensity in a given
country, and will be lower in countries with high transmission, and higher in countries with low
transmission. The optimal age group to be targeted is the age at which severe dengue disease
incidence is highest, and this can be ascertained from national and subnational routine hospital
surveillance data.
Schedule
In the absence of data on vaccine efficacy and safety with fewer than three doses, CYD-TDV is
recommended as a three dose series given 6 months apart. Should a vaccine dose be delayed for any
reason, it is not necessary to restart the course and the next dose in the series should be administered.
Booster
There are currently no data on the use of booster doses. Additional studies to determine the utility of a
booster dose and its best timing are under way. Accordingly, there is no current recommendation for a
booster dose.
Research priorities
Development of a highly sensitive and specific rapid diagnostic test to determine serostatus, and
assessment of simplified immunization schedules and booster needs should be prioritized.
The full report of the SAGE April 2018 meeting will be published in the WHO Weekly
Epidemiological Record on Friday, 8 June 2018.
Item No. VI: QA & LT Division:
Sr. Subject Status

no.
01 MANUFACTURE & SALE OF COUNTERFEIT DRUG Personal hearing.
PYODON SOLUTION 7.5% W/V BATCH NO.PY-126.
REG. NO. 071551 MANUFACTURED BY M/S PARADISE
PHARMA, LAHORE.
02 MANUFACTURE & SALE OF SUB-STANDARD DRUG Personal hearing.
MUFLEX SYRUP BATCH NO. 014, BY M/S KAIZEN
PHARMACEUTICALS, (PVT) LTD, KARACHI.
03 MANUFACTURING AND SALE OF SUBSTANDARD Personal hearing.
INJECTION HEPAFERON (INTERFERON) B.NO. 85 BY
M/S PHARMEDIC LAB, LAHORE.
04 MANUFACTURE & SALE OF SUB-STANDARD DRUG N/A
ZEBOXIL 500MG CAPSULES BATCH NO. 614C01 REG.
NO. 031010 MANUFACTURED BY M/S MEDICAIDS
PAKISTAN (PVT) LTD. KARACHI.
05 CASE REFERRED BY PQCB LAHORE REGARDING N/A
SUBSTANDARD LOSARA-P 50 MG TABLETS BATCH
NO. 9E-100 MANUFACTURED BY M/S ANEEB
PHARMACEUTICALS, LAHORE.
06 CASE REFERRED BY PQCB LAHORE REGARDING N/A
SUBSTANDARD ALENSTRAN 10 MG TABLET BATCH
NO. F-T-940 MANUFACTURED BY M/S
FARMACEUTICS INTERNATIONAL KARACHI
07 MANUFACTURE & SALE OF SUB-STANDARD N/A
RAYLOX (LEVOFLOXACIN 250MG) TABLETS BATCH
NO. A002 BY M/S RAY PHARMA (PVT) LTD. KARACHI
08 MANUFACTURE & SALE OF SUB-STANDARD TERRA- Personal hearing.
ROK-M 20% INJECTION BATCH NO. TKI043 BY M/S
MANHATTAN PHARMA, KARACHI.
09 CASE REFERRED BY PQCB PUNJAB REGARDING SUB- Personal hearing.

STANDARD MERONIDE TABLET 400MG
MANUFACTURED BY M/S IRZA PHARMA (PVT) LTD
SHEIKHUPURA ROAD, LAHORE.
10 MANUFACTURE & SALE OF ADULTERATED & SUB- N/A
STANDARD “OXYTOCIN INJECTION (FOR
VETONLY)”BATCH NO. 2876 MANUFACTURED BY
M/S. ELKO ORGANIZATION PVT, LTD, KARACHI.
11 MANUFACTURE & SALE OF SUB-STANDARD Personal hearing

PENTIUM TABLET 40MG BATCH NO. 31,
MANUFACTURED BY M/S SHROOQ
PHARMACEUTICAL, LAHORE.
12 PARTIAL WITHDRAWAL OF PERMISSION – EARLIER N/A
GRANTED FOR ORDER NOT TO DISPOSE OF BY THE
CHAIRMAN DRB– RECALL OF FREEZE-DRIED
HUMAN RABIES VACCINEMANUFACTURED BY
CHANGCHUN CHANSHENG BIOTECHNOLOGY CO.,
LTD. (NO. 60 OF 2018).
Case No.01:
MANUFACTURE & SALE OF COUNTERFEIT DRUG PYODON SOLUTION
7.5% W/VBATCH NO.PY-126. REG. NO. 071551 MANUFACTURED BY
M/SPARADISE PHARMA, LAHORE.
Federal Inspector of Drug-II-Karachi visited the premises of M/s Trend Pharma, situated at
Shop 10, Marvi Centre, MR-1/132, Katchi Gali no. 1 Marriot road, Karachi on 30th October, 2017.
2. The sample of pyodon solution 7.5 % w/v, batch no. PY-126 manufactured by M/s Paradise
Pharma, 23-km, Sheikhupura Road, Lahore was taken for the purpose of test/ analysis on prescribed
form 3. The CDL Karachi has declared the above sample counterfeit under section 3 (f) of the Drugs
Act, 1976 vide its test report no. R.KQ.608/2017 dated 20th December, 2017.
3. M/s Paradise Pharma Lahore was asked to provide the names of responsible persons who
involved in manufacturing of counterfeit drug by the FID Karachi. M/s Paradise Pharma Lahore did
not provide the names of responsible persons till to date. In this regard, the FID Karachi requested that
names of responsible persons may be obtained from Licensing Division.
4. It is submitted that Division of Licensing DRAP has provided the names of technical and
management staff vide letter no. 1-4/2009-Lic (Vol-I) dated 2nd August, 2018. The names are as
under:
Management as per Form-1A and partnership deed dated 15-12-2008.
i. Mr. Tariq Mahmood.
ii. Mr. Muhammad Sheraz Khan.
iii. Mr. Muhammad Shahzad khan.
Production Incharge as per appointment letter and approval letter.
i. Muhammad Ali S/o Muhammad Jamal Nasir.
Quality Control Incharge as per approval letter and Form-1A
i. Mr. Muhammad Sajid Manzoor S/o Hafiz Manzoor Hussain.
5. The FID Karachi submitted that M/s Paradise Pharma, Lahore has been found to have
contravened the provisions of Schedule II A(1) (a) (ii) of DRAP Act, 2012 read with Section 23(1) (a)
(ii) of the Drugs Act, 1976 and the rules made there under.
6. M/s Paradise Pharma Lahore has submitted its reply in response to show cause notice issued
by QA & LT, DRAP.
Proceeding and Decision:.

Mr. Muhammad Sheraz Khan, Director, Paradise Pharma Sheikhupura Road, Lahore
appeared on behalf of M/s Paradise Pharma to plead instant case of counterfeit drug
pyodon solution 7.5 % w/v before the Board in its 286th meeting on 16th November,
2018.The Board after hearing the accused deliberated the matter in depth in the light of
available record/ investigation report of FID decided as under:
1. The firm will process case for change in color scheme and brand name of the
product in question and inform the Board.
2. Registration will remain suspended till the submission of change in brand name
application and color scheme till its approval by the Division of PE&R.
3. The area Federal Inspectors of Drugs shall ensure the implementation of
decision in its true letter and spirit.
Case No.02:
Manufacture & Sale of Sub-Standard Drug Muflex Syrup Batch No. 014, by M/s
Kaizen Pharmaceuticals, (pvt) Ltd, Karachi.
The FID-VII Karachi visited the premises of M/s Kaizen Pharmaceuticals (pvt.) Ltd., plot No. E-127,
E-128, E-129, North Industrial Zone, Bin Qasim, Karachi on 01-08-2017 and taken following sample
U/S 18(1) (c) of the Drugs Act, 1976 for the purpose of test/analysis on prescribed Form-3:
Name: Muflex Syrup

composition Each 5ml contains 100 mg Carbocisteine
Registration No: 073899
Batch No: 014
Manufacturing Date: April, 2016
Expiry Date: April, 2018
Manufactured By: M/s Kaizen Pharmaceuticals (pvt.) Ltd, Karachi
2. The area FID, Karachi has forwarded one sealed portion of sample to Central Drugs
Laboratory, Karachi vide memorandum no. DMT-09-To-15/2017-FID-VII (K) dated 02-08-2018 as
required under Section 19(3)(i) of the Drugs Act, 1976.
3. The area FID, Karachi has also forwarded one sealed portion of sample as Board’s Portion
vide letter no. DMT-09/2017-To-15/2017-FID-VII (K) dated 02-08-2018 as required under Section
19(3)(ii) of the Drugs Act, 1976.
4. The Federal Government Analyst, CDL, Karachi declared the sample as of sub-standard
quality vide test/analysis report No. KQ. 400/2017, dated 29th September, 2017.
5. The area FID, Karachi vide letter no. DMT-15/17-FID-VII (DRAP) dated 05-10-2017 has
asked the M/s Kaizen Pharmaceuticals (pvt.) Ltd., plot No. E-127, E-128, E-129, North Industrial
Zone, Bin Qasim, Karachi to explain their position.
6. M/s Kaizen Pharmaceuticals (pvt.) Ltd., plot No. E-127, E-128, E-129, North Industrial
Zone, Bin Qasim, Karachi submitted reply vide letter dated 10-10-2017 and requested for retesting of
sample by appellate laboratory – NIH, Islamabad.
7. On the request of the firm, sample was sent for the appellate testing from Appellate
laboratory, NIH, Islamabad dated 17th November, 2017 under section 22(5) of the Drugs Act, 1976
after seeking due approval from the Chairman, Registration Board (in exercise of delegated power of
Registration Board in it 283rd Meeting held on 27 to 29th June, 2018) as required U/S 22(5) of the
Drugs Act, 1976.
8. The Appellate Laboratory – NIH, Islamabad vide their test report No. 020-M/2017 dated 08-
12-2017, has also declared the sample as of sub-standard quality. The comparison of the CDL report
and NIH test report of the said sample is as under:
S.No Test performed CDL report No. NIH report No.
KQ.400/2017 020-M/2017
01 Description Complies Does not comply
02 pH Complies Does not comply
03 Weight per milliliter Did not perform Does not comply
04 Identification of Carbocistein Complies Complies
05 Assay of Carbocistein Does not comply Complies
9. The Federal Inspector of Drugs VII, Karachi has directed the M/s Kaizen Pharmaceuticals
(pvt.) Ltd., plot No.E-127, E-128, E-129, North Industrial Zone, Bin Qasim, Karachi vide letter no.
DMT.2-1/2018-FID-VII dated 02-02-2018 as FID-VII, Karachi to disclose information including
names of responsible persons for violating the Section 23(1)(a)(v) of the Drugs Act, 1976, but the
firm didn’t provided the names of responsible persons.
10. The Division of Drugs Licensing, DRAP Islamabad was requested vide letter no. 3-56/2017-
QC dated 16-02-2018 to provide the names of owner of the firm and its technical staff.
11. The Division of Drug Licensing, DRAP Islamabad vide their letter no. 2-5/2009-Lic. (Vol-I)
dated 31-07-2018 submitted the names of technical staff/management of the firm for April, 2016
which is as under:
S No. Name Designation CNIC
1 Mr. Naushad Muhammad Director 42301-0257390-3
2 Ms. Ghazala Naushad Director 42301-10952595-8
3 Mr. Haji Muhammad Arif Production Incharge 42201-0246587-9
4 Mr. Sheikh Muhammad Quality Control Incharge 42101-1370486-7
Amir
12. Show cause notice have been issued to the technical staff/management of the firm –
responsible persons U/S 7(11) of the Drugs Act, 1976 vide letter no. 3-57/2017-(QC) dated 29-08-
2018.
13. In response to the show cause issued, vide letter no. 3-57/2017-(QC) dated 29-08-2018, M/s
Kaizen Pharmaceuticals (Pvt.) Ltd has submitted their reply vide letter no. NIL dated 06-09-2018
wherein, they have shown serious concerns regarding the reports of NIH and CDL and also requested
to give a chance to discuss the matter in person with the DRAP, by firm’s representative.
Proceeding and Decision:

Mr. Fahim Lakhani, Plant Manager, M/s Kaizen Pharmaceuticals (Pvt.) Ltd., plot No.E-127, E-
128, E-129, North Industrial Zone, Bin Qasim, Karachi appeared on behalf of M/s M/s Kaizen
Pharmaceuticals (Pvt.) Ltd., Karachi to plead instant case of Substandard drug Muflex Syrup
before the Board in its 286th meeting on 16th November, 2018.The Board after hearing the
accused deliberated the matter in depth in the light of available record/ investigation report of
FID decided as under:
1. Submission of product development data by the firm.
2. Suspend the registration of the product in question till submission of the product
development data by the firm and verification of same by Product Specific Inspection by
the following panel of inspectors:
 Dr.Rafeeq Alam Khan (Member, Registration Board)
 Area Federal Inspector of Drugs
Case No.03:
Manufacturing and sale of substandard injection Hepaferon (Interferon) B. no. 85
by M/s Pharmedic lab, Lahore.
The brief of the case for consideration of the Registration Board

Background of the case
The background of the case is that the Registration Board in its 248th meeting held on 18th-19th March,
2015 discussed the case of supply of sub-standard Hepaferon Injection (Interferon) to Government of
Khyber Pakhtunkhwa Batch No.80-87. The Federal Inspector of Drugs (FID) Peshawar was directed
by the Registration Board to submit the certified copies of decisions of Drug Court Peshawar and
Peshawar High Court, Peshawar in the instant case. The FID has submitted the copies of the orders
the Peshawar High Court, Peshawar and the copies of decision of Drug Court Khyber Pakhtunkhwa,
Peshawar The Board after thorough deliberations and in the light of decisions of the Courts and view
point of the member from the M/o Law Justice and Human Rights decided the case as under:-
“Registration Board was briefed about the background of the case. Sheikh Sarfraz Ahmad,
representative from Ministry of Law was of the view that after the decision of the Drug Court
Peshawar a fresh reference requires to be sent to Law Division for seeking opinion. The Board
agreed to the proposal”.
Decision:
The Drugs Registration Board decided that the opinion of Law Division may be solicited in the
light of decision of the Drug Court, Khyber Pakhtunkhwa, and Peshawar which are self
explanatory in which the Honorable Drug Court ordered that the complaint of the prosecution is
dismissed.
Decision of the 254th Meeting of the Registration Board.
Report was being prepared both by the Federal Inspector of Drugs and Provincial Drug Inspector for
submission the Honorable Court. When the investigation was under process by FID and Provincial
Drug Inspector completed his investigation is submitted before the Court on the basis of report
submitted by Provincial Drug Inspector the court acquitted the accused Later when the report of FID
was completed, the time for filing appeal had also lapsed.
In this case Federal Drug Inspector should have intervened through Peshawar High Court for stopping
the drug court from announcing its decision till the time the report of Federal Inspector of Drug was
completed this was must done.
Presently the accused stand acquainted and Board cannot ensure notice to the accused on the here of
report of FID because the accused stand accqumtted by the Court
The Law division has decided to consult additional Attorney General DAG for filling application
before the court for already condonation of delay in order to file an appeal.
The Board has decided to consult the DAG through Legal Affairs Division of DRAP for filing
application on condo nation of delay The decision was communicated to Deputy Director Legal
Affairs on 22nd August 2016.
The Federal Inspector of Drugs (FID) Peshawar was directed by the Registration Board to submit the
certified copies of decisions of Drug Court Peshawar and Peshawar High Court, Peshawar in the
instant case. The FID has submitted the copies of the orders the Peshawar High Court, Peshawar and
the copies of decision of Drug Court Khyber Pakhtunkhwa, Peshawar The Board after thorough
deliberations and in the light of decisions of the Courts and view point of the member from the M/o
Law Justice and Human Rights decided the case as under:-
“Registration Board was briefed about the background of the case. Sheikh Sarfraz Ahmad,
representative from Ministry of Law was of the view that after the decision of the Drug Court
Peshawar a fresh reference requires to be sent to Law Division for seeking opinion. The Board
agreed to the proposal”.
The Drugs Registration Board decided that the opinion of Law Division may be solicited in the light
of decision of the Drug Court, Khyber Pakhtunkhwa, and Peshawar which are self explanatory in
which the Honorable Drug Court ordered that the complaint of the prosecution is dismissed.
Keeping in view of the decision of the Drug Court Khyber Pakhtunkhwa, Peshawar the M/o Law
Justice and Human Rights is requested to furnish view/ comments as whether the responsibility fixed
by Federal Inspector of Drugs, Peshawar under Section 23(1)(a)(v)(vii) and 23(1)(a)(vii), 23(1)(b)(f)
of Drugs Act, 1976 for prosecution (Annex-IV) may be set aside after the decision of the Drug Court
Khyber Pakhtunkhwa, Peshawar or otherwise.
As per reference para 433/N FID Peshawar informed that he sent 02 letters to DAG office Peshawar
on 05th August and 25th August 2016 but no reply receive from DAG office Peshawar then on 30th
August 2016. The FID mentioned that he personally went to DAG office Peshawar High court
Peshawar Mr. Manzoor Khan Khalil Senior DAG Peshawar High Court. The DAG informed the FID
Peshawar that they cannot give any opinion/comments on the case relevant case.
The FID Peshawar further informed that the DAG also directed him to submit an application to Law
Division Islamabad for legal opinion and when Law Division Islamabad shall refer the subject case to
DAG office Peshawar High Court then they will look into the subject matter and give legal
opinion/comments.
The Federal Inspector of Drug Peshawar forwarded the FR to Director QA, DRAP Islamabad wherein
the FID submitted the details of the instant case which are as under:
The case of Hepaferon (Interferon) manufactured by Pharmadic Lahore has been devided into three
phases/parts as under:-
1. Part/phase 1.
On 01/04/2013 on the Telephonic direction of DDC (QC) (QA) the FID visited Chief
Drugs Inspector Khyber Pakhtunkhwa Mr. Sabir Ali to get initial information about the case which
was communicated to DRAP Islamabad on 26.04.2014 vide letter No.F.3-20/2013-FID-DRAP-119
after getting the initial and unsigned substandard report from provincial govt. the FID issued a letter to
Chief Executive Pharmedic Lab. Lahore and asked to provide the following information vide this
officer letter No.F.3-20/2013-FID-DRAP 868 dated 08-04-2013 and reminder and in reference to
telephonic direction from Director Biological directed the FID to get the status and storage condition
of the Hepaferon lying in LRH Car parking premises the detailed report submitted to Director
Biological DRAP Islamabad vide this office letter No. F.3-20/2013-FID-DRAP-1288 dated 25-04-
2013 desiring detailed information about the case the FID and in reference to Director Biological
Drugs letter No.F-1/-4/2013 dated 25-04-2013 desiring detailed information about the case the FID
submitted a detailed report about the preceding of sampling by provincial drugs inspector and report
submitted by Director DTL and by anticorruption from unknown Laboratory submitted to Director
Biological vide this office letter No. F.3-20/2013-FID DRAP-1288 dated 08-05-2013. Under direction
of Chief Justice High Court Peshawar the Director General Health Services requested DRAP
Islamabad to conduct sampling from the stock of Interferon lying in the premises of LRH Peshawar.
The Director General Health Services issued a letter on 02-08-2013 vide office letter No. S.O
(Drugs)/H/2-43/2013-Re-examination to Director Federal Govt. Analyst National Control Laboratory
for Biological Islamabad and in response DG Health Services KPK letter the DRAP Islamabad issued
a letter to the FID to take sample of Hepaferon Inj. Mfg and supplied by Pharmadic Lahore from
LRH and from the stores the stock lying in the company M/s Pharmadic Lahore premises vide letter
No. F.3-15/2013-QC dated 19th August 2013
The FID vide DRAP Islamabad letter No. F.3-15/2013-QC dated 31-005-2013 coordination with
Director General Health office and Director Anticorruption office to send their representative as
witness during sampling on 15-08-2013 and reminder issued on 24-06-2013 vide this office letter
No.F.3-20/2013-FID-DRAP-1674. The FID along with representative of DG Health and Director Anti
Corruption office drawn samples from three containers on Form-3 on 15-08-2013 from the stock of
Interferon (Hepaferon) Injections of the available batches of Batch No. 80,82,85 and 87 lying at
different temperature of 4.7 C 35 and 38 C and sent to govt. Analyst Biological NCLB on Form 4
dated 15-08-2013 summary of storage condition and samples submitted to Director Biological
National Laboratory Islamabad vide this office letter No.F.No.3-20/2013-FID-DRAP dated 15-08-
2013. Sampling received by Director Biological Islamabad on16-08-2013 copies of Form3 and Form-
4 and detail report of storage condition submitted to Director Biological and DG Health Services KPK
and DDC (QC) Islamabad for Information.
On 27-08-2013 vide this office letter No. F.3-20/2013-FID-DCA (P)2134 a detail report about
sampling and storage condition submitted to Director General Health Services for information
On 26-08-2013 manufacture portion sent to Manager (QC) M/s Pharmadic Lab Lahore
On 22-10-2013 the office receive all the test report of Interferon from NCLB from B.No.80-87 stock
lying in three containers at the basement car parking of LRH hospital Peshawar which are as under :-
S.No. Name of Drug B.No. and Test Report No. Results/Remarks
Temperature & date
01. Hepaferon Injection 3 80(+38 C) FS-2013/17 Substandard
MIU (Interferon Alpha 14-10-2013
2a)
02. do 81(4.7 C) FS-2013/13 Substandard
14-10-2013
03. do 82(+38 C) FS-2013/13 Substandard
14-10-2013
14-10-2013
14-10-2013
14-10-2013
14-10-2013
08. do 85(35C) FS-2013/13 Substandard
14-10-2013
14-10-2013
On 22-10-2014 copies of attested tests reports were submitted to DG Health KPK Peshawar Chief
Executive officer DRAP Islamabad Director Anti Corruption Peshawar and Director Pharmadic Lab
Lahore with direction to stop sale and recall all the stock from the market.
On 30-10-2013 after receiving the substandard tests reports of Hepaferon (Interferon) from batch
No.81-87 the FID visited the storage area of Hepaferon at LRH Car Parking and took the details of
stock by physical checking/counting batch wise quantity manufacturing and expiry date recorded on
Form-I and ordered under section 18(1) of the Drugs Act 1976 requiring a person not to dispose of
stock in his position and sign taken from the store keeper of cold chain system kept in three container
at LRH under safe custody of Rehmatullah Khan Sahibzada Khan Barkat Ali Cold Chain operators
and Mr. Mohammad Ibrahim Cold Chain supervisor Signature taken on Form-I from all the
responsible persons mentioned above.
In reference to the substandard report show cause issued to Chief Exeutive M/s Pharmadic Lahore
vide this office letter No.F.10-77-85/2013-LRH-DRAP-2651 dated 28-10-2013 and directed the firm
to recall the stock of the said drug from the market and from your distributer outlets under intimation
to this office and also directed to provide the sale record batch History and names of Directors and
technical staff in QA and production with NIC No.
Another letter No.F.10-77-85/201-LRH-DRAP 2951 dated 29th November 2013 issued to DG Health
Services KPK Peshawar with direction not to use these substandard drugs Hepaferon (Injection)
B.No.80-87 kept in three container at LRH car parking and inform the same to all field DHQs offices
and Health centers not to use the same batch no. whereas available.
On 12.3.2014 a letter issued to Chief Executive M/s Pharmadic Lahore to provide the name of
Director/Chief Executive with NIC copy Name of Production Incharge Name of QC Incharge valid
copy of DML issued by DRAP Islamabad The same letter was sent to DDG (E&M) Lahore vide this
office letter of even No. dated 12-03-2014 with request to ensure the compliance of this letter through
your area FID.
The reply of the firm was received vide their letter No. Ref.No.PH/LHR/18225 dated 28-03-204 in
which they have provided all the required information name of director/chief executive name of
production Incharge QC Incharge along with copies of CNIC and valid copy of DML
Another reply of the firm was communicated to this office by area FID Lahore on 25-112013 vide
firm letter No.RefPh/LRH/18062 dated November 02, 2013 in which the firm blames the Director
Health for not maintaining the temperature of the cold storage rooms of the 3 containers lying at LRH
car Parking but did not provide the undertaking about the storage condition between the firm and DG
Health Services KPK who was responsible to maintain the storage condition 2-8 C
In light of above mentioned storage condition and substandard test report received form govt. analyst
NCL Biological Islamabad the firm has violated section 23 of Drugs Act 1976 therefore the Director
Itikhar Ahmad Sheikh CNIC No.35202-0328994-9 production Incharge Mazhar Hussainan Quality
control Incharge Mr. Asim Mehmood of the firm as mentioned above may please be prosecuted in
Drugs Court alongwith Director program Hepatitis KPK Dr. Ghulam Subhani store keeper Mr.
Mubarak shah may please be nominated as co accused in the case due to negligence or intentionally
the storage condition was not maintained from 2-8 C nor tested after purchase and gave huge loss to
public money The FID ordered to stop the use of hepaferon on Form-I under section 18(1) of Drugs
Act 1976 due to particle and not maintaining the storage condition of the 3 containers lying/kept in the
premises of LRH Hospital by KPK Govt.
Part 2.
On the other hand interferon Injection Batch Nos. 87 and 88 sampling conducted from DHQ Hospital
Mardan on 23-12-2013 on Form-3 and samples sent to the Director National Biological Islamabad on
24-12-2013 and test reports received from National Institute Biological Islamabad with standard
Quality vide Test report No.FS2013/31 and 32 dated 22-02-2014 with the remarks The sample is of
standard quality with regards to tests performed however being a biological product this sample report
is not applicable to whole lot or some other portion of the same lot stored elsewhere under different
storage conditions which needs clarification by the govt analyst NCL Biological because when any
sample is drawn from any stock/premises in random it covers the whole stock but the remarks of govt.
analyst is doubtful needs clarifications The same repot communicated to DDC (QC) DRAP Islamabad
and copy to DG Health KPK and Director M/s Pharmadic Lahore on 20-03-2014 and letter issued to
Director NCL for Biological/Govt. Analyst for clarification Reply is still awaited
During sampling of Hepaferon Injection (Interferon Alpha 2A 3MIU/ml batch No. 87 and 88 storage
condition was found maintained between 2-8C
However on further scrutiny of the record of DHQ Mardan following fact were revealed
1. The hospital was supplied 180.000 vial of Hepaferon vials in 2011 as per receipt No. Nil
dated 22-04-2011. The receipt did not indicate any batch No..
2. However as per statement of store keeper MS DHQ Mardan the stock was returned to M/s
Pharmadic for keeping in their cold storage facilities on behalf of hospital then the hospital
make arrangement for its own appropriate storage facilities.
3. An undertaking by M/s Pharmadic Lab Dated 22-04-2014 was also found in the record to
that effect that the firm will supply the balanced interferon as and when required by DHQ
Mardan
4. A receipt dated 26-05-2012 issued by M/s Pharmadic indicate the 180,000 vials interferon
was received by M/s Pharmadic Lab Lahore
5. A delivery Challan D.C No.3 dated 26-02-2011 issued by M/s Pharmadic indicate that DHQ
Mardan was supplying 180,000 Hepaferon Injection Batch No.87 and 88
6. Lot release certificate of Batch No. 87 and 88 is enclosed
In view of above documents/ statement obtained from record of DHQ Hospital Mardan there appeared
to be a number of Locumas which create doubts on the whole process of receipt and return of stock by
DHQ Mardan.
Some documents received from the store Keeper given to Anti Corruption during investigation copies
stock of 180,000 vials on dated 26th May 2012 and another letter of undertaking issued by pharmedic
on 22-04-2011 regarding 180,000 vials letter received by the office of the Medical superintendent
DHQ Hospital Mardan by Aurangzeb store Incharge dated 22-04-2011
Statement of MS Dr. Nigar Ahmed DHQ Hospital Mardan dated 03-06-2013 given to Anti Corruption
Circle Peshawar In which he states that store Keeper informed him about the arrival of Hepaferon and
with the directive of Director Hepatitis on telephone we received the stock and on the direction of
Project Director Hepatitis as per the statement of store keeper Mr. Aurangzeb the stock was received
and retuned back to M/s Pharmadic Lahore for keeping at their cold storage until the DHQ Mardan
will not arrange their own cold storage facilities as per stamen of store keeper Mr. Aurangzaib DHQ
Mardan.
Part 3
On the request of Director Hepatitis Program KPK and the DRAP Islamabad issued direction to Fid
Lahore to take samples from the stock of KPK Government lying with M/s Pharmedic Lahore custody
quantity is 837894 vide letter No.4186/PHCP dated 13-01-2014
In continuation to DRAP letter direction Mr. Ajmal sohail area FID Lahore and Dr. Akbar Ali area
ADC Lahore visited the premises of M/s Pharmedic Lahore an checked the stock of Hepaferon of the
stock of KPK government and it was observed that all the stock of interferon of B.No. 81, 82, 88, 89,
90, 91, 92, 93, 94 and 95 was found kept at room temperature. Therefore the panel could not take
samples for test analysis as the storage condition was not maintained under section 18(I) of the Drug
Act 1976 requiring a person not to dispose of the stock in his possession on Form-I and required the
concerned authority to grant permission for extension in not to dispose of period under clause (i) of
subsection (I) of the section 18 of the Drug Act 1976 for 3 months or till the decision
The FID submitted that they are also sending complete suo Moto judgment copies of Honorable High
Court Peshawar for information and necessary action attached with this letter.
Keeping in view all the facts and correspondence and substandard tests reports issued by Govt.
analyst NCL Biological Islamabad the following persons may please be included in prosecution under
section 23(1)(a)(v)(vii) and 23(1)(a)(vii) and 23 (1) (b) (f) violation of cold chain storage condition
who are directly or indirectly involved
Accused
i. Mr. Iftikhar Ahmed Shiekh, Director/C.E.O
ii. Mr. MazharHussain, Production Incharge.
iii. Mr. AsimMehmood, Quality Control Inchage
Co Accused
i. Dr. GhulamSubhani Director Hapatitis Program (Co-accused)
ii. Mubarik Shah, Store Keeper LRH Hapatitis Program (Co-accused)
iii. Dr. Nigar Ahmed, Ms DHQ Mardan
iv. Mr. Aurengzaib, Store Incharge, DHQ Mardan (Co-accused)
v. Dr. Chuhan Director (Co-accused),
vi. Dr. Sharif, Director (Co-accused)
Witness
1. Mr. Abdul Samad Khan Director/ Federal Govt.analyst NCL for Biological Islamabad.
2. Mr. Rehmatullah Baig Alvi, FID, Peshawar.
3. Mr. Adnan Shaidullah ADC Peshawar.

4. Mr. Ajmal Sohail Asif area FID Lahore.
5. Dr. Akbar Ali area ADC Lahore.
6. Dr. Haroon Director Hepatitis Programme, KPK.
7. Mr. Khawaja Mohammad Kahn sub inspector then anti corruption Peshawar.
8. Mr. Zahid Ali Khan Pharmacist Government KPK MCC Director office.
9. Mr. Zakir Drugs Inspector Peshawar.
10. Mr. Tayyab Abbas Drugs Inspector Peshawar.
Proceeding and decision of 279th meeting of DRB:
The Board decided to issue the show cause notice and personal hearing to the accused persons of the
firm responsible for manufacturing and selling of substandard interferon injection, as the purchaser
had purchased the injection under the warranty issued by the manufacturer. Hence, they are protected
under section 32 of The Drugs Act, 1976.
Proceeding and decision of 284th meeting of DRB:
The board deferred the case till the next meeting of Registration Board.
Mr. Syed Anees Ur Rehman Kirmani (Manager Regulatory Affairs) of M/s Pharmedic
Laboratories (Pvt.) Ltd., Lahore and Shahid, Advocate (35200-1420583-9) appeared on behalf
of M/s Pharmedic Laboratories (Pvt.) Ltd., Lahore to plead instant case of Substandard
Hepaferon Injection (Interferon) drug before the Board in its 286th meeting on 16th November,
2018. The Board decided to defer the case keeping in view of the request of the firm for detailed
show cause notice to the accused persons and to come up in the upcoming meeting of
Registration Board.”
Case No.04
Manufacture & Sale of Sub-Standard Drug Zeboxil 500mg Capsules Batch No.
614C01 Reg. No. 031010 manufactured by M/S Medicaids Pakistan (Pvt) Ltd.
Karachi.
The Federal Inspector of Drugs FID-I, Karachi, on 22-06-2016, drew samples of Zeboxil 500
mg Capsule Batch No. 614C01, manufactured by M/s Medicaids Pakistan (Pvt) Ltd, Karachi from
manufacturer’s premises for test/analysis. The samples were declared substandard by the F.G Analyst
vide Test Report No.KQ.239/2016 dated 19-08-2016. The remarks of Government Analyst, CDL,
Karachi are as under:-
Dissolution Test Result:
Stage-1
Capsule No. (%)age
01. 56.475
02. 129.109
03. 86.87
04 87.19
05. 37.27
06. 76.259
Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 80+5=85%
Stage-2
Capsule No. (%)age
01. 102.139
02. 51.631
03. 104.704
04 79.049
05. 105.346
06. 65.741
Average of 12 units= 981.783/12=81.815%

Limits for (Stage-2):- Average of 12 units (S1+S2) is equal to or greater than Q (80%) and no
unit is less than Q-15% (80-15=65%)
Limits for (stage-3):- Average of 24 units (S1+S2+S3) is equal to or greater than Q (80%). Not more
than 2 Units are less than Q-15 (80-15=65%) & no units is less than Q-25% (80-25=55%)
Since, 01 capsule is already below 55% therefore, the sample does not comply with USP 37.
Remarks: - The sample is of “Sub-Standard” quality under the Drugs Act 1976.
In response to FID explanation letter the firm did not agree with the CDL’s test report and has
pointed out that the test report of CDL suffers from patent faults, errors and obvious deviations from
the prescribed method of testing given in USP for Cefadroxil Capsule. But the firm did not request for
re-testing by the Appellate Laboratory as per Section 22(5) of Drugs Act 1976 within prescribed time
period.
As per procedure show cause notices were issued to the firm on 10-01-2017 as recommended
by the FID-I Karachi, and accused persons, offering opportunity of personal hearing before the Drug
Registration Board.
The firm has submitted its reply in response to Show Cause notice on 23-01-2017. They
submitted that they detected and observed three basic, crucial and vital flaws and errors in such report
which tended to invalidate and nullify the same and the declaration of substandard declared on such
flawed test report.
They highlighted the following three errors which are as follows;
1. Use of paddle instead of dissolution basket;
2. Absorbance shown at 363nm instead of 263nm; and,
3. Vessel operated at speed of 50 rpm instead of 100 rpm.
The firm did not agree with the CDL test report and want to appear for personal hearing
before Registration Board.
They were called for personal hearing in 274th Meeting of RB, but no person appeared before the
Board.
Decision of the 274th Meeting of Registration Board:
The Board decided to defer the case and give last opportunity of personal hearing to the firm in the
next meeting of Registration Board.
278th Meeting of Registration Board held on 29th, 30th & 31st January 2018:
The accused persons were again called for personal hearing but no person appeared before the Board
due to delayed dispatch of personal hearing letter.
The Board decided to defer the case and give last opportunity of personal hearing to the firm in the
next meeting of Registration Board.
279th Meeting of Registration Board:
They have been called for personal hearing.
The legal expert Mr. Idrees appeared before the Board in its 279th meeting and pleaded the case.
The Registration Board after detailed discussion decided as under:-
I. To suspend the Registration for six months or till the verification of root cause
analysis report and corrective and preventive action by the firm and by the firm
whichever is later.
II. The PSI will be conducted after the submission of above mentioned report by the firm
for physical verification by the panel, constituted by the Board including the
following members:-
 Additional Director, DRAP, Karachi.
 Director, DTL, Karachi.
 Area FID, Karachi.
Proceeding of the 286th Meeting of Registration Board:
The panel constituted by the Board in its 279th meeting held on 28th February, 2018 to 2nd March,
2018 has forwarded the report of product specific inspection (PSI) of M/s Medicaids Pakistan (Pvt)
Ltd, Karachi vide letter No. F. 03-04/2018-DRAP (K) dated 20th August, 2018. Conclusion of PSI
report is as under:-
“Keeping in view the people met, documents reviewed including manufacturing, Quality control and
Quality assurance and ware house record and finding of the inspection, the firm is found complying
GMP as of today. The manufacturing of the product in question was found satisfactory and in
accordance with the SOP’s. Testing of the product Cap. Zeboxil 500mg was also according to the
USP and found satisfactory. The product was declared substandard due to non-compliance to
dissolution test i.e. less than 55% instead of not less than 80% (Q) of the labeled amount (as per USP
limits). Firm has changed the source of empty hard gelatin capsules shell from Ningbo Zhourui
Import & Export China to M/s Gelcaps, Hub Balochistan that may be the possible reason of the out of
specification results”.
Based on the above facts panel recommends the recommencement of the manufacturing of Zeboxil
500mg capsule, after necessary approval from the Drug Registration Board, DRAP, Islamabad.”
The case was presented before the Registration Board in its 286th meeting on 16th
November, 2018 and the Board after perusing the record/ document of the instant case
deliberated the matter in depth and decided that the firm shall submit product
development data of new studies for consideration of the Board.”
Case No:05.
CASE REFERRED BY PQCB LAHORE REGARDING SUBSTANDARD
LOSARA-P 50 MG TABLETS BATCH NO. 9E-100 MANUFACTURED BY
M/S ANEEB PHARMACEUTICALS, LAHORE.
The Secretary, PQCB, Punjab vide letter no. PQCB R-521-09/2009 dated 31-7-2018, which
are about order of PQCB for Tehsil Rahim Yar Khan stating the proceeding and decision of PQCB
regarding Sub-standard Losara-P tablets batch no. 9E-100 manufactured by M/s Aneeb
Pharmaceuticals, Lahore, in its 190th meeting held on 31-7-2018.
2. That case states that Provincial Inspector of Drugs, Tehsil Rahim Yar khan reported that:
i. He took the drugs sample tablet Losara-P 50mg batch no. 9E-100 for the purpose of
test/ analysis from the premises of medicine store Sheikh Zaid Medical College Rahim Yar Khan.
ii. The drug sample was declared as sub-standard by Government Analyst Drug Testing
Laboratory Lahore as detailed below:
Name of Batch Name of DTL report DTL test report results
drug no manufacturer TRA no. and
date
Tablet No. M/s Aneeb TRA no. Analysis with specifications:
Losara-P 9E-100 Pharmaceutical, 7925/DTL Manufacturer’s specifications
50mg Lahore Dated: 02-09- Description:
2009 Pink color round coated tablets.
Having rough outer surface with white
patches and have granular appearance
packed in blister. A part of some
tablets remained stick with aluminum
foil on pressing out tablet from blister
Assay: (Losartan Potassium)
Percentage: 97.4%
Result: the sample is sub-standard on
the basis of tests performed.
PREVIOUS PROCEEDINGS AND DECISION BY THE BOARD:

2. The case was considered in 60th meeting of PQCB dated: 30-1-2010. The board decided to
issue warning to the firm with direction to replace the entire substandard stock with fresh stock and
the destruction of substandard stock according to contractual obligations. The board further decided to
constitute a committee comprising of the followings for inspection of the firm to ascertain GMP
compliance and submit the report.
 Professor Dr. Naveed Iqbal Ansari (Member PQCB).
 Professor Dr. MahboobRabbani (Member PQCB).
 Muazzam Ali khan (Chief Drugs Inspector).
3. That the case was again considered by the Provincial Quality Control Board in its 161 st
meeting held on 15-4-17. The board reconstituted the inspection committee comprising of Chief Drug
Controller, Punjab to conduct Specific Inspection along with drug inspectors industries and submit
report to PQCB. The conclusion is as under:
 The panel is of opinion that batch size 9E100 was 2000000 tablets while capacity of
film coating pan was less than batch size (200000/ pan & two pans were available)
so coating was performed in different portions. Coating was also not uniform that
lead to physical deformity.
 The firm is directed to produce batch size of each product according to capacity of
production equipment.
4. The case was again considered by the Provincial Quality Control Board, under Section 11 of
the Drugs Act, 1976 in its 190th meeting held on 31-7-2018. Secretary PQCB informed the board the
subject case had already been disposed of with warning to the firm however report of the inspection
committee was awaited. Chief Drugs Controller Punjab (the inspection committee) presented the
above- mentioned inspection report and apprised the board that coating of tablets was being
performed in multiple cycles due to limited capacity of the coating pans. Resultantly the coating was
not uniform. This nonconformity was the possible reason for physical deformity in tablets as reported
by the Government Analyst vide above- mentioned test/ analysis. The board agreed with the
recommendations/ advice tendered by the inspection panel to the firm to overcome this
nonconformity.
5. The board after due diligence and deliberation on various aspects of the case and detailed
scrutiny of the inspection report unanimously decided to forward the Product Specific Inspection
(PSI) report to the Central Licensing Board (CLB) DRAP Islamabad through Chief Executive Officer
DRAP for information and necessary action as required under law.

deliberated the matter in depth and decided as under:
“to issue the show cause notice and personal hearing to the firm/ responsible
persons as provided by the provincial quality control board (PQCB), Lahore for
manufacturing and selling of substandard Losara-P 50mg tablets, Batch No. 9E-100,
Manufactured by M/s Aneeb Pharmaceutical, Lahore.”
Case No.06:
CASE REFERRED BY PQCB LAHORE REGARDING SUBSTANDARD
ALENSTRAN 10 MG TABLET BATCH NO. f-T-940 MANUFACTURED BY
M/S FARMACEUTICS INTERNATIONAL KARACHI.
The Secretary, PQCB, Punjab vide letter no. PQCB/R 151-04/2016 dated 31-7-2018, which
are about order of PQCB for Tehsil Darya Khan District Bhakkar stating the proceeding and decision
of PQCB regarding Sub-standard Alenstran 10 mg tablet batch no. f-T-940 manufactured by M/s
Farmaceutics International, F1-A3, S.I.T.E Karachi, in its 190th meeting held on 31-7-2018.
2. That case states that Provincial Inspector of Drugs, Tehsil Darya Khan District Bakkhar
reported that:
i. He, on 23-12-2015, inspected the business premises of M/s Yousaf Medical Store
AddaKohawarKalan District Bakkar and took samples of two different types of drugs on Form 4 for
the purpose of test and analysis.
ii. One out of the two drug samples after test/ analysis was declared as sub-standard by
Government Analyst Drug Testing Laboratory Faisalabad as detailed below:
Name of Batch Name of DTL report DTL test report results
drug no manufacturer TRA no. and
date
Tablet f-T- M/s TRA no. Analysis with specifications:
Alenstran 940 Farmaceutics 4222/DTL Manufacturer’s specifications
10 mg International F1- Dated: 15-4-2016 Description:
A3, S.I.T.E, Oblonged, biconvex film coated tablets,
Karachi having line of bisection at one side,
contained in plastic blister of 10 tablets,
packed in unit carton. The blister
contains 8 tablets instead of 10 tablets
moreover do not bear batch no. of the
product on blister.
Assay: (Cetirizine)
Percentage: 96.50%
Limit: 90-110%
Disintegration: Not More Than 30
minutes.
Determined: comply with the
specifications.
Result: the Sample is sub-standard/
misbranded on the basis of tests
performed.
3. That M/s Farmaceutics International, Karachi challenged the DTL report. But the request was
not processed as the sample got expired at that time.
4. That the case was considered by the Provincial Quality Control Board, under section 11 of the
Drugs Act, 1976 in its 175th meeting held on 29-11-2017 and 176th meeting held on 15-12-2017. The
board decided to Conduct Product Inspection by the said panel as under:
Prof. Dr. Mehmood Ahmad (Member PQCB) convener
Mr. Munawar Hayat (Chief Drugs Controller, Punjab (member PQCB) member
5. The conclusion is as under:

“The product tablet Alenstran 10 mg, B. no. f-T-940 was declared sub-standard/
misbranded on physical grounds “blister contains 8 tablets of 10 tablets and batch number
not mentioned on blister”. As per DTL test report assay was 96.5%. The firm is directed,
before starting actual blistering procedure, took specimen samples of blisters and make a
part of batch manufacturing record to verify batch number, manufacturing and expiry
date. The firm is advised to improve quality control checks on the packaging of tablets
(sorting) of blisters before packaging.”
6. The case was again considered by the Provincial Quality Control Board, under Section 11 of
the Drugs Act, 1976 in its 190th meeting held on 31-7-2018. Chief Drugs Controller Punjab (member
of inspection panel) presented the above-mentioned product specific inspection report and apprised
the board regarding major short comings observed during inspection which includes “ In-House
specifications/ methods of test/ analysis of drugs were not validated, Daily calibration of the
instruments such as UV Spectrophotometer, weighing balance and glassware was not being
performed, non-availability of the instruments i.e FTIR and TOC and incorrect schedule for ongoing
stability studies etc. The report was reviewed critically and the board expressed serious concerns over
these short comings/ nonconformities which were critical in nature. The board agreed with the
recommendations/ advice tendered by the inspection panel to the firm.
7. The board after due deliberation on various aspects of the case and detailed scrutiny of the
inspection report and keeping in view the gravity of nonconformities, unanimously decided to refer
the Product Specific Inspection (PSI) report to the Central Licensing Board (CLB) DRAP Islamabad
through Chief Executive Officer DRAP for information and necessary action as required under law.
“to issue the show cause notice and personal hearing to the firm/ responsible
persons as provided by the provincial quality control board (PQCB), Lahore for
manufacturing and selling of substandard Alenstran 10mg tablets, Batch No. f-T-940,
manufactured by M/s Farmaceutics International F1-A3, S.I.T.E, Karachi.”
Case No:07
Manufacture & Sale of Sub-Standard Raylox (levofloxacin 250mg) Tablets Batch
No. A002 By M/S Ray Pharma (Pvt) Ltd. Karachi.
The sample of Raylox Tablet Batch No.A002, Reg. No.053306, manufactured by M/S Ray
Pharma (Pvt) Ltd Karachi, has been declared as Sub-standard. The sample of sub-standard drug was
taken by FID Karachi-II, on 13-05-2016 from manufacturer’s premises for test/analysis. The sample
was declared substandard by Federal Government Analyst vide his test report No.KQ.168/2016, dated
14th July 2016. On explanation letter issued by the FID, M/S Ray Pharma (Pvt) Ltd Karachi has
submitted a reply vide its letter No. Nil, dated Nil, which is self explanatory & has not challenged the
test/analysis report of CDL Karachi. The firm submitted that CDL analyst tested their product keeping
the parameter of RPM of paddle at 50 whereas USP recommends that product should be tested at
75RPM. The wrong parameter of RPM might lead to poor disintegration of tablet and ultimately the
poor solubility and relevant release rate of drug. However they further mentioned that they have taken
measures very seriously and assured that there will be no such issue in future and have requested that
their product can be sampled at any time.
The results of test/analysis of CDL, Karachi are as under:
The FID Karachi-II furnished the names of the responsible persons of the firm as under;
Sr. Tests
Results of Test/Analysis
No. Performed
Determined: All Twelve (12) tablets are below 65% and seven (07) tablets are
Dissolution below 55%.
1.
test Limits: Average of 12 units is equal to or greater than Q (80%) and no unit is less
than Q-15% (80-15=65%). Does not comply with manufacturer’s specifications.
M/s Ray Pharma (Pvt) Ltd. Karachi.
i. Mr. Nadeem Ahmed, Director Marketing
ii. Mr. Ekram Uddin, Production Manager
iii. Mrs. Rizwana Waseem Quality Control Manager
As per procedure show cause notices was issued to the firm and above named accused
persons, offering opportunity of personal hearing before the Drug Registration Board.
In response to show cause notice to the firm dated 04th November 2016 the firm vide its reply
dated 11th November 2016 stated that they want to avail the opportunity of the personal hearing before
the Registration Board.The accused persons of the firm have also been called for personal hearing.
263rd meeting of Registration Board held on 29-30th November 2016

Proceeding:
The representative of the firm appeared before the board and argued that CDL analyst tested the
dissolution of their product at 50rpm whereas according to specifications, the product should be tested
at 75rpm.
Decision:
The Board after detailed discussion, deliberation, considering the facts and legal provisions decided as
under:
“The Board decided to get the product tested from Appellate Laboratory NIH Islamabad as per
specifications.”
Current Status of the case:

As per decision of 263rd meeting of Registration Board the sample was sent to the Appellate Lab NIH
Islamabad for retesting the sample. The Appellate Lab NIH has declared the samples as of
substandard quality vide test report No. 01-M/2017 dated 15th March 2017. The result on the basis of
which the sample has been declared substandard is as under:-
Dissolution Test:
Determined Amount: 57.56%
Limit: Not less than 80% after 30 minutes
(Does not comply with manufacturers specifications)
Tablet No. Absorbance of sample % contents by Formula
1. 0.592 47.44%
2. 0.791 63.38%
3. 0.709 56.81%
4. 0.651 52.16%
5. 0.857 68.66%
6. 0.604 48.39%
Average%= 57.56%
The firm was issued the show cause notice on 21st April 2017, the firm replied the show cause notice
on 28th April 2017 wherein the firm requested to give chance to be heard personally before reaching to
any decision, so that they could explain their position in detail.
The accused persons have been called for personal hearing.
Proceedings & Decision of 270th Meeting:
Mr. Raees on behalf of Quality Control Manager appeared before the Board and pleaded their case.
He explained that they have a compression and hardness issue before but now they have improved
their in process checking facility. The area FID has now picked the samples of different batches of the
same product and sent to CDL Karachi for testing and they have passed all the quality control tests.
Decision:
“The Board after detailed discussion, deliberation, considering the facts and legal provision
decided to suspend the Registration of Raylox (levofloxacin 250mg) Tablets Batch No. A002 By M/S
Ray Pharma (Pvt) Ltd. Karachi for six months and to conduct the PSI by following panel:-
a. Additional Director QA&LT, DRAP, Islamabad.
b. Director DTL, Karachi
c. Area FID Karachi.
Proceeding of the 286th Meeting.
FID-V, Karachi forwarded the said PSI report of M/s Pharma (Pvt.) Ltd. Karachi in reference to letter
No.F.03-29/2016-QC dated 03rd August, 2018 and the conclusion of the report is reproduced as
under:-
“In the light of the meeting with staff, documents review including manufacturing,
testing and ware house record and finding of the inspection, the firm is found non
complying in manufacturing of the said product. However the firm has purchased
new dissolution apparatus and replaced the older one. Based on the facts, it is
recommended that the suspension time for production of tablets Raylox 250mg may
please be extended and the manufacturing in tablet manufacturing section may be
suspended till the up gradation and re-inspection by the panel. ”
Evaluation remarks by the Deputy Director QC-II.

“As per inspection report by the panel for PSI, record showed that product was tested
as per specifications approved by registration Board, however the document record/
log sheet and record of relevant raw calculations was found to be unsatisfactory and
non traceable. Panel concluded that the firm is not complying in manufacture of said
product. So, suspension may be extended till remodeling of section.”

“The registration Board acceded the recommendation of the panel constituted by
the Board who conducted the product specific inspection and extended the suspension
period till the submission of product development data and re-inspection by the panel.”
Case No.08:
Manufacture & Sale of Sub-Standard TERRA-ROK-M 20% Injection Batch No.
TKI043 By M/S Manhattan Pharma, Karachi.
The FID-II Karachi visited the premises of M/s Manhattan Pharma, Plot No. 209/3-B, Sector-
5 Korangi Industrial Area, Karachi on 14-11-2017 and taken following sample U/S 18(1) (c) of the
Drugs Act, 1976 for the purpose of test/analysis on prescribed Form-3:
Name: Terra-Rok-M 20% injection

Composition Each ml contain 200mg Oxytetracycline.
Batch No: TKI043
Manufacturing Date: Sep. 17
Expiry Date: Use within Two Years
Manufactured By: M/s Manhattan Pharma, Plot No. 209/3-B, Sector-5
Korangi Industrial Area,
Karachi
2. The area FID, Karachi has forwarded one sealed portion of sample to Central Drugs
Laboratory, Karachi vide memorandum No.MK-226-234/2017-FID-II (K) dated 14-11-2017 as
required under Section 19(3) (i) of the Drugs Act, 1976.
3. The area FID, Karachi has also forwarded one sealed portion of sample as Board’s Portion
vide letter No.MK-226-234/2017-FID-II (K) dated 14-11-2017 as required under Section 19(3)(ii) of
the Drugs Act, 1976.
4. The Federal Government Analyst, CDL, Karachi declared the sample as of sub-standard
quality vide test/analysis report No. KQ. 625/2017, dated 01st January, 2018.
5. The area FID, Karachi vide letter No.MK-226-234/2017-FID-II (K) dated 04th January,
2018 has asked the M/s Manhattan Pharma, Plot No. 209/3-B, Sector-5 Korangi Industrial Area,
Karachi to explain their position.
6. M/s Manhattan Pharma, Plot No. 209/3-B, Sector-5 Korangi Industrial Area, Karachi
submitted reply vide letter number nil dated 16th January, 2018 and requested for retesting of sample
by appellate laboratory – NIH, Islamabad U/S 22 (4) of the Drugs Act, 1976.
laboratory, NIH, Islamabad dated 01-03-2018 under section under section 22(5) of the Drugs Act,
1976 after seeking due approval from the Chairman, Registration Board (in exercise of delegated
power of Registration Board in it 283rd Meeting held on 27 to 29th June, 2018) as required U/S 22(5)
of the Drugs Act, 1976.
04-2018, has also declared the sample as of sub-standard and misbranded quality. The comparison
of the CDL report and NIH test report of the said sample is as under:
S.No Test performed CDL report No. NIH report No.
KQ.625/2017 06-M/2018
01 Description Does not comply with Does not comply with official
Manufacturer pharmacopeia
Specifications
02 pH Complies Complies.
03 Volume Did not perform Does not comply with volume stated
on the label.
04 Identification of Oxytetracycline Oxytetracycline Identified.
Oxytetracycline identified
05 Assay of Oxytetracycline Complies Complies with USP 39.
Sterility test Complies Complies with USP 39
Bacterial Endotoxin test Complies with USP 39
9. The Federal Inspector of Drugs II, Karachi vide reference No.MK-226-234/2017-FID-II (K)
dated 29-05-2018 has forwarded the names of responsible persons involved in violation of sections 23
(1) (a) (iii) and 23 (1) (a) (v) of the Drugs Act 1976. Details are as follows:
S.No. Name Designation CNIC
1 Syed Ibnul Hassan Director/Partner 42201-6212683-9
Hashmi
2 Mrs. Naeema Production Incharge 42201-7115658-4
Khatoon
3 Miss. Rabia Q/A Pharmacist 41304-1223752-2
Suleman
10. The Division of Drugs Licensing, DRAP Islamabad was requested to verify the names of
responsible personsfor the period of September, 2017 and provided the following details of the
responsible persons/technical staff as per available record.
S.No. Name Designation
1 Syed Muhammad Shakeel Director
2 Aqeel Hashmi Director
3 Syed Ibnul Hassan Hashmi Director
4 Mrs. Naeema Khatoon Production Incharge
5 Syed Ibnul Hassan Q/C Incharge
12. Show cause notice has been issued to the technical staff/management of the firm – responsible
persons U/S 7(11) of the Drugs Act, 1976 vide letter No. 03-03/2018-(QC) dated 08th October, 2018.
13. M/s Manhattan Pharma provided their statement and clarification in response to the show
cause notice issued to them vide reference No.03-03/2018-QC dated 08th October, 2018 and requested
to consider the cause of change in description as just mild deviation from the description stated and
this change did not affect the efficacy of the product nor any adverse drug reaction has been reported
for this veterinary drug. However they assure to take every measure to stop this “out of the
specification” error to happen again.
Mr. Syed Ibnul Hasan Hashmi, Partner, M/s Manhattan Pharma, Plot No. 209/3-B,
Sector-5 Korangi Industrial Area, Karachi appeared on behalf of M/s Manhattan
Pharma, Karachi plead instant case of Substandard drug Terra-Rok-M 20% injection,
Batch No. TKI043 before the Board in its 286th meeting on 16th November, 2018.The
Board after hearing the accused deliberated the matter in depth in the light of available
record/ investigation report of FID decided as under:
1. The firm will perform the Root Cause Analysis and inform the Board
accordingly.
development data by the firm and verification of same by Product Specific
Inspection by the following panel of inspectors:
 Dr.Rafeeq Alam Khan (Member, Registration Board)
Case No.09:
CASE REFERRED BY PQCB PUNJAB REGARDING SUB-STANDARD
MERONIDE TABLET 400MG MANUFACTURED BY M/S IRZA PHARMA
(PVT) LTD SHEIKHUPURA ROAD, LAHORE.
Abid Saeed Baig, Secretary Provincial Quality Control Board, Punjab has forwarded the cases
which are about orders of PQCB for Districts Narowal, Sargodha, and Faisalabad, dated 28-4-2018
stating the proceedings and decision of PQCB regarding sub-standard Meronide tablet 400mg
manufactured by M/s Irza Pharma (pvt) ltd, 10.2 km Sheikhupura Road, Lahore , in its 185th meeting
held on 28-4-2018.
2. Case no.1 state the brief of the case as under;

Inspector of Drugs, Tehsil & district Narowal reported that:
i. He, on 13-04-2016, inspected the premises of MSD, EDO (H) Narowal situated at old
DHQ Hospital Narowal and took the sample of below mentioned drug on form-4
which after test/ analysis was declared substandard by Government Analyst Drug
Testing Laboratory, Faisalabad as detailed below:
Batch Name of DTL Report DTL Report
Name of Drug
No. Manufacturer TRA No &Date Result
M/s Irza Pharma ltd,, TRA no. Substandard on
Tablet Meronide 400
6A13 10.2 km Sheikhupra 4545/DTL Dated: the basis of
mg
road Lahore. 22-04-2016 Friability test
ii. The Storekeeper of MSD, EDO (H) Narowal situated at old DHQ hospital Narowal
provided invoice/warranty nos. 5165, 5164, 5163, 5162, 5160, 5159, 5158, 5157,
5156 dated 8-4-2016 issued by M/s Irza Pharma, Lahore as a proof of their purchase.
iii. A copy of test report of the drug sam0ple was sent to M/s Irza Pharma, Lahore and
they were asked to explain their position and to provide requisite information in this
regard but they failed to do so.
03. Case no.2 state the brief of the case as under;
Inspector of Drugs, tehsil & district Sargodha reported that:
i. His predecessor, on 12-04-2016, inspected the premises of Main Medicine Store,
DHQ Teaching Hospital, Sargodha and took the twenty four samples of below
mentioned drugs on form-4 for test/ analysis.
ii. One out of twenty four samples after test/ analysis was declared substandard by
Government Analyst Drug Testing laboratory Faisalabad as detailed below:
Batch Name of DTL Report DTL Report
Name of Drug
No. Manufacturer TRA No & Date Result
M/s Irza Pharma ltd,, TRA no. Substandard on
Tablet Meronide
6A10 10.2 km Sheikhupra 5014/DTL Dated: the basis of
400 mg
Road Lahore. 30-04-2016 friability test
iii. He, on 20-7-2017, also seized the stock of subject substandard drug on form 5.
iv. The Storekeeper of Main Medicine Store, DHQ teaching hospital Sargodha provided
invoice/warranty nos. 4755, dated 16-03-2016 issued by M/s Irza pharma, Lahore as
a proof of their purchase.
v. Warrantor portion and a copy of test report of the drug sample was sent to M/s Irza
pharma, Lahore and they were asked to explain their position and to provide requisite
information in this regard.
04. Case no. 3 states the brief of the case as under;
Inspector of Drugs, Tehsil Samundri, district Faisalabad, reported that:
i. His predecessor, on 28-03-2016, inspected the business premises of THQ Hospital
Tehsil Samundri district Faisalabad and took samples of one type of drug on form 4
for the purpose of test and analysis.
ii. The sample after test/ analysis was declared substandard by Government Analyst
drug Testing Laboratory Faisalabad as detailed below:
Batch Name of DTL Report TRA DTL Report
Name of Drug
No. Manufacturer No & Date Result
M/s Irza Pharma ltd,, Substandard
Tablet Meronide TRA no. 4578/DTL
6B4 10.2 km Sheikhupra on the basis of
400 mg Dated: 23-04-2016
road Lahore. friability test
iii. Stock Keeper THQ Hospital Tehsil Samundri district Faisalabad provided
invoice/warranty nos. 4596, dated 11-3-2016 issued by M/s Irza Pharma, Lahore as a
proof of their purchase.
iv. A copy of test report & warrantor portion was sent to M/s Irza Pharma ltd Sheikhupra
road, Lahore and they were asked to explain their position but they failed to do so.
05. case no.4 state the brief of the case as under;
Inspector of Drugs, DHQ Teaching Hospital, Sargodha reported that:
i. His predecessor, on 20-05-2016, inspected the Main Medicine Store, DHQ Teaching
hospital Sargodha and took the samples of one drug on form-4 for test/ analysis.
ii. The sample after test/ analysis was declared substandard by Government Analyst
drug testing laboratory Faisalabad as detailed below:
Name of Drug
m/sirzapharma ltd,, Substandard
Tablet meronide TRA no. 6846/DTL
6A9 10.2c km sheikhupra on the basis of
400 mg Dated: 09-06-2016
iii. He, on 20-7-2017, also seized the stock of subject substandard drug on form 5.
iv. The Storekeeper, Main Medicine Store, DHQ Teaching Hospital Sargodha provided
invoice/warranty nos. 4755 dated 16-3-2016 issued by M/s Irza Pharma, Lahore as a
proof of their purchase.
v. Warrantor portion and copy of test report was sent to M/s Irza Pharma, Lahore and
they were asked to explain their position and to provide requisite information in this
regard but they failed to do so.
Inspector of Drugs, Layyalpur Town, district Faisalabad reported that:
v. He, on 29-03-2016, inspected the Main Medicine Store office of Executive District
Officer (Health) Faisalabad and took thirty samples of drugs on Form-4 for test/
analysis.
vi. One out of these sample after test/ analysis was declared substandard by Government
Analyst drug Testing Laboratory Faisalabad as detailed below:
Name of Drug
M/s IrzaPharma ltd,, Substandard on
6B4 10.2 km Sheikhupra the basis of
400 mg Dated: 20-04-2016
vii. Incharge of Main Medicine Office of Chief Executive Officer (Health) Faisalabad
provided invoice/warranty nos. 4583, 4584, 4589, 4590 and 4591 dated 11-3-2016
issued by M/s IrzaPharma, Lahore as a proof of their purchase.
viii. A copy of test report & warrantor portion was sent to M/s Irza Pharma ltd
Sheikhupura road, Lahore and they were asked to explain their position and to
provide requisite information in this regard.
Inspector of Drugs, tehsil Bhalwal district Sargodha reported that:
i. Drug inspector, on 02-04-2016, inspected the premises of Medicine Store T.H.Q
hospital Bhalwal district Sargodha and took samples of three different types of drugs
on form-4 for test/ analysis.
ii. One out of these sample after test/ analysis was declared substandard by Government
Analyst Drug Testing Laboratory Faisalabad as detailed below:
Name of Drug
Tablet M/s IrzaPharma ltd,, Substandard on
TRA no. 4246/DTL
Meronide 400 6A9 10.2 km Sheikhupra the basis of
Dated: 16-04-2016
mg road Lahore. friability test
iii. Medical Superintendent of T.H.Q hospital, Bhalwal provided invoice/warranty nos.

4735 dated 16-3-2016 issued by M/s Irza Pharma, Lahore as a proof of their
purchase.
iv. Warrantor portion was sent to the M/s irza Pharma, Lahore. A copy of test report was
sent to M/s Irza Pharma was directions to explain their position and provide requisite
information in this regard.
Inspector of Drugs, Lyallpur town, district Faisalabad reported that:
i. He, on 28-4-2016, inspected the main medicine store office of Executive District
Officer (Health), Faisalabad and took samples of four types of drugs on form-4 for
test/ analysis.
ii. Two out of four samples after test/ analysis was declared substandard by Government
Analyst Drug Testing Laboratory Faisalabad as detailed below:
Name of Drug
M/s IrzaPharma ltd,, Substandard
5L3 10.2c km sheikhupra on the basis of
400 mg Dated: 10-05-2016
M/s IrzaPharma ltd,, Substandard
6B5 10.2c km Sheikhupra on the basis of
400 mg Dated: 10-05-2016
road Lahore. friability test.
iii. Incharge main medicine store provided invoice/warranty nos. 5410 dated 23-4-2016
issued by M/s Irza pharma, Lahore as a proof of their purchase.
iv. Incharge main medicine store provided invoice/warranty nos. 5411 dated 23-4-2016
issued by M/s Irza Pharma, Lahore as a proof of their purchase.
v. A copy of test report and warrantor portion was sent to M/s Irza Pharma with
directions to explain their position and provide requisite information in this regard.
9. All the Drug Inspectors as mentioned above requested for grant for prosecution
against the firm and accused persons who have contravened the provisions of sections
23/27 of the Drugs Act, 1976/ DRAP Act 2012 and rules framed there under.
10. The said cases were presented before PQCB Lahore in its 177th meeting held on 30-
12-2017. The board decided to conduct PSI of M/s Irza Pharma Lahore.
11. The conclusion of PSI is as under:
“The firm is manufacturing uncoated tablet Meronide without research and
development. Whereas the leading brands of this product are available in film
coating form in market. The firm has shifted the uncoated formulation into film
coating in May 2016 without any permission/ intimation to DRAP. On evaluation of
bmr it was observed that following changes in the master formula was made by
adding sugar in two batches and without adding sugar in four batches. The result of
friability result varying by adding binder and non-addition of binder. Average weight
of tablet shows that amount of excepients added in 400 mg tablet is slow. In this
regard firm is violating many conditions of schedule B-II of the Drugs Act 1976. So.
The firm is directed to redesign and reevaluate its formulation and perform stability
study of following products under intimation and approval of DRAP.
Tablet Meronide 400mg R.no 025636
Tablet meronide200mg R. N 025635”
12. The PSI report was presented before PQCB in its 185th meeting held on 28-4-2018.
The board unanimously decided to grant permission for prosecution against the
following accused persons in the drug court.
i. M/s Irza Pharma ltd, 10.2 km Sheikhpura road, Lahore through its chief
executive Muhammad Imran Jawa.
ii. Muhammad Imran Jawa Chief Executive
iii. Abid Ali Jawa Warrantor
iv. IftikharMasud Plant Manager
v. Savaira Sultan Director
vi. Azamali production Incharge
iv. AsimMehmood Quality Control Incharge
Of M/s Irza pharma Lahore for the offences of
i. Manufacturing for sale/ stocking for sale/ sale of substandard drug.
ii. Issuance of its false warranty.
The board further decided to recommend Drug Regulatory Authority of Pakistan (DRAP)
Islamabad for cancellation of the registration of the subject drug product i.e Meronide tablet.
13. Decision of 284th meeting of Registration Board
The board decided to issue the show cause notice and personal hearing to firm responsible
persons as provided by PQCB lahore for manufacturing and selling of different batches of
substandard i.e meronide tablets.
14. The show cause notice was served to the firm on 23rd October, 2018.
Mr. Muhammad Imran Jawa (Managing Director) and Azam Ali (production
Manager) of M/s Irza Pharma ltd, 10.2 km Sheikhupra road Lahore appeared on behalf
of M/s Irza Pharma, Lahore plead instant case of Substandard drug Meronide 400 mg
Tablet, Batch No. 6A13, 6A10, 6B4, 6A9, 5L3 and 6B5 before the Board in its 286 th
meeting on 16th November, 2018.The Board after hearing the accused deliberated the
matter in depth in the light of available record/ investigation report of FID decided as
under:
1. Show cause notice should be served to the firm for violation of the condition of
the registration as the firm was having registration of the uncoated tablets. Why
they shifted for manufacturing of coated tablets without prior approval from
Registration Board, DRAP, Islamabad.
2. They should submit product development data for change in the coating of the
tablets.
3. The registration of the said product shall remain suspended till the verification
of data following panel:
a. Director DTL, Lahore
b. Area FID, DRAP, Lahore
Case No.10:
Manufacture & Sale Of Adulterated & Sub-Standard “Oxytocin Injection (for
vetonly)”Batch No. 2876 Manufactured By M/S. Elko Organization Pvt, Ltd,
Karachi.
The matter of Adulterated and Substandard Oxytocin Injection Batch no 2876
manufactured by M/s Elko organization, Karachi, by CDL, Karachi vide report no. KQ.461/2014(B)
dated 26th November, 2014, was placed before the Registration Board in its 248th meeting and RB
decided as under:
I. Suspended the registration of oxytocin injection, registration no. 011122 of M/s Elko
Organization (Pvt), Ltd, Karachi for a period of six months.
II. Investigation through a Product Specific inspection (PSI) by a panel comprising of director
DTL Quetta, Chief Drug Inspector, Sindh and Area FID karachi.
III. The panel will also witness the destruction of the recalled/withheld stocks of the drug under
reference.
That the letter regarding PSI was conveyed to panel members vide letter no. 3-56/2014-QC
dated 22nd April, 2015. It was requested to conduct PSI by the panel members as under:
I. Dr. Amanullah Khan, Director, Drug Testing Laboratory, Quetta.
II. Syed Kalb-e- Hasan Rizvi, Chief Drug Inspector, Sindh.
III. Abdul Rasool sheikh, Area FID, Karachi.
That the reminders were issued to Additional Director, DRAP, Karachi to conduct PSI and
submit the report by panel vide letter no. 3-56/2014-QC dated 9th October, and 26th October, 2017.
PSI report received from Additional Director, DRAP, Karachi vide F. no. 01-04/2017-
DRAP(K)(Insp) dated 15th November, 2017 received on 23rd November, 2017 wherein he enclosed
the detailed PSI report (duly signed) conducted by panel vide f. ARS.000245/2015-FID-III(k) dated
15th November, 2017.The panel members are as under:
I. Dr. Amanullah Khan, Director, Drug Testing Laboratory, Quetta.
II. Syed Kalb-e- Hasan Rizvi, Chief Drug Inspector, Sindh.
III. Abdul Rasool sheikh, Area FID, Karachi.
That the following points in the report submitted by Additional Director, DRAP, Karachi are as
under:
 Good practices in production: The root cause of failure was rubber stoppers which
was not washed properly as rubber stoppers were being washed manually. Factors
triggering such incidents were reviewed in detail. Keeping in view the instant failure
stringent checking was found in place to avoid the occurrence and recurrence of such
failures in future.
 QA system: with respect to the subject case their SOPS regarding failures and
controlling the deviation were reviewed in detail. After receiving the report the firm
had started to find out the root cause of the problem and total three batches were also
investigated. The firm was found capable enough to investigate their failures as per
SOPs. Appropriate in process checks were noted in place.
That the conclusion of the report submitted by panel is reproduced as under:
After investigating the root cause analysis (RCA) of the failure and subsequent
rectification of the problem the firm had resumed the manufacturing of oxytocin
injection after the lapse of suspension period and keeping in view the current status of
their compliance the panel recommends that the firm may be allowed to continue the
manufacturing of oxytocin injection. The panel further observed that the retained
stocks in quarantine were destructed as per their approved SOP on 01.11.2016.
 Meanwhile, it is pertinent to mention that FIA Karachi is conducting enquiry 22/2017 on
the complaint of Provincial Inspector of Drugs, Karachi about illegal import of oxytocin
and manufacturing of oxytocin injections manufactured by M/s Elko organization,
Karachi during suspension period. The FIA raised the following queries in this respect as
under:
I. Copies of minutes of meeting of 248th Drug Registration Board where registration no. 011122
of M/s Elko organization Pvt., ltd was suspended.
II. Import details of oxytocin by M/s Elko Organization during 2015 to till date.
III. Procedure/ DRAP regulations to import oxytocin (in any form) into Pakistan by
manufacturers of oxytocin for human and veterinary usage.
IV. Details of importers viz name of company, quantity imported, etc.
V. Details of any ban imposed on manufacturing or importing (in any form) of oxytocin by
DRAP.
Similarly, NAB is also conducting an enquiry.
Proceeding and Decision of 278th Meeting of RB:
Product Specific Inspection report and import data forwarded by AD (I&E) DRAP Karachi about
import of oxytocine raw material was contained by the DRB and discussed in details.
 The queries of the FIA Karachi and NAB were also brought in the knowledge of the Board
members. The DRB after through deliberation decided as under:-
 That the company violated the orders of the DRB, statutory body and continued import of raw
material during the suspension period as per detail are given below.
 The company resumed production of oxytocin vials without approval of the DRB.
 The Board decided to issue show cause notice & personal hearing letter to the firm for their
violation in the forthcoming meeting.
 It was also decided that the Registration of the oxytocin shall remain suspended till final
decision by the DRB in the forthcoming meeting.
 Registration Board advised PE&R Division to present the case regarding alleged use of
oxytocin vials for enhancement of milk production in the animals.
The Board decided to issue show cause notices of multi dose vials on the same lines which have been
adopted by India. They allow only one ml oxytocin ampoule for human use only.
Proceeding and Decision of 281st meeting of DRB
Representatives of the M/s Elko appeared before the DRB and stated that M/s Elko did not
manufactured oxytocin vials whose registration was suspended by the DRB. They manufactured 1cc
injection of oxytocin which was also registered by the DRB. They further contented that after the
expiry of suspension period they were legally authorized are manufacturing of oxytocin vials. DRB
member law also opined that after the expiry of suspension period, the bar on the company is
automatically revoked. The DRB after detailed deliberations and discussion constituted a Committee
comprising of (Dr. Saif ur Rehman Khattak Director CDL Karachi and Additional Director Karachi)
to investigate following issues:-
1. It shall be verified whether API of oxytocin vial for veterinary use and oxytocin
ampoules for human use is of same specification as per their registration letters issued by the
DRAP and cleared by the Karachi DRAP office during the suspension period.
2. The Quantity of oxytocin vials and oxytocin ampoules manufactured, sold and
distributed during suspension period should be verified by the Committee after evaluation of
manufacturing data of oxytocin vials and ampules from the manufacturing and distribution
records. Random verification should also be obtained from the distributors etc. past
manufacturing trend of the oxytocin ampoules may also be taken into account while evaluating
the manufacturing of oxytocin ampoules and vials during the suspension period
3. The Committee should submit its conclusive report for consideration of the Board
with candid opinion whether M/s Elko conducted manufacturing of oxytocin vials during the
suspension period of six months or not. It shall also be verified that the firm import of raw
material was on the basis of oxytocin vials or oxytocin ampoules registrations.
4. Decision of cancellation of registration of Oxytocin vial in the light of show cause
notice issued to the firm will be taken after the receipt of committee report.
Proceeding of 286th Meeting of Registration Board.
Inspection report is received on 05-10-2018 in response to DRAP, Islamabad letter No.03-56/2014-
QC dated 12-06-2018 on the subject regarding “Investigation report on manufacturer and sale of
adulterated and substandard Oxytocin injection (for vet only) Batch No. 2876 manufactured by M/s
Elko Organization (Pvt.) Ltd., Karachi” wherein the finding of the investigation with respect to the
scope are as under:
The committee mainly focused on the areas / issues as mandated to it by the Registration Board under
the scope of this investigation.
A. Official specifications of oxytocin raw material and registration of the firm

1. Oxytocin injection has been used in humans as well animals. Monographs of oxytocin
raw material and oxytocin injection are available both in United States Pharmacopeia and British
Pharmacopeia. The raw material of oxytocin for veterinary use has the same specifications as that for
human use and the imported raw material of oxytocin was also of the same specifications. However, it
also revealed that M/s Elko Organization (Pvt.) Ltd., Karachi does not hold registration of oxytocin
ampoule for human use (undertaking of the firm attached as Annex-A).
02. M/s Elko Organization (Pvt.) Ltd., Karachi holds following registrations of products
containing oxytocin:
Name of product Strength Registration Packing Use
Numbers
Oxytocin 5 I.U 5 I.U 011121 100x1ml ampoule Veterinary Use
injection
Oxytocin 10 I.U 10 I.U 011122 100x1ml ampoule Veterinary Use
injection 50ml Vial Veterinary Use
100ml Vial (that was declared Veterinary Use
substandard)
XZ injection 20 I.U 085466 100ml Veterinary Use
(Oxytocin 20 I.U)
(Annex-B)
Upon cross checking of import documents pertaining to the period of suspension of the referred
products i.e. (22-04-2015 to 21-10-2015) that were submitted in the DRAP, Karachi office for
obtaining clearance including undertaking of the firm regarding utilization and Form-8 under Drug
import & Export rules 1976 of the Drugs Act, 1976, it was observed that the import of oxytocin
was raw material was not made for oxytocin 10 I.U. (Annex-C).
B. Oxytocin raw material import and manufacturing of oxytocin injection (10 I.U, 50/100ml
vials and 100x1ml ampoules).
01. Review of oxytocin raw material import record:
 As per import and warehouse record of M/s Elko Organization (Pvt.) Ltd., Karachi
following quantities of oxytocin were available/ received in the firm:
Sr. LC No. LC Date Invoice No. Invoice Delivered Quantit

No. Date On y (MIU)
Opening balance on 23-04-2015 322.7
1 LC4731/15 13-13-2014 TM1504C007 07-04-2015 24-04-2015 500
2 CONT 12315 14-04-2015 RH20150520 20-05-2015 25-06-2015 100
3 LC 4833/15 10-04-2015 TM1505C012 12-05-2015 28-06-2015 500
4 LC 4595/15 16-02-2015 EXP/ELKO/15-16 25-062015 16-07-2015 300
5 CONT 17415 10-06-2015 ZY201506056 19-06-2015 16-07-2015 100
6 LC 5074/15 15-06-2015 TM150703C001 30-07-2015 11-08-2015 500
7 CONT 591/15 16-07-2015 ZY201508030 07-08-2015 27-08-2015 300
8 LC 5171/15 15-07-2015 TM150817C01 02-09-2015 10-09-2015 500
9 CONT 591/15 16-07-2015 ZY201508079 02-09-2015 29-09-2015 250
10 LC 2574/15 26-08-2015 TM150909M01 09-09-2015 05-10-2015 500
11 CONT 591/15 16-07-2015 Zy201509032 07-10-2015 07-10-2015 250
Total quantity MIU 4122.7
Related invoices and record attached as Annex-D
 The documents on the yearly planned for import show that 3800 MIU oxytocin raw
material was imported during the suspension period with the undertaking of
manufacturing of oxytocin containing registration product but not for product under
suspension, as per pre established agreement of the firm for annual supply with the
API manufacturers (copies of bin cards attached as Annex-F).
02. Review of purchase record of packing material (Glass vials, Glass ampoules, Rubber
Stoppers, Al. Seals, Unicartons and Labels).
The purchase record related to the packing material of 50ml and 100ml oxytocin
injection (10 IU vials) show that no purchase/ use of 50ml, 100ml vials, Al. Sealslabels and unicarton
was made by the firm during the referred product suspension period. Since rubber stoppers for 50ml
and 100ml are also used for other products therefore, rubber stoppers have been purchased during the
referred product suspension period but for other registered products of the firm. Similarly no glass
ampoules have been purchased by the firm during the suspension period. (Copies of bin cards
attached as Annex-F).
03. Review of production record of oxytocin injection (50/100ml vials).
 Physical inspection of the manufacturing equipments and confirmation by the
manufacturer (copy attached as Annex-G) establish that the manufacturer has the
capacity of manufacturing oxytocin injection as under:
 Minimum batch size capacity = 600 liters (12,000 vials of 50ml 0r 6000 vials of
100ml)
 Maximum batch size capacity = 3000 liters (60,000 vials of 50ml or 30,000 vials of
100ml).
 Maximum filling/ packing capacity = 70,000 vials/ 8 hours.
The previous record of the production shows that before and after suspension period the firm
has manufactured mainly 50ml and 100ml oxytocin vials in 10I.U. potency.
 The scrutiny of production record i.e. raw material bin cards, daily production record,
finished goods store bin cards etc. (copies attached as Annex-H) revealed that M/s
Elko Organization did not conduct manufacturing of oxytocin products (the product
suspended and oxytocin product whose registrations were valid ) in the section of the
firm during the suspension period i.e. 22-04-2015 ton 21-10-2015.
04. Review of quality control and quality assurance documents and record.
As per record of QC (Test/ analysis reports) and instruments utilization log books and tests
log books the production and testing of the referred product could not be establish during the
suspension period. The assay (potency) test of oxytocin injection is based on HPLC method as per
United States Pharmacopeia therefore the specific HPLC (Shemadzu, LC-20AT) system was also
checked for audit trial for the same. Although proper audit trial was not available on the instrument,
however, the available data on the instrument show that no batch of oxytocin injection was tested on
the instrument during the suspension period (copies of log book attached as Annex-I).
The quality assurance record show that no batch number of the referred product was issued nor any
new batch history record reviewed / authorized during the suspension period.
C. Review of sales record.
The firm has selling their veterinary products through their sole authorized agent for
sale/distribution with the name and address as under:
M/s Shaheen Enterprises, Road No.9, Cattle Colony, Bin Qasim Town Karachi (Copies of
appointment of the distributor and related documents attached as Annex-J).
As per record related to sale available at factory premises and at M/s Shaheen Enterprises, the
sale/purchase of the referred product could not be established for the period of suspension other than
the batches which were manufactured before suspension period (copies of the sale record attached
as Annex-K).
D. Feedback from employees at manufacturing and sale premises.

The following employees/personnel were asked specifically for related information to assist the
investigation process and to authenticate the record provided:-
S.No Name of Technical person Designation
1. Mr. Muhammad Farooq Plant Manager (DRAP approved person for
production)
2. Mr. Muneer Ahmad QC Manager (DRAP approved person for QC)
3. Ms. Shama Anees Production Manager
4. Ms. Leena Baig Production Officer, Injection Section
5. Mr. Mirza Ayaz Baig Quality Operation Manager
6. Ms. Syeeda Mahwish QC Microbiologists
7. Mr. Muzaffar Nawab Raw Material Store Incharge
8. Mr. Muhammad Ali Finished Goods Store Incharge
9. Mr. Tahir Javed Proprietor Shaheen Enterprises
As per statement attached of the technical persons the production of any of the Oxytocin strength was
not conducted (copies attached as Annex-L).
Conclusion
Keeping in view of the investigation, through scrutiny/review of record pertaining to the Import of
Oxytocin Raw Material, production of Oxytocin products, quality control, storage, sales and
distribution of 10 IU Oxytocin Injection, physical inspection of manufacturing, storage and
distribution/retail sale site/outlets, examination of log books related to equipment/instrument
utilization and processes and information/feedback gathered from related people it is concluded:
a. the firm has imported 3800 IU Oxytocin Raw Material (USP Grade) during the suspension period
for utilization in 5 IU (Registration No.011121, 100x1ml ampoules packs) however, as per record the
material was not utilized till 12.01.2016 i.e. resumption of 10 IU 50ml and 100 ml vials (Registration
No.011122) production.
b. That, production of the Oxytocin vial 10 IU (100 ml) could not be established during the
suspension period.
c. Firm resumed production by their self after the expiry of the suspension period i.e. 22.04.2015 to
21.10.2015.
d. The committee is also of the opinion that the necessary sale record could be verified in detail, if
necessary, through provincial health authorities because of availability of adequate field force.
e. The committee also recommends that necessary directions may please be issued to the firm for
availability of 21 CFR compliant equipments/ instrument in the QC Lab for audit trail purposes.
Decision: The Board considered the report of the committee and after deliberation, the
Board decided as under:
1. The registration of oxytocin vial shall remain suspended till the final decision by
the Registration Board about the cancellation of registration of multi dose
oxytocin vials in the light of show cause notices approved by the RB. Its fate will
be decided collectively as a policy decision.
2. The provincial governments shall be requested to verify the sales data of
oxytocin vials during the suspension period (22-04-2015 to 21-10-2015) of
oxytocin which is subject matter. The sales data oxytocin ampoules shall also be
verified that was sold by M/s Elko Organization during the said period.
3. Certified copy of the List of Distributors and sales and distribution data of the
oxytocin vials and ampoules will be obtained from the company through area
FID.
Case No.11:
Manufacture & Sale of Sub-Standard Pentium Tablet 40mg Batch No. 31,
Manufactured by M/s Shrooq Pharmaceutical, Lahore.
Assistant Director (I&E) Lahore, visited the premises of M/s Shrooq Pharmaceuticals (Pvt.,)
Ltd., Lahore on 21-04-2017 and taken following sample for the purpose of test/analysis on prescribed
Form-3:
Name: Pentium 40mg tablet

Composition Each tablet contains 40mg Pantoprazole
Batch No: 31
Manufacturing Date: 2-17
Expiry Date: 1-19
Manufactured By: M/s Shrooq Pharmaceuticals, (Pvt.) Ltd, Lahore.
02. One portion of the sample was sent to Federal Government Analyst, Central Drugs
Laboratory, Karachi vide memorandum No.4504/2017-DRAP (AD-CD) (I&E) dated 24-04-2017
under the Drugs Act, 1976 and the rules framed there under.
03. One portion of the sample was forwarded to Central Licensing Board, DRAP, Islamabad
along with a copy of Form-4, dated 24-04-2017.
04. The Federal Government Analyst, CDL, Karachi declared the sample as of substandard
quality on the basis of dissolution test vide test/analysis report No.LHR.124/2017 dated 30 th June,
2017 under the Drugs Act, 1976.
05. The manufacturer M/s Shrooq Pharmaceuticals (Pvt.,) Ltd., Lahore was provided the
above said test/analysis report and was directed to explain their position in this regard within 03 days
vide letter No. 9196/2017-DRAP (AD-CD), dated 12-07-2017.
06. In response to the explanation letter, M/s Shrooq Pharmaceuticals (Pvt.,) Ltd., Lahore
submitted their reply vide letter Nil dated 18-07-2017 and requested for retesting of sample by
appellate laboratory – NIH, Islamabad under section 22 of the Drugs Act, 1976.
laboratory, NIH, Islamabad dated 17th August, 2017 under section 22(5) of the Drugs Act, 1976 after
seeking due approval from the Chairman, Registration Board as required U/S 22(5) of the Drugs Act,
1976.
10-2017, has also declared the sample as of sub-standard quality on the basis of dissolution.
9. Assistant Director (I&E) Lahore, forwarded the complete case wherein she has submitted that
the firm is involved in manufacturing and sale of substandard drug which is prohibited under
schedule-II Section A(1) (a) (v) of DRAP Act, 2012 and section 23 (a) (v) of the Drugs Act, 1976and
recommended that the registration of the drug may be cancelled / suspended or any other action may
deemed fit may be taken by the Board against the firm and responsible persons. Names of responsible
persons are as under:
i. Dr. Riaz Ahmad Managing Partner/ CEO.
ii. Mr. QamarJavaid Production Incharge
iii. Mr. Rana Anwar Ahmad Quality Control Incharge.
The firm stated that they had stopped the production of said product.
10. The Division of Drugs Licensing, DRAP Islamabad was requested to verify the responsible
persons provided by the Assistant Director (I&E) Lahore and the Licensing Division, DRAP,
Islamabd provided the following names:
i. Dr. Riaz Ahmad CEO.
ii. Mrs. AnjumRiaz Director
iii. Mr. QamarJavaid Production Incharge
iv. Mr. Rana Anwar Ahmad Quality Control Incharge.
11. Show cause notice has been issued to the technical staff/management of the firm – responsible
persons U/S 7(11) of the Drugs Act, 1976 vide letter no. 3-39/2017-(QC) dated 08-10-2018 and reply
of the firm is still awaited.
Mr. Qamar Javed, (Plant Manager) and Rana Anwar Ahmad (QC Manager) of M/s
Shrooq Pharmaceuticals (Pvt.) Ltd., Lahore appeared on behalf of M/s Shrooq
Pharmaceuticals (Pvt.,) Ltd., Lahore to plead instant case of Substandard drug Pentium
40mg tablets, Batch No.31 before the Board in its 286th meeting on 16th November,
2018.The Board after hearing the accused deliberated the matter in depth in the light of
available record/ investigation report of FID decided as under:
1. The firm will perform the Root Cause Analysis and inform the Board
accordingly.
development data by the firm and verification by Product Specific Inspection by
the following panel of inspectors:
 Dr. Shafiq Ur Rehamn (Director Drugs Testing Laboratory, Lahore)
Case No:12: PARTIAL WITHDRAWAL OF PERMISSION – EARLIER GRANTED FOR

ORDER NOT TO DISPOSE OF BY THE CHAIRMAN DRB– RECALL OF
FREEZE-DRIED HUMAN RABIES VACCINEMANUFACTURED BY
CHANGCHUN CHANSHENG BIOTECHNOLOGY CO., LTD. (NO.60 OF
2018).
01. It is submitted that the Federal Inspector of Drugs-I, Lahore, vide letter no. 10820/2018-
DRAP(L-I) dated 10.08.2018 has referred to the Drug Regulatory Authority of Pakistan letter
No.F.No.03-64/2018-QC dated 09-08-2018, on the subject cited matter.
02. That the FID-I, Lahore along with Mr. Ajmal Sohail Asif, Federal Inspector of Drugs, Mr.
Akbar Ali, Assistant Director, and Ms. MahamMisbah, Assistant director, DRAP Lahore
visited the premises of M/s Hi Warble Pharmaceuticals (Pvt) Ltd, 44-B,II phase-I, Johar town,
Lahore on 09-08-2018. The following vaccines, manufactured by M/s Changchun Chansheng
Biotechnology Co., Ltd., China and imported by M/s M/s Hi Warble Pharmaceuticals (Pvt)
Ltd, 44-B,II phase-I, Johar town, Lahore were found in the cold store of the importer.
S.N0. Name of product Reg. Batch No. Mfg. Exp. Manufacturer Quantity
No. Date Date
1 Rabiling 052299 201711086 02-11- 01-11- Changchun 320 Vials x
lyophilized 17 20 Chansheng Life 0.5ml
Injection Sciences Ltd,
Changchun P.R
China.
2 Varivac 052299 201802020 10-02- 09-02- M/s Life 8625 Vials
Lyophilized 18 20 Sciences Ltd., x 0.5ml
powder for Changchun P.R
Injection China.
3 Varivac 052299 201710056 10-10- 09-10- M/s Life 72 Vials x
Lyophilized 17 19 Sciences Ltd., 0.5ml
powder for Changchun P.R
Injection China.
03. FID-I, Lahore informed that the said product were ordered not to dispose of by the
undersigned on Form-1, for 28 days under section (18) (1) (i) of the Drugs Act, 1976 in
compliance to the direction from DRAP, Islamabad conveyed vide letter referred above. The
vaccine mentioned in the above said letter was Rabiling lyophilized injection but other
vaccine Varivac Lyophilized powder for Injection, being manufactured by same source i.e.
Changchun Chansheng Life Sciences Ltd, Changchun P.R China, was also ordered not to
dispose of for precautionary measures.
04. That the FID-I, Lahore requested to grant further extension for three months for not to dispose
of the above said stock under section (18) (1) (i) of the Drugs Act, 1976 and rules framed
there under and also requested guidance with reference to action taken against varivac
vaccine.
05. That the Chairman, Registration Board has granted permission for extension in the period of
not to dispose of in the light of powers delegated to him by Board in its 283rd Meeting held on
27 to 29th June, 2018 for the period of three (03) months.
06. That the permission for extension in the period of “not to dispose of” has already been granted
to the area FID, Lahore vide letter of 03-64/2018-QC dated 25.09.2018.
07. That the M/s Hi-Warble Pharmaceuticals, Pvt Ltd, Lahore vide letter no. Nil dated 13.08.2018
has requested to grant permission to dispose of the Stock (approx.. 9000vials) of Varicella
Vaccine (VarivacInj.) (B. No. 201802020 & 201710056)ordered not to dispose of by the area
FID, Lahore during his visit of M/s Hi-Warble, Lahore with reference to subject cited recall.
“The firm has also submitted that varicella vaccine (varivac inj.) is not under question even by SFDA
China. The firm has also informed that this Varicella Vaccine (Varivacinj.) is the single varicella
vaccine brand which is available in Pakistan market, no other brand is available in the country.
Further added, that varicella disease (chicken pox) has multiple time outbreaks in different cities like
Faisalabad, Multan, Bahawalpur, D.G. Khan and Rahim Yar Khan during last 6 to 7 months, the
same may be confirmed from health department of Government of Punjab who are working on it.”
08. That the recall was made in the light of communication made through a Circular of State Drug
Administration, China, wherein it wasinformed that the Jilin Provincial Food and Drug
Administration took back the “Drug GMP Certificate” (Certificate No.:JL20180024)
ofChangchun Changsheng Biotechnology Co. Ltd., China and ordered to stop the production
of rabies vaccines as well as recall the said vaccine.The matter was taken up by the DRAP
and directed field force to take legal action where required. While taking action against rabies
vaccine manufactured byM/s Changchun Changsheng Biotechnology Co. Ltd., China,the
FID-Lahore also“ordered not to dispose of” following quantitiesof Varicella Vaccine (Varivac
inj.)of the same source which was not under question as per the Circular.
1 Varivac 052299 201802020 10-02-18 09-02-20 M/s Life Sciences 8625 Vials
Lyophilized Ltd., x 0.5ml
powder for Changchun P.R China.
Injection
2 Varivac 052299 201710056 10-10-17 09-10-19 M/s Life Sciences 72 Vials x
Lyophilized Ltd., Changchun P.R 0.5ml
powder for China.
Injection
09. That the matter is submitted before theBoard with request to revoke the permissionfor
extensionin the period not to dispose of granted earlier by the Chairman, DRBas per delegated
powers of DRB, only to the extent of Varicella Vaccine (Varivac inj.) (B. No. 201802020 &
201710056) manufactured byM/s Changchun Changsheng Biotechnology Co. Ltd., China, in
the instant case to avoid shortages of life saving vaccine.
1. Registration Board decided to withdraw the not to dispose period of products at
serial No. 2 and 3 which were not included in the list of products for which
advisory was issued by the Chinese government.
2. The Board also specifically delegated the power to its Chairman to revoke the
not to dispose of orders in the special circumstances as and when required in the
justifiable manner.
Item No. VII: Additional agenda
Pharmaceutical Evaluation Cell
S.No. Detail
Case No. 01 Registration applications of drugs for which stability study data is submitted
c. Deferred cases
d. Verification of stability study data
e. Exemption from onsite verification of stability data
Case No. 02 Registration applications of newly granted DML or New section (Human)
d. New DML
Case No. 03 Registration applications of categories to be considered on priority
b. Deferred cases
c. Import applications of priority categories defined by Registration Board in
its 257th meeting
Case No. 04 Registration applications for local manufacturing of (Human) drugs
b. New cases
c. Deferred cases
Case No. 05 Registration applications for local manufacturing of (veterinary) drugs
a. Deferred cases
Case No. 06 Registration applications of import cases

d. New Cases (Veterinary)
e. Deferred cases
iii. Human
iv. Veterinary
Case No. 07 Miscellaneous cases
e. Ten molecules Policy Instead of ten products For New Section/Factory
f. Manufacturing facility for steroidal and non-steroidal hormone
Case No. 01: Registration applications of drugs for which stability study data is submitted
a. Deferred cases
Evaluator PEC-III
No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Date, Availability / Local
Applicant Form + Strength), Fee (including Availability
Pharmacological Group, Demanded Price / GMP Inspection
Finished Product Pack size Report Date &
1. M/s Hudson Pharma Deeferol Injection 200,000IU 15.09.2016 Not found in
(Pvt) Ltd., D-93, Each ampoule contains: 1189 Rs. FDA, MHRA
North Western Cholecalciferol 20,000/-
Industrial Zone Port BP………5mg
Qasim Karachi (Manufacturer‘s
Specifications)
Decision of 263rd meeting of Registration Board:
The product is available in UK in transparent PVC/PVDC/PE single dose oral solutions in strength
of 50,000 I.U with brand name of INVITA D3 of M/s Consilient health Ltd. UK.
Decision: Deferred for submission of stability data as per guidelines approved in 251st meeting.
Evaluation by PEC:
Firm has submitted stability study data dated 14-06-2018
Drug Deeferol Injection 200,000IU
Name of Manufacturer M/s Hudson Pharma (Pvt) Ltd., D-93, North Western Industrial Zone
Port Qasim Karachi
Manufacturer of API Fermenta Biotech Ltd., Z-109 B & C, Dahej SEZ Part-II, Taluka-
Vagara, Dist: Bharuch, 392130, Gujrat India
API Lot No. CLC0417033
Description of Pack
LDPE Ampoules
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 1, 3, 6 (Months)
Batch No. 005 006 007
Batch Size 20,000 ampoules 20,000 ampoules 20,000 ampoules
No. of Batches 03
1. COA of API Yes
Firm has provided GMP certificate of API
manufacturer issued by Food and Drug control
manufacturer issued by regulatory authority
administration Gujarat state India
Yes
attested respective documents like Firm has submitted that they have tested this
chromatograms, laboratory reports, data product on UV as per the method specified in BP
sheets etc.
5. Documents confirming import of API etc. Firm has submitted ADC attested invoice and
License to import 0.45Kg Cholecalciferol dated
11-08-2017
(name, sign and stamp) for ensuring No
Yes
Yes
Rules, 1978.
 Firm has used BP method for conducting assay, the BP method have used UV spectrophotometry.
Firm has submitted that since their method was as per BP therefore chromatograms are not
applicable in this case. Firm has only provided manual values of absorption of reference and
sample in tabular form without any spectra.
 The BP specification defines colecalciferol injection as “a sterile solution containing 0.75% w/v
of Colecalciferol in Ethyl Oleate”. While the applied product contains 0.5% cholecalciferol.
 Firm has used LDPE ampoule which is a semi permeable container. As per ICH guidelines for
drug products packaged in semi-permeable containers the testing conditions are:
Study Storage conditions
Long Term 30°C ± 2°C/35% RH ± 5% RH
Accelerated 40°C ± 2°C/not more than (NMT) 25% RH
Decision of previous meeting of Registration Board deferred the case for further deliberation
Registration Board: regarding the stability study data requirements for LDPE
containers. (M-284)
Evaluation by PEC:
As per ICH guidelines “Stability Testing of New drug substances and products” Q1A(R2)
2.2.7.3. Drug products packaged in semi-permeable containers
Aqueous-based products packaged in semi-permeable containers should be evaluated for potential water
loss in addition to physical, chemical, biological, and microbiological stability. This evaluation can be
carried out under conditions of low relative humidity, as discussed below. Ultimately, it should be
demonstrated that aqueous-based drug products stored in semi-permeable containers can withstand low
relative humidity environments.
Other comparable approaches can be developed and reported for non-aqueous, solvent-based products.
Study Storage condition Minimum time period covered
by data at submission
Long term* 25°C ± 2°C/40% RH ± 5% RH 12 months
or 30°C ± 2°C/35% RH ± 5%
RH
Intermediate** 30°C ± 2°C/65% RH ± 5% RH 6 months
Accelerated 40°C ± 2°C/not more than 6 months
(NMT) 25% RH
*It is up to the applicant to decide whether long term stability studies are performed at 25 ± 2°C/40% RH
± 5% RH or 30°C ± 2°C/35% RH ± 5% RH.
**If 30°C ± 2°C/35% RH ± 5% RH is the long-term condition, there is no intermediate condition.
For long-term studies conducted at 25°C ± 2°C/40% RH ± 5% RH, additional testing at the intermediate
storage condition should be performed as described under the general case to evaluate the temperature
effect at 30°C if significant change other than water loss occurs during the 6 months’ testing at the
accelerated storage condition. A significant change in water loss alone at the accelerated storage condition
does not necessitate testing at the intermediate storage condition. However, data should be provided to
demonstrate that the drug product will not have significant water loss throughout the proposed shelf life if
stored at 25°C and the reference relative humidity of 40% RH.
A 5% loss in water from its initial value is considered a significant change for a product packaged in a
semi-permeable container after an equivalent of 3 months’ storage at 40°C/NMT 25% RH. However, for
small containers (1 mL or less) or unit-dose products, a water loss of 5% or more after an equivalent of 3
months’ storage at 40°C/NMT 25% RH may be appropriate, if justified.
An alternative approach to studying at the reference relative humidity as recommended in the table above
(for either long term or accelerated testing) is performing the stability studies under higher relative
humidity and deriving the water loss at the reference relative humidity through calculation. This can be
achieved by experimentally determining the permeation coefficient for the container closure system or, as
shown in the example below, using the calculated ratio of water loss rates between the two humidity
conditions at the same temperature. The permeation coefficient for a container closure system can be
experimentally determined by using the worst case scenario (e.g., the most diluted of a series of
concentrations) for the proposed drug product.
Decision: Registration Board deferred the case for further deliberation.
b. Verification of stability study data

Evaluator PEC-II
Sr. Name & Address of Brand Name Type of Form, International Previous DRB Decision /
No. Manufacturer / (Proprietary Name + Initial Diary & Availability / Local Remarks
Applicant Dosage Form + Date, Fee Availability (if any)
Strength), Composition, (including
Finished Product Demanded Report Date &
Specification Price / Pack size Remarks
2. M/s Bio-Labs, Bio-Glif tablets 300 Form 5D Invokana tablet  Firm has claimed
Islambad mg USFDA Manufacturer’s
Each film coated Dy. No. 997 approved Specifications.
tablet contains: dated 17-02-  Patient information leaf
Canagliflozin ….. 300 2016 Not applicable. and outer carton design
mg has not been submitted.
Rs. 50,000/- GMP compliant  Dissolution parameters
Glucose co transporter As dated 20-01- stated in finished product
2 (SGLT2 inhibitor recommended 2017. testing method are not as
by PRC recommended by
USFDA
Drug Bio-Glif 300 mg tablets (Canagliflozin)

Name of Manufacturer M/s Bio-Labs, Islambad
Manufacturer of API M/s NANTONG Chanyoo Pharmatech Co., Ltd, China
API Lot No. RD-CLF-201604221
Description of Pack
Not provided
Stability Storage Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 12 months
Time Period
Real Time: 0,3,6,9 & 12 months
Frequency
Accelerated: 0,3 & 6 months
Batch No. TT-001 TT-002 TT-03
No. of Batches 03
Sr.
Documents To Be Provided Status
No.
1. COA of API Yes
Approval of API by regulatory authority of country of Copy of GMP certificate issued by Nantong
2. origin or GMP certificate of API manufacturer issued by Chemical & Medical Industry Association
regulatory authority of country of origin. valid upto 05-12-2019 has been submitted.
Protocols followed for conduction of stability study and Stability study protocol has not been
3.
details of tests. submitted.
4. respective documents like chromatograms, laboratory Raw data sheets have not been submitted.
6. Yes
7. Yes
8. Commitment to follow Drug Specification Rules, 1978. No
(AD PEC-II)
 The firm has submitted 24 Weeks Accelerated and 24 Weeks Real Time Stability Study Data for 03 Batches.
 There is a significant change in Assay results of accelerated stability studies of Batch#. TT-002 i.e. initial
results were 103.97% while those at 6th month were 97.89%.
 There is a significant change in Assay results of accelerated stability studies of Batch#. TT-003 i.e. initial
results were 103.83% while those at 6th month were 95.76%.
 There is a significant change in Assay results of real time stability studies of Batch#. TT-001 i.e. initial results
were 104.25% while those at 12th month were 96.82%.
 Disintegration results at 12th month of real time stability study is stated as 57 minutes.
 Finished product testing method has not been submitted.
 Raw data sheets are incomplete.
Decision: Registration Board in its 272nd meeting deferred for submission of following:
i. Justification for disintegration results of 57 minutes at 12th month time point of real time stability study.
ii. Clarification of variation in dissolution parameters from that recommended by USFDA.
iii. Raw data sheets.
iv. Commitment to follow Drug Specification Rules, 1978.
v. Patient information leaf and outer carton design.
Evaluation by PEC:
Firm has submitted following:
i. Disintegration time of 57 minutes at 12th month time point of real time of Trial no. TT-001stability study
was mistakenly mentioned due to typographical error. Correct disintegration time of real time stability
study at 12th month time point of real time of Trial no. TT-001 is 7 minutes.
ii. Raw data sheets for stability studies have been submitted.
iii. Commitment to follow Drug Specification Rules, 1978 has been submitted.
iv. Commitment for Patient information leaf and outer carton design has been submitted.
v. Firm has stated that they have performed dissolution analysis during stability studies as per method
recommended by USFDA.
Decision: Registration Board directed the firm to submit clarification for their request to ignore the data
submitted with the dossier including Master Formula, Source of API and Stability Studies.
Moreover Registration Board decided to constitute the following panel for onsite investigation to confirm
genuineness / authenticity of stability data and associated documents, import of API, quality, specification,
test analysis, facilities etc.
 Additional Director QA & LT Division, DRAP Islamabad
 Dr. Qurban Ali. (Member Registration Board)
 Mr. Haseeb Tariq (Assistant Director, PEC)
Report on investigation of genuineness / authenticity of data submitted for registration of Bio-Glif Tablets
300mg (Canagliflozin) by M/s. Bio-Labs, Islamabad.
Reference No: F.2-16/2016-PEC (M-277) dated 17th January, 2018.

Investigation Date: 26th July, 2018.
Investigation Site: Factory premises of M/s. Bio-Labs, Islamabad.
Background:
The Registration Board in its 277th Meeting directed the firm to submit clarification for their request to
ignore the data submitted with the dossier including Master Formula, Source of API and Stability Studies.
Moreover, Registration Board decided to constitute the following panel for onsite investigation to confirm
genuineness / authenticity of stability data and associated documents, import of API, quality, specification, test
analysis, facilities etc.
1. Dr. Qurban Ali, Member Registration Board
2. Dr. Hafsa Karam Elahi, Additional Director, QA&LT-I, DRAP Islamabad
3. Mr. Haseeb Tariq (Assistant Director, PEC)
(Mr. Haseeb Tariq, Assistant Director (PEC) was occupied at the day of inspection, therefore Mr. Muhammad
Tahir Waqas, Assistant Director (QA&LT) was directed to assist Additional Director, QA&LT-I, DRAP
Islamabad in the inspection).
Investigation to confirm genuineness / authenticity of stability data and associated documents, import of
API, quality, specification, test analysis, facilities etc.

involved, ongoing studies, printed data and integrity and security of data in respective databases were also audited.
The details of investigation may be summarized as under:
Detail of Investigation:
Q. No. Question Observation by Panel
1. Do you have documents confirming Firm have copy of ADC (Islamabad) attested commercial
the import API including approval invoice for import of Canagliflozin batch no. RD-CLF-
from DRAP? 201604221.
2. What was the rationale behind Firm informed that they have selected API’s supplier on the
selecting the particular manufacturer of basis of GMP Certification and the information submitted on
API? Vendor Evaluation Form.
3. Do you have documents confirming Firm claims that the Working Standard was imported along
the import of API reference standard with the API.
and impurity standards? Firm showed an undertaking from the API Manufacturer that
Impurity Standard and Working Standards were sent.
4. Do you have certificate of Analysis of Firm have copies of certificate of analysis of the API (Batch
the API, reference standards and No. RD-CLF-201604221) Working Standard and Impurity
impurity standards? Standard.
5. Do you have GMP certificate of API Firm have shown copy of GMP Certificate No: JS170005
manufacturer issued by regulatory issued by Jiangsu FDA, China for EU. License Number of
authority of country of origin? API Manufacturer mentioned as SU20160512.
6. Do you use API manufacturer method Firm have used API manufacturer method of testing for
of testing for testing API? testing API.
7. Do you have stability studies reports Firm have shown copy of 06 Months (Accelerated) and 09
on API? Months (Real Time) Stability Study Reports on 03 Batches of
API (Canagliflozin).
8. If yes, whether the stability testing has Impurities were tested by API Manufacturer during stability
been performed as per SIM method testing.
and degradation products have been
quantified?
9. Do you have method for quantifying Firm have used API Manufacturer’s method for quantifying
the impurities in the API? the impurities in the API.
10. Do you have some remaining Firm claims to have no remaining quantity of API, its
quantities of the API, its reference Working Standard and Impurity Standards.
standard and impurities standards?
11. Have you used pharmaceutical grade Firm have used pharmaceutical grade excipients.
excipients?
12. Do you have documents confirming Firm have shown ADC Clearance for Microcrystalline
the import of the used excipients? Cellulose only.
13. Do you have test reports and other Firm have test reports and other records on the excipients
records on the excipients used? used.
14. Do you have written and authorized Firm have written and authorized protocol (approved by QA
protocols for the development of Manager) for the development of applied product.
applied product?
15. Have you performed Drug-excipients Firm have not performed Drug-excipients compatibility
compatibility studies? studies and claims to use same excipients as that of Innovator.
16. Have you performed comparative Firm have performed comparative dissolution studies of their
dissolution studies? product with reference product (Invokana 300mg by M.s
Janssen Cilag int. Belgium). Details are as follows:
Details Test Reference Product
Product
Brand Bio-Glif 300mg Invokana 300mg
Tab Tab
Batch No. TT001 HFL5X00
Dissolution 0.1N HCl, pH 4.5 0.1N HCl, pH 4.5
Medium Buffer and pH 6.8 Buffer and pH 6.8
Buffer. Buffer.
Time 30 mins 30 mins
RPM 75 75
Test product showed comparable dissolution profile with the
reference product.
17. Do you have product development Firm have product development (R&D) section.
(R&D) section?
18. Do you have necessary equipment Firm have used equipment in Production Area (compression
available in product development and coating) for development of applied product.
section for development of applied
product?
19. Are the equipment in product The equipment in production area were qualified.
development section qualified?
20. Do you have proper maintenance / Third party calibrations are performed thrice a year by QCS.
calibration / re-qualification program
for the equipment used in PD section?
21. Do you have qualified staff in product Firm have qualified staff of 02 pharmacists – R&D Manager
development section with proper and Executive R&D, involved in Product Development.
development?
22. Have you manufactured three stability Three stability batches TT001, TT002 and TT003 have been
batches for the stability studies of manufactured on 21-05-2016, 22-05-2016 and 24-05-2016
applied product as required? respectively for the stability studies of applied product having
batch size of 533 Tablets each.
23. Do you have any criteria for fixing the Keeping in view the number of tests and frequency of testing,
batch size of stability batches? the firm have developed a criteria for fixing batch size of
stability batches.
24. Do you have complete record of Firm have shown record (BMRs) of production of 03 stability
production of stability batches? batches.
25. Do you have protocols for stability Firm have shown protocols for stability testing of stability
testing of stability batches? batches.
26. Do you have developed and validated Firm have developed and validated the method for testing of
the method for testing of stability stability batches.
batches?
27. Do you have method transfer studies in Not applicable.
case when the method of testing being
lab?
28. Do you have documents confirming Firm have documents confirming the qualification of
the qualification of equipment / equipment / instruments being used in the test and analysis of
instruments being used in the test and API and the finished drug.
analysis of API and the finished drug?
29. Is your method of analysis stability Firm claims that their method of analysis is stability
indicating? indicating.
Impurity Testing was performed on 18th and 24th month
interval only.
30. Is your HPLC software 21CFR For 24th Month Real Time Analysis the firm have used HPLC
Compliant? system from Schimadzu (LC-20AT VP) for testing of stability
batches. Lab Solutions® Software (version 6.5) which is
21CFR Compliant.
06 Months Accelerated and up to 18 Months Real Time
Analysis was performed on Non-21 CFR Compliant software
for which log books were shown.
31. Can you show Audit trail reports on Audit trail was available for 24th Month Real Time stability
stability study testing? study testing only.
32. Do you have some remaining Firm claims to have no remaining quantities of stability
quantities of degradation products and batches and degradation products.
stability batches?
33. Do you have stability batches kept on Stability batches are not kept on stability testing as 24 Months
stability testing? Study have been completed.
34. Do you have valid calibration status Firm have valid calibration status for the equipment used in
for the equipment used in production production and analysis.
and analysis?
35. Do proper and continuous monitoring Real Time Stability Chamber from Equipment Pakistan and
and control are available for stability
Accelerated Stability Chamber from SUPICO, 5KV Backup
chamber? Generator with ATS.
USB Data loggers were placed in stability chambers. 9th
Month onwards record was shown of data loggers.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are as per GMP compliance to satisfactory level.
CONCLUSION:
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Bio-Glif Tablets 300mg (Canagliflozin) is NOT VERIFIABLE to satisfactory level since Audit Trail
was available for 24th Month Real Time Analysis only.
Decision of 284th meeting of Registration Board: Registration Board referred the case back to the panel for
assessment of genuineness / authenticity of the submitted stability data from the log books of the firm.
Report on re-investigation of genuineness / authenticity of data submitted for registration of Bio-Glif Tablets
300mg (Canagliflozin) by M/s. Bio-Labs, Islamabad.
Reference No: F.13-11/2017-PEC dated 25th Oct, 2018.

Investigation Date: 08th November, 2018.
Investigation Site: M/s. Bio-Labs (Pvt) Ltd, Plot # 145, Industrial Triangle, Kahuta Road, Islamabad.
Background:
M/s. Bio-Labs (Pvt) Ltd, Plot # 145, Industrial Triangle, Kahuta Road, Islamabad applied for registration of
“Bio-Glif Tablets 300mg (Canagliflozin)” along with stability data. Accordingly inspection for verification of
authenticity of submitted stability data was conducted by the following panel:
1. Dr. Qurban Ali, Member Registration Board
2. Dr. Hafsa Karam Elahi, Additional Director, QA&LT-I, DRAP Islamabad
3. Mr. Muhammad Tahir Waqas (Assistant Director, QA&LT) DRAP Islamabad
The case was placed before the Registration Board in 284th meeting and the Board decided as under:
“Registration Board referred the case back to the panel for assessment of genuineness / authenticity of the
submitted stability data from the log books of the firm”.
Findings of Inspection:
The panel members checked the Log Books of equipment (HPLCs) maintained at Quality Control Lab of the firm
and observed the following entries:-
Date Product / Material B. No. / Lot No. Mfg. Date
22-5/16 Canagliflozin 300mg Tab (0 Month) TT-001 05-16
24-8/16 Canagliflozin 300mg Tab (3rd Month) Acc TT-001 05-16
24-8/16 Canagliflozin 300mg Tab (3rd Month) RT TT-001 05-16
25-11/16 Canagliflozin 300mg Tab (6th Month) Acc TT-001 05-16
25-11/16 Canagliflozin 300mg Tab (6th Month) RT TT-001 05-16
23-2/17 Canagliflozin 300mg Tab (9th Month) TT-001 05-16
The panel members also observed the supporting evidences (Raw data / Calculation sheets, Chromatograms etc.).
For 24th Month Real Time Analysis the firm have used HPLC system from Schimadzu (LC-20AT VP) for testing of
stability batches. Lab Solutions® Software (version 6.5) which is 21CFR Compliant, as reported in previous
inspection as well.
Decision: Registration Board decided to approve registration of Bio-Glif Tablets 300mg (Canagliflozin) by
M/s. Bio-Labs, Islamabad. Manufacturer will place first three production batches of product on long term
stability studies throughout proposed shelf life and on accelerated studies for six months.
Sr. Name & Address of Brand Name Type of International Previous DRB
No. Manufacturer / (Proprietary Name + Form, Availability / Decision /
Applicant Dosage Form + Initial Diary Local Availability Remarks
Strength), & Date, Fee (if any)
Composition, (including GMP Inspection
Pharmacological differential Report Date &
Group, fee), Remarks
Finished Product Demanded
Specification Price / Pack
size
3. M/s Medizan DEXILAN DDR Form-5D DEXILANT Firm has claimed
Laboratories Pvt. Ltd. Capsules60mg Capsules 60mg by Mfg.
Dy. No.1273 M/s. Takeda Specifications.
313, Industrial Triangle, Each capsule contains: 06-10-2016 Pharms, USA.
Kahuta Road Islamabad. Dexlansoprazole ( as
Dual Delayed Release Rs. 50,000/- Not applicable
Pellets)…60mg
As per DPC / GMP compliance
(Proton Pump 14’s, 28’s, status not
Inhibitor) 30’s. confirmed.
Firm has claimed Mfg.
Specifications.
DEXILAN DDR Capsules60mg

Drug
(Dexlansoprazole as Dual Delayed Release Pellets)
Name of Manufacturer M/s Medizan Laboratories Pvt. Ltd., Islamabad.
Manufacturer of API M/s. Vision Pharmaceuticals, Islamabad.
API Lot No. DLP155T
Description of Pack
Alu-Alu Blister Pack.
Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C &65±5%RH
Time Period
Accelerated: 0,1,3,6 (Month)
Frequency
Real Time: 0,1,3,6 (Month)
Batch No. T001 T002 T003
Batch Size 616 Capsules 616 Capsules 616 Capsules
No. of Batches 03
Sr.# Documents To Be Provided Status
1. COA of API Yes
Approval of API by regulatory authority of country of origin or Copy of GMP Certificate issued
2. GMP certificate of API manufacturer issued by regulatory authority by DDG (E&M), Islamabad is
of country of origin. submitted.
Protocols followed for conduction of stability study and details of
3. Yes
tests.
Data of 03 batches will be supported by attested respective
4. Yes
documents like chromatograms, laboratory reports, data sheets etc.
The firm has purchased API
5. Documents confirming import of API etc. from local source – M/s. Vision
All provided documents will be attested (name, sign and stamp) for
6. Yes
ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned shelf
7. Yes
life of the product.
(AD PEC-I)
 The firm has provided 6 Months Accelerated and 6 Months Real Time Stability Data for 03 batches.
 Firm has claimed Mfg. Specifications. Supporting documents in the light of 267 th RB Meeting should be
provided for Finished Product Specifications.
Decision: The Registration Board decided to constitute the following panel for onsite investigation to confirm
 Director DTL Rawalpindi (Chairman).
 Additional Director (E&M), Islamabad.
 Area FID, DRAP (Member/Convener).
Sr. Name & Address of Brand Name Type of Form, International Availability Previous DRB
No. Manufacturer / (Proprietary Name + Initial Diary & / Local Availability Decision /
Applicant Dosage Form + Date, Fee Remarks
Strength), Composition, (including GMP Inspection Report (if any)
Pharmacological Group, differential fee), Date & Remarks
4. M/s Medizan DEXILAN DDR Form-5D DEXILANT Capsules Firm has
Laboratories Pvt. Capsules60mg 60mg by M/s. Takeda claimed Mfg.
Ltd. Dy. No.1273 Pharms, USA. Specifications.
Each capsule contains: 06-10-2016
313, Industrial Dexlansoprazole ( as Not applicable
Triangle, Kahuta Dual Delayed Release Rs. 50,000/-
Road Islamabad. Pellets)…60mg GMP compliance status
As per DPC / not confirmed.
(Proton Pump Inhibitor) 14’s, 28’s, 30’s.
Firm has claimed Mfg.

Specifications.
DEXILAN DDR Capsules60mg
Drug
(Dexlansoprazole as Dual Delayed Release Pellets)
Name of Manufacturer M/s Medizan Laboratories Pvt. Ltd., Islamabad.
Manufacturer of API M/s. Vision Pharmaceuticals, Islamabad.
API Lot No. DLP155T
Description of Pack
Alu-Alu Blister Pack.
Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C &65±5%RH
Time Period
Accelerated: 0,1,3,6 (Month)
Frequency
Real Time: 0,1,3,6 (Month)
Batch No. T001 T002 T003
Batch Size 616 Capsules 616 Capsules 616 Capsules
No. of Batches 03
Sr.# Documents To Be Provided Status
1. COA of API Yes
Approval of API by regulatory authority of country of
Copy of GMP Certificate issued by
2. origin or GMP certificate of API manufacturer issued by
DDG (E&M), Islamabad is submitted.
regulatory authority of country of origin.
3. Yes
details of tests.
Data of 03 batches will be supported by attested respective
4. documents like chromatograms, laboratory reports, data Yes
sheets etc.
The firm has purchased API from local
5. Documents confirming import of API etc. source – M/s. Vision Pharmaceuticals,
Islamabad.
6. Yes
7. Yes
(AD PEC-I)
 The firm has provided 6 Months Accelerated and 6 Months Real Time Stability Data for 03 batches.
 Firm has claimed Mfg. Specifications. Supporting documents in the light of 267th RB Meeting should be
provided for Finished Product Specifications.
Decision: The Registration Board decided to constitute the following panel for onsite investigation to confirm
 Director DTL Rawalpindi (Chairman).
 Additional Director (E&M), Islamabad.
 Area FID, DRAP (Member/Convener).
Registration Board in its 276th meeting further directed the firm to to submit their own analysis record of
dissolution testing on pellets confirming their dual delayed release profile at pH 5.5 & pH 6.75 / 7.
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Dexilan 30mg Capsule
(Dexlansoprazole (as Dual Delayed Release Pellets 17%)) by M/s Medizan Labs (Pvt.) Ltd., Plot No. 313, Industrial
Trinale, Kahuta Road, Model Town, Islamabad.
Reference No: F.13-11/2017-PEC (Pt) dated 6th November, 2018.
Inspection Date and Time: November 13, 2018 (Morning)
Inspection Site: M/s Medizan Labs (Pvt.) Ltd., Plot No. 313, Industrial Trinale, Kahuta Road, Model
Town, Islamabad.
Background:
The In-charge PEC, PE&R Division vide letter no. 13-11/2017-PEC(pt) dated 06.11.2018 has
communicated that the Chairman, DRB has constituted three member panel for on-site verification of authenticity of
stability data and associated documents, import of API, quality, specifications, test analysis and facilities etc. of M/s
Medizan Labs, Pvt. Ltd., Plot No. 313, Industrial Triangle, Kahuta Road, Islamabad for registration of following
products:
Sr. No. Brand Name and Composition of Drug
1 Dexilan DDR Capsule 30 mg
Each Capsule contains:
Dexlansoprazole (as Dual Delayed Release Pellets 17%) (as Dual Delayed Release Pellets) … 30 mg
2 Dexialn DDR Capsule 60mg
1. Prof. Dr. Usman, Member Central Licensing Board.
2. Dr. Muhammad Fakhruddin Aamir, Additional Director (QA&LT), DRAP, Islamabad
3. Mr. Arslan Tariq, Assistant Director, QA&LT, DRAP, Islamabad.
Advised to verify and report on-site verification of authenticity of stability data and associated documents,
import of API, quality, specifications, test analysis and facilities etc. Further advised to verify and report date of
manufacturing initiation of stability studies of trial batches alongwith performance of dual delayed release profile at
pH 5.5 & pH 7.

The inspection was conducted by using a structured questionnaire of DRAP. For objective evidence
The details of inspection may be summarized as under:-
Q. No. Question Observation by panel
1. Do you have documents confirming the Firm did not import Dexlansoprazole (as Dual Delayed
import of API including approval from Release Pellets 17%) and purchased 1.00Kg of
DRAP? Dexlansoprazole (as Dual Delayed Release Pellets 17%)
Batch no. DLP155T from M/s Vision Pharmaceuticals, Pvt.
Ltd Islamabad vide invoice number 300099 dated
29.07.2016. Firm also presented Delivery Challan No.
300101 dated 29.07.2016 of same quantity of
Dexlansoprazole (as Dual Delayed Release Pellets 17%)
Batch No. DLP155T. Goods Receiving Note (GRN) of firm
at Sr. No. 4206 dated 29 07.2016 verify the delivery of the
same quantity of same batch of Dexlansoprazole (as Dual
Delayed Release Pellets 17%) from M/s Vision
Pharmaceuticals, Islamabad. Page 39 of Stock Book (Stock
Ledger) was also checked to verify the receiving and issuing
status of Dexlansoprazole (as Dual Delayed Release Pellets
17%). The date of issue of Dexlanoprazole used in
manufacturing of trial batches for stability studies were same
as mentioned on BMRs. Firm has used all 1.00Kg in
manufacturing of trial batches (Dexilan 30mg and Dexilan
60mg) for stability studies and balance quantity of
Dexlansoprazole (as Dual Delayed Release Pellets 17%) is
Nil at the time of inspection.
2. What was the rationale behind selecting GMP compliant source (M/s Vision Pharmaceuticals Pvt Ltd,
the particular manufacturer of API? Islamabad) has been selected for Dexlansoprazole (as Dual
Delayed Release Pellets 17%).
3. Do you have documents confirming the As replied in para 1 above.
import of Dexlansoprazole (as Dual Furthermore, the firm neither purchased impurity standards
Delayed Release Pellets 17%) nor performed tests of identification/quantification of
reference standard and impurity impurities during stability studies.
standards?
4. Do you have certificate of Analysis of The firm has certificates of analysis for the API and working
the API, reference standards and standard provided by supplier. Certificate of analysis (COA)
impurity standards? of impurity standard was not available as the firm neither
purchased impurity standards nor performed tests of
identification/quantification of impurities during stability
studies
5. Do you have any approval of API or Yes, the firm presented documents of approval of API and
GMP certificate of API manufacturer GMP certificate of API manufacturer i.e. M/s Vision
issued by regulatory authority of Pharmaceuticals Pvt Ltd. Islamabad issued by Drug
country of origin? Regulatory Authority of Pakistan.
6. Do you use API manufacturer method Yes, it was informed that the firm is using API
of testing? manufacturer’s method of testing but neither the firm has
performed method transfer studies nor they have data of
method validation.
7. Do you have stability studies reports on The firm has accelerated and real time stability studies
API? reports on the API (Dexlansoprazole – as Dual Delayed
Release Pellets 17%) conducted by the API manufacturer i.e.
M/s Vision Pharmaceuticals Pvt Ltd. Islamabad.
8. If yes, whether the stability testing has The stability testing has been performed as per SIM method
been performed as per SIM method and and degradation products have been quantified by the API
degradation products have been manufacturer i.e. M/s Vision Pharmaceuticals Pvt Ltd.
quantified? Islamabad.
9. Do you have method for quantifying the No, the firm did not have any method for quantifying the
impurities in the API? impurities in the API.
10. Do you have some remaining quantities The quantities of the API and working standard of API are
of the API, its reference standard and Nil. The firm did not purchased the impurities of the API.
11. Have you used pharmaceutical grade The firm is only filling the prepared API pellets in the Hard
excipients? Gelatin Capsule Shells which were purchased from M/s
Pharmacaps, Karachi. Further informed that vendor
qualification SOP is available but not implemented.
12. Do you have documents confirming the The firm is only filling the prepared API pellets in the Hard
import of the used excipients? Gelatin Capsule Shells which were purchased from M/s
Pharmacaps, Karachi.
13. Do you have test reports and other The firm has presented QC test reports of the excipient i.e.
records on the excipients used? Hard Gelatin Capsule used for manufacturing of Dexilan
30mg Capsule.
14. Do you have written and authorized No, SOP for production of Dexilam 30mg Capsules was
protocols for the development of available.
Dexilan 30mg Capsules?
15. Have you performed Drug-excipients The firm has not performed Drug-excipients compatibility
compatibility studies? studies.
16. Have you performed comparative The firm has not performed comparative dissolution studies.
dissolution studies? The firm replied that they were unable to arrange the
Innovator/brand leader. During discussion the firm the
Managing Director (MD) – Mr. Qasim Farooq has
undertaken that they will perform comparative dissolution
and will inform the Board concerned accordingly.
17. Do you have product development No specific Product Development (R&D) Section is
(R&D) section available in the firm at the time of inspection. The
manufacturing of trial batches has been carried out in
equipment used for commercial production which are
internally qualified.
18. Do you have necessary equipment’s No Product Development (R&D) Section is available in the
available in product development firm at the time of inspection. The manufacturing of trial
section for development of Dexilan batches has been carried out in equipment used for
30mg Capsule? commercial production which are internally qualified.
19. Are the equipment in product No Product Development (R&D) Section is available in the
development section qualified? firm at the time of inspection. The manufacturing of trial
batches has been carried out in equipment used for
commercial production which are internally qualified.
20. Do you have proper maintenance / The firm has SOP for Master calibration Plan / Calibration /
calibration / re-qualification program for qualification & re-qualification and master validation plan
the equipment used in PD section? for the equipment used in production and QC of trial batches
of Capsule dosage form which was found implemented.
21. Do you have qualified staff in product The QCM of the firm is not approved as of today, currently
development section with proper Ms. Saliha (total 7 years of experience) is looking after the
knowledge and training in product matters of Quality Control (QC) as QCM.
development? List of qualified staff is Annexed with the report.
22. Have you manufactured three stability The firm has manufactured three stability batches for the
batches for the stability studies of stability studies of Dexilan 30mg Capsule with batch
Dexilan (DDR 17%) 30mg Capsule as numbers T001, T002 and T003 with actual batch size of 616
required? Capsules for each trial.
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is the
batch size of stability batches? number of capsules per testing frequency and number of
testing frequencies while keeping in view the decision of
Registration Board (RB) in its 249th Meeting.
24. Do you have complete record of The firm has record of production of stability batches.
production of stability batches? Necessary log books of equipment used has been available
with the firm, assuring the traceability of manufacturing of
stability batches.
25. Do you have protocols for stability The firm has protocol of testing of stability batches with
testing of stability batches? them.
26. Do you have developed and validated It was informed that the firm is using API manufacturer’s
the method for testing of stability method of testing but neither the firm has performed method
batches? transfer studies nor they have data of method validation.
27. Do you have method transfer studies in It was informed that the firm neither conducted method
case when the method of testing being transfer studies; nor they have data of method validation.
lab?
28. Do you have documents confirming the The firm has documents confirming the qualification &
qualification of equipments / calibration of equipment (UV- Spectrophoto-meter, Stability
instruments being used in the test and Chamber & isocratic HPLC) being used in the test and
analysis of Dexlansoprazole (as Dual analysis of Dexlansoprazole API and the finished drug
Delayed Release Pellets 17%) API and Dexlian 30mg Capsule (as Dual Delayed Released Pellets).
the finished drug (Dexilan 30mg
Capsule)?
29. Do your method of analysis stability The firm method of testing is not stability indicating for
indicating? stability testing of their finished product.
30. Do your HPLC software is 21CFR Whole stability study is being carried out on isocratic HPLC
compliant? which is not 21CFR compliant. While verifying the
chromatograms with respect to available log book it was
observed that instead of showing date/time when actual
analysis was performed current date/time appeared on the
chromatogram.
31. Can you show Audit Trail reports on Whole stability study is being carried out on HPLC which is
Dexilan 30mg Capsule testing? not 21CFR compliant. So not audit trail is available with the
firm.
32. Do you have some remaining quantities The firm has following remaining quantities of stability
of degradation products and stability batches of Dexlian 30mg Capsule (T001-63Caps, T002-
batches? 49Caps, T003-56Caps). However, the firm did not perform
degradation studies hence there is no quantity of degradation
products.
33. Do you have stability batches kept on The firm has submitted Six (06) months accelerated and real
stability testing? time stability testing on the three stability batches of each
Dexilan 30mg Capsules and Dexilan 60mg Capsules at the
time of submission of dossier. However, further stability
testing could not be carried out due to expiry of trial batches.
After expiry of said trial batches the frim removed samples
from stability chambers.
34. Do you have valid calibration status for The firm has valid calibration/qualification (where required)
the equipment’s used in Dexilan 30mg status for the equipment used in Dexilan 30mg Capsule
Capsule production and analysis? production and analysis.
35. Do proper and continuous monitoring Continuous power supply and monitoring with back up from
and control are available for stability generator are available for stability chamber.
chamber?
36. Do related manufacturing area, The related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are rated as GMP compliant at Satisfactory level.
Decision: Registration Board after thorough deliberation rejected application of Dexilan DDR Capsule 30 mg
of M/s Medizan Labs (Pvt.) Ltd., Plot No. 313, Industrial Trinale, Kahuta Road, Model Town, Islamabad on
the basis of following observations reported by panel:
i. The firm is using API manufacturer’s method of testing for FPP testing but neither the firm has
performed method transfer studies nor they have data of method validation.
ii. The firm has submitted Six (06) months accelerated and real time stability testing on the three
stability batches of each Dexilan 30mg Capsules and Dexilan 60mg Capsules at the time of submission
of dossier. However, further stability testing could not be carried out due to expiry of trial batches.
After expiry of said trial batches the frim removed samples from stability chambers.
iii. The firm method of testing is not stability indicating for stability testing of their finished product.
iv. Whole stability study is being carried out on isocratic HPLC which is not 21CFR compliant. While
verifying the chromatograms with respect to available log book it was observed that instead of
showing date/time when actual analysis was performed, current date/time appeared on the
chromatogram.
v. Whole stability study is being carried out on HPLC which is not 21CFR compliant. So no audit trail is
available with the firm.
vi. The firm has not performed comparative dissolution studies. The firm replied that they were unable
to arrange the Innovator/brand leader.
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Dexilan 60mg
Capsule (Dexlansoprazole (as Dual Delayed Release Pellets 17%)) by M/s Medizan Labs (Pvt.) Ltd., Plot No.
313, Industrial Trinale, Kahuta Road, Model Town, Islamabad.
Reference No: F.13-11/2017-PEC (Pt) dated 6th November, 2018.
Inspection Date and Time: November 13, 2018 (Morning)
Inspection Site: M/s Medizan Labs (Pvt.) Ltd., Plot No. 313, Industrial Trinale, Kahuta Road, Model
Town, Islamabad.
Background:
The In-charge PEC, PE&R Division vide letter no. 13-11/2017-PEC(pt) dated 06.11.2018 has
communicated that the Chairman, DRB has constituted three member panel for on-site verification of authenticity of
stability data and associated documents, import of API, quality, specifications, test analysis and facilities etc. of M/s
Medizan Labs, Pvt. Ltd., Plot No. 313, Industrial Triangle, Kahuta Road, Islamabad for registration of following
products:
Sr. No. Brand Name and Composition of Drug
1 Dexilan DDR Capsule 30 mg
2 Dexialn DDR Capsule 60mg
i. Prof. Dr. Usman, Member Central Licensing Board.
ii. Dr. Muhammad Fakhruddin Aamir, Additional Director (QA&LT), DRAP, Islamabad
iii. Mr. Arslan Tariq, Assistant Director, QA&LT, DRAP, Islamabad.
Advised to verify and report on-site verification of authenticity of stability data and associated documents,
import of API, quality, specifications, test analysis and facilities etc. Further advised to verify and report date of
manufacturing initiation of stability studies of trial batches alongwith performance of dual delayed release profile at
pH 5.5 & pH 7.

The inspection was conducted by using a structured questionnaire of DRAP. For objective evidence
The details of inspection may be summarized as under:-
Q.
Question Observation by panel
No.
1. Do you have documents confirming Firm did not import Dexlansoprazole (as Dual Delayed Release
the import of API including Pellets 17%) and purchased 1.00Kg of Dexlansoprazole (as Dual
approval from DRAP? Delayed Release Pellets 17%) Batch no. DLP155T from M/s
Vision Pharmaceuticals, Pvt. Ltd Islamabad vide invoice
number 300099 dated 29.07.2016. Firm also presented Delivery
Challan No. 300101 dated 29.07.2016 of same quantity of
Dexlansoprazole (as Dual Delayed Release Pellets 17%) Batch
No. DLP155T. Goods Receiving Note (GRN) of firm at Sr. No.
4206 dated 29 07.2016 verify the delivery of the same quantity
of same batch of Dexlansoprazole (as Dual Delayed Release
Pellets 17%) from M/s Vision Pharmaceuticals, Islamabad. Page
39 of Stock Book (Stock Ledger) was also checked to verify the
receiving and issuing status of Dexlansoprazole (as Dual
Delayed Release Pellets 17%). The date of issue of
Dexlanoprazole used in manufacturing of trial batches for
stability studies were same as mentioned on BMRs. Firm has
used all 1.00Kg in manufacturing of trial batches (Dexilan 30mg
and Dexilan 60mg) for stability studies and balance quantity of
Dexlansoprazole (as Dual Delayed Release Pellets 17%) is Nil
at the time of inspection.
2. What was the rationale behind GMP compliant source (M/s Vision Pharmaceuticals Pvt Ltd,
selecting the particular manufacturer Islamabad) has been selected for Dexlansoprazole (as Dual
of API? Delayed Release Pellets 17%).
3. Do you have documents confirming As replied in para 1 above.
the import of Dexlansoprazole (as Furthermore, the firm neither purchased impurity standards nor
Dual Delayed Release Pellets 17%) performed tests of identification/quantification of impurities
reference standard and impurity during stability studies.
standards?
4. Do you have certificate of Analysis The firm has certificates of analysis for the API and working
of the API, reference standards and standard provided by supplier. Certificate of analysis (COA) of
impurity standards? impurity standard was not available as the firm neither
purchased impurity standards nor performed tests of
identification/quantification of impurities during stability studies
5. Do you have any approval of API or Yes, the firm presented documents of approval of API and GMP
GMP certificate of API certificate of API manufacturer i.e. M/s Vision Pharmaceuticals
manufacturer issued by regulatory Pvt Ltd. Islamabad issued by Drug Regulatory Authority of
authority of country of origin? Pakistan.
6. Do you use API manufacturer Yes, it was informed that the firm is using API manufacturer’s
method of testing? method of testing but neither the firm has performed method
transfer studies nor they have data of method validation.
7. Do you have stability studies reports The firm has accelerated and real time stability studies reports
on API? on the API (Dexlansoprazole – as Dual Delayed Release Pellets
17%) conducted by the API manufacturer i.e. M/s Vision
Pharmaceuticals Pvt Ltd. Islamabad.
8. If yes, whether the stability testing The stability testing has been performed as per SIM method and
has been performed as per SIM degradation products have been quantified by the API
method and degradation products manufacturer i.e. M/s Vision Pharmaceuticals Pvt Ltd.
have been quantified? Islamabad.
9. Do you have method for quantifying No, the firm did not have any method for quantifying the
the impurities in the API? impurities in the API.
10. Do you have some remaining The quantities of the API and working standard of API are Nil.
quantities of the API, its reference The firm did not purchased the impurities of the API.
standard and impurities standards?
11. Have you used pharmaceutical grade The firm is only filling the prepared API pellets in the Hard
excipients? Gelatin Capsule Shells which were purchased from M/s
Pharmacaps, Karachi. Further informed that vendor qualification
SOP is available but not implemented.
12. Do you have documents confirming The firm is only filling the prepared API pellets in the Hard
the import of the used excipients? Gelatin Capsule Shells which were purchased from M/s
Pharmacaps, Karachi.
13. Do you have test reports and other The firm has presented QC test reports of the excipient i.e. Hard
records on the excipients used? Gelatin Capsule used for manufacturing of Dexilan 60mg
Capsule.
14. Do you have written and authorized SOP for production of Dexilan 60mg Capsule was available.
protocols for the development of
Dexilan 60mg Capsules?
15. Have you performed Drug- The firm has not performed Drug-excipients compatibility
excipients compatibility studies? studies.
16. Have you performed comparative The firm has not performed comparative dissolution studies. The
dissolution studies? firm replied that they were unable to arrange the
Innovator/brand leader. During discussion the firm the
Managing Director (MD) – Mr. Qasim Farooq has undertaken
that they will perform comparative dissolution and will inform
the Board concerned accordingly.
17. Have you performed comparative The firm has not performed comparative dissolution studies. The
dissolution studies? firm replied that they were unable to arrange the
Innovator/brand leader.
18. Do you have product development No specific Product Development (R&D) Section is available in
(R&D) section the firm at the time of inspection. The manufacturing of trial
batches has been carried out in equipment used for commercial
production which are internally qualified.
19. Do you have necessary equipment’s No Product Development (R&D) Section is available in the firm
available in product development at the time of inspection. The manufacturing of trial batches has
section for development of Dexilan been carried out in equipment used for commercial production
30mg Capsule? which are internally qualified.
20. Are the equipment in product No Product Development (R&D) Section is available in the firm
development section qualified? at the time of inspection. The manufacturing of trial batches has
been carried out in equipment used for commercial production
which are internally qualified.
21. Do you have proper maintenance / The firm has SOP for Master calibration Plan / Calibration /
calibration / re-qualification qualification & re-qualification and master validation plan for
program for the equipment used in the equipment used in production and QC of trial batches of
PD section? Capsule dosage form which was found implemented.
22. Do you have qualified staff in The QCM of the firm is not approved as of today, currently Ms.
product development section with Saliha (total 7 years of experience) is looking after the matters
proper knowledge and training in of Quality Control (QC) as QCM.
product development? List of qualified staff is Annexed with the report.
23. Have you manufactured three The firm has manufactured three stability batches for the
stability batches for the stability stability studies of Dexilan 30mg Capsule with batch numbers
studies of Dexilan (DDR 17%) T001, T002 and T003 with actual batch size of 616 Capsules for
30mg Capsule as required? each trial.
24. Do you have any criteria for fixing The criteria for fixing the batch size of stability batches is the
the batch size of stability batches? number of capsules per testing frequency and number of testing
frequencies while keeping in view the decision of Registration
Board (RB) in its 249th Meeting.
25. Do you have complete record of The firm has record of production of stability batches. Necessary
production of stability batches? log books of equipment used has been available with the firm,
assuring the traceability of manufacturing of stability batches.
26. Do you have protocols for stability The firm has protocol of testing of stability batches with them.
testing of stability batches?
27. Do you have developed and It was informed that the firm is using API manufacturer’s
validated the method for testing of method of testing but neither the firm has performed method
stability batches? transfer studies nor they have data of method validation.
28. Do you have method transfer studies It was informed that the firm neither conducted method transfer
in case when the method of testing studies; nor they have data of method validation.
any other lab?
29. Do you have documents confirming The firm has documents confirming the qualification &
the qualification of equipments / calibration of equipment (UV- Spectrophoto-meter, Stability
instruments being used in the test Chamber & isocratic HPLC) being used in the test and analysis
and analysis of Dexlansoprazole (as of Dexlansoprazole API and the finished drug Dexlian 30mg
Dual Delayed Release Pellets 17%) Capsule (as Dual Delayed Released Pellets).
API and the finished drug (Dexilan
60mg Capsule)?
30. Do your method of analysis stability The firm method of testing is not stability indicating for stability
indicating? testing of their finished product.
31. Do your HPLC software is 21CFR Whole stability study is being carried out on isocratic HPLC
compliant? which is not 21CFR compliant. While verifying the
chromatograms with respect to available log book it was
observed that instead of showing date/time when actual analysis
was performed current date/time appeared on the chromatogram.
32. Can you show Audit Trail reports on Whole stability study is being carried out on HPLC which is not
Dexilan 60mg Capsule testing? 21CFR compliant. So not audit trail is available with the firm.
33. Do you have some remaining The firm has following remaining quantities of stability batches
quantities of degradation products of Dexilan 60mg Capsules (T001-70Caps, T002-60Caps, T003-
and stability batches? 70Caps). However, the firm did not perform degradation studies
hence there is no quantity of degradation products.
34. Do you have stability batches kept The firm has submitted Six (06) months accelerated and real
on stability testing? time stability testing on the three stability batches of each
Dexilan 60mg Capsules and Dexilan 60mg Capsules at the time
of submission of dossier. However, further stability testing could
not be carried out due to expiry of trial batches. After expiry of
said trial batches the frim removed samples from stability
chambers.
35. Do you have valid calibration status The firm has valid calibration/qualification (where required)
for the equipment’s used in Dexilan status for the equipment used in Dexilan 60mg Capsule
60mg Capsule production and production and analysis.
analysis?
36. Do proper and continuous Continuous power supply and monitoring with back up from
monitoring and control are available generator are available for stability chamber.
for stability chamber?
37. Do related manufacturing area, The related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are rated as GMP compliant at Satisfactory level.
Submitted for consideration of the Board
Decision: Registration Board after thorough deliberation rejected application of of Dexilan DDR Capsule 60
mg submitted by M/s Medizan Labs (Pvt.) Ltd., Plot No. 313, Industrial Trinale, Kahuta Road, Model Town,
Islamabad on the basis of following observations reported by panel:
i. The firm is using API manufacturer’s method of testing for FPP testing but neither the firm has
performed method transfer studies nor they have data of method validation.
ii. The firm has submitted Six (06) months accelerated and real time stability testing on the three stability
batches of each Dexilan 30mg Capsules and Dexilan 60mg Capsules at the time of submission of dossier.
However, further stability testing could not be carried out due to expiry of trial batches. After expiry of
said trial batches the frim removed samples from stability chambers.
iii. The firm method of testing is not stability indicating for stability testing of their finished product.
iv. Whole stability study is being carried out on isocratic HPLC which is not 21CFR compliant. While
verifying the chromatograms with respect to available log book it was observed that instead of showing
date/time when actual analysis was performed, current date/time appeared on the chromatogram.
v. Whole stability study is being carried out on HPLC which is not 21CFR compliant. So no audit trail is
available with the firm.
vi. The firm has not performed comparative dissolution studies. The firm replied that they were unable to
arrange the Innovator/brand leader.
Evaluator PEC-XII
No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Date, Fee / Local Availability
Dosage Form + (including differential
Strength), fee), GMP Inspection Report
Composition, Demanded Price / Pack Date & Remarks
Pharmacological size
Group,
Finished Product
Specification
5. M/s Pharmevo (Private) Apixa 2.5mg Tablets Form 5-D ELIQUIS (apixaban) film
Limited, Dy.No.746, coated tablets 2.5mg by
A-29, North Western Each film coated Dated: 14-5-2014 M/s Bristol-Myers
Industrial Zone, Port tablet contains: Rs: 20,000/- Squibb Company
Qasim, Karachi. Apixaban …2.5mg Dated 12-05-2014, (USFDA approved)
Challan#0062880.
Antithrombotic agent Rs: 30,000/- Last inspection dated 23-
(Direct factor Xa Dated 02-4-2018, 02-2018 confirms that the
inhibitor) Challan#0582404. firm is operating at an
10’s, Rs: 700/-, acceptable level of GMP
Manufacturer’s 14’s, Rs:980/-, compliance
Specifications. 30’s, Rs: 2100/-.
Decision in previous meeting of Registration Board:
 Registration Board in its 262nd Meeting held on 20-21st October 2016 deferred the application for
confirmation of me too status.
 Firm had initially applied on Form-5.
Drug Apixa 2.5mg Tablets
Name of Manufacturer M/s Pharmevo (Private) Limited, Karachi.
Manufacturer of API M/s Megafine Pharma (P) Ltd, Plot no.31 to 35 & 48 to 51,5,26 & K/201,
Lakhmapur, Tal.: Dindori, Dist.: Nashik, Maharashtra, India.
API Lot No. APB/A529/X/116
Description of Pack
Alu-alu foil in printed unit carton.
Stability Storage Condition Real time: 30°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 24 weeks
Frequency Accelerated: 0,1,2,3,4,6,8,10,12,14,16,18,20,22,24. (Weeks)
Real Time: 0, 1, 2, 3, 4, 6. (Months)
Batch No. 16PD-1923-02-T 16PD-1924-03-T 16PD-1925-04-T
No. of Batches 03
Date of Submission Dy.No.12094, Dated: 02-04-18.
No.
1. COA of API Yes
2. Approval of API by regulatory authority of The firm M/s MEGAFINE PHARMA (P) LTD.
country of origin or GMP certificate of API (PLOT NO. 31 TO 35 & 48 TO 51, 5,26 & K/201,
manufacturer issued by regulatory authority of VILLAGE LAKHMAPUR TALUKA DINDORI,
country of origin. NASHIK 422202) is WHO-GMP certified as per
the details available on FDA Maharashtra
https://fdawhogmp.maharashtra.gov.in/(X(1)S(zl1lqf
ba3uq4dtiokiyyw1bc))/Report/RptWHOGMPholder
s.aspx (accessed on 21/04/2018)
GMP valid up to 21/11/2018
Yes
5. Documents confirming import of API etc. Firm has submitted copy of invoice attested by
ADC, DRAP, dated 22-06-2016.
documents.
Yes
Yes
1978.
Query Reply
Identification, assay and dissolution studies have We would like to inform you that we have
not been performed at 1st and 3rd month time performed partial testing of Apixaban tablets 2.5mg
point of long term stability study of batch 16PD- & Apixaban tablets 5mg at 3rd month for samples
1923-02-T, 16PD-1924-03-T and 16PD-1925-04- kept at long term stability conditions and after
T. 6months we have performed complete testing of
Apixaban tablets 2.5mg & Apixaban tablets 5mgfor
samples kept at long term stability conditions and
their result are satisfactory and no degradation or
OOS results observed after 6 months testing which
proves that Apixaban tablets 2.5mg & Apixaban
tablets 5mg are stable and have satisfactory results
after 3rd month and also after 6 months.
No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Date, Fee / Local Availability
Dosage Form + (including differential
Strength), fee), GMP Inspection Report
Composition, Demanded Price / Pack Date & Remarks
Pharmacological size
Group,
Finished Product
Specification
6. M/s Pharmevo (Private) Apixa 5mg Tablets Form 5-D ELIQUIS (apixaban) film
Limited, A-29, North Dy.No.739, coated tablets 5mg by
Western Industrial Zone, Each film coated Dated: 14-05-2014 M/s Bristol-Myers
Port Qasim, Karachi. tablet contains: Rs: 20,000/- Squibb Company
Apixaban …5mg Dated 13-05-2014, (USFDA approved)
Challan#0062878.
Antithrombotic agent Rs: 30,000/- Last inspection dated 23-
(Direct factor Xa Dated 02-4-2018, 02-2018 confirms that the
inhibitor) Challan#0582405. firm is operating at an
10’s, Rs: 700/-, acceptable level of GMP
Manufacturer’s 14’s, Rs:980/-, compliance
Specifications. 30’s, Rs: 2100/-.
Decision in previous meeting of Registration Board:
 Registration Board in its 262nd Meeting held on 20-21st October 2016 deferred the application for
confirmation of me too status.
 Firm had initially applied on Form-5.
Drug Apixa 5mg Tablets
Name of Manufacturer M/s Pharmevo (Private) Limited, Karachi.
Manufacturer of API M/s Megafine Pharma (P) Ltd,
Plot no.31 to 35 & 48 to 51,5,26 & K/201, Lakhmapur, Tal.: Dindori, Dist.:
Nashik, Maharashtra, India.
API Lot No. APB/A529/X/116
Description of Pack
Alu-alu foil in printed unit carton.
Stability Storage Condition Real time: 30°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months Accelerated: 24 weeks
Frequency Accelerated: 0,1,2,3,4,6,8,10,12,14,16,18,20,22,24. (Weeks)
Real Time: 0,1,2,3,4,6. (Months)
Batch No. 16PD-1927-03-T 16PD-1926-02-T 16PD-1928-04-T
No. of Batches 03
Date of Submission Dy.No.12095, Dated: 02-04-18.
No.
1. COA of API Yes
2. Approval of API by regulatory authority of The firm M/s MEGAFINE PHARMA (P) LTD.
country of origin or GMP certificate of API (PLOT NO. 31 TO 35 & 48 TO 51, 5,26 & K/201,
manufacturer issued by regulatory authority of VILLAGE LAKHMAPUR TALUKA DINDORI,
country of origin. NASHIK 422202) is WHO-GMP certified as per
the details available on FDA Maharashtra
https://fdawhogmp.maharashtra.gov.in/(X(1)S(zl1lqf
ba3uq4dtiokiyyw1bc))/Report/RptWHOGMPholder
s.aspx (accessed on 21/04/2018)
GMP valid up to 21/11/2018
Yes
5. Documents confirming import of API etc. Firm has submitted copy of invoice attested by
ADC, DRAP, dated 22-06-2016.
documents.
Yes
Yes
1978.
Query Reply
Identification, assay and dissolution studies have We would like to inform you that we have performed
not been performed at 1st and 3rd month time point partial testing of Apixaban tablets 2.5mg & Apixaban
of long term stability study of batch 16PD-1927-03- tablets 5mg at 3rd month for samples kept at long
T, 16PD-1926-02-T and 16PD-1928-04-T. term stability conditions and after 6months we have
performed complete testing of Apixaban tablets
2.5mg & Apixaban tablets 5mgfor samples kept at
long term stability conditions and their result are
satisfactory and no degradation or OOS results
observed after 6 months testing which proves that
Apixaban tablets 2.5mg & Apixaban tablets 5mg are
stable and have satisfactory results after 3rd month
and also after 6 months.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of

Apixa (Apixaban) 2.5mg & 5mg Tablets by M/s PharmEvo (Pvt.) Limited, A-29, North Western
Industrial Zone, Port Qasim , Karachi.
Reference No: F.13-11/2017-PEC dated 3rd August, 2018.

Investigation Date and Time: 6th November, 2018. (Forenoon)
Investigation Site: Factory premises of M/s PharmEvo (Pvt.) Limited, A-29, North Western
Industrial Zone, Port Qasim , Karachi.
Background:
Chairman Registration Board considered the applications of M/s PharmEvo (Pvt.) Limited, A-29,
North Western Industrial Zone, Port Qasim , Karachi for registration of Apixa (Apixaban) 2.5mg &
5mg Tablets and constituted a three member panel to investigate the authenticity / genuineness of data
(import of raw material and stability data). Panel was advised to conduct inspection of the firm and to
submit report for further consideration. It was also advised to verify and report:
“Justification and scientific rationale for identification, assay and dissolution studies not
performed at 1st and 3rd month time point of long term stability study of all three batches”
4. Dr. Rafeeq Alam Khan, Meritorious Professor, Department of Pharmacology, University of
Karachi. (Member Registration Board)
5. Mr. Adnan Rizvi, Director DTL Sindh, Karachi (Member Registration Board)

personnel involved, ongoing studies, printed data and integrity and security of data in respective
databases were also audited. The details of investigation may be summarized as under:
Details of Investigation:
Apixa (Apixaban) Tablets 2.5mg & 5mg
Q. Queston Observations by Panel
No.
1. Do you have documents confirming the The firm has i mpor t ed Apixaban 85gm vi de
Import of Apixaban API including approval In voi ce No. MX 1617171 dat ed 09/ 06/ 2016
from DRAP? f r om M /S Megafine Pharma Ltd India for the
manufacturing of lab scale batches of APIXA 2.5mg
& 5mg Tablets. The firm has proper approval for the
import of the API from DRAP, Karachi.
2. What was the rationale behind selecting the The rationale behind selecting the particular source
particular manufacturer of API? of API is the laid down criteria of the firm in their
Vendor Evaluation procedure which include the
GMP status of the firm, DMF source and capability
to provide API reference standard and impurity
standard.
3. Do you have documents confirming the Firm has documents confirming the import of
import of Apixaban, reference standard and Apixaban, The APIs working standard was imported
impurity standards? at the time of import of the APIs whereas the
manufacturer has provided the impurity standards
after 24months of manufacturing stability batches.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API,
API, reference standards and impurity Working standards of the API and impurities
standards? standards.
5. Do you have GMP certificate of API Firm has GMP certificate issued by the Food and
Manufacturer issued by regulatory Authority Drug Administration M.S Bandra Mumbai,
of country of origin? Mahrashtara India.
6. Do you use API manufacturer method of The firm has u s e d API manufacturer method for
testing for testing API? testing the API.
7. Do you have stability studies reports on The firm has stability studies reports on API.
8. API?
If yes, whether the stability testing has been The stability testing has been performed as per SIM
performed as per SIM method and method and degradation products have been
degradation products have been quantified? quantified.
9. Do you have method for quantifying the The firm has API manufacturer method for
impurities in the API? quantifying the impurities in the API.
10. Do you have some remaining quantities of the Firm has some quantities of the API, working
API, its reference standard and Standard of the API and Impurities working
impurities standards? standards.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients
excipients? and include microcrystalline cellulose PH.102,
Cross Carmellose Sodium, Magnesium Stearate,
Lactose anhydrous and Sodium Lauryl Sulphate
12. Do you have documents confirming the The firm has necessary documents confirming the
import of the used excipients? import of the used excipients.
13. Do you have test reports and other records on The firm has test reports and other records on the
the excipients used? excipients used.
14. Do you have written and authorized The firm has written and authorized protocols for
protocols for the development of APIXA 2.5 the development of A P I X A 2 . 5 m g & 5 m g
mg & 5mg Tablets? Tablets
15. Have you performed Drug-excipient The firm has not performed Drug-excipient
compatibility studies? compatibility studies as the composition of their
tablets is similar to that of the innovator product
(Eliquis Tablets).
16. Have you performed comparative The firm has performed comparative dissolution
dissolution studies? studies with innovator (Eliquis Tablets)
17. Do you have product development (R&D) The firm has dedicated R&D section with
section? reasonable facilities of equipment, human resource
and utilities.
18. Do you have necessary equipment The firm has all necessary equipment related to
available in product development section for manufacturing available in R&D section for
development of Apixa 2.5mg & 5mg Tablets? manufacturing of A p i x a 2 . 5 m g & 5 m g
T a b l e t s . The quality control related to
development work has been done in the routine
quality control laboratory; however, there are
dedicated HPLCs and Human Resource for this
purpose.
19. Are the equipment in product All the equipment used in product development
development section qualified? are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration
calibration / re-qualification program for the programme. Re-qualification program for the
equipment used in PD section? equipment used in PD section.
21. Do you have qualified staff in product The firm has 06 pharmacists and 01 chemist in
development section with proper knowledge manufacturing section of product development
and training in product development? section currently with suitable knowledge and
training in product. 03 QC Analysts are dedicated
for New products testing.
22. Have you manufactured three stability The firm has manufactured three stability batches
batches for the stability studies of for the stability studies of:
Apixa 2.5 mg & 5 mg Tablets as required?Apixa 2.5mg Tablets with Batch Numbers:
16PD-1923-02-T, 16PD-1924-03-T & 16PD-1925-
04-T
Apixa 5mg Tablets with Batch Numbers:
16PD-1926-02-T, 16PD-1927-03-T & 16PD-1928-
04-T each batch is of 2500 tablets respectively. The
tablets packed in Alu / Alu blisters with pack size of
6 x10’s.
The manufacturing process is direct compression.
23. Do you have any criteria for fixing the The criteria for fixing batch size is number of tablets
batch size of stability batches? required per testing and number of testing
frequencies.
24. Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches.
25. Do you have protocols for stability testing of The firm has detailed protocols for stability testing
stability batches? of stability batches.
26. Do you have developed and validated the The firm has developed and validated stability
method for testing of stability batches? indicating method for testing of their finished
product. Firm has developed and validated another
method with gradient mode for related substances
and forced degradation studies. This new method
has been used for 24 months study on stability
batches kept on real time. The results of stability
studies have been thoroughly reviewed and the
results are satisfactory as per specifications of the
APIs manufacturers.
27. Do you have method transfer studies in case Method transfer studies have not been done,
when the method of testing being used by however, validation of the method has been
your firm is given by any other lab? performed.
28. Do you have documents confirming the The firm has documents confirming the installation
qualification of equipments / instruments being and operational qualification of the equipment /
used in the test and analysis of Apixaban and instruments being used in the test and analysis of
the finished drug? Apixaban and the finished drug.
29. Do your method of analysis stability Firm has used two different methods for testing of
indicating? stability batches. The first method is an isocratic
method used for testing of stability batches up to 18
months testing and this method is not stability
indicating. A second method has been developed,
validated and used for 24 months study of stability
batches kept on real time. This method is gradient
method and is stability indicating and properly
validated and supported by forced degradation
studies.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per
Compliant? record available with the firm.
31. Can you show Audit trail reports on Audit trail on the testing reports are available.
Apixaban testing?
32. Do you have some remaining quantities of The firm has remaining quantities of the stability
degradation products and stability batches? batches.
33. Do you have stability batches kept on The firm has kept all the three batches on
stability testing? real time and accelerated stability testing. Currently,
24 months studies have been completed with
satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the
Equipment used in Apixa2.5mg & 5mg tablets equipment used in Apixa tablets production and
production and analysis? analysis.
35. Do proper and continuous monitoring and The firm has 14 stability chambers, 02 for
control are available for stability chamber? accelerated and 12 for real time stability testing. All
the chambers are properly qualified. All the
chambers are provided with continuous power supply
and data loggers for continuous monitoring. The data
of data loggers is reviewed every 15th day.
36. Do related manufacturing area, equipment, The firm has manufacturing area provided with
personnel and utilities be rated as GMP necessary qualified equipment and utilities. The
compliant? manufacturing personnel are suitable in number
and qualification to run the manufacturing
processes as per GMP requirements. The
environmental conditions and their controls are also
proper. The overall GMP conditions can be rated as
compliant.
37 Any other query raised by Registration Board: The panel did not find any scientific rationale behind
Justification and scientific rationale for non-performance of identification, assay and
identification Assay and Dissolution studies not dissolution studies at 1st and 3rd month time points.
performed at 1st and 3rd month time point of However, the results of later time points establish the
long term stability studies of all three batches. products to be stable throughout the stability studies.
Conclusions:
1. On the basis of risk-based approach the genuineness/authenticity of stability data submitted by the
firm for registration of Apixa (Apixaban) 2.5mg & 5mg Tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well
suited for the manufacturing of Apixa 2.5mg & 5mg Tablets.
Recommendations:
The firm may kindly be granted necessary registration of Apixa 2.5mg & 5mg tablets.
Decision: Registration Board decided to approve registration of “Apixa 2.5mg and Apixa
5mg Tablet” with Innovator’s specifications by M/s Pharmevo (Pvt) Ltd. Karachi.
Manufacturer will place first three production batches of both products on long
term stability studies throughout proposed shelf life and on accelerated studies
for six months.
Evaluator PEC-VII
Sr. Name & Address Brand Name Type of Form, International Availability / Local
No. of Manufacturer / (Proprietary Name + Initial Diary & Date, Availability
Group,
Finished Product
Specification
7. M/s BioLab, Plot Dacvir Tablets Form-5 Daclatasvir Dihydrochloride Eq
No. 145, Industrial 30 mg Dy. No: 3512 30mg Base USFDA
Triangle, Kahuta Each film coated Dated.22-5-2017 Decvir of Pharmevo
Road, Islamabad. tablet contains: Rs.20,000/- According to last inspection
Daclatasvir (as (22-May-2017) report date 5-6 December 2017
dihydrochloride) As per SRO the company is given GMP
…… 30mg certificate
(Anti-viral)
(In-house
specifications)
Drug Dacvir Tablets 30 mg
Name of Manufacturer M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad.
Manufacturer of API Each film coated tablet contains:
Daclatasvir (as dihydrochloride) …… 30mg
API Lot No. Daclatasvir dihydrochloride: DSV-RD201612101
DSV-RD201703101
Description of Pack
(Container closure 28’s, in Alu Alu blister
system)
Stability Storage Real time : 30°C ± 2°C / 75% ± 5% RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5% RH
Frequency Accelerated: 0,1, 2,3,4,6,12,16,20, 26 (Week)
Batch No. DTT-001 DTT-002 DTT-003
Batch Size 1580 1580 1580

No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority Daclatasvir Dihydrochloride: Copy of GMP
of country of origin or GMP certificate certificate issued to Ruyuan HEC pharma Co. Ld
of API manufacturer issued by Xiaba development zone. Ruyuan country Shaoguan
regulatory authority of country of origin. city, 512721, Guangdong province. valid upto
14/3/2018. The said certificate has been verified from
following website link when accessed on 23-4-2018
from http://www.jxda.gov.cn/ the issuing authority is
Shaoguan city, not Guangdong province.
yes
Yes
sheets etc.
5. Documents confirming import of API Daclatasvir: Copy of commercial invoice has been
etc. submitted, Drug import license has been issued by
ADC, Islamabad DRAP for 250 gm Daclatasvir HCL.
Another COA and form 3, form 7 from batch DSV-
RD201703101 is also provided.
stability study till assigned shelf life of Yes
the product.
Yes
i. Submitted GMP certificate of supplier of API (Daclatasvir dihydrochloride), i.e Ruyuan HEC
pharma Co. Ld Xiaba development zone. Ruyuan country Shaoguan city, 512721, Guangdong
province has been issued by Shaoguan Food and Drug of People’s Republic of China, which is not
the relevant Drug regulatory authority.
ii. The formula used to calculate the assay and dissolution is not correct.
iii. Why there is so much variation in retention time of principle peaks i.e. Daclatasvir (as
dihydrochloride) in chromatograms of drug assay and dissolution area at different time points.
iv. The method of dissolution is not according to USFDA dissolution method as Phosphate
Buffer, pH 6.8 with 0.75% Brij 35 is used as dissolution media in USFDA.
v. Clarification is required, regarding variation in run time of chromatograms in assay and dissolution
analysis.
vi. Detailed method of testing including assay, pH and sterility etc. is not provided along with the
stability protocols and specifications
vii. Clarification is required, since the pack size and packaging material of container.
viii. Clarification is required, regarding the use of 2 batches of API.
Sr.# Deficiency/Observation Response by Biolabs Pharma.
i. Submitted GMP certificate The GMP provided was of Ruyan HEC pharma Co. Ltd.
of supplier of API Xiaba development zone, 512721 Shaoguan city, Ruyuan
(Daclatasvir county, Guangdong province china, issued by shaoguan
dihydrochloride), i.e Ruyuan USFDA
HEC pharma Co. Ld Xiaba (attested and already approved in 283) GMP certificate
development zone. Ruyuan issued to same firm by European and US agencies are
country Shaoguan city, also provided
512721, Guangdong
province has been issued by
Shaoguan Food and Drug of
People’s Republic of China,
which is not the relevant
Drug regulatory authority.
ii. The formula used to The formula used for the calculation of dissolution and
calculate the assay and assays per pharmacopeia, As per official books factors
dissolution is not correct. and potency might not be mentioned in the calculated
formula.
iii. Why there is so much 1. The results were calculated based on system suitability
variation in retention time of performance during each test however the retention time
principle peaks i.e. of the sample peak correlates with the retention time of
Daclatasvir (as the reference peaks during each run i.e. assay and
dihydrochloride) in dissolution.
chromatograms of drug 2. 06 batches of declatasvir 30 mg tablet were
assay and dissolution area at manufactured in the same month (may 2017) and
different time points. stability testing was performed on weekly basis per
DRAP guideline. So in the first month 24 test for decvir
30 mg were to be performed. In order to complete the
testing on weekly basis as per new schedule run time was
shortened. However it is reflected through
chromatograms that in each analysis the retention time of
principle peak obtained in the reference standard
correlates to the principle peak obtained in the same
chromatograms.
iv. The method of dissolution is As per USFDA the dissolution medium is phosphate
not according to USFDA buffer pH 6.8 with brij 35. In the SAP provided with
dissolution method as dossier the medium mentioned was also phosphate buffer
Phosphate Buffer, pH 6.8 pH 6.8 with brij 35 but brij 35 was missing during
with 0.75% Brij 35 is used typing. However we have used the same medium as per
as dissolution media in USFDA. The invoice and purchase requisition of the brij
USFDA. 35 are attached here within.
v. Detailed method of testing SAP and stability protocols is provided
including assay, pH and
sterility etc. is not provided
along with the stability
protocols and specifications
vi. Clarification is required, 28’s and packed in Alu Alu blister
since the pack size and
packaging material of
container.
vii. Clarification is required, Initially the 250 gm material was purchased for monthly
regarding the use of 2 stability study. However after on in order to comply with
batches of API. DRAP guideline for weekly stability study additional
material was required. So additional 250 gm API was
purchased from same vendor. So in 2 batches of dacavir
60 mg single lot of API was used but in 3rd batch 2 lots of
API were used.
Report on investigation of genuineness / authenticity of data submitted for registration of Dacvir
30mg Tablet (Daclatasvir) of M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road,
Islamabad.
Reference No: F.13-11/2017-PEC dated 28 September 2018
Investigation Date and Time: 8 November, 2018 (Afternoon)
Investigation Site: Factory premises of M/s Biolab Pharmaceuticals.
Background:
M/s. Biolab Pharmaceuticals, Islamabad have applied for registration of Dacvir 30mg Tablet
(Daclatasvir). PEC considered scientifically rational laboratory scale data submitted by the firm as pre-
requisite of registration, and the Chairman Registration Board constituted a three member panel for
on-site investigation to confirm genuineness / authenticity of stability data and associated documents,
1. Dr. Qurban Ali, (Member Registration Board)
2. Mr. Fakhruddin Amir, Additional director DRAP, Islamabad
3. Mst Sidra Khalid (Assistant Director, PE& R Division, DRAP)
Investigation to confirm genuineness / authenticity of stability data and associated documents,

databases were also audited. The details of investigation is summarized as under:
a. General Information.
Name of Manufacturer M/s Bio Pharmaceuticals (Pvt) Ltd,

Physical Address M/s BioLab, Plot No. 145, Industrial Triangle,
Contact Address M/s BioLab, Plot No. 145, Industrial Triangle,
Date of Inspection. 8-November-2018
Purpose of Inspection Verification of Authenticity of Stability Data for
Purpose of Registration of Drugs with reference
DRAP’s Letter dated 28 September 2018
1. Dacvir 30mg Tablet
Q.No. Question Observation by panel
1. Do you have documents confirming Firm have copy of ADC (Islamabad) attested 10-
the import of API including approval 2-17, Commercial invoice, Form 3, Form 7.
from DRAP? B# DSV-RD201612101 (0.250Kg)
Ruyuan HEC Pharm Co., China
2. What was the rationale behind Selected on the basis of GMP status of the firm &
selecting the particular manufacturer Vendor prequalification proforma. They have
of API? selected this vendor by following the approved
procedure. Selection is based on availability of
GMP, open part of DMF and supply to other firms
by the suppliers.
3. Do you have documents confirming Firm imported reference standard and impurity
the import of API reference standard working standards along with API package.
and impurity standards? Presence of API reference standard and impurities
working standards were physically verified. Under
taking from API manufacturer for standard
submission available.
4. Do you have certificate of Analysis of COA of API, Reference standard and impurity
the API, reference standards and standard were available
impurity standards?
5. Do you have GMP certificate of API The GMP certificate issued to Ruyuan HEC
manufacturer issued by regulatory pharma Co. Ld Xiaba development zone. Ruyuan
authority of country of origin? country Shaoguan city, 512721, Guangdong
province has been issued by Center for
certification and evaluation, Guangdong food and
drug administration valid up to 20/8/2016. It was
found from available record that above source is
USFDA approved.
6. Do you use API manufacturer method The firm used API manufacturer’s method of
of testing for testing API? testing
7. Do you have stability studies reports The firm has stability studies reports of API from
on API? API manufacturer.
8. If yes, whether the stability testing The stability testing had been performed as per
has been performed as per SIM SIM method and degradation products had been
method and degradation products quantified.
have been quantified?
9. Do you have method for quantifying Firm had testing method to quantify the impurities
the impurities in the API? in API.
10. Do you have some remaining Firm has some remaining quantities of API, its
quantities of the API, its reference reference standard while impurities standards are
standard and impurities standards? nil.
API: 9.00gm Aprox.
Reference Standard: 190mg Aprox.
Impurity standards: Nil
11. Have you used pharmaceutical grade Firm has used pharmaceutical grade excipients in
excipients? the manufacturing of stability batches.
12. Do you have documents confirming Firm has necessary documents confirming import
the import of the used excipients? / purchase of used excipients in the formulation.
13. Do you have test reports and other The firm has test reports and other records of the
records on the excipients used? excipients used. ADC clearance for Avicel 102
attached.
Remaining imported through local intender.
protocols for the development of the development of product.
applied formulation?
15. Have you performed Drug-excipient Firm has informed that their formulation is
compatibility studies? qualitatively similar to the innovator product,
therefore they have not performed drug-excipient
16. Have you performed comparative Comparative dissolution was performed by
dissolution studies? comparator brand (Daklana 30mg Tab) by
Ferozsons Laboratories.
Detail Test product Reference
product
Brand Dacvir 30mg Tab Daklana
30mg Tab
Medium Phosphate buffer 6.8 with0.75%
Brij 35
RPM 75 75
Test product showed comparable dissolution
profile with reference product.
(R&D) section
18. Do you have necessary equipment Product development section had necessary
available in product development equipment to develop products
formulation?
19. Are the equipment in product The available equipment in product development
development section qualified? section were qualified. Documents for installation
and operation qualification were presented.
20. Do you have proper maintenance / The firm has SOP for maintenance / calibration /
calibration / re-qualification program re-qualification program for the equipment used in
for the equipment used in PD section? production and QC used for product development
section. Third party calibrations are performed
thrice a year.
21. Do you have qualified staff in product Firm has dedicated qualified staff available in
development section with proper product development section (Manager R&D,
knowledge and training in product Executive R&D, Analyst).
development?
22. Have you manufactured three stability The firm had manufactured three stability batches
batches for the stability studies of for the stability
applied formulation as required? Product Batch 1 Batch 2 Batch 3
Dacvir 30mg DTT-001 DTT-002 DTT-003

Tablet
(Daclatasvir) 1580 1580 Tablet 1580
Tablet Tablet
5-17 5-17 5-17
The Batch size for each batch is 1580 tablet
23. Do you have any criteria for fixing As per statement of the firm the criteria for fixing
the batch size of stability batches? the batch size of stability batches is the number of
tablets per testing frequency and number of
testing frequencies.
24. Do you have complete record of The firm had complete record of production of
production of stability batches? stability batches. Necessary log books of
equipment used has been available with the firm,
assuring the traceability of manufacturing and
analysis of stability batches.
25. Do you have protocols for stability The firm had protocols for stability testing of
testing of stability batches? stability batches.
26. Do you have developed and validated The firm had developed and validated method of
the method for testing of stability testing for finished product based on method of
batches? testing of API manufacturer.
27. Do you have method transfer studies The firm has not conducted method transfer
in case when the method of testing studies.
any other lab?
28. Do you have documents confirming The firm had proper documents confirming the
the qualification of equipment’s / qualification of equipment / instruments being
instruments being used in the test and used in the test and analysis of API and the
analysis of API and the finished drug? finished drug.
29. Do your method of analysis stability Firm had validated testing method which was
indicating? stability indicating.
30. Do your HPLC software 21CFR Firm has more than 1 HPLCs.
Compliant? The firm have HPLC system from Schimadzu
(LC-20AT VP) Lab Solutions® Software (version
6.5) which is 21CFR Compliant. It was used for
stability studies of tablet at most of the time
points. For other time points, analysis was
performed on Non-21 CFR Compliant software
for which log books were shown. however the
record from logbooks, analytical test reports was
verifiable onsite.
31. Can you show Audit trail reports on Firm had demonstrated audit trail reports (assay &
applied formulation testing? dissolution analysis on HPLC) for the submitted
stability batches at some time points. however the
verifiable onsite
32. Do you have some remaining The firm had remaining quantities of stability
quantities of degradation products and batches kept in stability chamber. Firm has 18
stability batches? packs of each batch.
stability testing?
34. Do you have valid calibration status The firm had valid calibration status for the
for the equipment used in production equipment used in production and analysis.
and analysis?
35. Do proper and continuous monitoring The firm has stability chambers for carrying out
and control are available for stability accelerated and real time stability studies provided
chamber? with uninterrupted power supply and USB data
loggers. Digital data logger attached with chamber
is along with 5KV backup generator with ATS.
36. Do related manufacturing area, Firm has dedicated area for product development.
equipment, personnel and utilities be Related manufacturing area, equipment, personnel
rated as GMP compliant? and utilities were cGMP compliant to satisfactory
level.
On the basis of available records, discussions with the technical staff and the facilities
provided, the genuineness / authenticity of stability data submitted by the firm for Dacvir 30mg Tablet
(Daclatasvir) is verifiable to satisfactory level. Related manufacturing area, equipment, personnel &
Utilities are rated as GMP Compliant to satisfactory level.
Decision:
Registration Board decided to approve registration of “Dacvir 30mg Tablet (Daclatasvir)” by
M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad. Manufacturer will
place first three production batches of both products on long term stability studies throughout
Group,
Finished Product
Specification
8. M/s BioLab, Plot Dacvir Tablets Form-5 Daclatasvir Dihydrochloride Eq
No. 145, Industrial 60 mg Dy. No: 3514 60mg Base USFDA
Triangle, Kahuta Each film coated Dated.22-5-2017 Decvir of Pharmevo
Road, Islamabad. tablet contains: Rs.20,000/- According to last inspection
Daclatasvir (as (22-May-2017) report date 5-6 December 2017
dihydrochloride) As per SRO the company is given GMP
…… 60mg certificate
(Anti-viral)
(Innovators
specifications)
Drug Dacvir Tablets 60 mg
Name of Manufacturer M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad.
Manufacturer of API Each film coated tablet contains:
Daclatasvir (as dihydrochloride) …… 60mg
API Lot No. Daclatasvir dihydrochloride: DSV-RD201612101
DSV-RD201703101
Description of Pack
28’s and packed in Alu Alu blister
Frequency Accelerated: 0,1, 2,3,4,6,12,16,20, 26 (Week)
Batch No. DTT-001 DTT-002 DTT-003
Batch Size 1580 1580 1580

No. of Batches 03
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority Daclatasvir Dihydrochloride: Copy of GMP
of country of origin or GMP certificate certificate issued to Ruyuan HEC pharma Co. Ld
of API manufacturer issued by Xiaba development zone. Ruyuan country Shaoguan
regulatory authority of country of origin. city, 512721, Guangdong province. valid upto
14/3/2018. The said certificate has been verified from
following website link when accessed on 23-4-2018
from http://www.jxda.gov.cn/ the issuing authority is
Shaoguan city, not Guangdong province.
Yes
Yes
sheets etc.
5. Documents confirming import of API Daclatasvir: Copy of commercial invoice has been
etc. submitted, Drug import license has been issued by
ADC, Islamabad DRAP for 250 gm Daclatasvir HCL.
Another COA and form 3, form 7 from batch DSV-
RD201703101 is also provided.
stability study till assigned shelf life of Yes
the product.
Yes
i. Submitted GMP certificate of supplier of API (Daclatasvir dihydrochloride), i.e Ruyuan HEC
pharma Co. Ld Xiaba development zone. Ruyuan country Shaoguan city, 512721, Guangdong
province has been issued by Shaoguan Food and Drug of People’s Republic of China, which is not
the relevant Drug regulatory authority.
ii. The formula used to calculate the assay and dissolution is not correct.
iii. Why there is so much variation in retention time of principle peaks i.e. Daclatasvir (as
dihydrochloride) in chromatograms of drug assay and dissolution area at different time points.
iv. The method of dissolution is not according to USFDA dissolution method as Phosphate Buffer, pH
6.8 with 0.75% Brij 35 is used as dissolution media in USFDA.
v. Clarification is required, regarding variation in run time of chromatograms in assay and dissolution
analysis.
vi. Detailed method of testing including assay, pH and sterility etc. is not provided along with the
stability protocols and specifications
vii. Clarification is required, since the pack size and packaging material of container.
viii. Clarification is required, regarding the use of 2 batches of API.
It is specially recommended to the panel to verify the following from onsite inspection
v. Clarification regarding variation in run time of chromatograms in assay and dissolution
analysis.
vi. The method of dissolution is not according to USFDA dissolution method as
Phosphate Buffer, pH 6.8 with 0.75% Brij 35 is used as dissolution media in USFDA. Firm
claim that in the SAP provided with dossier the medium mentioned was also phosphate buffer
pH 6.8 with brij 35 but brij 35 was missing during typing. However this should be checked
from there records.
Sr.# Deficiency/Observation Response by Biolabs Pharma.
i. Submitted GMP certificate of The GMP provided was of Ruyan HEC pharma Co. Ltd.
supplier of API (Daclatasvir Xiaba development zone, 512721 Shaoguan city, Ruyuan
dihydrochloride), i.e Ruyuan county, Guangdong province china, issued by shaoguan
HEC pharma Co. Ld Xiaba USFDA
development zone. Ruyuan (attested and already approved in 283) GMP certificate
country Shaoguan city, 512721, issued to same firm by European and US agencies are
Guangdong province has been also provided
issued by Shaoguan Food and
Drug of People’s Republic of
China, which is not the relevant
Drug regulatory authority.
ii. The formula used to calculate The formula used for the calculation of dissolution and
the assay and dissolution is not assays per pharmacopeia, As per official books factors
correct. and potency might not be mentioned in the calculated
formula.
iii. Why there is so much variation 1. The results were calculated based on system suitability
in retention time of principle performance during each test however the retention time
peaks i.e. Daclatasvir (as of the sample peak correlates with the retention time of
dihydrochloride) in the reference peaks during each run i.e. assay and
chromatograms of drug assay dissolution.
and dissolution area at different 2. 06 batches of declatasvir 30 mg tablet were
time points. manufactured in the same month (may 2017) and
stability testing was performed on weekly basis per
DRAP guideline. So in the first month 24 test for decvir
30 mg were to be performed. In order to complete the
testing on weekly basis as per new schedule run time was
shortened. However it is reflected through
chromatograms that in each analysis the retention time of
principle peak obtained in the reference standard
correlates to the principle peak obtained in the same
chromatograms.
iv. The method of dissolution is not As per USFDA the dissolution medium is phosphate
according to USFDA dissolution buffer pH 6.8 with brij 35. In the SAP provided with
method as Phosphate Buffer, pH dossier the medium mentioned was also phosphate buffer
6.8 with 0.75% Brij 35 is used pH 6.8 with brij 35 but brij 35 was missing during
as dissolution media in USFDA. typing. However we have used the same medium as per
USFDA. The invoice and purchase requisition of the brij
35 are attached here within.
v. Detailed method of testing SAP and stability protocols is provided
including assay, pH and sterility
etc. is not provided along with
the stability protocols and
specifications
vi. Clarification is required, since 28’s and packed in Alu Alu blister
the pack size and packaging
material of container.
vii. Clarification is required, Initially the 250 gm material was purchased for monthly
regarding the use of 2 batches of stability study. However after on in order to comply with
API. DRAP guideline for weekly stability study additional
material was required. So additional 250 gm API was
purchased from same vendor. So in 2 batches of dacavir
60 mg single lot of API was used but in 3rd batch 2 lots of
API were used.
Report on investigation of genuineness / authenticity of data submitted for registration of Dacvir

60mg Tablet (Daclatasvir) of M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road,
Islamabad.
Reference No: F.13-11/2017-PEC dated 28 September, 2018.

Background:
M/s. Biolab Pharmaceuticals, Islamabad have applied for registration of Dacvir 60mg Tablet
(Daclatasvir). PEC considered scientifically rational laboratory scale data submitted by the firm as pre-
requisite of registration, So the chairman Registration board has constituted a three member panel for

2. Mr. Fakhruddin Amir, Additional director QA.& LT DRAP, Islamabad


Physical Address M/s BioLab, Plot No. 145, Industrial Triangle,
Contact Address M/s BioLab, Plot No. 145, Industrial Triangle,
Purpose of Inspection Verification of Authenticity of Stability Data for
Purpose of Registration of Drugs with reference
DRAP’s Letter dated 28 September 2018
1. Dacvir 60mg Tablet (Daclatasvir)

No.
1. Do you have documents confirming the Firm have copy of ADC (Islamabad) attested
import of API including approval from 10-2-17, Commercial invoice, Form 3, Form 7.
DRAP? B# DSV-RD201612101 (0.250Kg)
2. What was the rationale behind selecting Selected on the basis of GMP status of the firm
the particular manufacturer of API? &
Vendor prequalification proforma. They have
selected this vendor by following the approved
GMP, open part of DMF and supply to other
firms by the suppliers.
3. Do you have documents confirming the Firm imported reference standard and impurity
import of API reference standard and working standards along with API package.
impurity standards? Presence of API reference standard and
impurities working standards were physically
verified. Under taking from API manufacturer
for standard submission available.
4. Do you have certificate of Analysis of the COA of API, Reference standard and impurity
API, reference standards and impurity standard were available
standards?
manufacturer issued by regulatory pharma Co. Ld Xiaba development zone.
authority of country of origin? Ruyuan country Shaoguan city, 512721,
Guangdong province has been issued by Center
for certification and evaluation, Guangdong
food and drug administration valid up to
20/8/2016. It was found from available record
that above source is USFDA approved.
6. Do you use API manufacturer method of The firm used API manufacturer’s method of
testing for testing API? testing
7. Do you have stability studies reports on The firm has stability studies reports of API
API? from API manufacturer.
8. If yes, whether the stability testing has The stability testing had been performed as per
been performed as per SIM method and SIM method and degradation products had been
degradation products have been quantified.
quantified?
9. Do you have method for quantifying the Firm had testing method to quantify the
impurities in the API? impurities in API.
10. Do you have some remaining quantities of Remaining quantities of API and impurity
the API, its reference standard and standards are nil while reference standard is
impurities standards? available.
API: Nil
Impurity Standard: Nil
11. Have you used pharmaceutical grade Firm has used pharmaceutical grade excipients
excipients? in the manufacturing of stability batches.
12. Do you have documents confirming the Firm has necessary documents confirming
import of the used excipients? import / purchase of used excipients in the
formulation
13. Do you have test reports and other records The firm has test reports and other records of
on the excipients used? the excipients used. ADC clearance for Avicel
102 attached.
14. Do you have written and authorized The firm has written and authorized protocols
protocols for the development of applied for the development of product.
formulation?
therefore they have not performed drug-
dissolution studies? comparator brand (Daklana 60mg Tab) by
Ferozsons Laboratories.
product
Brand Dacvir 60mg Daklana
Tab 60mg Tab
Medium Phosphate buffer 6.8
with0.75% Brij 35
RPM 75 75
Test product showed comparable
dissolution profile with reference product.
17. Do you have product development (R&D) The firm had product development (R&D)
section section.
available in product development section equipment to develop products
for development of applied formulation?
19. Are the equipment in product The available equipment in product
development section qualified? development section were qualified. Documents
for installation and operation qualification were
presented.
20. Do you have proper maintenance / The firm has SOP for maintenance / calibration
calibration / re-qualification program for / re-qualification program for the equipment
the equipment used in PD section? used in production and QC used for product
development section. Third party calibrations
are performed thrice a year.
development?
22. Have you manufactured three stability The firm had manufactured three stability
batches for the stability studies of applied batches for the stability
formulation as required? Product Batch 1 Batch 2 Batch 3
Dacvir DTT-001 DTT-002 DTT-003
60mg
Tablet 1580 1580 1580
(Daclatas Tablet Tablet Tablet
vir) 5-17 5-17 5-17
23. Do you have any criteria for fixing the As per statement of the firm the criteria for
batch size of stability batches? fixing the batch size of stability batches is the
number of tablets per testing frequency and
number of testing frequencies.
equipment used has been available with the
firm, assuring the traceability of manufacturing
and analysis of stability batches.
25. Do you have protocols for stability testing The firm had protocols for stability testing of
26. Do you have developed and validated the The firm had developed and validated method
method for testing of stability batches? of testing for finished product based on method
of testing of API manufacturer.
27. Do you have method transfer studies in The firm has not conducted method transfer
case when the method of testing being studies.
lab?
28. Do you have documents confirming the The firm had proper documents confirming the
qualification of equipment’s / instruments qualification of equipment / instruments being
being used in the test and analysis of API used in the test and analysis of API and the
and the finished drug? finished drug.
(LC-20AT VP) Lab Solutions® Software
(version 6.5) which is 21CFR Compliant. It was
used for stability studies of tablet at most of the
time points. For other time points, analysis was
for which log books were shown. However the
record from logbooks, analytical test reports
was verifiable onsite.
31. Can you show Audit trail reports on Firm had demonstrated audit trail reports (assay
applied formulation testing? & dissolution analysis on HPLC) for the
submitted stability batches at some time points.
however the record from logbooks, analytical
test reports was verifiable onsite
32. Do you have some remaining quantities of The firm had remaining quantities of stability
degradation products and stability batches kept in stability chamber.
batches? Batch DTT-001=18packs
Batch DTT-002=21packs
Batch DTT-003=19packs
33. Do you have stability batches kept on The firm had stability batches on stability
stability testing? testing.
34. Do you have valid calibration status for The firm had valid calibration status for the
the equipment used in production and equipment used in production and analysis.
analysis?
35. Do proper and continuous monitoring and The firm has stability chambers for carrying out
control are available for stability accelerated and real time stability studies
chamber? provided with uninterrupted power supply and
USB data loggers. Digital data logger attached
with chamber is along with 5KV backup
generator with ATS.
36. Do related manufacturing area, Firm has dedicated area for product
equipment, personnel and utilities be rated development. Related manufacturing area,
as GMP compliant? equipment, personnel and utilities were cGMP
compliant to satisfactory level.
provided, the genuineness / authenticity of stability data submitted by the firm for Dacvir 60mg Tablet
(Daclatasvir) is verifiable to satisfactory level. Related manufacturing area, equipment, personnel &
Utilities are rated as GMP Compliant to satisfactory level.
Decision:
Registration Board decided to approve registration of “Dacvir 60mg Tablet (Daclatasvir)” by
M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad. Manufacturer will
place first three production batches of both products on long term stability studies throughout
Group,
Finished Product
Specification
9. M/s Biolabs (Pvt.) Sofos 400mg tablet Form-5 Sovaldi 400mg film-coated
Limited, Plot # Each film-coated Dy. No: 3511 tablets of M/s Gilead Sciences
145, Industrial tablet contains: Dated.22-05-2017 International Limited, UK
Triangle, Kahuta Sofosbuvir….400m Rs.20,000/- (22-05- (MHRA Approved)/ Sofiget of
Road, Islamabad. g 2017) M/s Getz Pharma (Reg. #
(Anti-viral) 15’s ; as per PRC 079982)
In-house (MOH) Last GMP inspection was
Specifications 28’s; as per PRC conducted on 05-12-2017 & 06-
(MOH) 12-2017 and the report
concludes “fair” GMP
compliance.
Evaluation by PEC:
Firm has submitted 6 months and 2 weeks (26 weeks) accelerated and real time stability studies
data.
Drug Sofos 400mg tablet
Name of Manufacturer M/s Biolabs (Pvt.) Limited, Plot # 145, Industrial Triangle, Kahuta Road,
Islamabad.
Manufacturer of API M/s Ruyuan Hec Pharm Co. Ltd., Xiaba Development Zone, Ruyuan
Country, Shaoguan City, Guangdong Province, China
API Lot No. YAKB-EM201703201
Description of Pack 28’s
Frequency Accelerated: 0, 3, 6 (month) Real Time: 0, 3, 6 (month)
Batch No. Sofos-T01 Sofos-T02 Sofos-T03
Batch Size 2000 tablets 2000 Tablets 2000 Tablets
No. of Batches 03
No.
1. COA of API Firm has submitted CoA of Sofosbuvir Form-VI
Batch # YAKB-EM201703201 by M/s Ruyuan HEC
Pharm.
2. Approval of API by regulatory authority Firm has submitted GMP certificate of M/s Ruyuan
of country of origin or GMP certificate HEC Pharm Co. Ltd., Xiaba Development Zone,
of API manufacturer issued by Ruyuan Country, Shaoguan City, Guangdong
regulatory authority of country of origin. Province issued by SHAOGUAN FOOD AND DRUG
ADMINISTRATION, CHINA.
The issuing authority is a District Regulatory

Authority.
sheets etc.
5. Documents confirming import of API Firm has submitted ADC Clearance documents Dated:
etc. 21-04-2017 confirming import of Sofosbuvir 2.5kg
and Ledipesvir 1.5kg from M/s WIS Pharmatek
Company Co. limited China, manufactured by M/s
Ruyuan HEC Pharm.
Firm has also submitted copy of Airway Bill, Form-3
and Form-7.
As per the ADC clearance, the API Sofosbuvir and
Ledipesvir is imported for manufacturing of Bio-
Sofledi Tablet (Reg. # EX-005765).
7. Commitment to continue real time Yes
stability study till assigned shelf life of
the product.
8. Commitment to follow Drug Yes
 GMP Certificate of the API manufacturer should be issued by relevant regulatory authority as
per the decision of 274th meeting of the Registration Board but the submitted GMP is issued by
SHAOGUAN FOOD AND DRUG ADMINISTRATION, CHINA which is a District
regulatory authority.
 As per the ADC clearance, the API Sofosbuvir and Ledipesvir is imported for manufacturing
of Bio-Sofledi Tablet (Reg. # EX-005765) while the applied drug is a different one i.e. Sofos
400mg tablet.
S. Deficiencies communicated through letter Reply by the firm
No.
1. Provide GMP Certificate of the API Firm has submitted GMP certificate of
manufacturer issued by relevant Regulatory Daclatasvir Dihydrochloride issued by
Authority as per the decision of 274th meeting SHAOGUAN FOOD AND DRUG
of the Registration Board, since the submitted ADMINISTRATION, CHINA which is a
GMP is issued by SHAOGUAN FOOD AND District regulatory authority.
DRUG ADMINISTRATION, CHINA which is
a District regulatory authority.
2. As per the ADC clearance, the API Sofosbuvir In ADC it was written that API is for
and Ledipesvir is imported for manufacturing export only for Biosofledi (Reg No. Ex-
of Bio-Sofledi Tablet (Reg. # EX-005765). 005765). However, the API (Sofosbuvir)
Justification is required in this regard. was imported for stability study of
Sofosbuvir for R&D purpose as mentioned
in commercial invoice (Invoice #
WIS170024, Date: 10-04-17).
3. Submit Commercial Invoice of the relevant Commercial invoice submitted is of
drug duly signed and attested by the ADC, Sofosbuvir and Ledipasvir.
DRAP.
4. Submit stability studies protocols including raw  Firm has submitted its stability
data sheets of standard samples, absorbance protocols.
values of standards and all samples and all the  Firm has now submitted correct
relevant calculations especially the formula on formula of calculating the
which the percentage of assay has been percentage of assay while the
calculated. submitted calculations are
according to the following
formula:
%age of assay= average peak of
samples x 100
average peak of standards
5. Provide Description of container closure As per innovator specs, the pack size of
system. Sofos 400mg tablet (Sofosbuvir) is 28’s
and packed in HDPE bottles with child
resistant closure.
6. Provide finished product specifications and In-house specifications and test methods
detail of test methods. provided.
7. Provide undertaking to follow Drug Provided
8. Dissolution tests are not performed in the As per Drap guideline in 251st Registration
accelerated and real time conditions of first Board meeting, there is partial testing on 1st
and third week of all the batches. Justify. & 3rd week so we have performed the assay
test and omitted the dissolution test on
these points.
9. Peaks are not symmetrical in the The peak symmetry parameter e.g. tailing
chromatograms and fronting is observed for factor etc. is within limit so it is in the
both standard and sample. Justify. acceptable range. So we consider it for
analysis purpose. (Justification of fronting
is asked while given one is of tailing
factor).
10. Average weight of the tablets is not provided. As per formulation, the average weight is
1040mg/ tablet.
11. Provide initial data of all the three batches. The raw data sheets of initial data provided
of all three batches do not match the
stability data sheets.
i. The dissolution of first batch i.e.
Sofos- T01 in raw data sheets is
89.59% while in stability data
sheets, it is 98.51%. (Both
accelerated and real time conditions
are not mentioned in the raw data
sheets.)
ii. The %age of assay of third batch i.e.
Sofos- T03 in raw data sheets is
99.44% while in stability data
sheets, it is 101.07%. (Both
accelerated and real time conditions
are not mentioned in the raw data
sheets.)
Report on investigation of genuineness / authenticity of data submitted for registration of Sofos

400mg Tablet (Safosbovir) of M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road,
Islamabad.
Reference No: F.13-11/2017-PEC dated 29-oct, 2018.

Background:
M/s. Biolab Pharmaceuticals, Islamabad have applied for registration of Sofos 400mg Tablet
(Safosbovir). PEC considered scientifically rational laboratory scale data submitted by the firm as pre-
requisite of registration, So the chairman Registration board has constituted a three member panel for
Physical Address M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad
Contact Address M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad
Purpose of Inspection Verification of Authenticity of Stability Data for Purpose of
Registration of Drugs with reference DRAP’s Letter
1. Sofos 400mg Tablet

No.
1. Do you have documents confirming Firm have copy of ADC (Islamabad) attested 21-4-
the import of API including approval 17, Commercial invoice, Form 3, Form 7, airway
from DRAP? bill.
Sofosbuvri: BYAKBIII-EM2017003201 (2.50Kg)
2. What was the rationale behind Selected on the basis of GMP status of the firm &
selecting the particular manufacturer Vendor prequalification proforma. They have
of API? selected this vendor by following the approved
GMP, open part of DMF and supply to other firms
by the suppliers.
3. Do you have documents confirming Firm imported sofosbuvir reference standard and
the import of API reference standard impurity working standards along with API
and impurity standards? package. Presence of API reference standard and
impurities working standards were physically
verified. Under taking from API manufacturer for
standard submission available.
4. Do you have certificate of Analysis of COA of API, Reference standard and impurity
the API, reference standards and standard were available
impurity standards?
manufacturer issued by regulatory pharma Co. Ld Xiaba development zone. Ruyuan
authority of country of origin? country Shaoguan city, 512721, Guangdong
province has been issued by Center for
certification and evaluation, Guangdong food and
drug administration valid up to 20/8/2016. It was
found from available record that above source is
USFDA approved.
6. Do you use API manufacturer method The firm used API manufacturer’s method of
of testing for testing API? testing
7. Do you have stability studies reports The firm has stability studies reports of API from
on API? API manufacturer.
8. If yes, whether the stability testing The stability testing had been performed as per
has been performed as per SIM SIM method and degradation products had been
method and degradation products quantified.
have been quantified?
9. Do you have method for quantifying Firm had testing method to quantify the impurities
the impurities in the API? in API.
10. Do you have some remaining Firm has some remaining quantities of API, its
quantities of the API, its reference reference standard and impurities standards are nil.
standard and impurities standards? API: 70.00 gm Aprox.
Impurity Standard: Nil.
11. Have you used pharmaceutical grade Firm has used pharmaceutical grade excipients in
excipients? the manufacturing of stability batches.
12. Do you have documents confirming Firm has necessary documents confirming import /
the import of the used excipients? purchase of used excipients in the formulation for
sofosbuvir tablets.
13. Do you have test reports and other The firm has test reports and other records of the
records on the excipients used? excipients used. ADC clearance for Avicel 102
attached.
protocols for the development of the development of product.
applied formulation?
therefore they have not performed drug-excipient
dissolution studies? innovator brand (Sovaldi) by Gilead Sciences.
product
Brand Sofos 400mg Sovaldi 400mg
Tab Tab
Medium Phosphate buffer 6.8
RPM 75 75
(R&D) section
available in product development equipment to develop products
formulation?
19. Are the equipment in product The available equipment in product development
development section qualified? section were qualified. Documents for installation
and operation qualification were presented.
calibration / re-qualification program re-qualification program for the equipment used in
for the equipment used in PD section? production and QC used for product development
section. Third party calibrations are performed
thrice a year.
development?
22. Have you manufactured three stability The firm had manufactured three stability batches
batches for the stability studies of for the stability
applied formulation as required? Product Batch 1 Batch 2 Batch 3
Sofos 400 Sofos-T1 Sofos-T2 Sofos-T3
mg
2000 Tablet 2000 Tablet 2000
Tablet
5-19 5-19 5-19
23. Do you have any criteria for fixing As per statement of the firm the criteria for fixing
the batch size of stability batches? the batch size of stability batches is the number of
tablets per testing frequency and number of testing
frequencies.
equipment used has been available with the firm,
assuring the traceability of manufacturing and
analysis of stability batches.
25. Do you have protocols for stability The firm had protocols for stability testing of
testing of stability batches? stability batches.
26. Do you have developed and validated The firm had developed and validated method of
the method for testing of stability testing for finished product based on method of
batches? testing of API manufacturer.
27. Do you have method transfer studies The firm has not conducted method transfer
in case when the method of testing studies.
any other lab?
28. Do you have documents confirming The firm had proper documents confirming the
the qualification of equipment’s / qualification of equipment / instruments being
instruments being used in the test and used in the test and analysis of API and the
analysis of API and the finished drug? finished drug.
(LC-20AT VP) Lab Solutions® Software (version
6.5) which is 21CFR Compliant. It was used for
stability studies of tablet at most of the time points.
For other time points, analysis was performed on
Non-21 CFR Compliant software for which log
books were shown. However the record from
logbooks, analytical test reports was verifiable
onsite.
31. Can you show Audit trail reports on Firm had demonstrated audit trail reports (assay &
applied formulation testing? dissolution analysis on HPLC) for the submitted
stability batches at some time points. however the
verifiable onsite
32. Do you have some remaining The firm had remaining quantities of stability
quantities of degradation products and batches kept in stability chamber.
stability batches?
stability testing?
34. Do you have valid calibration status The firm had valid calibration status for the
for the equipment used in production equipment used in production and analysis.
and analysis?
35. Do proper and continuous monitoring The firm has stability chambers for carrying out
and control are available for stability accelerated and real time stability studies provided
chamber? with uninterrupted power supply and USB data
loggers. Digital data logger attached with chamber
is along with 5KV backup generator with ATS.
36. Do related manufacturing area, Firm has dedicated area for product development.
equipment, personnel and utilities be Related manufacturing area, equipment, personnel
rated as GMP compliant? and utilities were cGMP compliant to satisfactory
level.
provided, the genuineness / authenticity of stability data submitted by the firm for Sofos Tablets 400
mg is verifiable to satisfactory level. Related manufacturing area, equipment, personnel & Utilities are
rated as GMP Compliant to satisfactory level.
Decision: Registration Board decided to approve registration of “Sofos Tablets 400 mg” by M/s
BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad. Manufacturer will place
first three production batches of both products on long term stability studies throughout
Sr. Name & Address Brand Name Type of Form, International
No. of Manufacturer / (Proprietary Name + Dosage Initial Diary & Availability / Local
Applicant Form + Strength), Composition, Date, Fee Availability
Pharmacological Group, (including
Finished Product Specification differential fee), GMP Inspection Report
Demanded Price / Date & Remarks
Pack size
10. M/s Bio-Labs Hepacure tablet 90mg/400mg Form 5 Harvoni, UK-MHRA
(Pvt.) Ltd, Plot Each film coated tablet Dairy No. 3513 -
No. 145, Industrial contains: dated 22-05-2017
Triangle, Kahuta Sofosbuvir…400mg Rs.20,000/- The panel inspection
Road, Islamabad. Ledipasvir…90mg 28’s conducted on 28-08-
(Anti-viral/nucleotide As recommended 2017 & 29-08-2017
polymerase inhibitor) by the PRC unanimously
(Innovator’s Specifications) recommends the
issuance of GMP
certificate.
Drug Hepacure tablet 90mg/400mg
Name of Manufacturer M/s Bio-Labs (Pvt.) Ltd, Islamabad
Manufacturer of API Sofosbuvir: M/s Ruyuan HEC Pharma Co., Ltd.
Ledipasvir and Copovidone solid dispersion: M/s Ruyuan HEC Pharma Co.,
Ltd.
API Lot No. Sofosbuvir: YAKBIII-EM201703201
Ledipasvir and Copovidone solid dispersion: YAXII-201703002
Description of Pack
(Container closure HDPE Bottle
system)
Time Period Real time: 26 weeks
Frequency Accelerated: 0,1,2,3,4,6,8,12,16,20,24 & 26th week
Real Time: 0,1,2,3,4,6,8,12,16,20,24 & 26th week
Batch No. LST-T01 LST-T02 LST-T03
Date of Initiation -- -- --
No. of Batches 03
No.
1. COA of API COA of Sofosbuvir for the batch # S104B-
RD201701204 mentioned in stability study
data sheet has not been submitted.
2. Approval of API by regulatory authority of country Copy of GMP Certificate for
of origin or GMP certificate of API manufacturer Pharmaceutical Products issued by
issued by regulatory authority of country of origin. Shaoguan Food and Drug Administration
of the People’s Republic of China is
submitted.
Yes
5. Documents confirming import of API etc.
documents.
Yes
Yes
1978.
ix. Firm has submitted 26 weeks of accelerated and long term stability studies of three batches
Report on investigation of genuineness / authenticity of data submitted for registration of

Hepacure Tablet 90/400mg (Ledipasvir/Sofosbuvir) of M/s BioLab, Plot No. 145, Industrial
Triangle, Kahuta Road, Islamabad.
Reference No: F.13-11/2017-PEC dated 29-october, 2018.
Background:
M/s. Biolab Pharmaceuticals, Islamabad have applied for registration of Hepacure Tablet
90/400mg (Ledipasvir/Sofosbuvir). PEC considered scientifically rational laboratory scale data
submitted by the firm as pre-requisite of registration, So the chairman Registration board has
constituted a three member panel for on-site investigation to confirm genuineness / authenticity of
stability data and associated documents, import of API, quality, specification, test analysis, facilities
etc.


Physical Address M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad.
Contact Address M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad.
Purpose of Inspection Verification of Authenticity of Stability Data for Purpose of Registration
of Drugs with reference DRAP’s Letter dated …………, 2018
1. Hepacure Tablet 90/400mg (Ledipasvir/Sofosbuvir)
No.
1. Do you have documents confirming the Firm have copy of ADC (Islamabad) attested,
import of API including approval from Commercial invoice, Form 3, Form 7.
DRAP? Sofosbuvri: B# S104B-RD201701204 (3.00Kg)
Ledipasvir Copovidone: B# YAXII-201703002
(1.5Kg)
2. What was the rationale behind selecting Selected on the basis of GMP status of the firm
the particular manufacturer of API? &
Vendor prequalification proforma. They have
selected this vendor by following the approved
GMP, open part of DMF and supply to other
firms by the suppliers.
3. Do you have documents confirming the Firm imported reference standard and impurity
import of API reference standard and working standards along with API package.
impurity standards? Under taking from API manufacturer for
standard submission available.
4. Do you have certificate of Analysis of the COA of API, Reference standard and impurity
API, reference standards and impurity standard were available
standards?
manufacturer issued by regulatory pharma Co. Ld Xiaba development zone.
authority of country of origin? Ruyuan country Shaoguan city, 512721,
Guangdong province has been issued by Center
for certification and evaluation, Guangdong
food and drug administration valid up to
20/8/2016. It was found from available record
that above source is USFDA approved.
6. Do you use API manufacturer method of The firm used API manufacturer’s method of
testing for testing API? testing
Sofosbuvir: 6month Accelerated and 24 month
Real time.
Ledipasvir: 6month Accelerated and 24 month
7. Do you have stability studies reports on The firm has stability studies reports of API
API? from API manufacturer.
8. If yes, whether the stability testing has The stability testing had been performed as per
been performed as per SIM method and SIM method and degradation products had been
degradation products have been quantified.
quantified?
9. Do you have method for quantifying the Firm had testing method to quantify the
impurities in the API? impurities in API.
10. Do you have some remaining quantities of Firm has some remaining quantities of API & its
the API, its reference standard and reference standard and impurities standards are
impurities standards? nil.
API: Ledipasvir (142.00gm Aprox.), Sofosbuvir
(10.00gm aprox.)
Reference standard: (Sofosbuvir: 180mg,
Ledipasvir: 165mg Aprox)
Impurity standard: Nil
11. Have you used pharmaceutical grade Firm has used pharmaceutical grade excipients
excipients? in the manufacturing of stability batches.
12. Do you have documents confirming the Firm has necessary documents confirming
import of the used excipients? import / purchase of used excipients in the
formulation for sofosbuvir/ledi tablets.
13. Do you have test reports and other records The firm has test reports and other records of the
on the excipients used? excipients used.
ADC clearance for Avicel 102 attached.
14. Do you have written and authorized The firm has written and authorized protocols
protocols for the development of applied for the development of product.
formulation?
therefore they have not performed drug-
16. Have you performed comparative Comparative dissolution were performed by
dissolution studies? comparator brand (Syneget-LS) by Getz
Pharma.
Detail Test product Referenc
e product
Brand Hepacure Tab Syneget-
LS Tab
Medium Phosphate buffer with
BHA and Polysorbate 80
RPM 75 75
17. Do you have product development (R&D) The firm had product development (R&D)
section section.
available in product development section equipment to develop products
for development of applied formulation?
19. Are the equipment in product The available equipment in product

development section qualified? development section were qualified. Documents
for installation and operation qualification were
presented.
calibration / re-qualification program for re-qualification program for the equipment used
the equipment used in PD section? in production and QC used for product
development section. Third party calibrations
are performed thrice a year.
development?
22. Have you manufactured three stability The firm had manufactured three stability
batches for the stability studies of applied batches for the stability
formulation as required? Product Batch 1 Batch 2 Batch 3
Hepacure LST- LST-002 LST-003
90/400mg 001
Tablet 2475 2475 2475
Tablet Tablet Tablet
6-17 6-17 6-17
23. Do you have any criteria for fixing the As per statement of the firm the criteria for
batch size of stability batches? fixing the batch size of stability batches is the
number of tablets per testing frequency and
number of testing frequencies.
equipment used has been available with the
firm, assuring the traceability of manufacturing
and analysis of stability batches.
25. Do you have protocols for stability testing The firm had protocols for stability testing of
26. Do you have developed and validated the The firm had developed and validated method of
method for testing of stability batches? testing for finished product based on method of
testing of API manufacturer.
27. Do you have method transfer studies in The firm has not conducted method transfer
case when the method of testing being studies.
lab?
28. Do you have documents confirming the The firm had proper documents confirming the
qualification of equipment’s / instruments qualification of equipment / instruments being
being used in the test and analysis of API used in the test and analysis of API and the
and the finished drug? finished drug.
(LC-20AT VP) Lab Solutions® Software
(version 6.5) which is 21CFR Compliant. It was
used for stability studies of tablet at most of the
time points. For other time points, analysis was
for which log books were shown. However the
verifiable onsite.
31. Can you show Audit trail reports on Firm had demonstrated audit trail reports (assay
applied formulation testing? & dissolution analysis on HPLC) for the
submitted stability batches at some time points.
however the record from logbooks, analytical
test reports was verifiable onsite
32. Do you have some remaining quantities of The firm had remaining quantities of stability
degradation products and stability batches kept in stability chamber.
batches?
33. Do you have stability batches kept on The firm had stability batches on stability
stability testing? testing.
34. Do you have valid calibration status for The firm had valid calibration status for the
the equipment used in production and equipment used in production and analysis.
analysis?
35. Do proper and continuous monitoring and The firm has stability chambers for carrying out
control are available for stability accelerated and real time stability studies
chamber? provided with uninterrupted power supply and
USB data loggers. Digital data logger attached
with chamber is along with 5KV backup
generator with ATS.
36. Do related manufacturing area, Firm has dedicated area for product
equipment, personnel and utilities be rated development. Related manufacturing area,
as GMP compliant? equipment, personnel and utilities were cGMP
compliant to satisfactory level.
provided. Firm had demonstrated audit trail reports (assay & dissolution analysis on HPLC) for the
submitted stability batches at some time points. However, the previous record was verifiable onsite
from logbooks, analytical test reports. The genuineness/authenticity of stability data submitted by the
firm for Hepacure Tablet 90/400mg (Ledipasvir/Sofosbuvir) is verifiable to satisfactory level. Related
manufacturing area, equipment, personnel & Utilities are rated as GMP Compliant to satisfactory
level.
Decision: Registration Board decided to approve registration of “Hepacure Tablet 90/400mg
(Ledipasvir/Sofosbuvir)” by M/s BioLab, Plot No. 145, Industrial Triangle, Kahuta Road,
Islamabad. Manufacturer will place first three production batches of both products on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.
Evaluator PEC-V
Sr. Name & Address of Brand Name Type of Form, International Previous
No Manufacturer / (Proprietary Name Initial Diary & Availability / DRB
. Applicant + Dosage Form + Date, Fee Local Availability Decision /
Strength), (including Remarks
Composition, differential fee), GMP Inspection (if any)
Pharmacological Demanded Report Date &
Group, Price / Pack size Remarks
Finished Product
Specification
11. M/s Weather Folds Taglor 90mg tablets Form 5-D Approved by
Pharmaceuticals Each film coated Diary No. 31237 USFDA
69/2, Phase II, tablet contains: dated 17-09- Not applicable.
Industrial Area, Hattar, Ticagrelor …… 2018. Last GMP
Pakistan 90mg Rs.50,000/- inspection was
(Platelet aggregation dated 13-07- conducted on 15-
inhibitor) 2018 09-2017 and the
As per SRO report concludes
satisfactory level of
GMP compliance
Drug Taglor 90mg tablets
Name of Manufacturer M/s Weatherfolds Pharmaceuticals
Manufacturer of API MSN Organics Private Limited
API Lot No. TK0030816
Description of Pack Alu-Alu blister foil with unit carton
Time Period Real Time: 6 months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,1,2,3,4 & 6 (months)
Batch No. T-06 T-05 T-04
No. of Batches 03
No.
1. COA of API Yes
Batch No. TK0030816
Mfg. Aug 2016

country of origin or GMP certificate of Approved source as per decision of 275th meeting of
API manufacturer issued by regulatory Registration Board
authority of country of origin.
Yes
Yes
sheets etc.
5. Documents confirming import of API etc. No ADC Attested invoice
Invoice no. 29005007
Quantity of API:350g
Dated: 27-10-2017
Yes
Yes
Rules, 1978.
Sr. No. Deficiencies/Shortcomings Replies
Approval of API by regulatory L.Dis.No: 9906/A3/2017
authority of country of origin or GMP Issue of WHO GMP Certificate
1. certificate of API manufacturer issued Date of issue: 21-10-2017
by regulatory authority of country of
origin.
The stability studies should include the Firm has replied that degradation of product not
following tests degradation products, performed whereas, hardness and friability of core
2. microbiological testing water content tablet performed.
and hardness/friability which are not
determined. Clarify.
Firm has provided worksheets showing calculations
mentioning formula that doesnot include the average
weight of tablet and potency of standard. The
concentrations of standard and sample mentioned
could not be verified. The formula on basis of which
Provide worksheets showing calculations have been made needs reference.
3. calculations and COA of analysis at Moreover, variations have been observed in raw data
each point. worksheets and stability summary report. For e.g.
Tests Stability Summary Raw data sheet
report
T-04
0 Month
Dissolution 97.41%. 98.43%
T-06
0 Month
Assay 99.74% 99.72%
Dissolution 98.43% 96.6%
T-06
6 Month(Real)
Assay 99.81% 101.98%
Dissolution 97.75%. 97.71%
Submit system suitability sheets System suitability sheets mentioning % RSD,
4. mentioning %RSD, Tailing factor and Tailing factor and theoretical plates not provided by
theoretical plates. the firm.
Firm has submitted that standard of assay and
dissolution is same as concentration remain same for
The standards of assay and dissolution both assay and dissolution that is 0.01mg/ml and
5.
for are same. Clarify. also by adding 5ml media solution of dissolution
have no change in area or retention time.
No scientific justification provided by the firm.
Date of initiation of stability is 15-11- Date of initiation is written mistakenly, correct date
20-2017. However, batch has been is 16-11-2017.
6.
release for stability on 16-11-2017.
Clarify and justify the same.
Document confirming import of API ADC Attested invoice not provided. However, DHL
7.
.i.e. ADC attested invoice. provided.
Should be within period of one year as the provided
8. Latest GMP inspection report.
one is of 15-09-2017.
1. Taglor 90mg Tablet
Background:
Registration Board considered the applications of M/s. Weather Folds Pharmaceutical for registration of
Taglor 90mg Tablet. Registration Board decided to constitute the following panel for onsite investigation
to confirm genuineness / authenticity of stability data and associated documents, import of API, quality,
specification, test analysis and facilities etc.
1. Dr. Muhammad Usman, Dean, Faculty of Pharmacy, University of Lahore.
2. Mr. Faisal Shahzad, Deputy Director (C.D.), DRAP Islamabad.
3. Hafiz M. Ali Tayyab, Assistant Director (RRR), DRAP, Islamabad.
The inspection report is being submitted for your kind perusal.
Sr.
Description Observation by panel
No.
Q.No. Do you have documents confirming the Goods Declaration indicating 350gm of
1 import of Ticagrelor API? Ticagrelor sample exported by M/s. MSN
Pharmachem (Pvt.) Ltd., India. Along with
invoice No. 2900500710/16-17 dated 27-10-2015.
Q.No. What was the rationale behind selecting Selection of the manufacturer has been based
2 the particular manufacturer of API? upon its GMP Certification and availability of
DMF (open part) & adequate sample for initial
testing for prequalification. The firm has vender
qualification criteria.
Q.No. Do you have documents confirming the Goods Declaration indicating 100mg of
3 import of Ticagrelor reference standard Ticagrelor working standard exported by M/s.
and impurity standards? MSN Pharmachem Pvt. Ltd., India. Along with
invoice No. 2900500710/16-17 dated 27-10-2015.
No evidence of Reference standard and impurity
standard provided.
Q.No. Do you have certificate of Analysis of the COA of sample is verified.
4 API, reference standards and impurity COA of working standard provided instead of
standards? reference standard.
COA of impurities not provided.
Q.No. Do you have any approval of API or GMP GMP certificate issued by DCA Government of
5 certificate of API manufacturer issued by Telangana to M/s. Organics Pvt. Ltd., Sy. No.
regulatory authority of country of origin? 224/A, Bibinagar (Village), Bibinagar (Manadal),
Yadadari Bhuvanagiri district, Telangana,
Pincode: 508126, India.
Q.No. Do you use API manufacturer method of Firm use their own validated testing method for
6 testing? API testing.
Q.No. Do you have stability studies reports on Stability studies reports on API are available.
7 API?
Q.No. If yes, whether the stability testing has Degradation products have not been quantified.
8 been performed as per SIM method and
quantified?
Q.No. Do you have method for quantifying the No
9 impurities in the API?
Q.No. Do you have some remaining quantities of Small quantity of API and working standard
10 the API, its reference standard and available
Q.No. Have you used pharmaceutical grade Firm use pharmaceutical grade excipients.
11 excipients?
Q.No. Do you have documents confirming the Locally purchased material
12 import of the used excipients?
Q.No. Do you have test reports and other records Test reports were available.
13 on the excipients used?
Q.No. Do you have written and authorized Firm has written general protocol for product
14 protocols for the development of development.
Ticagrelor tablets?
Q.No. Have you performed Drug-excipient No. Firm informed that they use brand leader
15 compatibility studies? formulation.
Q.No. Have you performed comparative Dissolution studies confirmed.
16 dissolution studies? Virata Tablet Batch No. P11 (CCL) was used for
comparative dissolution.
Q.No. Do you have product development (R&D) No separate product development (R&D) section.
17 section
Q.No. Do you have necessary equipments No separate product development (R&D) section.
18 available in product development section However manufacturing of stability batches was
for development of Ticagrelor tablets? carried out in commercial manufacturing area.
Q.No. Are the equipments in product No separate product development (R&D) section
19 development section qualified?
Q.No. Do you have proper maintenance / No separate product development (R&D) section.
20 calibration / re-qualification program for
However firm has proper maintenance /
the equipment used in PD section? calibration/re-qualification program for the
equipment used
Q.No. Do you have qualified staff in product Firm has technical and qualified staff in the
21 development section with proper concerned commercial manufacturing area.
development?
Q.No. Have you manufactured three stability Three stability batches have been manufactured
22 batches for the stability studies of for stability studies of Taglor 90mg Tablet.
Ticagrelor tablets as required? T-04 1200 Tablets
T-05 1200 Tablets
T-06 1200 Tablets
Q.No. What was the criteria for fixing the batch As per statement of the firm the criteria for fixing
23 size of stability batches? the batch size of stability batches is the number of
tablet per testing frequency and number of testing
frequencies.
Q.No. Do you have complete record of Complete record of production of stability batches
24 production of stability batches? available.
Q.No. Do you have protocols for stability testing Firm has detailed protocol for stability testing of
25 of stability batches? stability bathes.
Q.No. Do you have developed and validated the Firm adopted method for testing of stability
26 method for testing of stability batches? batches published in research paper containing
validation of that method. However, firm has not
performed validation of that method.
Q.No. Do you have method transfer studies in Not applicable
27 case when method of testing being used
by your firm is given by any other lab?
Q.No. Do you have documents confirming the Proper documents confirming the qualification of
28 qualification of equipments / instruments equipment / instruments being used in the test and
being used in the test and analysis of analysis of API and the finished drug
Ticagrelor API and the finished drug?
Q.No. Do your method of analysis stability Degradation product testing was not performed.
29 indicating?
Q.No. Do your HPLC software is 21CFR HPLC Software is not 21CFR compliant. Firm has
30 compliant? Nave chrome software.
Q.No. Can you show Audit Trail reports on Audit trail on the testing reports is verifiable.
31 Ticagrelor testing?
Q.No. Do you have some remaining quantities of Stability batches are available.
32 degradation products and stability
batches?
Q.No. Do you have commitment batches kept on Yes
33 stability testing?
Q.No. Do you have valid calibration status for Valid calibration status for the equipment used in
34 the equipments used in Ticagrelor tablets production and analysis of Ticagrelor
production in analysis?
Q.No. Do proper and continuous monitoring and Manual record of stability chamber available
35 control are available for stability along with UPS
chamber?
Q.No. Do related manufacturing area, Related manufacturing area, equipment, personnel
36 equipment, personnel and utilities be rated and utilities are in compliance
as GMP compliant?
(i) Verification of raw data worksheets of assay and dissolution for values in raw data sheets and
summary report along with percentage of dissolve content of each tablet.
Data was verified for raw data worksheets with summary report of assay and dissolution. Percentage of
dissolve content for each tablet was verified.
(ii) Verification of performance of system suitability mentioning %RSD of standards, tailing factor
and theoretical plates along with chromatographic conditions.
Performance of system suitability mentioning %RSD of standards, tailing factor and theoretical plates
along with chromatographic conditions was verified from record.
(iii) Verification whether same standard can be used for both assay and dissolution as firm has
submitted that the concentration remain same for both assay and dissolution that is
0.01mg/ml and also by adding 5ml media solution of dissolution have no change in area or
retention time.
Firm has provided following data/justification.
Dilution of assay Sample
100mg of sample x 1ml = 0.01mg/ml
100ml 100ml
Dilution of Dissolution Sample
100mg of sample x 5ml = 0.01mg/ml
100ml 50ml
Dilution of Reference
100mg of reference x 1ml = 0.01mg/ml
100ml 100ml
(iv) Verification of polymorphic form of Ticagrelor as the FDA chemistry review mentions four
polymorphic firms and only one form is not converted into other form on storage.
Exact polymorphic form could not be verified as no data of types of polymorphic forms available/provided
by the firm and it’s not possible to precisely identify the stable polymorphic form of Ticagrelor.
Decision: Registration Board after thorough discussion decided to reject application on the basis of
points observed by panel and the following reasons:
 Firm has not performed test method validation of finished product.
 Dilution of dissolution sample provided by the firm is not equivalent to 0.01mg/ml. However,
it is equivalent to 0.1mg/ml.
 Exact polymorphic form could not be verified as no data of types of polymorphic forms
available/provided by the firm and it’s not possible to precisely identify the stable
polymorphic form of Ticagrelor.
c. Exemption from onsite verification of stability data
Evaluator PEC-III
Group, Pack size
Finished Product
Specification
12. M/s Sami Apandol 50mg IR Form 5D Nucynta Tablets 50mf by Depomed
Pharmaceuticals Tablets Dy No. 27553: Inc (USFDA Approved)
(Pvt) Ltd., F-95, Each film coated 10-08-2018
SITE Karachi. tablet contains: PKR 50,000/- Last GMP Inspection dated 26-04-
Tapentadol HCl eq to 09-08-2018 2018 Panel recommended renewal
Tapentadol…..50mg 10’s: Rs. 225/- of DML.
Opioid Analgesic
(Innovator’s specs)
(Dy.# 27553 dated 10-08-2018)
Drug Apamdol 50mg IR Tablets
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt) Ltd., F-95, SITE Karachi.
Manufacturer of API M/s Precise Chemipharma Pvt Ltd, C-384, TTC Industrial Area, Village
Pawne, Navi Mumbai
API Lot No. 6004022017
Description of Pack
Alu-Alu blister
Frequency Accelerated: 0, 1, 3, 4, 6 (Months)
Batch No. Lab-01 Lab-02 Lab-03
Manufacturing Date December 2017 December 2017 December 2017
Date of Initiation December 2017 December 2017 December 2017
No. of Batches 03
1. COA of API Yes
Firm has submitted copy of GMP certificate of
Precise Chemipharma issued by FDA Mahrashtra.
The certificate is valid till 10-10-2018
country of origin.
Yes
Yes
etc.
5. Documents confirming import of API etc. Firm has submitted ADC attested invoice confirming
import of 6.5Kg Tapentadol from Precise
chemipharma dated 26-04-2017 for Batch No.
6004022017
data / documents.
Yes
Yes
Rules, 1978.
DATA
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
instant dosage form conducted during last two product ―TONOFLEX-P FORTE 75mg / 650mg
years. (Tramadol HCl + Paracetamol) Tablets‖, which was
conducted on 08th January, 2018 and was
presented in 278th meeting of Registration Board
held on 29-31st January, 2017.
Following two observations were reported in the
report:
iii. Adequate monitoring and control are available
for stability chambers. Data Loggers are also
placed in stability chambers for monitoring
2. Documents for the procurement of API with Firm has submitted ADC attested invoice
approval from DRAP (in case of import). confirming import of 6.5Kg Tapentadol from
Precise chemipharma dated 26-04-2017 for Batch
No. 6004022017
3. Documents for the procurement of reference Firm has submitted COA of reference standard and
standard and impurity standards. submitted that it was procured along with the API
4. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate of
manufacturer issued by regulatory authority ofPrecise Chemipharma issued by FDA Mahrashtra.
country of origin. The certificate is valid till 10-10-2018
5. Mechanism for Vendor pre-qualification Firm has submitted copy of vendor evaluation form
and vendor evaluation report
standards and impurity standards standard.
7. Documents for the procurement of excipients used Firm has submitted documents for procurement of
in product development? excipients.
PRODUCTION DATA
9. Authorized Protocols/SOP for the development & Firm has submitted authorized protocols/SOPs for
stability testing of trial batches. the development & testing of trial batches.
10. Complete batch manufacturing record of three Firm has provided Batch Manufacturing Record for
stability batches. all the three batches
11. Record of remaining quantities of stability Firm has provided following remaining quantities
batches. for each batch
 Lab-01: 1133 Tablets
QA/QC DATA
12. Record of Digital data logger for temperature and Firm has submitted record of Digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated) chambers.
13. Method used for analysis of API along with COA. Firm has submitted COA and method of analysis of
API.
chromatograms, lab reports, raw data sheets etc.) with chromatograms
manufacturer. 75±5%RH) stability studies & long term (30°C ±
2°C & 65±5%RH) stability studies reports of three
batches.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all
excipients used.
innovator but the data of drug excipient
compatibility studies including mixing of API with
all excipients in different proportions and
determination of assay by HPLC.
18. Record of comparative dissolution data.  Firm has submitted data of comparative
dissolution profile only at 0.1N HCl with the
innovator brand NUCYNTA. The testing of
innovator brand was done in 2014 while that of
test product on December 2017.
19. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports for HPLC
audit trail reports on product testing. analysis for all the three batches.
Evaluation by PEC:
 Firm has only performed comparative dissolution profile at 0.1N HCl and that too at different times i.e.
the innovator brand was tested in 2014, while the applied product was tested in 2017. In response to this
query firm has submitted dissolution profile data at pH 1.2, 4.5 and 6.8. Firm has also submitted that
“According to FDA BCS classification Tapentadol falls in BCS-I Class so it can easily be dissolved in all
recommended medias described in FDA guidance of industry for CDP. Further as per guidelines the
dissolution should be more than 85% at pH 1.2, 4.5, 6.8 in comparison with reference product.
We did perform dissolution test at all pH and got satisfactory results however due to non-availability of
reference product at that time we could not compare it with reference product. Tapentadol in few
countries is classified as controlled substance and its tablets cannot be obtained without
prescription.Our products meet the dissolution criteria according to FDA guidelines at all pH, hence we
hope DRAP will approved our product on the basis of provided dissolution data”
The following guidelines of FDA is hereby presented for consideration by the Board:
 As per FDA guidance for industry “Waiver of In Vivo Bioavailability and Bioequivalence Studies for
Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System”
VII. DATA TO SUPPORT A BIOWAIVER REQUEST
The drug product for which a biowaiver is being requested should include a drug substance that is highly
soluble (BCS class 1 and BCS class 3) and highly permeable (BCS class 1), and the drug product should
be rapidly dissolving (BCS class 1) or very rapidly dissolving (BCS class 3). Sponsors/applicants
requesting biowaivers based on the BCS should submit the following information to the Agency for
review.
A. Data Supporting High Solubility
B. Data Supporting High Permeability
C. Data Supporting Rapid, Very Rapid, and Similar Dissolution
D. Additional Information
Data Supporting Rapid, Very Rapid, and Similar Dissolution is summarized in guideline III-C
Determining Drug Product Dissolution Characteristics and Dissolution Profile Similarity. The exact
guidelines are:
Dissolution testing should be carried out in USP Apparatus 1 or USP Apparatus 2 using 500 mL (or 900
mL with appropriate justification) of the following dissolution media: (1) 0.1 N HCl or Simulated Gastric
Fluid USP without enzymes; (2) a pH 4.5 buffer; and (3) a pH 6.8 buffer or Simulated Intestinal Fluid
USP without enzymes.
For final analysis:
Two dissolution profiles are considered similar when the f2 value is ≥ 50. To allow the use of mean data,
the coefficient of variation should not be more than 20 % at the earlier time points (e.g., 15 minutes), and
should not be more than 10 % at other time points. Only one measurement should be considered after
85% dissolution of both products. In addition, when both test and reference products dissolve 85% or
more of the label amount of the drug in 15 minutes using all three dissolution media recommended
above, the profile comparison with an f2 test is unnecessary.
Decision of previous meeting of Deferred for submission of complete data of comparative dissolution
Registration Board profile of their product against the reference product in all the three
dissolution medias i.e. (1) 0.1 N HCl or Simulated Gastric Fluid USP
without enzymes; (2) a pH 4.5 buffer; and (3) a pH 6.8 buffer or
Simulated Intestinal Fluid USP without enzymes as recommended by
USFDA. (M-285)
Evaluation by PEC Firm has submitted that
 We did develop develop this product in 2014, but after the
decision of Registration Board in 251st meeting we carried out
stability studies in accordance with RB directives.
 In 273rd meeting the Registration Board approved our product
APANDOL IR 75mg. Apandol 50mg and 100mg are line
extensions which have been developed based on already
developed strength of 75mg.
 We have additionally submitted the dissolution profile of our
product at different pH i.e. 1.2, 4.5 & 6.8 along with FDA
recommended dissolution for finished product of tapentadol
tablets. Furthermore, tapentadol HCL also falls in BCS class I
and its dissolution criteria is already developed by FDA.
Decision: Registration Board decided to approve registration of “Apandol 50mg IR Tablets
(Tapentadol HCl eq to Tapentadol 50mg” with Innovator’s specifications by M/s Sami
Pharmaceuticals (Pvt) Ltd., F-95, SITE Karachi. Manufacturer will place first three production
batches of both products on long term stability studies throughout proposed shelf life and on
Group, Pack size
Finished Product
Specification
13. M/s Sami Apandol 100mg IR Form 5D Nucynta Tablets 100mg by
Pharmaceuticals Tablets Dy No. 27552: Depomed Inc (USFDA Approved)
(Pvt) Ltd., F-95, Each film coated 10-08-2018
SITE Karachi. tablet contains: PKR 50,000/- Last GMP Inspection dated 26-04-
Tapentadol HCl eq to 09-08-2018 2018 Panel recommended renewal
Tapentadol..100mg 10’s: Rs. 330/- of DML.
Opioid Analgesic
(Innovator’s specs)
251st meeting of Registration Board. Detailsof submitted data are as under: (Dy.# 27552 dated 10-8-
2018)
Drug Apamdol 10 0mg IR Tablets
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt) Ltd., F-95, SITE Karachi.
Manufacturer of API M/s Precise Chemipharma Pvt Ltd, C-384, TTC Industrial Area, Village
Pawne, Navi Mumbai
API Lot No. 6004022017
Description of Pack
Alu-Alu blister
Frequency Accelerated: 0, 1, 3, 4, 6 (Months)
Manufacturing Date December 2017 December 2017 December 2017
Date of Initiation December 2017 December 2017 December 2017
No. of Batches 03
1. COA of API Yes
Firm has submitted copy of GMP certificate of
Precise Chemipharma issued by FDA Mahrashtra.
The certificate is valid till 10-10-2018
country of origin.
Yes
Yes
etc.
5. Documents confirming import of API etc. Firm has submitted ADC attested invoice confirming
import of 6.5Kg Tapentadol from Precise
chemipharma dated 26-04-2017 for Batch No.
6004022017
data / documents.
Yes
Yes
Rules, 1978.
DATA
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
instant dosage form conducted during last two product ―TONOFLEX-P FORTE 75mg / 650mg
years. (Tramadol HCl + Paracetamol) Tablets‖, which was
conducted on 08th January, 2018 and was
presented in 278th meeting of Registration Board
held on 29-31st January, 2017.
report:
iv. The HPLC software is 21CFR Compliant.
v. Firm has shown all Audit trail reports.
vi. Adequate monitoring and control are available
for stability chambers. Data Loggers are also
placed in stability chambers for monitoring
2. Documents for the procurement of API with Firm has submitted ADC attested invoice
approval from DRAP (in case of import). confirming import of 6.5Kg Tapentadol from
Precise chemipharma dated 26-04-2017 for Batch
No. 6004022017
3. Documents for the procurement of reference Firm has submitted COA of reference standard and
standard and impurity standards. submitted that it was procured along with the API
4. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate of
manufacturer issued by regulatory authority of Precise Chemipharma issued by FDA Mahrashtra.
country of origin. The certificate is valid till 10-10-2018
5. Mechanism for Vendor pre-qualification Firm has submitted copy of vendor evaluation form
and vendor evaluation report
standards and impurity standards standard.
7. Documents for the procurement of excipients used Firm has submitted documents for procurement of
in product development? excipients.
PRODUCTION DATA
9. Authorized Protocols/SOP for the development & Firm has submitted authorized protocols/SOPs for
stability testing of trial batches. the development & testing of trial batches.
10. Complete batch manufacturing record of three Firm has provided Batch Manufacturing Record for
stability batches. all the three batches
11. Record of remaining quantities of stability Firm has provided following remaining quantities
batches. for each batch
QA/QC DATA
12. Record of Digital data logger for temperature and Firm has submitted record of Digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated) chambers.
13. Method used for analysis of API along with COA. Firm has submitted COA and method of analysis of
API.
chromatograms, lab reports, raw data sheets etc.) with chromatograms
manufacturer. 75±5%RH) stability studies & long term (30°C ±
2°C & 65±5%RH) stability studies reports of three
batches.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all
excipients used.
innovator but the data of drug excipient
compatibility studies including mixing of API with
all excipients in different proportions and
determination of assay by HPLC.
18. Record of comparative dissolution data.  Firm has submitted data of comparative
dissolution profile only at 0.1N HCl with the
innovator brand NUCYNTA. The testing of
innovator brand was done in 2014 while that of
test product on December 2017.
19. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports for HPLC
audit trail reports on product testing. analysis for all the three batches.
Evaluation by PEC:
 Firm has only performed comparative dissolution profile at 0.1N HCl and that too at different times i.e.
the innovator brand was tested in 2014, while the applied product was tested in 2017. In response to this
query firm has submitted dissolution profile data at pH 1.2, 4.5 and 6.8. Firm has also submitted that
“According to FDA BCS classification Tapentadol falls in BCS-I Class so it can easily be dissolved in all
recommended medias described in FDA guidance of industry for CDP. Further as per guidelines the
dissolution should be more than 85% at pH 1.2, 4.5, 6.8 in comparison with reference product.
We did perform dissolution test at all pH and got satisfactory results however due to non-availability of
reference product at that time we could not compare it with reference product. Tapentadol in few
countries is classified as controlled substance and its tablets cannot be obtained without
prescription.Our products meet the dissolution criteria according to FDA guidelines at all pH, hence we
hope DRAP will approved our product on the basis of provided dissolution data”
The following guidelines of FDA is hereby presented for consideration by the Board:
 As per FDA guidance for industry “Waiver of In Vivo Bioavailability and Bioequivalence Studies for
Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System”
VII. DATA TO SUPPORT A BIOWAIVER REQUEST
The drug product for which a biowaiver is being requested should include a drug substance that is highly
soluble (BCS class 1 and BCS class 3) and highly permeable (BCS class 1), and the drug product should
be rapidly dissolving (BCS class 1) or very rapidly dissolving (BCS class 3). Sponsors/applicants
requesting biowaivers based on the BCS should submit the following information to the Agency for
review.
A. Data Supporting High Solubility
B. Data Supporting High Permeability
C. Data Supporting Rapid, Very Rapid, and Similar Dissolution
D. Additional Information
Data Supporting Rapid, Very Rapid, and Similar Dissolution is summarized in guideline III-C
Determining Drug Product Dissolution Characteristics and Dissolution Profile Similarity. The exact
guidelines are:
Dissolution testing should be carried out in USP Apparatus 1 or USP Apparatus 2 using 500 mL (or 900
mL with appropriate justification) of the following dissolution media: (1) 0.1 N HCl or Simulated Gastric
Fluid USP without enzymes; (2) a pH 4.5 buffer; and (3) a pH 6.8 buffer or Simulated Intestinal Fluid
USP without enzymes.
For final analysis:
 Two dissolution profiles are considered similar when the f2 value is ≥ 50. To allow the use of mean data,
the coefficient of variation should not be more than 20 % at the earlier time points (e.g., 15 minutes), and
should not be more than 10 % at other time points. Only one measurement should be considered after
85% dissolution of both products. In addition, when both test and reference products dissolve 85% or
more of the label amount of the drug in 15 minutes using all three dissolution media recommended
above, the profile comparison with an f2 test is unnecessary.
Decision of previous meeting of Deferred for submission of complete data of comparative
Registration Board dissolution profile of their product against the reference product in
all the three dissolution medias i.e. (1) 0.1 N HCl or Simulated
Gastric Fluid USP without enzymes; (2) a pH 4.5 buffer; and (3) a
pH 6.8 buffer or Simulated Intestinal Fluid USP without enzymes
as recommended by USFDA. (M-285)
Evaluation by PEC Firm has submitted that
 We did develop develop this product in 2014, but after the
decision of Registration Board in 251st meeting we carried out
stability studies in accordance with RB directives.
 In 273rd meeting the Registration Board approved our product
APANDOL IR 75mg. Apandol 50mg and 100mg are line
extensions which have been developed based on already
developed strength of 75mg.
 We have additionally submitted the dissolution profile of our
product at different pH i.e. 1.2, 4.5 & 6.8 along with FDA
recommended dissolution for finished product of tapentadol
tablets. Furthermore, tapentadol HCL also falls in BCS class I
and its dissolution criteria are already developed by FDA.
Decision: Registration Board decided to approve registration of “Apandol 100mg IR Tablets
(Tapentadol HCl eq to Tapentadol 100mg” with Innovator’s specifications by M/s Sami
Pharmaceuticals (Pvt) Ltd., F-95, SITE Karachi. Manufacturer will place first three production
batches of both products on long term stability studies throughout proposed shelf life and on
Evaluator PEC-V
14. Name and address of manufacturer / M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub
Applicant River Road, S.I.T.E., Karachi
Brand Name +Dosage Form + Strength Provas Rapid 500mg/200mg Tablet
Diary No. Date of R& I & fee Dyn:24290, 12-07-2018, Rs.50,000/- (12-07-2018)
Paracetamol …… 500 mg
Ibuprofen ….…. 200 mg
Pharmacological Group Analgesic and Antipyretic
Type of Form Form-5 D
Finished Product Specification As per innovator
Pack size & Demanded Price Rs. 360 /30 Tabs
Approval status of product in Reference Approved by UK
Me-too status N/A
GMP status Last GMP Inspection dated 3-10-2017 with conclusive
remarks of good level of GMP compliance.
Drug Provas Rapid 500mg/200mg Tablet
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, Off. Hub River Road,
S.I.T.E., Karachi
Manufacturer of API Ibuprofen Paracetamol
M/s Hubei Granules Biocause M/s Hebei Jiheng Group Pharmaceutical
Pharmaceutical Co., Ltd. China Co LTD China
API Lot No. Ibuprofen Paracetamol
C100-1607120M 31611030
Description of Pack Alu –PVC blister
Time Period Real Time: 6 months Accelerated: 6 months
Frequency Real Time: 0,3 & 6 (months)
Accelerated:0,1,3,4,6 (months)
Manufacturing Date Nov 2017 Nov 2017 Nov 2017
Date of Initiation Nov 2017 Nov 2017 Nov 2017
No. of Batches 03
Date of Submission Dyn:24290, 12-07-2018
1. COA of API Yes
2. Approval of API by regulatory authority Ibuprofen Paracetamol
of country of origin or GMP certificate of Verified from Company HE20160062
API manufacturer issued by regulatory website. Verified from CFDA.
authority of country of origin. Yes
Yes
Yes
sheets etc.
5. Documents confirming import of API etc. Ibuprofen
 Copy of Form 6 (License to Import drug for clinical
trial examination, test or analysis) issued by ADC
(Karachi) dated 09-03-2017, for the import of
Ibuprofen (2000 g) from the M/s Hubei Granules
Biocause Pharmaceutical Co., Ltd. China has been
submitted.
 Copy of Commercial Invoice (invoice
no.W170213-026) attested by ADC (Karachi) dated
09-03-2017 has been submitted. Batch No C100-
1607120M.
Paracetamol
 Copy of Commercial Invoice (invoice
no.1701ZP07) attested by ADC (Karachi) dated 28-
03-2017
 Quantity: 7500 Kg.
Invoice to be verified.
 Form 6 not provided.
Firm submitted that Form 6 is required for importing
material for test & analysis. Firm imported the material
in commercial quantity for consuming it in their
registered drugs; copy of relative Form 5 provided.
Yes
stability study till assigned shelf life of the
product.
Rules, 1978.
 The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab
Scale Batches.
REQUEST OF EXEMPTION ROM ON SITE INSPECTION

its 278th Meeting:
for instant dosage form conducted during product “TONOFLEX-P FORTE 75mg / 650mg
last two years. (Tramadol HCl + Paracetamol) Tablets”, which was
conducted on 08th January, 2018 and was presented in
278th meeting of Registration Board held on 29-31st
January, 2017.
Following two observations were reported in the report:
iii. Adequate monitoring and control are available for
stability chambers. Data Loggers are also placed in
stability chambers for monitoring
2. Documents for the procurement of API  Copy of Form 6 (License to Import drug for clinical
with approval from DRAP (in case of trial examination, test or analysis) issued by ADC
import). (Karachi) dated 09-03-2017, for the import of
Ibuprofen (2000 g) from the M/s Hubei Granules
Biocause Pharmaceutical Co., Ltd. China has been
submitted.
 Copy of Commercial Invoice (invoice no.W170213-
026) attested by ADC (Karachi) dated 09-03-2017
has been submitted. Batch No C100-1607120M.
Paracetamol
 Copy of Commercial Invoice (invoice no.1701ZP07)
attested by ADC (Karachi) dated 28-03-2017.
 Copy of Form 5 issued by ADC (Karachi) dated 24-
03-2017, for the import of paracetamol from the M/s
Hebei Jiheng Group Pharmaceutical China has been
submitted.
• Form 6 not provided.
Firm submitted that Form 6 is required for importing
material for test & analysis. Firm imported the material
in commercial quantity for consuming it in their
registered drugs; copy of relative Form 5 provided.
3. Documents for the procurement of Samples of reference standard and impurity standard of
reference standard and impurity standards. paracetamol and ibuprofen imported from EDQM and
US Pharmacopoeia in 2016 and 2017 by paying full
duty/taxes under HS Code 3822.0000.Hence, invoices
could not be endorsed.
4. Approval of API/ DML/GMP certificate of Bulk Drug Ibuprofen
API manufacturer issued by regulatory Copy of GMP certificate (certificate no. HB20170363)
authority of country of origin. has been submitted for M/s Hubei Granules Biocause
Pharmaceutical Company Ltd. issued by Hubei FDA,
China, and valid upto 28-08-2022.
Bulk Drug Paracetamol
Copy of GMP certificate (certificate no. HB20160062)
has been submitted for M/s Hubei Jiheng (Group)
Pharmaceutical Co. Ltd. issued by Hubei FDA, China,
and valid upto 14-11-2021.
5. Mechanism for Vendor pre-qualification The firm has submitted Vendor evaluation Form.
6. Certificate of analysis of the API, reference  Copies of COAs of API have been submitted,
standards and impurity standards detailed as under:
API Batch. # Quantity
Paracetamol 31611030 9675Kg
Ibuprofen C100-1607120M 1120Kg

Firm has not submitted COAs of working/reference
standards and impurity standards.
Firm has cleared samples of Reference Standards and
Impurity Standards of Paracetamol & Ibuprofen
imported from EDQM & US Pharmacopeia in 2016 &
2017 by paying full duty / taxes under HS Code
3822.0000
Its invoices however could not be endorsed by ADC; we
onward will apply for endorsement of invoice / FORM 6
as desired
7. Documents for the procurement of The firm has submitted commercial invoices & COAs of
excipients used in product development? all the excipients used in formulation from relevant
manufacturers.
MCC Ph-101 has been dispatched from Lahore via TCS.
Submit how storage condition has been maintained.
The firm submitted that No specific storage condition is
required as per Pharmacopeia Monograph and MSDS.
Excipient Source Batch No.
MCC-PH 101 JRS Pharma 260171711
Loan Received from
Highnoon
2000Kg
Croscarmellose Mingtai Chemical D1705015
sodium 2000Kg
Cab-o-sil Cabot Switzerland 4198966
Fumed Metal Oxide 1800Kg
Magnesium Peter Greven C646502
Stearate Netherlands
1680 Kg
Stearic Acid Southern Acid 609500816
Industries
50 Kg
Opadry Silver Colorcon TKL40401
050 Kg
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified
development with relevant experience. staff along with their training record involved in product
development.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted SOP of Product development
development & stability testing of trial and protocol for stability studies specific to the product.
batches.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch
three stability batches. Manufacturing Record and batch packaging record of
the following 03 Batches.
Lot no of paracetamol in issuance note is PGS17-030
whereas COA mentions 31611030.Clarify.
With reference to your query regarding difference in Lot
no. of Paracetamol mentioned on Issuance note and
COA, we would like to clarify that, the Paracetamol of
M/s Hebei Jiheng (group) Pharmaceutical Co. Ltd.; Lot
No. 31611030 is used in development of Provas Rapid
tablet. It is our in-house practice that a unique code
(Lab. Reference No.) is issued to each lot for
identification. In this, lab reference No. 170405-R01
was assigned to this lot of Paracetamol (Lot No.
31611030) as mentioned on COA, API calculation sheet,
issuance note and all other product development
documents (all these documents already with you). The
said error has been made during the entry of Lot No. of
Paracetamol in ERP system. Furthermore, for your
satisfaction, we have enclosed material issuance trail of
ERP, clearly indicating Lab reference No., issuance date
and quantity thereof. Hope this will resolve your query.
11. Record of remaining quantities of stability Batch size: 2500 Tablets
batches. Received for Stability: 1655 Tablets
The firm has submitted reconciliation sheet mentioning
that 1297 tablets of each of three trial batches are
remaining.
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of digital
temperature and humidity monitoring of printouts of graphical chart for Real Time and
stability chambers (real time and Accelerated Conditions starting from 11-01-2017 to
accelerated) 05-05-2018 that shows excursions. Provide
justification and submit tabular record of Digital
data logger for temperature and humidity monitoring
of stability chambers.
Firm has submitted that:
Stability samples of Provas Rapid Tablet having Batch
numbers Lab001, Lab 002, Lab003 kept in climatic
chamber Memmert serial no. W816.0166 and Memmert
serial no. W816.0167 for real time and accelerated
conditions respectively.
Tabulated data of Atmocontrol software of both
chambers are attached, from November 2017 to May
2018.
During stability period of Provas Rapid we have
maintenance issue of these climatic chambers for 3-4
days and for this period for maintenance working we
have transferred all samples into other chambers,
Binder 12-14510 for real time stability and Binder 02-
32241for accelerated stability
We also attached the print out of temperature and
humidity data of these chambers for this study period
Within a week the maintenance issue of Memmert

chambers was resolved by consulting the service
provider (copy attached of maintenance report) and
stability samples were again stored in their initial
location.
13. Method used for analysis of API along The firm has applied supplier’s method for analysis of
with COA. API and has submitted analytical reports, raw data sheets
& relevant chromatograms.
14. Method used for analysis of FPP &  The firm has submitted photocopy of Finished
complete record of testing of stability Product specification & Test method.
batches (i.e. chromatograms, lab reports,
raw data sheets etc.)  Firm has submitted complete record of testing of
stability batches (i.e. chromatograms, lab reports,
15. Reports of stability studies of API from Paracetamol
manufacturer. The firm has submitted copies of reports of 06 Months
Accelerated and 60 Months Real Time Stability Study
(25oC+2 oC, 60+5%) Data of 03 Batches of API.
Ibuprofen
The firm has submitted copies of reports of 06 Months
Accelerated and 48 Months Real Time Stability Study
16. Analysis reports for excipients used. The firm has submitted copies of its own Analytical
reports for all excipients used in product development.
17. Drug-excipients compatibility studies.  The firm has submitted Compatibility study report
(dated 01-03-2018) along with raw data sheets and
relevant chromatograms but not protocol.
Firm submitted protocol for drug-excipients
compatibility studies which doesnot provide the
conditions. Provas is similar to innovator Nuromol.
The coating material is not similar.
Nuromol Innovator Provas Rapid
Croscarmellose sodium Croscarmellose sodium
Microcrystalline cellulose Microcrystalline cellulose
Colloidal anhydrous Colloidal anhydrous
silica silica
Magnesium stearate Magnesium stearate
Stearic acid Stearic acid
Film Coat Film Coat

Polyvinyl alcohol Opadry Silver
Titanium Dioxide (Polyvinyl alcohol ,
Talc Titanium Dioxide ,
Macrogol Talc ,
Potassium aluminium Macrogol ,
silicate (E555) Polysorbate
Polysorbate
Purified Water
18. Record of comparative dissolution data. Provide protocol/analytical method for comparative
dissolution studies.
Firm has not submitted protocol for comparative

dissolution. Firm has submitted CDP report dated 21-11-
2017 for the Provas Rapid 200mg/500mg. The details of
reference product & Sample product are as follows:
Provide manufacturing date of Nuromol Tablets.
Pack size on Form 5 D 30’s whereas in comparative
dissolution studies you have mentioned 24’s.
Firm developed their R&D batches based on the
innovator samples NUROMOL which were in pack size
of 24’s Tablets and carried out the dissolution profile in
November 2017.
At the time of application of product, we re-evaluated

the Domestic as well as International market dynamics,
taking into consideration the various internationally
approved pack sizes which also consisted of 30’s
Tablets.
Feature Reference Product of
product M/s Sami
Brand name Nuromol Provas Rapid
200mg/500mg 200mg/500mg
Batch No. CB976 Lab-01
Mfg. date --- Nov 2017
19. Compliance Record of HPLC software Firm has submitted audit trail reports for complete
21CFR & audit trail reports on product stability studies analysis of three batches.
testing.
Decision: Registration Board deferred the case for submission of long-term stability studies of API at
30 °C ± 2 °C/65% RH ± 5% RH as according to ICH guidelines whether long-term stability studies
are performed at 25 °C ± 2 °C/60% RH ± 5% RH or 30 °C ± 2 °C/65% RH ± 5% RH or 30 °C ± 2
°C/75% RH ± 5% RH is determined by the climatic condition under which the API is intended to be
stored. Testing at a more severe long-term condition can be an alternative to testing condition 30
°C/65% RH.
15. Name and address of manufacturer / M/s Genome Pharmaceuticals Pvt. Ltd
Applicant 16/1, Phase IV, Industrial Estate, Hattar, Haripur
Brand Name +Dosage Form + Strength Lurasid Tablet 80 mg
Diary No. Date of R& I & fee Dy No. 315, Rs: 50,000/- 4-12-2015
Lurasidone HCl…80mg
Indole derivatives
ATC code: N05AE05
Type of Form Form 5-D
Finished Product Specification Manufacturer Specs.
Pack size & Demanded Price 1x10’s, 2x10’s, 3x10’s ,Alu alu blister, As per PRC
Approval status of product in Latuda-USFDA approved
Me-too status Not applicable
GMP status 12-05-2018; Good Level of compliance.
Remarks of the Evaluator.  Approved in USFDA with box warning.
Drug Lurasid Tablet 80 mg
M/s Genome Pharmaceuticals Pvt. Ltd
16/1, Phase IV, Industrial Estate, Hattar, Haripur
MSN Pharmachem Private Limited
Manufacturer of API Plot No. 212/A, B,C, D Phase II, IDA Pashamylaram (Village)
Patancheru Mandal , Medak District Telangana, India
API Lot No. LL0261216 Invoice attestation date: 17-01-2017
Description of Pack
Real time : 30°C ± 2°C / 65% ± 5%RH
Frequency Real time: 0,3,6 (months) Accelerated: 0,3,6 (months)
Batch No. LUR-80/T001 LUR-80/T002 LUR-80/T003
Batch Size 2000 Tab 2000 Tab 2000 Tab
No. of Batches 03
Date of Submission 26-03-2018 (Dy No. 10914)
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Yes
of origin or GMP certificate of API manufacturer Issue date: 12-01-2016
issued by regulatory authority of country of origin. Validity 2 years
1 kg
17-01-2017
documents.
1978.

its 278th Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their
inspection for instant dosage form product “Vertix Tablet 10mg and 20 mg (Vortioxetine
conducted during last two years. Hydrobromide)”, which was conducted on 18th July,
2018 and was presented in 277th meeting of Registration
Board.
Following two observations were reported in the report:
iv. The HPLC software is 21CFR Compliant.
v. Firm has shown all Audit trail reports.
vi. Adequate monitoring and control are available for
stability chambers. Data Loggers are also placed in
stability chambers for monitoring
2. Documents for the procurement of API  Copy of Commercial Invoice (invoice
with approval from DRAP (in case of no.2500500498) attested by ADC (Karachi) dated
import). 17-01-2017 has been submitted. Batch No
LL0261216 quantity 1 kg.
3. Documents for the procurement of The Reference standard and Impurity standards of
reference standard and impurity Lurasidone HCL was provided by manufacturer with lot
standards. of material. The Manufacturer provided COAs of
Reference standard and Impurity standards; at that time
it was not in practice to mention the reference standards
on invoice of material.
4. Approval of API/ DML/GMP Copy of WHO GMP certificate (certificate no.
certificate of API manufacturer issued
13087/E(R)/TS/2017) has been submitted for M/s MSN
by regulatory authority of country ofPharmachem Private Limited by WHO & Drug Control
origin. Administration, Government of Telangana and valid
upto 16-02-2020.
5. Mechanism for Vendor pre- The firm has submitted Vendor evaluation SOP and
qualification Vendor evaluation Form.
6. Certificate of analysis of the API,  Copies of COAs of API have been submitted,
reference standards and impurity detailed as under:
standards API Batch. #
Lurasidone LL0261216
HCl Assay
(Anhydrous)
Supplier:99.4%
Mfg. 99.70%
 Firm has submitted COAs of working/reference
standards and impurity standards. Source MSN
Pharma Chem.
Working Standard Batch. #
Lurasidone HCl LNWS1601
Piperazine Benzothiazole LDN/B690/M-019/01
impurity
Imine Impurity LDN/B592/imine
imp/01
Diastereomer-2 LDN/BB474/6-
isomer/01
Piperazinium impurity LDN/BB415/3/01
7. Documents for the procurement of The firm has submitted commercial invoices of all the
excipients used in product excipients used in formulation from relevant
development? manufacturers. Submit evidence that all excipients are
pharmaceutical grade.
The firm submitted that the excipients used in
manufacturing of Lurasid tablets 80 mg are
pharmaceutical grade. The Specifications of all
excipients mentioned on COA provided by
manufacturer are according to official pharmacopeia
USP and BP.
Maize starch purchased from Rafhan Pakistan ltd is
pharmaceutical grade and the specifications mentioned
on COA are complied with BP /USP.
All the excipients are tested according to USP/ BP
monograph. Analytical reports, COA and official
monograph of all excipients are enclosed for your kind
consideration.
Excipient Supplier Batch No.
Hydroxypropyl M.s DOW 00011073390
Methyl cellulose Europe GMBH 0024108250
ADC Attested Horgen,
903843621 Swizerland
Magnesium Faci Asia Pacific MGS-S0018
Stearate Singapore
ADC Attested
0216130415
Croscarmellose Multi Chem D2051560060
Sodium Accent
Titanium Dioxide Multi Chem 68801
Kronos Titan,
Germany
Mannitol Multi Chem 301703031
Singsino group
Limited
PEG 6000 Multi Chem Not traced
Starch Multi Chem 062014
Rafan Maize
Products Co. Ltd
IPA LCY Chemical I170410
Corp
Green Color Euro Hangzhou 20150724
Lake Zhongbao Ltd
8. List of qualified staff involved in The firm has submitted photocopy of List of qualified
product development with relevant staff along with their training record involved in product
experience. development.
Production Data
development & stability testing of trial and protocol for stability studies of the relevant product.
batches.
10. Complete batch manufacturing record The firm has submitted Batch Manufacturing Record
of three stability batches. and BPR of the following 03 Batches.
11. Record of remaining quantities of Batch size: 2000 Tablets
stability batches. Received for Stability and R&D: 1500 Tablets (50
packs)
Used for 6 month accelerated and real-time analysis: 35
pack.
Pack retained for real time and retained sample: 15
packs.
3 batches: 45 packs
Batch No. Batch Size Yield
T001 2000 Tablets 1631 Tablets
54 packs
52 packs
49 packs
How many packs are used for study at single time point?
Details of consumption and remaining quantities of
Lurasid 80mg.
Batch Batch Batch
T001 T002 T003
Packs kept on
real time stability 28 28 28
studies:
Packs kept
accelerated 20 20 20
stability studies:
Packs kept on
07 05 03
retained samples:
Total packs for
55 53 50
each batch
1650 1590 1500
received from
Tabs Tabs Tabs
production:
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of digital
temperature and humidity monitoring printouts of graphical chart for Real Time and
of stability chambers (real time and Accelerated Conditions starting from 1-06-2017 and
accelerated) 01-06-2017, respectively.
with COA. API and has submitted analytical reports.
14. Method used for analysis of FPP &  The firm has submitted photocopy of Finished
complete record of testing of stability Product specification & Test method.
batches (i.e. chromatograms, lab  Firm has submitted complete record of testing of
reports, raw data sheets etc.) stability batches (i.e. chromatograms, lab reports,
15. Reports of stability studies of API from The firm has submitted copies of reports of 06 Months
reports for all excipients used in product development.
17. Drug-excipients compatibility studies. All the excipients used in the development of Lurasid
are similar with innovator product Latuda tablets. The
excipient compatibility studies are performed by
innovator. Therefore, the excipient compatibility studies
are not performed in our lab.
Latuda Tablets 80 mg Lurasid Tablets 80 mg
Mannitol (E 421) Mannitol BP
Starch, Pregelatinised Maize Starch BP
Croscarmellose sodium Croscarmellose sodium
(E468) USP
Magnesium stearate (E Magnesium stearate BP
470b)
Hypromellose 2910 (E Hypromellose (HPMC)
464) USP
Titanium dioxide (E Titanium dioxide BP
171)
Macrogol 8000 Macrogol- (PEG 6000)
Carnauba wax (E 903) NA
yellow ferric oxide and Green Color Lake.
FD&C ,Blue No.2
Aluminum Lake.
18. Record of comparative dissolution Firm has not performed CDP in three pH mediums
data. clarify?
Feature Reference product
Brand name Latuda
Batch No. 6169002A
Exp. date 08/2018
Firm submitted that:
The comparative dissolution studies of Lurasid 80 mg
(lurasidone 80 mg) tablets are performed on Lurasid 80
mg and reference products Latuda 80 mg according to
FDA Draft Guidance on Lurasidone Hydrochloride
using recommended method.
https://www.accessdata.fda.gov/scripts/cder/dissolution/
dsp_getallData.cfm
The dissolution profile is compared with innovator
brand Latuda tablets and the Similarity Factor f2 is
greater than 95, and Difference Factor f1 is less than 7
in given medium.
The dissolution comparison with innovator product also
performed in 0.1 M HCl (pH 1.2) and Phosphate buffer
(pH 6.8). As Lurasidone HCl (active entity) is very
slightly soluble in water, practically insoluble or
insoluble in 0.1 N HCl and the dissolution of both
innovator product Latuda 80 mg and Lurasid tablets is
about 28 % in 60 minutes. Similarly, it is practically
insoluble in phosphate buffer pH 6.8 and the dissolution
of both innovator and Lurasid tablets is 0 % in 60
minutes.
21CFR & audit trail reports on product stability studies analysis of three batches which could
testing. not be verified.
File ID last digit in chromatogram is 2 whereas in Audit
trail report file ID last digit is 1e.g. for Batch no. T003,
accelerated condition 26 week stability data. Clarify and
justify the same.
On the audit trail reports, the file ID last digit V1 or V2
represent the version of file i.e. chromatogram. The
version 1 i.e. V1 on audit trail report represent the
version when the particular chromatogram is created.
The version on both chromatogram and report will
remain same when it is printed for the first time. When
the chromatogram is reprinted, or re scaled then the
version of the chromatogram automatically change to v2
while the version on the audit trail report remain
unchanged.
In Lurasid 80mg Tablet T003 Week 26, STD-1 FILE ID
on Audit trail report is: “6DC02DA0D1DEBECBv1 and
on Chromatogram is “6DC02DA0D1DEBECBv2”. The
file ID on both i.e. audit trail and chromatogram is
matched and the version is changed due to reprinting the
chromatogram. The printing date / time are mentioned
on provided chromatogram.
Similarly Lurasid 80mg Tablet T 003 Week 12, Sample-
2 FILE ID in Audit trail is:
“664AA110F6E55E6Av1” the file ID and version on
both i.e. audit trail and chromatogram is same. The
printing date / time are mentioned on provided
chromatogram.
Related chromatograms and the audit trail of Week 26
are attached for your kind consideration.
Remarks of the evaluator:
Decision: Registration Board deferred the case for clarification/justification due to variation in
previously and currently provided yield of tablets.
Previous Yield of tablets Current Yield of tablets
Batch No.
provided by firm provided by firm
54 packs 55 Packs
T001
1631 Tablets 1650 Tabs
52 packs 53 packs
T002
49 packs 50 Packs
T003
16. Name and address of manufacturer / M/s Genome Pharmaceuticals Pvt. Ltd
Applicant 16/1, Phase IV, Industrial Estate, Hattar, Haripur
Brand Name +Dosage Form + Strength Lurasid Tablet 40 mg
Diary No. Date of R& I & fee Dy No. 314, Rs: 50,000/- 4-12-2015
Lurasidone HCl…40mg
Indole derivatives
ATC code: N05AE05
Type of Form Form 5-D
Finished Product Specification Manufacturer Specs.
Pack size & Demanded Price 1x10’s, 2x10’s, 3x10’s ,Alu alu blister, As per PRC
Approval status of product in Reference Latuda-USFDA approved
Me-too status Not applicable
GMP status 12-05-2018
Good Level of compliance.
Remarks of the Evaluator.  Approved in USFDA with box warning.
Drug Lurasid Tablet 40 mg
M/s Genome Pharmaceuticals Pvt. Ltd
16/1, Phase IV, Industrial Estate, Hattar, Haripur
MSN Pharmachem Private Limited
Manufacturer of API Plot No. 212/A, B,C, D Phase II, IDA Pashamylaram (Village)
Patancheru Mandal , Medak District Telangana, India
API Lot No. LL0261216 Invoice attestation date: 17-01-2017
Description of Pack
Real time : 30°C ± 2°C / 65% ± 5%RH
Real time: 26 week ,
Time Period
Accelerated: 26 week
Accelerated:0,1,2,3,4,6,8,12,16,20,24,26(Week)
Frequency
Real Time:0,1,2,3,4,6,8,12,16,20,24,26 (Week)
Batch No. LUR-40/T001 LUR-40/T002 LUR-40/T003
Batch Size 2000 Tab 2000 Tab 2000 Tab
No. of Batches 03
Date of Submission 19-03-2018 (Dy No. 10116)
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Yes
country of origin or GMP certificate of API Issue date: 12-01-2016
manufacturer issued by regulatory authority Validity 2 years
sheets etc.
1 kg
17-01-2017
Rules, 1978.
Decision:
provided the following documents in conjunction with the checklist approved by the Registration Board
in its 278th Meeting:
for instant dosage form conducted during product “Vertix Tablet 10mg and 20 mg (Vortioxetine
last two years. Hydrobromide)”, which was conducted on 18th July,
2018 and was presented in 277th meeting of
Registration Board.
report:
iii. Adequate monitoring and control are available for
stability chambers. Data Loggers are also placed
in stability chambers for monitoring
2. Documents for the procurement of API  Copy of Commercial Invoice (invoice
with approval from DRAP (in case of no.2500500498) attested by ADC (Karachi) dated
import). 17-01-2017 has been submitted. Batch No
LL0261216 quantity 1 kg.
3. Documents for the procurement of The Reference standard and Impurity standards of
reference standard and impurity Lurasidone HCL was provided by manufacturer with
standards. lot of material. The Manufacturer provided COAs of
Reference standard and Impurity standards; at that
time it was not in practice to mention the reference
standards on invoice of material.
4. Approval of API/ DML/GMP certificate Copy of WHO GMP certificate (certificate no.
of API manufacturer issued by 13087/E(R)/TS/2017) has been submitted for M/s
regulatory authority of country of origin. MSN Pharmachem Private Limited by WHO & Drug
Control Administration, Government of Telangana
and valid upto 16-02-2020.
5. Mechanism for Vendor pre-qualification The firm has submitted Vendor evaluation SOP and
Vendor evaluation Form.
6. Certificate of analysis of the API,  Copies of COAs of API have been submitted,
reference standards and impurity detailed as under:
standards API Batch. # Quantity
Lurasidone LL0261216 63.50kg
HCl Assay
(Anhydrous)
Supplier:99.4%
Mfg. 99.70%
 Firm has submitted COAs of working/reference
standards and impurity standards. Source MSN
Pharma Chem.
Working Standard Batch. #
Lurasidone HCl LNWS1601
Piperazine LDN/B690/M-019/01
Benzothiazole
impurity
Imine Impurity LDN/B592/imine
imp/01
Diastereomer-2 LDN/BB474/6-
isomer/01
Piperazinium LDN/BB415/3/01
impurity
7. Documents for the procurement of The firm has submitted commercial invoices of all the
excipients used in product development? excipients used in formulation from relevant
manufacturers. Submit evidence that all excipients are
pharmaceutical grade.
The firm submitted that the excipients used in
manufacturing of Lurasid tablets 40 mg are
pharmaceutical grade. The Specifications of all
excipients mentioned on COA provided by
manufacturer are according to official pharmacopeia
USP and BP.
Maize starch purchased from Rafhan Pakistan ltd is
pharmaceutical grade and the specifications
mentioned on COA are complied with BP /USP.
All the excipients are tested according to USP/ BP
monograph. Analytical reports, COA and official
monograph of all excipients are enclosed for your kind
consideration.
Evaluation
Firm didn’t provide COA of IPA.
Excipient Supplier Batch No.

Hydroxypropyl M.s DOW 00011073390
Methyl cellulose Europe 0024108250
ADC Attested GMBH
903843621 Horgen,
Swizerland
Magnesium Faci Asia MGS-S0018
Stearate Pacific
ADC Attested Singapore
0216130415
Croscarmellose Multi Chem D2051560060
Sodium Accent
Titanium Multi Chem 68801
Dioxide Kronos Titan,
Germany
Mannitol Multi Chem 301703031
Singsino
group Ltd
PEG 6000 Multi Chem Not traced
Starch Multi Chem 062014
Rafan Maize
Products Co.
Ltd
IPA LCY I170410
Chemical
Corp
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified
development with relevant experience. staff along with their training record involved in
product development.
Production Data
development & stability testing of trial and protocol for stability studies of the relevant
batches. product.
10. Complete batch manufacturing record of The firm has submitted Batch Manufacturing Record
three stability batches. and BPR of the following 03 Batches.
In master formulation the quantity of Lurasidone HCl
is 40.40mg. However, the label claim is 500mg and
40mg. Clarify.
Submit formula for potency adjustment for Lurasidone
HCl.
11. Record of remaining quantities of Batch size: 2000 Tablets
stability batches. Batch No. Batch Size Yield
T001 2000 1648
Tablets Tablets
T002 2000 1564
Tablets Tablets
T003 2000 1509
Tablets Tablets
Firm has now submitted that:
Batch Batch Batch
T001 T002 T003
Packs kept on
real time stability 28 28 28
studies:
Packs kept
accelerated 20 20 20
stability studies:
Packs kept on
retained samples: 07 05 03
Total packs for

55 53 51
each batch
1650 1590 1530
received from
Tabs Tabs Tabs
production:
QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital printouts
temperature and humidity monitoring of of graphical chart for Real Time and Accelerated
stability chambers (real time and Conditions starting from 1-06-2017 and 01-06-2017,
accelerated) respectively.
with COA. API and has submitted analytical reports.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability specification & Test method.
batches (i.e. chromatograms, lab reports,Firm has submitted complete record of testing of
raw data sheets etc.) stability batches (i.e. chromatograms, lab reports, raw
data sheets etc.)
15. Reports of stability studies of API from The firm has submitted copies of reports of 06 Months
(30oC+2 oC, 75+5%) of 03 Batches of API.
reports for all excipients used in product development
except IPA.
17. Drug-excipients compatibility studies. All the excipients used in the development of Lurasid
are similar with innovator product Latuda tablets. The
excipient compatibility studies are performed by
innovator. Therefore, the excipient compatibility
studies are not performed in our lab.
Latuda Tablets 40 Lurasid Tablets 40 mg
mg
Mannitol (E 421) Mannitol BP
Starch, Maize Starch BP
Pregelatinised
Croscarmellose Croscarmellose
sodium (E468) sodium USP
Magnesium stearate Magnesium stearate
(E 470b) BP
Hypromellose 2910 Hypromellose
(E 464) (HPMC) USP
Titanium dioxide (E Titanium dioxide BP
171)
Macrogol 8000 Macrogol- (PEG 6000)
Carnauba wax (E NA
903)
Firm has submitted that:
As Latuda 40 mg tablets and Lurasid 40 mg tablets are
white color, therefore no coloring agent is used in
both brands. Carnauba wax used just for polishing
and shining of film coated tablets, and there is no
therapeutic or stability effect on product so it was not
used as the product was not for marketing purpose.
18. Record of comparative dissolution data. Firm has not performed CDP in three pH mediums
clarify.
Feature Reference
product
Brand name Latuda
Batch No. 6169002A
Exp. date 08/2018
Firm submitted that:
The comparative dissolution studies of Lurasid 40 mg
(lurasidone 40 mg) tablets are performed on Lurasid
40 mg and reference productsLatuda 40 mg according
to FDA Draft Guidance on Lurasidone Hydrochloride
usingrecommended method.
https://www.accessdata.fda.gov/scripts/cder/dissolutio
n/dsp_getallData.cfm
The dissolution profile is compared with innovator
brand Latuda tablets and the Similarity Factor f2 is
greater than 95, and Difference Factor f1 is less than
7 in given medium.
The dissolution comparison with innovator product
also performed in 0.1 M HCl (pH 1.2) and Phosphate
buffer (pH 6.8). As Lurasidone HCl (active entity) is
very slightly soluble in water, practically insoluble or
insoluble in 0.1 N HCl and the dissolution of both
innovator product Latuda 40 mg and Lurasid tablets is
about 28 % in 60 minutes. Similarly, it is practically
insoluble in phosphate buffer pH 6.8 and the
dissolution of both innovator and Lurasid tablets is 0
% in 60 minutes.
21CFR & audit trail reports on product stability studies analysis of three batches which could
testing. not be verified.
File ID last digit in chromatogram does not match with
last digit of file ID in audit trail report e.g. for Batch
no. T003, accelerated condition 26 week stability data.
Clarify and justify the same.
On the audit trail reports, the file ID last digit V1 or
V2 represent the version of file i.e. chromatogram. The
version 1 i.e. V1 on audit trail report represent the
version when the particular chromatogram is created.
The version on both chromatogram and report will
remain same when it is printed for the first time. When
the chromatogram is reprinted, or re scaled then the
version of the chromatogram automatically change to
v2 while the version on the audit trail report remain
unchanged.
Shortcomings
Sr. Deficiency Reply
No.
1. The assay analysis mentions the The weight of reference standard and sample for
concentration Cu used in assay preparation of respective dilution in stability studies of
calculation as 0.032mg/ml. However, Lurasid-40 mg are mentioned in analyst book. The
205/50*1/25 is not eq. to 0.032mg/ml. final concentration of sample and standard are
Justify the calculation of Cu as equivalent as mentioned in data sheet provided with
mentioned in raw data sheets for % stability studies.
age of Lurasidine HCl. Following are the details of calculations:
Standard Dilutions:
37.5 mg Lurasidone HCL / 50 ml * 1 ml / 25 ml =
0.03 mg/ml
Sample Dilution:
205 mg sample Lurasid ≈ (one tablet ≈ 40 mg
Lurasidone HCl) /50 ml * 1 ml / 25 ml = 0.032 mg/ml
Similarly 192 mg of Lurasid powder contained 37.5
mg Lurasidone HCL, and the sample dilution will be
as follow:
192 mg sample (≈ 37.5 mg Lurasidone HCl) /50 ml *
1 ml / 25 ml = 0.03 mg/ml
The table weight is 205 mg as mentio ed
on attached Data sheet.
Decision: Registration Board deferred for clarification/justification of variation in submitted
data for yield of tablets as detailed under:
Previous yield of tablets Yield of tablets provided by firm after
Batch No.
provided by firm communication of shortcomings
T001 1648 Tabs 1650 Tabs
T002 1564 Tabs 1590 Tabs
T003 1509 Tabs 1530 Tabs
Evaluator PEC-VIII
17. Name and Address of the M/s Genome Pharmaceuticals 16/1, Phase IV, Industrial
Manufacturer/Applicant Estate, Hattar, Haripur Islamabad.
Brand Name + Dosage form + Sofvel 400mg/100mg Tablets
Strength
Sofosbuvir….400mg
Velpatasvir….100mg
Diary No. Date of R&I & Fee Dy No.1470; 15-02-2017; Rs. 50,000/-
Pharmacological Group Anti-Viral
Type of Form Form-5
Packed Size and Demanded Price As per SRO
Me-too Status N/A
GMP Status Not submitted
Drug Sofvel Tablets 400/100mg (Sofosbuvir 400mg + Velpatasvir 100mg)
Name of Manufacturer M/s Genome Pharmaceuticals 16/1, Phase IV, Industrial Estate, Hattar,
Haripur Islamabad.
Manufacturer of API Sofosbuvir: M/s Hangzhou Maytime Bio-tec co., Ltd. No.1-2-801
NANAN MINGZHU, XIAOSHAN, ECONOMICAL TECNOLOGY
DEVELOPMENT ZONE, HANGZHOU, ZHEJIANG, CHINA.
Velpatasvir (Copovidone): M/s Hangzhou Maytime Bio-Tec Co.,
Ltd. No.1-2-801 NANAN MINGZHU, XIAOSHAN, ECONOMICAL
TECNOLOGY DEVELOPMENT ZONE, HANGZHOU, ZHEJIANG,
CHINA.
API Lot No. Sofosbuvir: (300kg): Imported on 25-08-2017.
S104A-201705205 & S104A-201705206 (As per commercial invoice)
Velpatasvir (Copovidone) solid dispersion :(1kg): Imported on 11-08-
2017.
VEPII-20177001 (as per commercial invoice)
Description of Pack
28’s: Alu-Alu blister pack
Frequency Accelerated: Initial, 1, 2, 3, 4, , 6, (month)
Real Time: Initial, 1, 2, 3, 4, , 6, (month)
Batch No. SFL/T001 SFL/T002 SFL/T003
Batch Size 1468 Tablet (S104A- 1468 Tablet (S104A- 1468 Tablet (S104A-
201705206) 201705206) 201705206)
No. of Batches 03
1. COA of API Yes
 Manufacturer of APIs (Sofosbuvir+
Velpatasvir) as evident by comercial
invoice is M/s Hangzhou Maytime
Bio-tec co., Ltd while submitted GMP
certificate of manufacturer and COA
of APIs are of another manufacturer
i.e. Ruyuan HEC(25-08-2017 & 11-
08-2017 respectively)
2. Approval of API by regulatory authority of Sofosbuvir: Firm has submitted copy of GMP
country of origin or GMP certificate of API certificate of M/s Ruyuan HEC.
manufacturer issued by regulatory authority of (The manufacturer is different from that
country of origin. mentioned on commercial invoice.)
Velpatasvir (Copovidone): Firm has submitted
copy of GMP certificate of M/s Ruyuan HEC.
(The manufacturer is different from that
mentioned on commercial invoice.)
Yes
5. Documents confirming import of API etc. Sofosbuvir: Copy of invoice attested by ADC
Peshawar on 25-08-2017 confirming import of
Sofosbuvir.
Velpatasvir (Copovidone): Copy of invoice
attested by ADC Peshawar on 11-08-2017
confirming import of Velpatasvir
(Copovidone)
documents.
Yes
Yes
1978.
Data for exemption from Onsite investigation of submitted stability data
for instant dosage form conducted during product “VERTIX Tablet 10mg, 20mg (Vortioxetine
last two years. (as Hydrobromide) Tablets”, which was presented in
284th meeting of Registration board. Registration Board
decided to approve registration of above stated drug
product by Genome Pharmaceuticals. According to the
report following points were confirmed.
 The firm has 21 CFR compliant HPLC software
 The firm has audit trail reports available.
22. Documents for the procurement of API Firm has submitted following documents.
with approval from DRAP (in case of  Sofosbuvir: Copy of invoice attested by ADC
import). Peshawar on 25-08-2017 confirming import of
Sofosbuvir.
 Velpatasvir: (Copovidone): Copy of invoice
attested by ADC Peshawar on 11-08-2017
confirming import of Velpatasvir (Copovidone)
23. Documents for the procurement of  Firm has not submitted any evidence for
reference standard and impurity standards. procurement of reference standards and
impurity standards.
However firm has submitted following:
COA of Sofosbuvir working standard by CAD.
COA of Velpatasvir (Copovidone) working standard by
Nantong Chanyu.
24. Approval of API/ DML/GMP certificate of Firm has submitted following:
API manufacturer issued by regulatory i. Copy of GMP certificate issued to M/s Ruyuan
authority of country of origin. HEC Pharm Co., LTD, Xiaba development
zone, Ruyuan County, Shougan city, 512721,
Guangdong province by Shaoguan Food &
Drug Administration for Sofobuvir &
Velpatasvir.
25. Mechanism for Vendor pre-qualification Firm has submitted following:
i. SOP for selection of Manufacturer of API.
ii. Manufacturer/Supplier Evaluation Form.
26. Certificate of analysis of the API, reference Firm has submitted following:
standards and impurity standards. Sofosbuvir:
i. COA of Sofosbuvir (Batch. #S104A-
201705206) from M/s Ruyuan HEC Pharm.
ii. COA of Sofosbuvir working stranded (Batch. #
WS/SOF/03) from CAD Middle East
Pharmaceutical Industries.
iii. Requalification Report of Sofosbuvir impurity
A, B & impurity C.
Velpatasvir:
i. COA of Velpatasvir Copovidone Solid
dispersion (Batch. # VEP II-2017001) from
M/s Nantong Chanyoo
ii. COA of Velpatasvir working stranded from
Nantong Chanyoo.
iii. COA of Velpatasvir Impurites has not been
submitted
(APIs are purchased from Ruyuan HEC Pharm
& their working standards are purchased from
some other source, to which the applicant has
submitted following justification that
Sofosbuvir is running product CHC-400mg &
the reference standard from USP is not yet
available to produce internal working standard.
The working standard provided by the
manufacturer is not sufficient to be used for
routine analysis of product and stability
studies. Therefore working standard of
Sofosbuvir is arranged from alternate
manufacturer CAD middle east
Pharmaceuticals LLC & the impurity Standards
of Sofosbuvir were provided by manufacturer
of API i.e. HEC Pharma China.
The working standard and impurity standard of
Velpatasvir was not available from API
manufacturer at that time & it was arranged
from alternate manufacturer M/s Nantong
Chanyoo Pharmatec)
27. Documents for the procurement of COA of empty shell from HuBEI HUMANWELL
excipients used in product development? PHARMACEUTRICALS EXCIPIENT is submitted.
28. List of qualified staff involved in product Firm has provided list of technical staff comprising of
development with relevant experience. one personnel directly dealing with product
development section.
Production Data
29. Authorized Protocols/SOP for the Firm has provided developmental protocols of Sofvel
development & stability testing of trial Tablets 400/100mg (Sofosbuvir 400mg + Velpatasvir
batches. 100mg)
Wherein Dissolution method used by the firm for the
testing of applied formulation is different to that of as
recommended by USFDA
30. Complete batch manufacturing record of Firm has provided Batch Manufacturing Record
three stability batches. including Master Formulation, Manufacturing Order,
and Standard manufacturing procedure. Analytical
reports.
31. Record of remaining quantities of stability Yes
batches.
QA/QC DATA
32. Record of Digital data logger for temperature Firm has submitted record of digital data logger for
and humidity monitoring of stability six month starting from 02nd October 2017 to 27th
chambers (real time and accelerated) April 2018.
33. Method used for analysis of API along with Firm has submitted following documents
COA.  Supplier method of Analysis
 Analytical reports
34. Method used for analysis of FPP & complete Firm has submitted following for both accelerated &
record of testing of stability batches (i.e. real time stability studies of all three stability batches:
chromatograms, lab reports, raw data sheets i. Method of analysis (Manufacturers)
etc.) ii. Lab reports
iii. Raw data sheets
iv. HPLC Chromatograms (for Assay analysis)
& for Dissolution analysis)
35. Reports of stability studies of API from Firm has submitted six month both only long term
manufacturer. (30°C ± 2°C & 65±5%RH) stability studies reports of
three batches of Velpatasvir co povidone & two
batches of Sofosbuvir from ---------- but accelerated
(40°C ± 2°C & 75±5%RH) stability studies for both
APIs have not submitted by the firm.
36. Analysis reports for excipients used. Firm has submitted analysis reports for following
excipients
 Crosscarmellose sodium(COA)
 Avicel pH 200(COA)
 Titanium dioxide (COA)
 Mg. stearate (COA)
 Pharmacoat(HPMC)
 Iso propyl alcohol
37. Drug-excipients compatibility studies. Firm has not performed drug excipient compatibility
studies rather it is submitted by the firm that
ingredients of Sofvel 400mg/100mg & Epclusa
tablets (Innovator brand) are same & all the
specifications of Sofvel 400mg/100mg are compared
with reference product Sofosvel tablet (also known as
Epclusa tablets), The excipient compatibility studies
are performed by the innovator therefore the excipient
compatibility studies are not performed in our lab.
38. Record of comparative dissolution data. Comparative dissolution study has not been
performed in following three recommended mediums:
i. pH 5.0 Buffer (Acetate buffer with
Cetyltrimethyl ammonium bromide (CTAB)
ii. pH 6.8 Buffer
iii. pH 1.2 buffer
 Instead Dissolution testing is performed at 5, 10,
20 & 30 minutes only at one pH which is also not
mentioned by the firm.
testing.
1. Manufacturer of APIs as evident by commercial invoice is M/s Hangzhou Maytime Bio-tec co., Ltd
while GMP certificate and COA of APIs are of another manufacturer i.e. Ruyuan HEC., Clarify
2. Reference standards from Nantong Chanyoo (Velpatasvir) & CAD Middle East Pharmaceutical
Industries LLC (sofosbuvir) is used while APIs are purchased from M/s Hangzhou Maytime. Clarify
3. GMP certificate of API manufacturer issued by regulatory authority of country of origin.
4. Submit raw data sheets of analytical method of submitted stability studies.
5. Commitment to continue real time stability study till assigned shelf life of the product.
6. Commitment to follow Drug Specification Rules, 1978.
7. Submit latest GMP inspection report conducted within the period of last one year.
8. You have purchased two lots of API as per commercial invoice (SOFOSBUVIR: S104A-201705205
& S104A-201705206) but submitted COA of one lot to DRAP and also not provided data that which
trail batch is prepared by which lot of API.
9. Analytical method used for dissolution testing of applied drug product is different from US-FDA
recommended dissolution method. Clarify/justify.
10. How the firm has prepared Hard Slugs during the dry granulation technique, Please provide evidence
of manufacturing equipment used in the process.
11. In initial testing of film coated tablet of batch # SFL –T002 & SFL –T003 assay is performed on 19-
10-2017 while dissolution is carried out on 20-10-2017 but there are no chromatograms attached for
the standard of dissolution. Justify/clarify it?
12. At one month both accelerated & real time stability studies of Batch # SFL –T003 standard injection
for assay is injected on 22-11-2017 while sample injection for assay & dissolution are injected on 23-
11-2017 as per attached chromatograms. Justify/clarify it?
13. What is meant by dew point submitted with the record of digital data logger?
14. Comparative dissolution studies are not performed by the applicant in three buffers. Justify/clarify
and also tell which buffer the firm used for CDP.
15. To check the System suitability there is need to run five injection of sample & two injections of
sample, but, you run three injections of standard instead of five. Justify/Clarify.
16. For batch No.SFL-002 at 2nd & 6th month of Real time stability studies you run only one sample
injection instead of two. Justify/Clarify.
The firm has submitted replies of the above queries.
Decision: Registration Board after thorough deliberation deferred the case for scientific justification of
use of working standard and impurity standard from manufacturer other than API manufacturer.
Case No. 02: Registration applications of newly granted DML or New section (Human)
a. New DML
Evaluator PEC-IX
New DML granted vide letter dated 29.08.2018 on the basis of inspection dated 03.07.2018. The firm has
applied for 10 molecules (11 products), wherein 01 productis included in the agenda; however, 10 products
were found deficient for documents for which the firm has been informed accordingly.
Brand Name +Dosage Form + Strength Trimoment Cream
Mometasone Furoate……1mg
PKR 20,000/-: 31.10.2017
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form 5
Approval status of product in Reference ELOCON® (mometasone furoate) Cream, 0.1% for
Regulatory Authorities. topical use by Merck Sharp Dohme. US-FDA approved
Me-too status Hivate Creamby Saffron Pharma. Reg. No. 46432
 Decision: Approved
Case No. 03: Registration applications of categories to be considered on priority

Evaluator-PEC-VI
M/s Genix pharma Pvt Ltd, Karachi has achieved the benchmark of USD 500,000 during the fiscal year 2017-
2018. In this regard, please find the applications submitted by the firm for priority consideration. Application was
received through letter No. F.7-7/2017-Reg-II (Vol-I).
In supersession to this office letter, the chairman registration board has approved the revised list of applications
submitted by the firm for priority consideration.
Firm has applied 5 molecules/ 10-Products as mentioned below.

Applicant Karachi, 75190, Pakistan"
Brand Name +Dosage Form + Strength Hylu 0.2% Opthalmic Solution
Sodium Hyaluronate…2mg
Diary No. Date of R& I & fee Dy.No 8237 dated 06-03-2018 Rs. 20,000/- Dated 05-03-
2018
Pharmacological Group Viscoelastic substance
Type of Form Form-5
Pack size & Demanded Price 5ml, 10ml, As per Drap Policy
Approval status of product in Reference Approved by TGA as medical devices

Me-too status Hylo of M/s Helix Pharma (Reg.#067031)
Remarks of Evaluator Firm has ophthalmic drop section.
20. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd.
Brand Name +Dosage Form + Strength Aclovir 400mg Tablet
Acyclovir…400mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 15’s, 20’s, 25’s, 30’s, As per Drap Policy

Me-too status Registration Number: 021188
Brand Name: Aclova 400mg Tablets
Manufacturer Name: Akhai Pharmaceutical
Decision: Approved.
Acyclovir…800mg
Type of Form Form-5

Brand Name: Aclova 800mg Tablets
Manufacturer Name: Akhai Pharmaceutical
Decision: Approved.
Acyclovir…200mg
Type of Form Form-5

Brand Name: Zoraxin 200mg Tablets
Manufacturer Name: Valor Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Aclovir 200mg/5ml Suspension
Acyclovir…200mg
Diary No. Date of R& I & fee Dy.No 28540 dated 24-08-2018 Rs.20,000/- Dated 24-08-
2018
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml, As per Drap Policy
Approval status of product in Reference Zovirax Suspension 200mg/5ml by M/s Mylan Pharma
Regulatory Authorities. Inc. (USFDA Approved)
Brand Name: Santovir Suspension
Manufacturer Name: Elko Organisation (Pvt) Ltd
Decision: Approved.
Brand Name +Dosage Form + Strength Gvia-M XR 50/500 mg Tablet
Composition Each Extended Release Tablet Contains:
Sitagliptin Phosphate eq to Sitagliptin…50mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’s, As per Drap Policy
Me-too status Tagipmet XR by M/s Highnoon Labs. (Reg.# 084649)
Remarks of Evaluator Firm has not submitted stability studies data.
Decision: Deferred for submission of stability data and relevant documents.
Brand Name +Dosage Form + Strength Gvia-M XR 50/1000 mg Tablet
Sitagliptin Phosphate eq to Sitagliptin…50mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’s, As per Drap Policy

Me-too status Tagipmet XR by M/s Highnoon Labs. (Reg.# 084650)
Remarks of Evaluator Firm has not submitted stability studies data.
Decision: Deferred for submission of stability data and relevant documents.
Brand Name +Dosage Form + Strength Zolereon 5mg/100ml Infusion
Zoledronic acid monohydrate eq to Zoledronic acid………5mg
Diary No. Date of R& I & fee Dy.No--- dated --- Rs.20,000/- Dated 06-10-2016 (Duplicate
Dossier))
Pharmacological Group Osteoclastic Bone resorption Inhibitor
Type of Form Form-5
Pack size & Demanded Price 1’s 100ml, As per Drap Policy
Approval status of product in Reference Reclast of (USFDA approved)

Me-too status Macdronic Infusion of M/S Macter Int
Remarks of Evaluator Fee challan photocopy attached.
Diary Number and date is not mentioned on Dossier.
Decision: Approved (with innovator’s specification) as a routine application since it was an
application of 2016. Verification of fee challan may be done as per decision of 285th meeting of
Registration Board.
Registration Board further decided to consider one (01) more molecule against export facilitation
priority in future if firm applies under export facilitation category.
Applicant Karachi, 75190, Pakistan contract manufacturing from M/s
Stallion Pharmaceuticals 581-Sundar Industrial Estate,
Lahore"
Brand Name +Dosage Form + Strength Tazora Powder for Injection 4.5gm
Piperacillin (as Piperacillin Sodium)……4gm
Tazobactam (as Tazobactam Sodium)…….0.50gm
Diary No. Date of R& I & fee Dy.No 3320 dated 12-04-2018 Rs.50,000/- Dated 11-04-2018
Pharmacological Group Broad Spectrum Penicillin
Type of Form Form-5
Pack size & Demanded Price 1’s & 5’s, As per Drap Policy

Me-too status Tanzo Injection Reg # 039439
GMP status (M/s Stallion Pharma) Certificate of cGMP issued based on
the evaluation conducted on 8-11-2017
Remarks of Evaluator M/s Stallion Pharma has Dry Powder Injection (Penicillin)
Decision: Approved.
Applicant Karachi, 75190, Pakistan contract manufacturing from M/s
Stallion Pharmaceuticals 581-Sundar Industrial Estate,
Lahore"
Brand Name +Dosage Form + Strength Tazora Powder for Injection 4.5gm
Piperacillin (as Piperacillin Sodium)……2gm
Tazobactam (as Tazobactam Sodium)…….0.250gm
Diary No. Date of R& I & fee Dy.No 3321 dated 12-04-2018 Rs.50,000/- Dated 11-04-2018
Pharmacological Group Broad Spectrum Penicillin
Type of Form Form-5
Pack size & Demanded Price 1’s & 5’s, As per Drap Policy

Me-too status Tanzo Injection Reg # 039593
GMP status (M/s Stallion Pharma)Certificate of cGMP issued based on
the evaluation conducted on 8-11-2017
Remarks of Evaluator M/s Stallion Pharma has Dry Powder Injection (Penicillin)
Decision: Approved.
b. Deferred cases
Evaluator PEC-IX
29. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd., Plot # 549, Sundar Industrial
Applicant Estate, Raiwand Road, Lahore
Brand Name +Dosage Form + Strength MFT-500 Tablets 500mg
Mycophenolate mofetil…… 500mg
PKR 20,000/-, 27.06.2018
Type of Form Form 5
Approval status of product in Reference Mycophenolate Mofetil 500 mg film-coated tablets by
Regulatory Authorities. Morningside Healthcare Ltd, Approved by MHRA
Me-too status Mycophenol 500 mg Tablets by Wellborne Pharmachem and
Biologicals, Hattar. Reg. No. 77412
GMP status The firm has been issued DML on the basis of inspection
dated 13.07.2017 and 04.10.2017.
Previous Decision Decision of 285th Meeting:
Registration Board referred the case to QA & LT Division to
conduct GMP inspection of Firm on priority.
Evaluation by PEC
30. Name and address of manufacturer / Shrooq Pharmaceuticals (Pvt.) Ltd., 21-km, Feroz Pur Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Referox tablet 500mg
Deferasirox……. 500mg
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer specs.
Pack size & Demanded Price As per SRO; 10’s, 30’s
Regulatory Authorities. Pharma.
Approved by US-FDA
Me-too status Arefed 500 mg dispersible tablets, by Genome
Evaluation by PEC
 Decision: Approved with innovator’s specifications
31. Name and address of manufacturer / Shrooq Pharmaceuticals (Pvt.) Ltd., 21-km, Feroz Pur Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Referox tablet 250mg
Deferasirox……. 250mg
PKR 20,000/-: 03.09.2018
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer specs.
Pack size & Demanded Price 10’s, 30’s
Regulatory Authorities. Pharma.
Approved by US-FDA
Me-too status Arefed 250 mg dispersible tablets, by Genome
Evaluation by PEC
 Decision: Approved with innovator’s specifications
c. Import applications of priority categories defined by Registration Board in its
th
257 meeting
Evaluator PEC-II
32. Name and address of Applicant "M/s Himmel Pharmaceuticals Pvt Ltd. 793-D Block ‘C’, Faisal
Town, Lahore, Pakistan”
Detail of Drug Sale License Address: M/s Himmel Pharmaceuticals Pvt Ltd. 793-D Block
‘C’, Faisal Town, Lahore, Pakistan
Status: License to sell drugs as a “Distributor”
Name and address of M/s Beacon Pharmaceuticals Limited. Kathali, Bhaluka,
manufacturer Mymensingh, Bangladesh
Name and address of marketing M/s Beacon Pharmaceuticals Limited. Kathali, Bhaluka,
authorization holder Mymensingh, Bangladesh
Name of exporting country Bangladesh
Brand Name +Dosage Form + Ibrutix Capsule 140mg
Strength
Composition "Each Capsule Contains:
Ibrutinib…140mg"
Pharmacological Group Antineoplastic agent
Demanded Price
Pack size 120’s in HDPE bottle
International availability Approved by USFDA
Me-too status N/A
Detail of certificates attached  CoPP (Original & legalized)
Certificate No: DA/6-110/2016/4363
Certifying Authority: Ministry of Health & family Welfare,
Directorate General of drug Administration Oushad Bhaban,
Mohakhali, Dhaka, Bangladesh.
 GMP: The facilities and operations of manufacturing site
conform to GMP as recommended by WHO.
 GMP Certificate (Original & legalized)
Certificate no. DA/6-110/06/10002 valid upto 19-07-2019
Manufacturer Address: M/s Beacon Pharmaceuticals Limited.
Kathali, Bhaluka, Mymensingh, Bangladesh
Issued by Ministry of Health & family Welfare, Directorate
General of drug Administration Oushad Bhaban, Mohakhali,
Dhaka, Bangladesh.
 Distribution agreement:
Original , legalized letter dated 03-03-2018 from M/s Beacon
Pharmaceuticals Limited., Kathali, Bhaluka, Mymensingh,
Bangladesh declaring M/s Himmel Pharmaceuticals Pvt Ltd.
793-D Block ‘C’, Faisal Town, Lahore, Pakistan as authorized
agent to register and sell the applied product in the territory of
Pakistan
 Firm has submitted 24 months long term stability data of three batches conducted at 30 oC + 2 o
C, 65% + 5% RH and 6 months accelerated stability data of three batches conducted at 40 oC +
2 o C & 75% + 5%.
Decision: Approved as per policy for inspections of manufacturer’s abroad.
Brand Name +Dosage Form + Tagrix tablet 80mg
Strength
Composition "Each film coated tablet contains:
Osimertinib mesylate 95.4 mg eq. to 80mg of Osimertinib
Pharmacological Group Protein kinase inhibitor (antineoplastic)
Demanded Price
Pack size 30’s in Alu-Alu blister
Me-too status N/A
Detail of certificates attached  CoPP (original & legalized)
Dhaka, Bangladesh.
Pakistan
C, 65 + 5% RH and 6 months accelerated stability data of three batches conducted at 40oC + 2 o
C & 75% + 5%.
 Salt form of API is not mentioned in Form 5-A.
 Dissolution parameters i.e. Dissolution medium & rpms mentioned in finished product
Analytical method validation protocol are different from that recommended by USFDA.
Parameter In-House USFDA Recommended
Medium 0.1N HCL 0.2% NaCl solution in
water (adjust to pH 1.3)
RPM 75 50
 Upon communication of above observation firm has submitted following:

i. Revised form 5-A with complete description of salt form of API as per submitted COPP i.e.
Osimertinib mesylate 95.4 mg eq. to 80mg of Osimertinib.
ii. USFDA recommended the dissolution method of Osimertinib tablet dated 20/10/2016 but we
developed this method dated April, 2016.
Decision: Deferred for submission of requisite fee for revision in Form-5A.
Brand Name +Dosage Form + Crizonix capsule 250mg
Strength
Crizotinib……250mg"
Pharmacological Group Antineoplastic
Demanded Price
Pack size 30’s in Alu-Alu blister
Me-too status N/A
Detail of certificates attached  CoPP (original & legalized)
Dhaka, Bangladesh.
th
| 927
Pakistan
C, 65 + 5% RH and 6 months accelerated stability data of three batches conducted at 40oC + 2 o
C & 75% + 5%.
Evaluator PEC-XIV
35. Name and address of Applicant M/s Himmel Pharmaceuticals Pvt Ltd.
793-D, Block “C” Faisal Town Lahore, Pakistan
Detail of Drug Sale License Adress: M/s Himmel Pharmaceuticals, 793D, Block C, Faisal
Town, District Lahore.
Status: License to sell drugs as a Distributor.
Name and address of the M/s BEACON Pharmaceuticals Limited, kathali, Bhaluka,
Head office:
BEACON Business Centre, 9/A, Toyenbee Circular Road,
Motijheel Dhaka, Bangladesh
Name and address of marketing M/s BEACON Pharmaceuticals Limited, kathali, Bhaluka,
Office Address: 9/A, Toyenbee Circular Road, Motijheel Dhaka,
Bangladesh
Diary No. & Date of R& I 27959, 16-08-2018
Fee including differential fee 50,000/-, 11-08-2018
Brand Name +Dosage Form + Regonix 40 Tablet
Strength
Regorafenib Monohydrate…..41.491mg eq. to 40mg
Regorafenib
Finished Product Specification In-house specifications
Pharmacological Group Anti-Cancer; Protein Kinase inhibitor
Demanded Price Not mentioned
Pack size 1 × 28’s in HDPE bottle
International availability STIVARGA 40mg Tablet of Bayer Hlthcare (USFDA approved)
Me-too status N/A
Detail of certificates attached ● Original legalized CoPP issued on 28-02-2018 by Directorate
General of Drug Administration, Aushad Bhaban, Mohakhali,
Dhaka-1212, Bangladesh confirms free sale of the product in
the exporting country. Certificate No: DA/ 6-110/2016/4366.
● Original legalized GMP certificate of the manufacturer is
submitted which is issued on 20-07-2017. Certificate No: DA/
6-110/06/10002.
● Original , legalized letter dated 03-03-2018 from M/s Beacon
Pakistan.
Remarks of the Evaluator.  Firm has submitted 6 months accelerated (40 oC ±2 oC,
75%RH±5%RH) stability study data and 24 months real-time
(30 oC ±2 oC, 65%RH±5%RH) stability study data of 3
batches.
 Manufacturing dates:
Batch #3100007 (05-2016)
Batch #3100008 (05-2016)
Batch #3100009 (05-2016)
Dissolution method mentioned in Finished product
specifications is not as per recommendation of FDA.
Clarification is required.
Clarification/ revision of label claim on Form-5A as per CoPP.
Clarification since the submitted dissolution test method is not in accordance with USFDA
recommendation.
36. Name and address of Applicant M/s Himmel Pharmaceuticals Pvt Ltd.
793-D, Block “C” Faisal Town Lahore, Pakistan
Detail of Drug Sale License Adress: M/s Himmel Pharmaceuticals, 793D, Block C, Faisal
Town, District Lahore.
Name and address of the M/s BEACON Pharmaceuticals Limited, kathali, Bhaluka,
Head office:
BEACON Business Centre, 9/A, Toyenbee Circular Road,
Motijheel Dhaka,Bangladesh
Name and address of marketing M/s BEACON Pharmaceuticals Limited, kathali, Bhaluka,
Office Address: 9/A, Toyenbee Circular Road, Motijheel
Dhaka,Bangladesh
Diary No. & Date of R& I 27958, 16-08-2018
Fee including differential fee 50,000/-, 11-08-2018
Brand Name +Dosage Form + Afanix 40 Tablet
Strength
Afatinib Dimaleate INN……….59.120 mg eq. to Afatinib 40mg
Pharmacological Group Other immunosuppressants. ATC code: L01XE13
Demanded Price Not mentioned
Pack size 3 × 10’s in Alu Alu Blister
International availability GILOTRIF 40mg Tablet of Boehringer Ingelheim (USFDA
approved)
Me-too status N/A
Detail of certificates attached ● Original legalized CoPP issued on 28-02-2018 by Directorate
General of Drug Administration, Aushad Bhaban, Mohakhali,
Dhaka-1212, Bangladesh confirms free sale of the product in
the exporting country. Certificate No: DA/ 6-110/2016/4360.
submitted which is issued on 20-07-2017. Certificate No: DA/
6-110/06/10002. Valid for two years from date of issue.
● Original, legalized letter dated 03-03-2018 from M/s Beacon
Pakistan.
Remarks of the Evaluator.  Firm has submitted 6 months accelerated (40 oC ±2 oC,
75%RH±5%RH) stability study data of 2 batches and 24
months real-time (30 oC ±2 oC, 65%RH±5%RH) stability study
data of 3 batches.
 Manufacturing dates:
Batch #3120001 (05-2016)
Batch #3120002 (05-2016)
Batch #3120003 (05-2016)
Accelerated stability data (40oC±2oC, 75%RH±5%RH) was
carried for two batches only.
Decision: Deferred for clarification/revision of label claim on Form-5A as per CoPP.
Evaluator PEC-XII
37. Name and address of Applicant M/s Himmel Pharmaceuticals (Pvt) Ltd,
House#793-D, Block-C, Faisal Town, Lahore.
Detail of Drug Sale License Address: House#793-D, Block-C, Faisal Town, Lahore.
License no.: 05-352-0065-016174D
Name and address of Product license holder: M/s Mylan Pharmaceuticals, S.L.
manufacturer Plom 2-4, 5 Planta, 08038, Barcelona, Espana/ Spain.
Manufacturing site: M/s PRASFARMA, S.L,
C/Sant Joan, 11-15, 08560, Manlleu (Barcelona), Espana/
Spain.
Name and address of marketing M/s Mylan Pharmaceuticals, S.L.
authorization holder Plom 2-4, 5 Planta, 08038, Barcelona, Espana/ Spain
Name of exporting country Spain
Brand Name +Dosage Form + HimTam 20mg Tablets
Strength
Tamoxifen (as citrate) …20mg
Pharmacological Group Hormone antagonists and related agents (Anti-estrogens)
Shelf life 2 Years
Pack size Type I glass vials containing 15ml concentrated solution in
pack size of 1’s
International availability TAMOXIFENO FUNK 20 mg Comprimidos by M/s Spain
(CIMA Spain Approved)
Me-too status Bilem Tablets 20mg by M/s Getz Pharma (Reg#036690)
Detail of certificates attached ● Original legalized CoPP issued on 05-10-2017 by
Agencia Espanola Del Medicamento Y Productos
Sanitarios confirms free sale of the product.
submitted which is valid until 16th June 2020. Certificate
# NCF/1739/001/CAT. The certificate is issued by
Ministry of Health of Government of Catalonia- Spain.
● Original, legalized and valid Sole agency agreement by
M/s PRASFARMA, S.L, C/Sant Joan, 11-15, 08560,
Manlleu (Barcelona), Espana/ Spain., issued on 16-11-
2017 and valid for 3 years is submitted by the firm.
 The product is registered in Spain by M/s Mylan under name: TAMOXIFENO FUNK 20 mg
Comprimidos (Marketing authorisation number: 58110)
 The Sole agency agreement/ contract is issued in the name of manufacturer i.e. M/s
PRASFARMA, S.L, who is not product license holder of the product.
 Firm has claimed in-house specifications whereas the product monograph is available in BP.
 The difference in BP and in-house specifications is as follows:
Tests BP specifications In-house specifications
Assay limits 90-110% 95-105%
 Firm has submitted 6 months accelerated stability study data and 36 months real-time stability
study data for 24 months of 3 batches of batch A-20, A-21 and H-7 manufactured in January
2016,(as per Zone IV-A)
Initiation dates:
Batch # A-20 (October 2007)
Batch # A-21(October 2007)
Batch # H-7(October 2014)
Decision: Deferred for submission of legalized and valid sole agency agreement between
the applicant and product licence holder i.e M/s Mylan Pharmaceuticals, S.L. Plot 2-4, 5
Planta, 08038, Barcelona, Espana/ Spain.
Case No. 04: Registration applications for local manufacturing of (Human) drugs
a. New cases
Evaluator PEC-IV
38. Name and address of manufacturer / M/s Evolution Pharmaceuticals Pvt Ltd. Plot # 25 & 26,
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Azirox 250mg Tablet
Azithromycin Dihydrate Eq. to Azithromycin…250mg
Diary No. Date of R& I & fee Dy.No. 22702; 22-12-2017 Rs. 20,000-( 22-12-2017)
Type of Form Form 5
Pack size & Demanded Price 6’s, 10’s ; As per SRO
Approval status of product in Azithromycin tablet of (MHRA approved)
Me-too status (with strength and Azic 250mg Tablet by M/s NabiQasim
dosage form)
GMP status Latest GMP inspection report conducted on 25-10-2018,
concluding as the operation has not started yet the GMP
status can only be ascertain upon the start of active
production however keeping in view the facilities the firm
has requisite facility for manufacturing
Decision: Approved.
39. Name and address of manufacturer / M/s Evolution Pharmaceuticals Pvt Ltd.
Applicant Plot # 25 & 26, Street S-3, RCCI, National Industrial
Zone, Rawat, Islamabad, Pakistan
Brand Name +Dosage Form + Strength Azirox 500mg Tablet
Azithromycin Dihydrate Eq. to Azithromycin…500mg
Type of Form Form 5
Approval status of product in Azithromycin tablet of (MHRA approved)
Me-too status (with strength and Azic 500mg Tablet by M/s NabiQasim
dosage form)
Decision: Approved.
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Clarox 500mg Tablet
Clarithromycin…………500mg
Type of Form Form 5
Me-too status (with strength and Clarmark 500mg tablet Of M/S Wel Mark Pharmaceutical
dosage form)
Decision: Approved.
Brand Name +Dosage Form + Strength Lenox 750mg Tablet
Levofloxacin Hemihydrate Eq. to Levofloxacin…750mg
Pharmacological Group Antibiotic (Quinolones)
Type of Form Form 5
Approval status of product in Levofloxacin Of ( USFDA Approved)
Me-too status (with strength and Fuvelox 750 mg Tablet Of M/S Martin Dow
dosage form)
Decision: Approved.
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Gemirox 320mg Tablet
Gemifloxacin Mesylate eq to Gemifloxacin…..…320mg
Pharmacological Group Antibiotic (Quinolones)
Type of Form Form 5
Approval status of product in Factive Of ( USFDA Approved)
Me-too status (with strength and Genflox 320mg Tablet Of M/S High-Q Pharmaceuticals
dosage form)
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Moxiva 400mg Tablet
Composition Each Film Coated tablet Contains:
Moxifloxacin HCL Eq. to Moxifloxacin…………400mg
Pharmacological Group Fluoroquinolons antibiotic
Type of Form Form 5
Approval status of product in AVELOX Tablets of USFDA apprpoved
Me-too status (with strength and Moxox 400mg Tablet by M/s. Wellborne Pharmachem and
dosage form) Biologicals
has requisite facility for manufacturing.
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Noxin 200mg Tablet
Ofloxacin………..200mg
Type of Form Form 5
Approval status of product in Tarivid 200 of MHRA apprpoved
Me-too status (with strength and Clamocid 200mg Tablets by M/s Rock Pharmaceuticals
Decision: Approved
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Noxin 400mg Tablet
Ofloxacin………..400mg
Type of Form Form 5
Approval status of product in Tarivid 400 of MHRA apprpoved
Me-too status (with strength and Clamocid 400mg Tablets by M/s Rock Pharmaceuticals
has requisite facility for manufacturing.
Decision: Approved.
Brand Name +Dosage Form + Strength Roxevo 100mg Tablets
Roxithromycin…100mg
Pharmacological Group Macrolide antibiotic
Type of Form Form 5
Finished product Specifications Manufacturer specifications
Approval status of product in Not found
Me-too status (with strength and Roxiban 100mg Tablets by M/s Opal Labs
dosage form)
authorities / agencies which were adopted by the Registration Board in its 275th meeting.
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Roxevo 150mg Tablets
Roxithromycin…………….150mg
Pharmacological Group Macrolide antibiotic
Type of Form Form 5
Approval status of product in Roximycin of TGA approved
Me-too status (with strength and Roxiban 150mg Tablets by M/s Opal Labs
dosage form)
48. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt) Ltd. Plot # 25 & 26,
Islamabad, Pakistan
Brand Name +Dosage Form + Strength Alvas Plus 5/10mg Tablet
Amlodipine as Besylate….…5mg
Atorvastatin as Calcium Trihydrate………10mg
Pharmacological Group Calcium channel blocker/ HMG CoA reductase inhibitors
Type of Form Form 5
Pack size & Demanded Price 7’s, 10’s ,14’s, & 20’s ; As per SRO
Approval status of product in Caduet of 5/10 USFDA approved
Me-too status (with strength and Co-Amlo Tablet by M/s M/s Rasco Pharma
dosage form)
Islamabad, Pakistan
Type of Form Form 5
Approval status of product in Caduet of 5/20 mg USFDA approved
Me-too status (with strength and Caprisk Tablets 5/20 mg by M/s Wilshire Laboratories
dosage form)
Islamabad, Pakistan
Type of Form Form 5
Approval status of product in Caduet of 10/10 mg USFDA approved
Me-too status (with strength and Caprisk Tablet 10/10mg by M/s Wilshire Laboratories
dosage form)
51. Name and address of manufacturer / M/s Helix Pharma Pvt Ltd. Hakimsons House, A/56, S.I.T.E,
Applicant Manghopir Road, Karachi, Pakistan
Brand Name +Dosage Form + Strength Acten/Abten 37.5/150/200mg Tablets
Carbidopa as Monohydrate…37.5mg
Levodopa…150mg
Entacapone…200mg
Pharmacological Group Anti-parkinson agent
Type of Form Form 5
Pack size & Demanded Price 10’s, 30’s; As per PRC
Approval status of product in Stalevo of USFDA apprpoved
Me-too status (with strength and Obsonerv tablet of OBS Pharma (Reg.# 070440)
dosage form)
GMP status Latest GMP inspection report conducted on 24-9-2018 at
satisfactory compliance.
52. Name and address of manufacturer / M/s Helix Pharma Pvt Ltd. Hakimsons House, A/56,
Applicant S.I.T.E, Manghopir Road, Karachi, Pakistan
Brand Name +Dosage Form + Strength Acten/Abten 25/100/200mg Tablets
Carbidopa as Monohydrate…25mg
Levodopa…100mg
Entacapone…200mg
Pharmacological Group Anti-parkinson agent
Type of Form Form 5
Pack size & Demanded Price 10’s, 30’s; As per PRC
Approval status of product in Stalevo of USFDA apprpoved
Me-too status (with strength and Obsonerv tablet of OBS Pharma (Reg.# 070440)
dosage form)
GMP status Latest GMP inspection report conducted on 24-9-2018
at satisfactory compliance.
53. Name and address of manufacturer / M/s Akhai Pharmaceuticals Pvt Ltd. Plot # A-248 & A-256 to
Applicant A-259, H.I.T.E. Lasbela Balochistan, Pakistan
Brand Name+Dosage Form + Strength Rovasta 5mg Tablet
Type of Form Form 5
Pack size & Demanded Price 10’s ;As per SRO
Me-too status (with strength and RosuBar 5mg Tablet by M/s Barrett Hodgson
dosage form)
GMP status GMP Certificate issued based on inspection dated 15 March
Good.
Type of Form Form 5
Pack size & Demanded Price 10’s ;As per SRO
dosage form)
Good.
Type of Form Form 5
dosage form)
Good.
56. Name and address of manufacturer / M/s Titlis Pharma.528-A, Sundar Industrial Estate, Raiwind
Brand Name+Dosage Form + Strength Sitaformin 50/500mg Tablet
Sitagliptin as Phosphate……..50mg
Metformin HCL……..…500mg
Type of Form Form-5
Pack size & Demanded Price 2 x 7’s ;As per DPC
dosage form)
GMP status GMP Certificate issued based on inspection dated 27-7- 2018.
4
Evaluator PEC-VII
57. Name and address of manufacturer / M/s Nabiqasim Industries (Pvt) limited.
Applicant 17/24, korangi industrial area, Karachi..
Brand Name +Dosage Form + Strength Doxefyl syrup
Doxofylline…. 100mg
Diary No. Date of R& I & fee Dy. No.Nil; 27-2-2015; Rs.20,000/- Duplicate
Pharmacological Group Antiasthema
Type of Form Form 5
Approval status of product in Approved in italy
Me-too status (with strength and Agolix 100mg/5ml syrup of Hiranis Pharmaceuticals(Reg No.
dosage form) 067129) (Pharmaguide)
GMP status Last GMP of Nabi qasim Inspection conducted on 03-08-2018
and report concludes that firm is considered to be operating at
an acceptable level of compliance of GMP requirements.
58. Name and address of manufacturer / M/s Nabiqasim Industries (Pvt) limited.
Applicant 17/24, korangi industrial area, Karachi..
Brand Name +Dosage Form + Strength Doxefyl 400 mg tablet
Doxofylline ………………………400mg
Diary No. Date of R& I & fee Dy. No.Nil; 27-2-2015; Rs.20,000/- Duplicate
Pharmacological Group Antiasthema
Type of Form Form 5
Pack size & Demanded Price 10’s & as per PRC
Approval status of product in Approved by Italian Medicine Agency (AIFA)
Me-too status (with strength and Agolix of Hiranis
dosage form)
GMP status Last GMP of Nabi qasim Inspection conducted on 03-08-2018
and report concludes that firm is considered to be operating at
an acceptable level of compliance of GMP requirements.
59. Name and address of manufacturer / M/s Curexa Health (Pvt.) Ltd., 517 sundar industrial estate
Applicant Lahore.
Brand Name +Dosage Form + Strength Curexa capsule 500 mg
Cephalexin as Monohydrate USP……….500mg
Diary No. Date of R& I & fee Dy. No.36833, 7-1-2018; Rs.20,000/-
Pharmacological Group First-generation cephalosporin
Type of Form Form 5
Pack size & Demanded Price Rs 12/-
Approval status of product in Cefalexin 500 mg Capsules, Hard [contains Cefalexin (as
Reference Regulatory Authorities Monohydrate) 500 mg] by Athlone Pharmaceuticals Limited.
Approved by MHRA
Me-too status (with strength and Lexofin Capsule 500mg by Hi-Medic Pharmaceuticals (Pvt)
dosage form) Ltd. Reg. No.
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| 939
GMP status GMP certificate issued based upon evaluation conducted on 20-
02-2018
Remarks of the Evaluator With reference to letter no F.8-6/2013-Reg-V the firm has
requested to considered above mentioned product on priority
(10 molecule per section criteria) New section was granted on
date 14-6-2017 status of applied molecule against cephalosporin
capsule section
Details is
Name of Applied Already Remaining
section molecule considered molecule
molecules
Cephalosporin 5 5 5
capsule
Decision: Approved
Evaluator-PEC-VI
60. Name and address of manufacturer / M/s Theramed Pharmaceutical Pvt Ltd.
Applicant 45-km, Multan Road, Lahore
Brand Name +Dosage Form + Strength Lamogen 50mg Tablet
Lamotrigine…50mg
26-12-2017
Pharmacological Group Anticonvulsant
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s, As per SRO
Approval status of product in Reference Lamictal 50 mg tablets by M/s The Wellcome Foundation
Regulatory Authorities. Ltd (MHRA Approved)
Me-too status Lamotec Tablets 50 mg by M/s Rotex Medica Pakistan (Pvt)
Ltd. (Reg#070154)
Decision: Approved
Brand Name +Dosage Form + Strength Lamogen 100mg Tablet
Lamotrigine…100mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Lamictal 100 mg tablets by M/s The Wellcome Foundation
Regulatory Authorities. Ltd (MHRA Approved)
Me-too status Lamotec Tablets 100 mg by M/s Rotex Medica Pakistan
(Pvt) Ltd. (Reg#070155)
Decision: Approved
Brand Name +Dosage Form + Strength Roxamed 20mg Tablet
Rivaroxaban…20mg
26-12-2017
Pharmacological Group Anticoagulant
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, As per SRO
Approval status of product in Reference Rivaroxaban 20 mg film-coated tablets by Milpharm

Regulatory Authorities. Limited. MHRA approved
Me-too status Rivaxo 20mg film-coated Tablet by Getz Pharma. Reg. No.
80791
Rivaroxaban…15mg
26-12-2017
Type of Form Form-5

Me-too status Rivaxo 15mg film-coated Tablet by Getz Pharma. Reg. No.
80790
Brand Name +Dosage Form + Strength T-Sartan 20mg Tablet
Telmisartan…20mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Telmisartan 20mg tablet;oral prinston Inc. USFDA
Regulatory Authorities. Approved
Me-too status Tasmi Tablets by Getz Pharma, karachi. (Reg. # 047481)
Decision: Approved
Telmisartan…40mg
26-12-2017
Type of Form Form-5
Decision: Approved
Brand Name +Dosage Form + Strength Topira 100mg Tablet
Topiramate…100mg
26-12-2017
Type of Form Form-5

Me-too status Engrax Tablets 100mg of M/s English Pharmaceuticals
Industries. (Reg.# 040144)
Decision: Approved
Brand Name +Dosage Form + Strength Topira 50mg Tablet
Topiramate…50mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Topiramate Teva 50mg film-coated tablets by TEVA UK
Regulatory Authorities. Limited(MHRA Approved)
Me-too status Topamax Tablets 50mg by Johnson &Johnson
(Reg# 025253)
Decision: Approved
Brand Name +Dosage Form + Strength V-Fexin 50mg Tablet
Venlafaxine Hydrochloride Eq. to Venlafaxine…50mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference 50mg tablets by M/s Teva Pharmaceuticals USA (USFDA
Regulatory Authorities. Venlafaxine Hydrochloride Approved)
Me-too status Amfax 50mg Tablets by M/s Amson (Reg#029070)
Decision: Approved
Brand Name +Dosage Form + Strength V-Fexin 75mg Tablet
26-12-2017
Type of Form Form-5

Me-too status Relaxine Tablets Reg # 070129
Decision: Approved
Brand Name +Dosage Form + Strength V-Fexin XR 75mg Tablet
26-12-2017
Type of Form Form-5
Approval status of product in Reference AXYANTAPID MHRA Approved XL, 75mg Prolong
Regulatory Authorities. release tablet
Me-too status Pracit XR 75mg Tablet Reg # 079555
Decision: Approved
Brand Name +Dosage Form + Strength V-Fexin 37.5mg Tablet
Venlafaxine Hydrochloride Eq. to Venlafaxine…37.5mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Venlafaxine Hydrochloride 37.5mg tablets by M/s Teva
Regulatory Authorities. Pharmaceuticals USA (USFDA Approved)
Me-too status Amfax 37.5mg Tablets by M/s Amson (Reg#029062)
Decision: Approved
Brand Name +Dosage Form + Strength DV-Faxin XR 100mg Tablet
Desvenlafaxine (as Succinate)…100mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Pristiq Extended release tablet 100mg of Wyeth, USFDA
Me-too status Denla XR 100mg tablet of Semos (Reg#070434)
Brand Name +Dosage Form + Strength DV-Faxin XR 50mg Tablet
Desvenlafaxine (as Succinate)…50mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference DESVENLAFAXINE extended-release tablets 50mg by

Regulatory Authorities. M/s Sun Pharmaceutical Industries (USFDA Approved)
Me-too status Denla XR 50mg Tablet by M/s Semos Pharmaceuticals
(Reg#070433)
Telmisartan…80mg
26-12-2017
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s, 20’s, As per SRO
Decision: Approved
Brand Name +Dosage Form + Strength Amimed 50mg Tablet
Amisulpride…50mg
26-12-2017
Pharmacological Group Dopamine receptor antagonist
Type of Form Form-5
Approval status of product in Reference Uncoated approved in MHRA
Me-too status Ampisol 50mg Tablet Reg # 076060
Decision: Approved
Amisulpride…200mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Uncoated MHRA Approved tablet

Decision: Approved
Amisulpride…400mg
26-12-2017
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s , 30’s As per SRO
Approval status of product in Reference MHRA Approved film coated tablet Solian
Me-too status Phrenic 400mg Film coated Tablet Reg # 076066
Decision: Approved
Amisulpride…100mg
26-12-2017
Type of Form Form-5
Pack size & Demanded Price Dopamine receptor antagonist
Approval status of product in Reference Uncoated MHRA Approved tablet

Decision: Approved
Brand Name +Dosage Form + Strength Mesam 400mg Delayed Release Tablet
Mesalazine…400mg
26-12-2017
Pharmacological Group Aminosalicylate
Type of Form Form-5
Approval status of product in Reference Approved in MHRA as Modified release tablet

Me-too status Mesal 400mg enteric coated Tablet Reg # 081381
Remarks of Evaluator Mesalazin also known as meslamine
Decision: Approved
Brand Name +Dosage Form + Strength Mesam 800mg Delayed Release Tablet
Mesalazine…800mg
26-12-2017
Pharmacological Group Aminosalicylate Anti-imflammatory
Type of Form Form-5
Approval status of product in Reference Approved in MHRA as Modified release tablet

Me-too status Masacol 800mg modified release Tablet Reg # 061348
Remarks of Evaluator Mesalazin also known as meslamine
Decision: Approved
Brand Name +Dosage Form + Strength D-Pin 25mg Tablet
Dothiepin Hydrochloride…25mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Not Confirmed
Me-too status Dothiepin Tablets 25mg by Glitz Reg # 051143
Remarks of Evaluator Dothiepin is also known as Dosulepin
International availability is not confirmed.
Brand Name +Dosage Form + Strength D-Pin 75mg Tablet
Dothiepin Hydrochloride…75mg
26-12-2017
Type of Form Form-5

Me-too status Dothiepin Tablets 75mg by Glitz reg # 051144
Remarks of Evaluator Dothiepin is also known as Dosulepin
Decision: Approved
Brand Name +Dosage Form + Strength Q-Pine 100mg Tablet
Composition Each Film Coated Tablet contains:
Quetiapine Fumarate Eq. to Quetiapine…100mg
22-12-2017
Type of Form Form-5

Me-too status Qusel tablet 100mg of M/s Hilton Pharma
Decision: Approved
Brand Name +Dosage Form + Strength Zanid 2mg Tablet
Tizanidine Hydrochloride Eq. to Tizanidine…2mg
26-12-2017
Pharmacological Group Sekeltan Muscle relexant
Type of Form Form-5

Me-too status Analar of M/s AGP (Pvt.) Limited (Reg. # 035422)
Decision: Approved.
Brand Name +Dosage Form + Strength Zanid 4mg Tablet
Tizanidine Hydrochloride Eq. to Tizanidine…4mg
26-12-2017
Pharmacological Group Sekeltan Muscle relexant
Type of Form Form-5
Approval status of product in Reference Zanaflex 4mg tablets by M/s Cephalon UK Limited (MHRA
Me-too status Tizorel 4mg Tablets by M/s Merck (Reg#047223)
Decision: Approved
Brand Name +Dosage Form + Strength lamogen 25mg Tablet
Lamotrigine…25mg
26-12-2017
Type of Form Form-5

Me-too status Lojin tablet 25mg of M/s Hilton Pharmaceuticals
Decision: Approved
Brand Name +Dosage Form + Strength Citam 10mg Tablet
Citalopram (as Hydrobromide)…10mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference MHRA Approved Citalopram 10mg tablets

Me-too status Citopram (Global) Reg. No. 030517
Decision: Approved
26-12-2017
Type of Form Form-5
Approval status of product in Reference MHRA Aproved Cipramil 20mg film coated tablet
Me-too status Citaladvan Tablet Reg # 070298
Decision: Approved
26-12-2017
Type of Form Form-5
Approval status of product in Reference Cipramil 40mg Tablet (Lundbeck Limited)

Regulatory Authorities. MHRA – UK approved
Me-too status Citopram (Global) Reg. No. 030517
Decision: Approved
Brand Name +Dosage Form + Strength Prodine 5mg Tablet
Procyclidine Hydrochloride…5mg
26-12-2017
Pharmacological Group Anticholinergic
Type of Form Form-5

Me-too status Proclidine Tablets Reg # 041018
Decision: Approved
Brand Name +Dosage Form + Strength O-Pine 10mg Tablet
Olanzapine…10mg
26-12-2017
Type of Form Form-5

Me-too status Zyprexa tablet 10mg of Eli Lilly, Pak
Decision: Approved
Brand Name +Dosage Form + Strength AV-Zide 10/320/25mg Tablet
Amlodipine as besylate…10mg
Valsartan…320mg
26-12-2017
Pharmacological Group Angiotension II antagonist/ Calcium antagonist
Type of Form Form-5

Me-too status Sofvasc –HCT Tablet of Wilson’s Pharmaceuticals, 387-
388, I-9, Sector, Industrial Area, Islamabad (Reg.# 077753)
Decision: Approved
Amlodipine…10mg
Valsartan…160mg
26-12-2017
Type of Form Form-5

388, I-9, Sector, Industrial Area, Islamabad.
Decision: Approved
Brand Name +Dosage Form + Strength O-Pine 5mg Tablet
Olanzapine…5mg
26-12-2017
Type of Form Form-5
Approval status of product in Reference Olanzapine Actavis 5 mg Film-coated Tablets by M/s

Regulatory Authorities. Actavis Group PTC ehf (MHRA Approved)
Me-too status Olepra Tablet 5mg by M/s Danas Pharmaceutical
(Reg#038671)
Decision: Approved.
Amlodipine…5mg
Valsartan…160mg
26-12-2017
Type of Form Form-5
Me-too status Aldric-H 5/160/25mg Tablet of M/s Martin Dow Ltd.
Karachi (Reg.# 081148)
Decision: Approved
Brand Name +Dosage Form + Strength AV-Zide 10/160/12.5mg Tablet
Amlodipine…10mg
Valsartan…160mg
26-12-2017
Type of Form Form-5
388, I-9, Sector, Industrial Area, Islamabad (Reg.# 077749)
Decision: Approved
Brand Name +Dosage Form + Strength Busmed 5mg Tablet
Buspirone HCL…5mg
26-12-2017
Pharmacological Group Anxiolytic
Type of Form Form-5
Approval status of product in Reference Buspar Tablets 5MG. by M/s Accord Healthcare Limited
Me-too status Buspar Tablets 5mg by M/s Bristol Myers, (Reg#010088)
Decision: Approved.
Rivaroxaban…10mg
26-12-2017
Type of Form Form-5
Me-too status Xaroban 10mg Tablet by Searle Company Ltd. Reg. No.
76284
Brand Name +Dosage Form + Strength AV-Zide 5/160/12.5mg Tablet
Amlodipine…5mg
Valsartan…160mg
26-12-2017
Type of Form Form-5
Me-too status Aldric-H 5/160/12.5mg of M/s Martin Dow Ltd. Karachi.
(Reg.# 081152)
Decision: Approved
Evaluator PEC-IX
100. Name and address of manufacturer / M/s EG Pharmaceuticals, Plot No. 13-A, Industrial
Brand Name +Dosage Form + Strength Densetron 8mg
Ondansetron hydrochloride dihydrate eq. to
Ondansetron…….8mg
PKR 20,000/-: 29.12.2017
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form 5
Approval status of product in Ondansetron 8mg Tablets (Ondansetron hydrochloride
Reference Regulatory Authorities. dihydrate) by Sandoz Limited. MHRA approved
Me-too status Ondonx Tablet by Genix Pharma Karachi. Reg. No. 81451
framed there under
Remarks of the Evaluator.  The firm revised the formulation to
Ondansetron hydrochloride dihydrate eq. to Ondansetron
(8mg) from Ondansetron (8mg) along with submission of
applicable fee Rs. 5000/-.
Decision: Approved
101. Name and address of manufacturer / ZAFA Pharmaceutical Laboratories (Private) Limited L1/B
Applicant Block-22 Federal B Industrial Area, Karachi
Brand Name +Dosage Form + Strength Azid Capsule 250mg
Composition Each capsule contains
Azithromycin as dihydrate…….250mg
PKR 20,000/-: 29.12.2017
Type of Form Form 5
Pack size & Demanded Price 10’s; as per PRC
Approval status of product in ZITHROMAX (azithromycin as dihydrate) 250 mg
Reference Regulatory Authorities. capsules by Pfizer Australia Pty Ltd. TGA Australia
approved
Me-too status Azorox capsules 250mg by Calyx Pharmaceuticals. Reg.
No. 23789
GMP status GMP certificate issued on the basis of inspection dated
03.01.2018

102. Name and address of manufacturer / M/s Lisko Pakistan (Pvt.) Ltd. L-10-D Block-21 Shaheed
Applicant Rashid Minhas Road, F.B. Industrial Area, karachi
Brand Name +Dosage Form + Strength Voltrex-KTablet 50mg
Diclofenac potassium…..50mg
PKR 20,000/-: 29.11.2017
steroids
Type of Form Form 5
Pack size & Demanded Price 2’s, 20’s, 30’s, 100’s , 200’s; Rs. 20/-
Approval status of product in Diclofenac Potassium 50 mg Tablets (film-coated ) by
Reference Regulatory Authorities. Focus Pharmaceuticals Ltd.MHRA approved
Me-too status Arnil-P 50mg Tablet by Brookes Pharma, Karachi. Reg.
No. 82129
GMP status Latest GMP inspection conducted on 24.04.2018 and the
103. Name and address of manufacturer / M/s Lisko Pakistan (Pvt.) Ltd. L-10-D Block-21 Shaheed
Brand Name +Dosage Form + Strength Q-T-Pine XR Tablet 150mg
Composition Each extended-release tablet contains:
Quetiapine as fumarate…..150mg
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 40’s, 50’s, 60’s, 70’s, 80’s, 90’s, 100’s;
Rs. 100
Approval status of product in SEROQUEL XR® (quetiapine as fumarate) extended-
Reference Regulatory Authorities. release tablets, fororal use by Astra Zeneca. US-FDA
approved
Me-too status Ziapine XR150mg Oral Tabletsby A’RAF (Pvt) Ltd,
(Formerly Remedy Pharmaceuticals (Pvt) Ltd). Reg. No.
78755
GMP status Latest GMP inspection conducted on 24.04.2018 and the
Evaluator PEC-XIII
104. Name and address of manufacturer / M/s Regal Pharmaceuticals, Plot # 2A, St # s-5 National
Applicant Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Setra tablet 50mg
Sertraline as HCl………....50mg
Pharmacological Group SSRI/ Anti-depressant
Pack size & Demanded Price 1x 10’s, 2x10’s, 3x10’s & as per SRO
Me-too status Zoloft tablets 50mg tablets of M/s Pfizer Laboratories
(Reg. # 020855)
the report shows the firm to be GMP compliant. However,
the points of improvement have been discussed and
agreed by the representatives of the firm.
Decision: Approved
Brand Name +Dosage Form + Strength Setra tablet 100mg
Sertraline as HCl………...100mg
Pack size & Demanded Price 1x 10’s, 2x10’s, 3x10’s & as per SRO
(Reg. # 020856)
Decision: Approved
Brand Name +Dosage Form + Strength Topro 50mg tablet
Topiramate ……………...50mg
Pack size & Demanded Price 3x10’s, 6x10’s & as per SRO
Me-too status Tomigraine 50mg tablet of M/s Merck Sharp & Dohme
(Reg. # 055498)
Decision: Approved
Brand Name +Dosage Form + Strength Serox 16mg tablet
Betahistine Dihydrochloride………….16mg
Pharmacological Group Anti- Vertigo
Pack size & Demanded Price 3x10’s & as per SRO
Me-too status Vertin 16mg tablets of M/s Remington Pharma (Reg. #
071250)
Decision: Approved
108. Name and address of manufacturer / M/s Avant Pharmaceuticals, M-028 H.I.T.E., Lasbela,
Applicant Balochistan
Brand Name +Dosage Form + Strength Cetofast tablet 20mg
Escitalopram as Oxalate ………20mg
Pharmacological Group Anti-psychotic
Type of Form Form-5
Approval status of product in CIPRALEX 20 mg film-coated tablets (MHRA)
Me-too status Repram 20mg tablet of M/s Regal Pharma (Reg. #
081963)
report concludes:
“All the observations pointed out during the
inspection were discussed with the management and they
assured for early compliance. Overall rating of the GMP
was found good at the time of inspection.”
Observations include “ Firm was asked to:
 Improve documentations and assign clear job
description to qualified personnel.
 Hire one microbiologist in their micro lab.
 Conduct periodic trainings for qualified personals and
maintain the training manuals.
 Hire more professional personals to carry out the
manufacturing process according to GMP guidelines.
Remarks of the Evaluator  The firm has applied Anti-psychotic while in
WHO ATC index it is Antidepressant (SSRI).
Decision: Deferred for applied pharmacological group as the firm has applied Anti-psychotic
while in WHO ATC index it is Antidepressant (SSRI).
Brand Name +Dosage Form + Strength Avecetam 500mg tablet
Levetiracetam…………...500mg
Pharmacological Group Anti-epiletic
Type of Form Form-5
Me-too status Saveta 500mg tablet of M/s Getz Pharma (Reg. # 081080)
report concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Rosuvant 20mg tablet
Rosuvastatin as Calcium…...…..20mg
Pharmacological Group Inhibitor of HMG CoA (Statins)
Me-too status Restore 20mg tablet of M/s Mission Pharma (Reg. #
080326)
report concludes:
Remarks of the Evaluator. The official monograph of the applied formulation is not
available in USP and BP.
Decision: Approved with innovator’s specifications
Brand Name +Dosage Form + Strength Lemowin tablet 25mg
Lamotrigine ……………..25mg
Pharmacological Group Anti-epileptic/ Anti-convulsant
Type of Form Form-5
Me-too status Lamictal 25mg tablet of M/s GSK (Reg. # 014918)
report concludes:
“All the observations pointed out during the inspection
were discussed with the management and they
assured for early compliance. Overall rating of the
GMP was found good at the time of inspection.”
Remarks of the Evaluator  Firm has applied as film-coated tablet while the
applied formulation is approved in MHRA as
uncoated.
Decision: Deferred for submission of evidence of approval of applied formulation as “film
coated tablets” in reference regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting or else the formulation may be revised in accordance
with reference product along with submission of requisite fee.
Brand Name +Dosage Form + Strength Lemowin tablet 50mg
Lamotrigine ……………..50mg
Pharmacological Group Anti-epileptic/ Anti-convulsant
Type of Form Form-5
Me-too status Lamotrin 50mg tablet of M/s Swan Pharma(Reg. #
083016)
report concludes:
Remarks of the Evaluator  Firm has applied as film-coated tablet while the
applied formulation is approved in MHRA as
uncoated.
Decision: Deferred for submission of evidence of approval of applied formulation as “film
coated tablets” in reference regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting or else the formulation may be revised in accordance
with reference product along with submission of requisite fee.
Brand Name +Dosage Form + Strength Avemate 25mg Tablet
Topiramate ……………....25mg
Pharmacological Group Anti- psychotic
Me-too status Tritop 25mg tablet of M/s Semos Pharma (Reg. # 075818)
report concludes:
Remarks of the Evaluator  Firm has submitted its applied pharmacological group
as Antipsychotic while it is Antiepileptic according to
WHO ATC index (N03AX11).
Decision: Deferred for correction of applied pharmacological group as the firm has submitted
its pharmacological group as Antipsychotic while it is Antiepileptic according to WHO ATC
index (N03AX11).
Brand Name +Dosage Form + Strength Avemate 50mg Tablet
Topiramate ……………....50mg
Pharmacological Group Anti- psychotic
Me-too status Tritop 50mg tablet of M/s Semos Pharma (Reg. # 075818)
report concludes:
Remarks of the Evaluator  Firm has submitted its applied pharmacological group
as Antipsychotic while it is Antiepileptic according to
WHO ATC index (N03AX11).
Decision: Deferred for correction of applied pharmacological group as the firm has submitted
its pharmacological group as Antipsychotic while it is Antiepileptic according to WHO ATC
index (N03AX11).
Brand Name +Dosage Form + Strength Respivant 2mg tablet

Risperidone…………….….2mg
Pharmacological Group Tranquiliser/ Sedative (Antipsychotic)
th
| 960
Me-too status Riss 2mg tablet of M/s Shawan Pharma (Reg. # 080378)
report concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Respivant 4mg tablet
Risperidone…………….….4mg
Pharmacological Group Tranquiliser/ Sedative (Anti-psychotic)
Me-too status Riss 4mg tablet of M/s Shawan Pharma (Reg. # 080376)
report concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Mirtazivant tablet 15mg
Mirtazapine……………....15mg
Pharmacological Group Anti-depressant
Me-too status Tizidan of M/s Danas Pharma
report concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Aveloft 50mg tablet
Sertraline ………………..50mg
(Reg. # 020855)
report concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Aveloft 100mg tablet
Sertraline ……………....100mg
Pharmacological Group SSRI
(Reg. # 020856)
report concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Avecetam 250mg tablet
Levetiracetam…………..250mg
Pharmacological Group Anti- epileptic
Me-too status Hevetam 250mg tablet of M/s Hygeia Pharmaceuticals
(Reg. # 081198)
report concludes:
Decision: Approved
b. Deferred cases
Evaluator PEC-III
121. Name and address of manufacturer / M/s Frontier Dextrose Ltd., Plot # 18/3, Phase-I Hattar
Applicant Industrial Estate, Haripur
Brand Name +Dosage Form + Strength Sterifluid-R Infusion
Calcium chloride di hydrate….…..0.033g
Potassium chloride……….0.03g
Sodium chloride…….0.86g
Water for injection qs
PKR 20,000/-: 30-10-2015
Pharmacological Group Electrolytes
Type of Form Form 5
Finished Product Specification Firm has claimed inhouse specification
GMP status Last inspection report dated 02-05-2018 confirms good
compliance to GMP
Remarks of the EvaluatorIII.  Evidence of approval of applied formulation in
reference regulatory authorities which were approved by
approved by DRAP (generic/ me-too status) along with
registration number, brand name and name of firm
Decision of previous meeting of Deferred for following submissions:
Registration Board  Evidence of approval of applied formulation in
reference regulatory authorities / agencies which were
meeting.
of firm. (M-285)
Evaluation by PEC: Firm has submitted following references which have been
verified.
International Availability:
Ringer's In Plastic Container by Baxter Healthcare (USFDA
Approved) Pack size 1000ml
Me-too status:
Solvein Ringer's Injection USP by Siza International (Reg#
015637) Pack size 1000ml
122. Name and address of manufacturer / M/s Medicaids Pak (Pvt) Ltd., Plot No. 10, Sector -27
Brand Name+Dosage Form+ Strength Cevocip 125mg suspension
Ciprofloxacin (as hydrochloride)……125mg
PKR 20,000/-: 30-09-2014
Type of Form Form 5
Pack size & Demanded Price 60ml: Rs 200/-
Approval status of product in Not available as 125mg/5ml suspension but already
approved by Registration Board based on domestic needs,
dosage for children and its stated quantitative composition in
SmPC.
Me-too status Nafcin suspension by Global Pharma
GMP status GMP inspection report within last 1 year is required
Remarks of the Evaluator. GMP inspection report within 1 year is required.
Firm has applied ciprofloxacin (as HCl) while the reference
product is available as ciprofloxacin base.
Evidence of section
Decision of previous meeting of Registration Board deferred the case for further deliberation.
Registration Board (M-284)
Evaluation by PEC Firm has submitted following:
 GMP certificate issued based on inspection dated 9th
August 2018.
 Fee PKR 5,000/- for revision of formulation
 Revised formulation as:
Each 5ml contains:
Ciprofloxacin ……125mg

Registration Board
123. Name and address of manufacturer / M/s Medicaids Pak (Pvt) Ltd., Plot No. 10, Sector -27
Brand Name +Dosage Form+ Strength Cevocip 250 mg suspension
Ciprofloxacin (as hydrochloride)……250 mg
PKR 20,000/-: 30-09-2014
Type of Form Form 5
Pack size & Demanded Price 60ml: Rs 200/-
Approval status of product in Ciproxin suspension by Bayer
Me-too status Nafcin suspension by Global Pharma
GMP status GMP inspection report within last 1 year is required
Remarks of the Evaluator. GMP inspection report within 1 year is required.
Firm has applied ciprofloxacin (as HCl) while the reference
product is available as ciprofloxacin base.
 GMP certificate issued based on inspection dated 9th
August 2018.
 Fee PKR 5,000/- for revision of formulation
 Revised formulation as:
Each 5ml contains:
Ciprofloxacin ……250mg
Registration Board
124. Name and address of manufacturer / M/s Wahabsons Pharmaceuticals, 4km Buner Road, Barikot,
Applicant Swat
Brand Name+ Dosage Form+ Strength Zinkowab Syrup 20mg/5ml
Zinc Gluconate eq. to 2.8mg Elemental Zinc…..20mg
Pharmacological Group Zinc supplement
Type of Form Form-5
Pack size & Demanded Price 60ml & Rs.62/-
Approval status of product in Orazinc of M/s Mericon Industries (USFDA Approved)
Me-too status E-Zinc syrup of M/s Woodwards Pharmaceuticals
GMP status Last GMP inspection was conducted on 23-01-2017, and the
report does not conclude GMP compliance.
Remarks of the Evaluator The date of last inspection doesn’t fall within one year.
Letter has been issued on 26th April, 2018 and reminder has
been issued on 10th July, 2018.
Evaluation by PEC Firm has submitted copy of GMP inspection report dated
25-10-2018, and the report does not have any conclusion
and the recommendations include “Apart from
aforementioned recommendations, the firm is further
advised to
 Develop an independent quality assurance department
and appoint an experienced assurance manager
 To improve water treatment system
Decision: Registration Board referred the case to QA&LT Division for updated GMP status of
the firm.
125. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt) Ltd., Plot No. E-145 to
Applicant E-149, North western industrial zone, Port Qasim, Karachi
Brand Name +Dosage Form + Strength Clovix plus 75/75mg Tablet
Diary No. Date of R& I & fee Dy No. 8291:11-7-2017
PKR 20,000/-: 13-7-2017
Clopidogrel (as bisulphate)…….75mg
Aspirin (as enteric coated)……75mg
Pharmacological Group Antiplatelet
Type of Form Form 5
Pack size & Demanded Price Not demanded by the firm
Approval status of product in CoPlavix Tablet (TGA Approved)
Me-too status Clodril Plus Tablet M/s Macter International
report concludes that the firm was considered to be
operating at satisfactory compliance with GMP guideline
Remarks of the Evaluator.  The applied formulation is of uncoated tablet
containing clopidogrel as bisulphate and aspirin as enteric
coated, while the reference product approved by TGA is
film coated tablet containing aspirin without enteric
coating.
Evaluation by PEC Firm has submitted revised master formulation with film
coating without submission of fee for revision of
formulation
Decision: Registration Board deferred the case for further deliberation on the TGA Australia
approved formulation.
Deferred cases (Export facilitation)
126. Name and address of manufacturer / M/s Medisure Lab Pak (Pvt) Ltd., A-115, S.I.T.E., Super
Applicant Highway Pakistan
Brand Name+Dosage Form + Strength Neurocoline 500mg/5ml Syrup
Citicoline…….500mg
Type of Form Form 5
Pack size & Demanded Price 30ml, 60ml (Amber bottle): As per SRO
Approval status of product in CITICOLINE KERN PHARMA 100 mg / ml oral solution
Reference Regulatory Authorities. EFG by KERN PHARMA, SL (Spain approved)
Me-too status Citolin Syrup by Global Pharmaceuticals (Reg # 029540)
GMP status Last inspection report dated 10-05-2017 confirms good
compliance to GMP
Remarks of the Evaluator.  Justify the formulation containing citicoline 100mg/ml
since the reference product approved by Spain contains
citicoline (as sodium) 100mg/ml.
 GMP inspection report conducted within a period of last 1
year
Decision of previous meeting of Registration Board referred the case to QA&LT division to
Registration Board conduct the GMP inspection of the firm on priority.
Registration Board further deferred the case for revision of
formulation from citicoline 100mg/5ml to citicoline (as
sodium) 100mg/5ml as per the reference product along with
submission of fee.
 revised formulation as per innovator product along with fee
PKR 5,000/-
 GMP certificate issued based on inspection dated 28-6-2018
Evaluator PEC-IV
127. Name and address of manufacturer / M/S Elite Pharma (Pvt) Ltd., P.D.H. Street, 9.5 K.M.
Applicant Sheikhupura Lahore.
Brand Name +Dosage Form + Strength Fusilite-H Cream
Composition Each grams of cream contains:
Fusidic acid (B.P) …………2%
Hydrocortisone acetate (B.P)……1%
Pharmacological Group Antibiotic, Corticosteroid
Type of Form Form 5
Finished product Specifications Manufacturer’s specification
Pack size & Demanded Price 10gram ; RS; 95/-
Approval status of product in Fucidin H Cream (UK MHRA Approved)
Me-too status (with strength and Melas H Cream of M/s Atco Laboratories
dosage form)
report concludes:
“It is advised to overcome the shortcomings and submit the
compliance report to the competent authorities so that
the inspection could be conducted accordingly.”
Decision of 284 meeting:
Updated status of GMP of the firm form QA & LT division as inspection report submitted by firm does
not conclude GMP compliant status
Last GMP inspection was conducted on 20-4-2018 and the report concludes satisfactory level
128. Name and address of manufacturer / M/S Elite Pharma (Pvt) Ltd., P.D.H. Street, 9.5 K.M.
Applicant Sheikhupura Lahore.
Brand Name +Dosage Form + Strength Clobesole Ointment
Composition Each grams of cream contains:
Clobetasol Propionate USP…………0.05%
Type of Form Form 5
Pack size & Demanded Price 15gram ; RS; 45/-
Approval status of product in ClobaDerm 0.05% ointment (UK MHRA Approved)
Me-too status (with strength and Cobi-Scot Ointment of M/s Scotmann Pharmaceuticals
dosage form)
report concludes:
“It is advised to overcome the shortcomings and submit the
compliance report to the competent authorities so that
the inspection could be conducted accordingly.”
Decision of 284 meeting:
Updated status of GMP of the firm form QA & LT division as inspection report submitted by firm does
not conclude GMP compliant status
Last GMP inspection was conducted on 20-4-2018 and the report concludes satisfactory level
Decision: Approved.
Evaluator PEC-XIV
129. Name and address of manufacturer / M/s Winthrox Laboratories (Private) Limited, Karachi
Applicant
Brand Name +Dosage Form + Strength Wincip 250mg/5ml Granules for Oral Suspension.
Composition Dy. No. 504 dated 21-09-2015, Rs: 20,000/-
Diary No. Date of R& I & fee Each 5ml of reconstituted suspension contains:
Ciprofloxacin as base …..250 mg
Granules:-
Each 100mg Granules contains 22.5mg of Ciprofloxacin base.
Solvent/Diluent:
Soya lecithin, Medium chain triglycerides, Strawberry flavor,
Sugar (Granular), Purified water.
Type of Form Form-5
Finished product Specification Manufacture Specification
Pack size & Demanded Price Pack size of 60 ml / as per price fixed by Government.
Approval status of product in Ciproxin-USFDA approved
Me-too status Hiflox (Hilton)
GMP status Oral Dry Powder Suspension (General) & Liquid Syrup
(General) granted in 239th meeting of Central Licensing Board.
Previous remarks of the Evaluator. --.
Previous decision(s) Deferred for verification of composition of diluents in 255th
Registration Board deferred the case as per decision of 269th
meeting regarding formulation of “ciprofloxacin 125mg/5ml
granules and solvent for oral suspension”. Wherein
Registration Board was apprised that already registered
products were either not providing diluent with the
ciprofloxacin suspension or the composition of diluent was not
as per the reference product. Registration Board advised
Pharmaceutical Evaluation Cell to prepare the case along with
details including manufacturing area requirements of the
solvent/diluent and considering the legal requirements for the
separate registration of the solvent for further deliberation in
Registration Board. (M-270)
Evaluation by PEC  Firm has submitted detailed composition of diluent as
under:
Sr.# Raw Material Req. volume per bottle
i. Soya lecithin 0.45g
ii. Medium chain triglycerides 0.500
iii. Sugar (Granular) 3.31
iv. Strawberry flavor 0.669
v. Purified water q.s 40.0 ml
 The above stated composition is qualitatively identical to
that of reference product approved by USFDA.
 Source: M/s Vision Pharma
Decision: Deferred for clarification of applied formulation since reference product contains
Ciprofloxacin as base only whereas submitted source contains Ciprofloxacin as hydrochloride
granules.
130. Name and address of manufacturer / M/s. Murfy Pharmaceuticals (Pvt) Ltd, 8th Km Raiwind Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Vital-D 1ml Injection
Composition Each ml injection contains:
Cholecalciferol…………5mg (200,000IU)
Type of Form Form-5
Finished product Specification As per innovator’s
Pack size & Demanded Price 1ml ampoule/150.00 Rs
Approval status of product in VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution for
Reference Regulatory Authorities. injection ANSM, France approved
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
GMP status 18th& 19th March 2014 showed considerable improvements
regarding previous GMP inspection.
Previous remarks of the Evaluator.  Latest GMP inspection report which should have been
conducted within period of one year.
Previous decision(s) Deferred for submission of latest GMP inspection report which
should have been conducted within period of one year(M-274).
Evaluation by PEC Routine GMP inspection conducted on 16th August, 2018
concluded that the firm was considered to be operating at fair
level of compliance with GMP guidelines.
Decision: Approved.
131. Name and address of manufacturer / M/s. Murfy Pharmaceuticals (Pvt) Ltd, 8th Km Raiwind Road,
Applicant Lahore
Brand Name +Dosage Form + Strength Vibra Capsule 100mg
Doxycycline hyclate eq. to Doxycycline……..100mg
Pharmacological Group Tetracycline
Type of Form Form-5
Finished product Specification As per innovator’s
Pack size & Demanded Price 6×10 capsule; 6×20 capsule; As per SRO
Approval status of product in Cap. Vibramycin, Pfizer (USFDA)
Me-too status Cap. Vibramycin of Pfizer
GMP status 18th& 19th March 2014 showed considerable improvements
regarding previous GMP inspection.
Previous remarks of the Evaluator.  Latest GMP inspection report which should have been
conducted within period of one year.
Previous decision(s) Deferred for submission of latest GMP inspection report which
should have been conducted within period of one year(M-274).
Evaluation by PEC Routine GMP inspection conducted on 16th August, 2018
concluded that the firm was considered to be operating at fair
level of compliance with GMP guidelines.
Decision: Approved.
132. Name and address of manufacturer / M/s Weather Folds Pharmaceuticals, Plot # 69/2, Phase, 2
Applicant Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Tamfold 0.4mg capsule
Tamsulosin HCl …………..0.4mg
(as modified release pellets)
Pharmacological Group Alpha-adrenergic antagonist
Type of Form Form-5
Pack size & Demanded Price As per SRO & as per PRC
Me-too status Tamsolin capsule of M/s Getz Pharma
report concludes the firm to be GMP compliant.
Previous remarks of the Evaluator.  Source of pellets has not been submitted.
Previous decision(s) Deferred for source of pellets, along with stability studies data,
GMP certificate of supplier and differential fee in case of
import of pellets. (M-279)
Evaluation by PEC The firm has submitted source of pellets: M/s Vision pharma
with COA, Stability study of 3 batches and GMP certificate of
supplier.
Decision: Approved.
133. Name and address of manufacturer / M/s Pearl Pharmaceuticals, Islamabad.
Applicant
Brand Name +Dosage Form + Strength Minoxil Plus Lotion
Composition Each bottle contains:-
Minoxidil………………5% w/w
Diary No. Date of R& I & fee Dy.No.2700, 11-03-2011, Rs.8000/-, 11-3-2011,
Rs.12,000/-, 13-04-2015
Pharmacological Group Hair Restorer
Type of Form Form-5
Pack size & Demanded Price 60ml; As Per SRO
Approval status of product in MINOXIDIL EXTRA STRENGTH (FOR MEN)
Reference Regulatory Authorities. (MINOXIDIL) 5% Topical Solution (MHRA approved)
Me-too status Minoxin By Brookes Pharma
GMP status Inspection conducted on 23-07-2018, the firm was found in
satisfactory compliance with GMP guidelines documents
including SOPs, log books were found intact and implemented.
Previous remarks of the Evaluator. Both International availability and me too products are topical
solution while the applied product is lotion. It is not confirmed
whether International and me too products is in 5% w/w or
w/v.
Previous decision(s) Deferred for evidence of approval by reference
regulatory authorities and me too status. (M-268)
Evaluation by PEC The firm has submitted revised Form-5 and master formulation
from %w/w to %w/v as per reference. Fee challan of Rs.
5000/- (deposit slip#0708029) dated 05-11-2018.
Decision: Approved.
Sr. Name and Brand Name Type of Form Approval Previous Evaluation
No address of (Proprietary name + Initial date, status in Decisions by PEC
manufacturer / Dosage Form + diary Reference
Applicant Strength) Fee including regulatory
Composition differential fee agencies /
Pharmacological Demanded authorities
Group Price /Pack Me-too status/
Finished product size GMP status
Specification
134. M/s MKB Ciprobid 125 mg / 5 Form 5 Ciproxin Deferred for
Pharmaceutica mL Dry powder 28-01-2015 (Bayer) review of
ls (Pvt) Ltd. suspension (Diary No. 77) formulation.
66, Hayatabad Rs. 20,000/- Novidat 125 (M-249)
Industrial Each reconstituted 5 As per DRAP mg/
Estate, mL contains: Policy/60 mL 5 mL of Sami
Peshawar, Ciprofloxacin (as Pharma
KPK. ciprofloxacin HCl
taste masked GMP
Oral Dry granules 22.2%) inspection
Powder …….………125 mg. dated 01-02-
Suspension Broad Spectrum 2018 concluded
Section Antibiotic that the firm is
(General): operating at the
(Fluoroquinolone satisfactory
No. F.6-3/ antibiotic) level of GMP
2014-Lic (M- compliance
234 dated 24- (Manufacturer’s with refer to
03- 2014) specs) section visited
Source: M/s. Surge at the time of
Laboratories (Pvt.) inspection.
Ltd; Sheikhupura.
Decision: Deferred for clarification of applied formulation since reference product contains Ciprofloxacin
as base only whereas the firm has applied Ciprofloxacin as hydrochloride.
135. M/s MKB Ciprobid 250mg Form 5 Ciproxin (Bayer) Deferred for
Pharmaceutica /5 mL 28-01-2015 review of
ls (Pvt) Ltd. Dry powder (Diary No. formulation.
66, Hayatabad suspension 86) Novidat 250mg/ (M-249)
Industrial Each reconstituted Rs. 20,000/- 5 mL of Sami
Estate, 5mL contains: As per DRAP Pharma
Peshawar, Ciprofloxacin (as Policy / 60
KPK. Ciprofloxacin HCl mL GMP inspection
taste dated 01-02-2018
Oral Dry masked granules 22.2 concluded that the
Powder %)….250 mg firm is operating at
Suspension Broad Spectrum the satisfactory
Section Antibiotic level of GMP
(General): (Fluoroquinolone) compliance with
No. F.6-3/ (Manufacturers specs) refer to section
2014-Lic (M- Source: M/s. Surge visited at the time
234 dated 24- Laboratories (Pvt.) of inspection.
03- 2014) Ltd; Sheikhupura.
Decision: Deferred for clarification of applied formulation since reference product contains Ciprofloxacin
as base only whereas the firm has applied Ciprofloxacin as hydrochloride.
136. M/s MKB Bronchodox 100 mg/ Form 5 Italian Medicine Deferred for The
Pharmaceutica 5 mL Syrup Dy. No.2176, agency evidence of approval
ls (Pvt) Ltd. Each 5 mL contains:- 14-06-2012 , DOXOFILLINA approval status has
66, Hayatabad Doxofylline …… 100 Rs.8,000/- ABC 200 mg / 10 status of been
Industrial mg (14-06-2012), ml Syrup applied confirmed
Estate, Rs.12,000/- formulation in Italian
Peshawar, Phosphodiesterase (28-01-2015) Unifyline Syrup in Medicine
KPK. inhibitor / 60 mL ; As per 100mg/5ml by reference Agency.
Bronchodilator SRO M/s Platinum regulatory
Pharmaceuticals authorities
(Reg# 047180) and Me-too
status. (M-
272).
GMP inspection
dated 01-02-2018 Deferred for
concluded that GMP
the firm is inspection
operating at the report
satisfactory level conducted
of GMP within the
compliance with period of
refer to section last 01 year
visited at the time (M-277).
of inspection.
Case No. 05: Registration applications for local manufacturing of (veterinary) drugs
a. Deferred cases
Evaluator PEC-XIV
137. Name and address of manufacturer / M/s Evergreen Pharmaceuticals, Plot No. 69-70/B, Main Glaxo
Applicant Town, Industrial Area, 20th KM, Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength E-Chlor 20 Oral Powder
Composition Each gm contains:-
Chlortetracycline hydrochloride…………….20%
Diary No. Date of R& I & fee Dy.No. 331, 27-04-2016 ; Rs.20,000/- 27-04-2016
Type of Form Form-5
Finished Product Specification BP specifications
Pack size & Demanded Price 100gm, 500gm, 1000gm; Decontrolled
Me-too status W.S. CTC 20% Powder of Lexicon Pharma (Reg#041268)
GMP status Last inspection report 03-01-2018, panel decided to
recommend the renewal of DML.
Remarks of the Evaluator. Firm has Oral Liquid General and Dry powder General
(Veterinary) section.
Previous decision Deferred for consideration on its turn as 10 molecules have
been granted registration (M-264).
Evaluation by PEC
Decision: Approved.
Brand Name +Dosage Form + Strength Empro-50 Oral Powder
Composition Each kg contains:
Amprolium HCl……….….500gm
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 10,000gm, 25000gm
Me-too status Ampro powder of Nawal Pharma (Reg # 072631)
Previous decision Deferred for submission of correct pharmacological group. (M-
282)
Evaluation by PEC The firm has submitted correct pharmacological group
“Anticoccidial”.
Decision: Approved.
Brand Name +Dosage Form + Strength FURADONE SOLUTION
Neomycin sulphate…………..30mg
Chlortetracycline HCl………..100mg
Furaltadone…………………..75mg
Diary No. Date of R& I & fee Dy. No.38; 15-1-2016 ; Rs.20,000/- (11-11-2017)
Type of Form Form-5
Finished Product Specification Manufacturers Specification
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml; Decontrolled
Me-too status FURANEC SUPER WSP of ZUMARS (Reg#048114)
GMP status Panel inspection dated 03-01-2018 decided to recommend the
renewal of DML.
Rationale of furaltadone in applied formulation.
The submitted me-too reference could not be verified.
Previous decision Deferred for evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm (M-279).
with change in dosage form from Solution to Powder as per
me-too reference :
FURADONE POWDER
Neomycin sulphate…………..30gm
Chlortetracycline HCl………..100gm
Furaltadone…………………..75gm
Formulation contains
Decision: R.egistration Board deferred the case for further delibration.
Brand Name +Dosage Form + Strength Quinodim Solution
Sulfadimerazine Sodium………..0.2gm
Sulfaquinoxaline Sodium……….0.025gm
Pyrimethamine……………...…..0.025
Furaltadone HCl………0.1gm
Vitamin A……………..0.008gm
Vitamin K3……………0.005gm
Diary No. Date of R& I & fee Dy. No.39; 15-1-2016 ; Rs.20,000/- (11-11-2017)
Type of Form Form-5
Finished Product Specification Manufacturers Specification
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, 5000ml;Decontrolled
Me-too status CARCOX POWDER of Attabak Pharma (Reg#053924)
The submitted me-too reference is of different dosage form.
Previous decision Deferred for evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm (M-279).
with change in dosage form from Solution to Powder as per
me-too reference :
QUINODIM POWDER
Each gm contains:
Sulfadimerazine Sodium………..200mg
Sulfaquinoxaline Sodium……….25mg
Pyrimethamine……………...…..25mg
Furaltadone HCl……………..…100mg
Vitamin A……………………...15000 IU
Vitamin K3………………………5mg
Decision: Registration Board deferred the case for further delibration.
Case No. 06: Registration applications of import cases

a. New Cases (Veterinary)
Evaluator PEC-III
141. Name and address of Applicant M/s Ghazi brothers, Ghazi house, D-35, KDA Scheme No. 1,
Miran Muhammad Shah Road Karachi
Detail of Drug Sale License Address: D-35, KDA Scheme No. 1, Miran Muhammad Shah
Road Karachi
Godown Address: B-32 Al Hilal Society KDA Scheme No. 7,
Karachi. Plot No. 335/15 Deh Tuppu Korangi
Validity: 25-5-2020
Status: License to sell drugs by way of wholesale
Name and address of manufacturer Pucheng Chia Tai Biochemistry Co. Ltd. No. 56, Da Shi Xi,
Putan Village, Pucheng, Nanping City, Fujian Province, China
Name and address of marketing Pucheng Chia Tai Biochemistry Co. Ltd. No. 56, Da Shi Xi,
authorization holder Putan Village, Pucheng, Nanping City, Fujian Province, China
Brand Name +Dosage Form + Strength ChlorGuard 20% P
Composition Each 100g contains:
Chlortetracycline (as calcium complex)……20g
Shelf life 2 Years
Pack size 25 kg
Me-too status Reo Ctc 20 Oral Powder by Delux Chemicals Industries
(Reg#035140)
Detail of certificates attached GMP Certificate: Original GMP certificate issued by Fujian
provincial agriculture department dated 17-1-2017 is provided
Free sale certificate: Original, legalized free sale certificate
issued by Pucheng Bureau of Agriculture is provided
Sole Agency Agreement:
Original, legalized sole agency agreement dated July 11, 2016
between the MA holder in China and applicant in Pakistan is
provided. (All original certificate are attached in Chlorguard
15%P dossier)
 Initially the firm has submitted the application as new drug with 50,000 fee, later the firm informed that
me-too of this product is also available and submitted differential fee PKR 50,000/- (Slip No. 0811202)
dated 14-11-2018.
 There is significant difference in values of assay in all the three batches of accelerated stability data
Accelerated stability Batch No Initial value of Value at last % Change
o o
(40 C ± 2 C/ 75 ± 5% assay testing interval
RH) G0612200 100.65% 92.20% 8.45%
G0612201 102.90% 93.0% 9.9%
G0612202 102.2% 93.5% 8.7%
Real time stability G1107106 100.71% 95.94% 4.7%
(30oC ± 2oC/ 70 ± 5% G1107107 101.44% 95.22% 6.2%
RH)
G1107108 101.07% 95.22% 5.8%
As per VICH GL3(R) Quality guidelines for stability testing of new veterinary drugs, if long-term
studies are conducted at 25°C ± 2°C/60% RH ± 5% RH and “significant change” (A 5% change in assay
from its initial value) occurs at any time during 6 months’ testing at the accelerated storage condition,
additional testing at the intermediate storage condition should be conducted and evaluated against
significant change criteria.
Decision: Approved with Innovator’s specifications as per Policy for inspection of Manufacturer
abroad.
Evaluator PEC-VIII
142. Name and address of Applicant Ghazi Brothers, Ghazi House, D-35, K.D.A Scheme No. 1,
Miran Muhammad Shah Road, Karachi-75350, Pakistan.
Detail of Drug Sale License Address: M/s. Ghazi Brothers, Gazi house
d-35, KDA Scheme No.1. Miran Muhammad Shah Road,
Karachi.
Validity: 25 May, 2020
Name and address of Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
manufacturer Industrial Park, Pucheng, Fujian, China.
Name and address of marketing Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
authorization holder Industrial Park, Pucheng, Fujian, China.
Brand Name +Dosage Form + Sinomd 15% Powder (for oral use)
Strength
Composition Each 1kg of powder contains:
Bacitracin (as methylene disalicylate)… 150g
750g of bacitracin methylene disalicylate eq. to 150g of
bacitracin base)
Target Species Chickens, Hen & growing turkeys
Shelf life 2 years
Demanded Price De-Controlled
Pack size 1kg, 2kg, 5kg & 10kg
International availability Could not be confirmed
Me-too status N/A
th
| 975
Detail of certificates attached  Original legalized free sale certificate:
 Issued by: Pucheng administration of Animal Husbandry &
Veterinary & Aquatic Products.
 Issued on: 14-01-2016.
Free sale in exporting country: Confirms the free sale of the
product in exporting country.
GMP Certificate (Copy):
Issued by: Ministry of Agriculture of the People Republic of
china, Fujian Province.
 Certificate No. (2015) S.Y.GMP Z.ZI, No.13003.
 Issued on: August 21, 2015
Valid till: August 20, 2020.
Decision: Registration Board referred the case to the Expert committee on the veterninary
drugs for their coments regarding need of this medicine within the country.
143. Name and address of Applicant Ghazi Brothers, Ghazi House, D-35, K.D.A Scheme No. 1,
Miran Muhammad Shah Road, Karachi-75350, Pakistan.
Detail of Drug Sale License Address: M/s. Ghazi Brothers, Gazi house d-35, KDA Scheme
No.1. Miran Muhammad Shah Road, Karachi.
Validity: 25 May, 2020
Name and address of Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
manufacturer Industrial Park, Pucheng, Fujian, China.
Name and address of marketing Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
authorization holder Industrial Park, Pucheng, Fujian, China.
Brand Name +Dosage Form + Sinobac 15% Powder (for oral use)
Strength
Composition Each 1kg of powder contains:
Bacitracin (as zinc)… 150g
(750g of bacitracin zinc eq. to 150g of bacitracin base)
Target Species Broiler, Hen , Cattle/Buffalo, Aquaculture
Shelf life 2 years
Demanded Price De-Controlled
Pack size 1kg, 2kg, 5kg & 10kg & 25kg
International availability Could not be confirmed
Me-too status N/A
Detail of certificates attached  Original legalized free sale certificate:
Issued by: Pucheng administration of Animal Husbandry &
Veterinary & Aquatic Products.
Issued on: 14-01-2016.
Free sale in exporting country: Confirms the free sale of the
product in exporting country.
GMP Certificate (Copy):
Issued by: Ministry of Agriculture of the People Republic of
china, Fujian Province.
Certificate No. (2015) S.Y.GMP Z.ZI, No.13003.
Issued on: August 21, 2015
Valid till: August 20, 2020.
Decision: Registration Board referred the case to the Expert committee on the veterninary
drugs for their coments regarding need of this medicine within the country.
b. Deferred cases
i. Human
Evaluator PEC-II
144. M/S AGP Avonza Tablet Form 5 A USA 262nd Meeting
(private) Limited Each tablet Dy # 856 N.A Registration
B-23, contains; Fee 50,000 Original COPP is checked. Board held on
S.I.T.E, Karachi Tenofovir Dated Copp has expired on 05- 20-21st
Manufacturer: Disoproxil 12-08-2016 08-2016 October, 2016.
Mylan fumarate (IH)…. 30 tablets Firm has provided copy of
Laboratories 300mg per bottle fresh COPP which is valid Deferred for
Limited Plot # Lamivudine USP Rs- upto 26-09-2018& is in the submission of
11, 12, 13, Indore ……300mg 12,942.72 process of attestation from original valid
SEZ Efavirenz USP Pakistan embassy legalized
Pharma Zone, ….400mg COPP.
Phase II, Sector
III
Pithampur-
454775
Dist- Dhar (M.P)
India
Evaluation By PEC
Firm has Submitted original Legalized COPP (Certificate# 7/2014) Valid Upto 26-09-2018 Issued by
FDA, Madhya Pardesh, India.
COPP confrms the GMP status of manufacturer i.e. M/s Mylan Laboratories, Dist- Dhar (M.P)
India
Reference product contains Efavirenz = 600 mg (USFDA)
Decision of 265th meeting: Deferred for evidence of approval of applied formulation by
reference regulatory authorities.
Evaluation by PEC-II: Following reference of applied formulation has been verified from USFDA:
“Symfi Lo of M/s Mylan Pharms INC (NDA# 208255)” approval date 02-05-2018.
Evaluator PEC-XIV
145. Name and address of Applicant M/s Zam Zam Corporation, Suit No. 205-206, Beaumont Plaza,
Beaumont Road, Karachi
Detail of Drug Sale License Adress: M/s Zam Zam Corporation, 205, 206, Beaumont Plaza,
Beaumont Road, 2nd Floor near PIDC, Karachi
Status: Drug License by way of wholesale
Name and address of M/s Alfa Sigma SpA, via Enrico Fermi 1, 65020 Alanno (PE),
manufacturer Italy.
Name and address of marketing M/s Karmed Handels GmbH, Arsenal Objekt 3, Top 15, 1030
authorization holder Wien, Austria
Name of exporting country Austria
Type of Form Form 5A
Brand Name +Dosage Form + Injection Triptofem 0.1mg/ml Prefilled Syringes
Strength
Triptorelin acetate……100mcg (0.1mg) corresponding to 95.6
mcg Triptorelin
Pharmacological Group Gonadotropin releasing hormone analogue
Demanded Price Rs. 950/- per syringe
Pack size 6 × 1ml Pre-filled syringes
International availability Decapeptyl 0.1 mg - pre-filled syringes of FERRING Arzneimittel
Ges.mbH, 1100 Vienna, Austria
Me-too status Decapeptyl Injection of M/s. Atco Lab (Reg#016110)
Detail of certificates attached The product is not actually in the market for use in exporting
country as mentioned in COPP.
Legalized GMP is not Provided.
Remarks of the Evaluator. Stability data as per ICH guidelines is not Provided.
It is not clear from the COPP who is manufacturer and market
authorization holder, requires the clarification
Previous Decision Deferred for clarification of market status for free availability in
exporting country and name of manufacturer and market
authorization holder, along with approval status by reference
regulatory authorities and Pakistan (M-259).
Evaluation by PEC The firm has submitted following:
● Original legalized CoPP issued on 16-11-2017 by Bundesamt für
Sicherheit im Gesundheitswesen Traisengasse 5, 1200 Wien,
AUSTRIA confirms free sale of the product in the exporting
country.
● Legalized GMP certificate of the manufacturer issued by AIFA,
Italy is submitted. The inspection was conducted on 31-03-2017.
Certificate No: IT/159-1/H/2017.
In response to query regarding the different name of the
manufacturer on Form-5A and CoPP, the firm has submitted that
“When we first submitted the registration application on Form-5A
on 26-Dec-2013, the manufacturer was Alfawassermann SpA.
Address: Via Enrico Fermi, 1, 65020 Alanno PE, Italy.
On 01-Aug-2017, the Alfawassermann was merged into Alfasigma
SPA, only changed the name without changing the address of the
manufacturing site.”
Both CoPPs have been submitted. Moreover, website reference of
merging information has been submitted.
Upon communication, the firm has submitted that we will provide
Legalized Sole agency agreement within 45 working days after the
receipt of this undertaking.
The firm has submitted 36 months stability data under long term
storage conditions (5oC±3 oC) and 12months stability data under
intermediate storage conditions (25oC±2 oC/60%±5%RH) for 5
batches and 6 months stability data under accelerated storage
conditions (40oC±2 oC/75%±5%RH) for 3 batches.
 Batch #8473 (20,000PFS)
 Batch #8474 (20,000PFS)
 Batch #8475 (20,000PFS)
 Batch #12047 (85,000PFS)
 Batch #12048 (85,000PFS)
The firm has submitted clarification that
“The higher storage temperature (storage conditions: 25oC±2
o
C/60%±5%RH) leads to a faster degradation of the drug
substance. D-Tyr-triptoreline and acid triptoreline are moving
towards the specified limit after 12 months. This can be observed
especially for accelerated storage conditions, where at the testing
point of 6 months, OOS value occurred.
The stability studies upto 36 months at storage conditions of 2 oC
to 8 oC show no significant changes of parameter if the product is
stored at the proposed condition in a refrigerator. Therefore, a
specified shelf-life of three years is acceptable under these
conditions.
Following the results of the intermediate and accelerated stability
studies a short term excusion outside the label storage condition
e.g., during shipment and handling of one week appears justified.”
Decision: Deferred for submission of legalized sole agency agreement.
Case No. 07: Miscellaneous cases.
i. Ten molecules Policy Instead of ten products For New Section/Factory.
With reference to 14th meeting of Policy Board of DRAP held on10th & 11th of Sep, 2015,
where in the Board decided to convert the earlier decision of Board of the Board for ten
products per section to ten molecules per section from the date of the implementation of ten
products per section. Al the firms whose registrations were restricted to ten products per
section shall be entitled for this facility. However, only those firms shall be considered for
grant of registration of ten molecules per section, whose registered products as of today are
less than ten molecules per new section. Keeping in view the burden on Division of
Pharmaceutical Evaluation & registration, it was further decided that these products shall be
considered by registration Board out of queue but in order of priority of date of grant of Drug
manufacturing License and date of approval of new section. Number of applications in the
subject context to be considered in each meeting of Registration Board may be decided by
Division of Pharmaceutical Evaluation & Registration.
Decision: Registration Board after thorough deliberation and considering the

decision of 14th meeting of Policy Board decided to grant 10 products per
section for all the firms for which section approval was granted by
Central Licensing Board before 14th meeting of Policy Board of DRAP.
However, only those firms shall be considered for grant of registration of
ten products per section, whose registered products as of today are less
than ten products per section.
In the light of above cited decision of Policy Board, various firms have requested for priority
consideration of their balance products as per Policy of ten products per section, detailed as
below:
I. Registration V section vide letter No. F.8-6/2013-Reg-V dated 29-10-2018 has

informed Incharge PEC that as per available record of Registration-V section only
two products (as detailed below) are registered yet in dry powder suspension section
(General) for M/s Don Valley Pharmaceuticals (Pvt.) Ltd. Lahore.
Name of Firm Name of the Products already Name of Section

approved
M/s Don Valley Pharmaceuticals Macrocid suspension 125mg/5ml Dry Powder suspension
(Pvt.) Ltd. Lahore. (Reg.# 019772) (General)
D-Mycin suspension 200mg/5ml Section approval dated 23-
(019774) 06-2009
Registration III section vide its letter no. F.6-2/2016 (R-III) dated 08-08-2018 has informed Incharge
PEC regarding following details of various sections of M/s Well & Well Pharma (Pvt.) Ltd, Rawat.
Name of Name of Number of approved Deferred Total Remaining

Firm Section products with cases considered products
reference of meeting cases
M/s Well & Dry Powder 07 00 07 03
Well suspension (M-255,M-229, M241 &
Pharma (General) M-265)
(Pvt.) Ltd, Section (Registration letter of 5
Rawat. approval dated products is issued while
24-06-2010 withheld for 2 for
confirmation of MRP
and strength)
Sachet 04 (M-229) 01 05 05
(General)
Section
approval dated
14-01-2011
Accordingly the above cited firms have submitted various registration applications, which
have been evaluated and presented here for consideration of Board please:
Dry Powder suspension (General) Section approval dated 24-06-2010

4 prodcuts
146. Name and address of manufacturer / M/s Well & Well Pharma Pvt Ltd. Plot 7, Street S-8,
Applicant RCCI, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Dexivel 100mg/5ml Dry Suspension
Dexibuprofen…100mg"
Diary No. Date of R& I & fee Dy. No 19396 dated 28-05-2018 Rs.20,000/- Dated 28-
05-2018
Type of Form Form-5
Pack size & Demanded Price 60ml; As fixed by Govt.
Approval status of product in Not verifiable
Me-too status (with strength and Detefen Liquid Suspension of M/s Fynk Pharmaceuticals
dosage form) (Reg.# 074443)
GMP status Last inspection conducted on 08-02-2018; firm is
operating at fair level of cGMP compliance.
reference regulatory authorities/agencies which
were adopted by the Registration Board in its
275th meeting
Brand Name +Dosage Form + Strength Nitavel 100mg/5ml Dry Suspension
Nitazoxanide…100mg"
05-2018
Pharmacological Group Antiprotozoal agent
Type of Form Form-5
Pack size & Demanded Price 60ml; Rs. 89.70/-
Me-too status (with strength and Izato 100 mg/5ml Suspension of M/s Sami
dosage form) Pharmaceuticals, Karachi (Reg.# 076309)
Brand Name +Dosage Form + Strength Erdost 175mg/5ml Dry Suspension
Erdosteine…175mg"
05-2018
Type of Form Form-5
Approval status of product in Approved by AIFA of Italy
Me-too status (with strength and Erdozet Suspension of M/s S.J&G Karachi, (Reg.#
dosage form) 073810)
Brand Name +Dosage Form + Strength Fungvel 50mg/5ml Dry Suspension
Composition "Each Reconstituted 5ml Contains:
Fluconazole…50mg"
05-2018
Type of Form Form-5
Finished product Specifications BP
Me-too status (with strength and Fungifight 50mg/5ml Dry Suspension of Baxter Karachi .
Decision: Approved.
Sachet (General) Section approval dated 14-01-2011

2 Products
Brand Name +Dosage Form + Strength Erdost 225mg Sachet
Erdosteine…225mg"
05-2018
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; Rs. 103.00/-
Approval status of product in Approved by AIFA of Italy
Me-too status (with strength and Erzing 225mg Sachet of M/s Hilton Pharma, Karachi.
Decision: Approved.
Brand Name +Dosage Form + Strength Relpain 50mg Sachets
Diclofenac Potassium…50mg"
Diary No. Date of R& I & fee Dy. No 17197 dated 09-05-2018 Rs.20,000/- 09-5-2018
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s: Rs. 30/-
Me-too status (with strength and Not verifiable
dosage form)
Remarks of the Evaluator  Evidence of applied formulation/drug already
alongwith registration number, brand name and
name of firm.
M/s Don Valley Pharmaceuticals (Pvt.) Ltd. Lahore

Dry Powder suspension (General) Section approval dated 23-06-2009
2 Products
152. Name and address of manufacturer / M/s Don Valley Pharmaceuticals (Pvt.) Ltd. Lahore.
Applicant
Brand Name +Dosage Form + Strength DV Cipro Suspension 125
Composition "Each 5 ml contains:
Ciprofloxacin as hydrochloride ……. 125mg
Pharmacological Group Fluroquinolones
Type of Form Form-5
Pack size & Demanded Price 60ml: As per brand leader
Approval status of product in Approved by Registration Board on the recommended
Reference Regulatory Authorities dosage basis
Me-too status (with strength and Quash 125mg/5ml suspension of M/s Wilshire
dosage form) Laboratories Pvt. Ltd.
GMP status Last inspection conducted on 09-07-2018 concluding
satisfactory compliance of GMP.
Remarks of the Evaluator  In contrary to reference product firm has applied
for Ciprofloxacin as HCl whereas reference
product contains Ciprofloxacin base only.
 Source of granules shall be submitted.
 Upon communication of above observations firm
has submitted following:
i. Revised Form 5 with following composition along
with Fee of Rs. 5000/- (vide deposit slip#
0789723) for revision of composition:
“Each 5 ml contains:
Ciprofloxacin ……. 125mg”
ii. Source of granules as M/s Pharmagen, Limited
Pakistan.
Decision: Aproved with innovator’s specifications.
Registration Board.
153. Name and address of manufacturer / M/s Don Valley Pharmaceuticals (Pvt.) Ltd. Lahore.
Applicant
Brand Name +Dosage Form + Strength Macrocid Suspension 250
Composition "Each 5 ml contains:
Clarithromycin ……. 250mg
Type of Form Form-5
Pack size & Demanded Price 60ml: As per brand leader
Me-too status (with strength and Loud 250mg/5ml Dry Suspension of M/s Sigma Karachi.
dosage form) (Reg.076735)
GMP status Last inspection conducted on 09-07-2018 concluding
satisfactory compliance of GMP.
Remarks of the Evaluator  Source of granules shall be submitted.
 Upon communication of above observations firm
has submitted following:
 Source of granules as M/s Surge Laboratories
Pakistan.
Decision: Approved.
Evaluator PEC-VIII
th th
CLB in its 238 Meeting held on 19 November, 2014 has considered & approved the grant of Capsule
Section (general) & Renewal of Injectable Ampoule (Psychotropic) Section of M/s. Venus Pharma, 23
km Multan road, Lahore.
R-V vides its letter No. F.8-6/2013-Reg-V dated 14th of November, 2018 informed about three molecules
& products registered in the Psychotropic Injection section:
Sr. Section Name of drug

No.
1. Renewal of Injectable Ampoule Nalbuphine hydrochloride
(Psychotropic) Section 20mg/ml Injection
2. Tramadol hydrochloride
50mg/ml Injection.
3. Ephedrine (as sulphate)
50mg/ml Injection
Now the applicant has applied for the following:
Injectable Ampoule (Psychotropic) Section; Molecule:07, Products; 07

154. Name and address of manufacturer / M/s Venus Pharma 23 km Multan Road, Lahore.
Applicant
Brand Name +Dosage Form + Strength Predol Injection 5mg.
Diary No. Date of R& I & fee Dy No.17645, 11-05-2018, Rs.20,000/-
Composition Each ml contains:-
Haloperidol….5mg
Type of Form Form-5
Pack size & Demanded Price 25’s (1ml); Rs.250/-

Me-too status Halotec Plain Injection of Pharmatec Karachi
GMP status

Decision: Registration Board deferred the case for detailed deliberation in next meeting.
Applicant
Brand Name +Dosage Form + Strength Fluzine Injection 25mg IM
Fluphenazine decanoate….25mg
Type of Form Form-5
Pack size & Demanded Price 1’s (1ml); Rs.95/-,10’s (1ml); Rs.650/-
Me-too status Halotec Plain Injection of Pharmatec Karachi
GMP status
Applicant
Brand Name +Dosage Form + Strength Viogesic Injection 0.3mg
Buprenorphine(as hydrochloride) ….0.3mg
Type of Form Form-5
Pack size & Demanded Price 5’s (1ml); Rs.95/-,10’s (1ml); Rs.650/-
Me-too status Segesic Injection 0.3mg/ml of Saydon Pharmaceuticals
Industries
GMP status
Remarks of the Evaluator. Applied formulation is not present in Available BP & USP.
Applicant
Brand Name +Dosage Form + Strength Diazocin Injection
Diazepam….5mg
Type of Form Form-5
Pack size & Demanded Price 5’s (2ml); As per SRO

Me-too status Dipam 5mg Injection of Medicraft Pharmaceuticals (Pvt)
Ltd
GMP status

Applicant
Brand Name +Dosage Form + Strength Midazocin Injection
Midazolam (as hydrochloride)….1mg/ml
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Pack size & Demanded Price 5’s & 10’s (5ml); As per SRO
Approval status of product in Approved in US-FDA but discontinued however it is
Reference Regulatory Authorities. mentioned **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy
reasons**
Me-too status Midaz 5mg/5ml Injection of Sami
GMP status
Applicant
Brand Name +Dosage Form + Strength Chlorozine Injection
Chlorpromazine hydrochloride….25mg
Type of Form Form-5
Pack size & Demanded Price 10’s (2ml); Rs.250/-

Approval status of product in Approved in MHRA (Emc)
Me-too status Chlorpromazine 2ml Injection Of Indus Pharma
GMP status
Applicant
Brand Name +Dosage Form + Strength Morfin Injection
Morphine sulphate….10mg
Type of Form Form-5
Pack size & Demanded Price 100’s (1ml); As per SRO

Me-too status Morfscot Injections 10mg of Scotmann Pharmaceuticals,
GMP status Reference product is approved as morphine sulphate
pentahydrate 10mg/ml Injection which is different from
applied formulation i.e. morphine sulphate 10mg/ml
injection. Submit Form 5, master formulation &
manufacturing method in accordance with label claim.
Decision: Registration Board deferred the case for detailed deliberation in next meeting..
Registration-I Section
A. HUMAN CASES.
Case. No.1 Request of M/s. Angelini Pharmaceuticals (Pvt) Ltd, Lahore for change of
name of manufacturer for registered products.
M/s. Angelini Pharmaceuticals (Pvt) Ltd, 221 Block CCA, Phase-4, DHA, Lahore has
requested for change of name of manufacturer for their following registered products. The
details are as under: -
Name of Proposed name
Existing Name/
S. Reg. Manufacturer of Initial reg. with Remark
Composition (as per
No No. (as per initial manufacturer renewal s
initial letter)
letter) (as per COPP)
1. 022663 Monurol Sachets M/s Inpharzam M/s Zambon Initial registration: Dy. No.
Each 3gm sachet SA, (Zambon Switzerland Ltd 10-12-1998 25594
contains: - Group), via Industria 13, 1st renewal: R&I
Fosfomycin Switzerland 6814 03-12-2003 dated
Trometamol…..5.631g Cadempino, 2nd Renewal: 24-5-
Equivalent to Switzerland. 03-12-2008 2018
Fosfomycin…..3gm. Transfer of drugs
25-05-2009
Change of
company Name:
25-11-2013
2. 021174 Fluimucil 200 sachet -do- -do- Initial registration: -do-
Each 1gm sachet 04-09-1998
contains:- 1st renewal:
Acetylcysteine… 23-08-2003
200mg 2nd Renewal:
13-08-2008
Transfer of drug;
25-05-2009
Change of
company Name:
25-11-2013
The firm informed that the change is only in the name and there will be no change
related to the manufacturing site, plant, building, process and quality. The aforementioned
letter also states that in address there is change in name only.
The firm has deposited fee of Rs. 5,000/- for each product and submitted the
following supporting documents: -
i. Original letter with declaration from manufacturer (Zambon)
ii. Original and attested COPPs for the both products (issued by Swissmedic)
iii. Original and attested GMP in name of Zambon Switzerland Ltd.
With reference to renewal of the said products it is submitted that the firm has
claimed that the “change of company name” approval on 25-11-2013 shall be considered as
the last renewal of the above mentioned products since they had applied with full fee for
change of company name. It is pertinent to mention that submission of full fee for change of
company name has been confirmed from the relevant company file. The case was discussed
in 14th PRVC meeting and decided as follow;
“The Committee evaluated the case in the light of SOP approved by Registration
Board. Chairman Registration Board, on the recommendations of the Committee,
decided to defer the case for getting documents of last import clearance of the subject
products from DRAP office Lahore in order to ascertain that the address of
manufacturer is the same or otherwise as the previous approval granted to firm
mentions the name of manufacturer only and not the complete address of
manufacturer.”
Accordingly the requisite details have been provided by DRAP office Lahore wherein
the name of manufacturer in the import clearance documents (Form-7 etc) for both products
has been mentioned as M/s. Zambon, Switzerland Ltd, Via Industria 13, 6814 Cadempino,
Switzerland.
Decision:- Registration Board deferred the case for detail deliberation in next
Board meeting.
Case. No. 02: Request of M/s. Chemifar International (Pvt.) Ltd, Karachi for
change of name of manufacturing site of their registered drug
Geriatric Pharmaton Capsule (Reg.No.018514).
M/s. Chemifar International (Pvt.) Ltd, Karachi has requested for change of name of
manufacturing site for their registered product Geriatric Pharmaton Cap (Reg.No.018514)
from M/s. Pharmaton SA, Via Mulini, 6934 Bioggio, Switzerland to M/s Ginsana SA, Via
Mulini, 6934 Bioggio, Switzerland.
However, since the CoPP provided by the firm, mentioned particulars different from
the one firm has requested, so the firm was asked to clarify the matter and also to explain
difference in composition as given in registration letter and the one given in CoPP. The firm
has provided following clarification/information.
(i) The fresh Form-5A submitted with following manufacturing & Packaging
sites, which are in accordance with CoPP.
Manufacturer:
M/s. Swisscaps AG Husenstrasse 35 9533 Kirchberg Switzerland.
Packaging, Analysis, Batch Release.
M/s. Ginsana SA Via Mulini 6934 Bioggio Switzerland.
Besides the Product License Holder mentioned in CoPP is M/s. Pharmaton
SA Hochbergerstrasse 60B 4057 Basel Switzerland.
(ii) The ingredients Choline, Inositol and Linolenic acid mentioned in the
registration letter are the components of Lecithin & Soybean Oil mentioned in
composition given in CoPP.
(iii) For Rutoside Trihydrate, mentioned in composition given in CoPP but not
mentioned in the registration letter, the firms claim that it was always part of
composition of the drug, but since it was earlier classified as inactive
ingredients so was not mentioned in the composition. However, it was later re-
classified as active ingredients and also included in B.P. 2003, therefore, it
now appears in the list of active constituents.
Registration Board deferred the case in its 259th meeting asking the firm to provide
information relating to safety and efficacy profile of Rutoside Trihydrate and reference
regarding claim that choline, Inositol and Linolenic acid mentioned in the registration letter
are the components of Lecithin & Soybean Oil mentioned in composition given in CoPP.
Now M/s. Chemifar International, Karachi has provided certain documents relating to
the safety and efficacy profile of Rutoside Trihydrate purported to be issued by Boehringer
Ingelheim claiming its therapeutic role in inflammatory diseases. Moreover, the firm has also
provided references from various sources including USP 39, PDR etc with reference to query
regarding their claim that choline, Inositol and Linolenic acid are the components of Lecithin
& Soybean Oil. Most of these references does not appears to specifically address the query
and their relevancy, however, needs to be ascertained. The case was discussed in 272nd
Registration Board meeting and the Board decided as follow:
“Registration Board deferred for getting information of last imported consignment
details of the said product from DRAP, Karachi.”
In compliance to Board decision, DRAP Karachi office was asked for provision of
requisite information/details. DRAP Karachi office has furnished the details of consignment
dated 09-06-2016. As per the consignment details provided, the composition and name &
address of manufacturer of the product is as follow:
Details of Source site(s):
Manufacturer as per Manufacturer as per CoPP Manufacturer as per import
Reg. letter clearance documents (Form-3
& 7)
M/s. Pharmaton SA, Manufacturer: M/s. Swisscaps AG M/s. Ginsana SA, Via Mulini,
Via Mulini, 6934 Husenstrasse 35, 9533 Kirchberg, Switzerland. CH-6934 Bioggio, Switzerland
Bioggio, Switzerland Packaging, Analysis, Batch Release.
M/s. Ginsana SA Via Mulini 6934 Bioggio
Switzerland
Product license Holder: M/s. Pharmaton SA,
Hochbergerstrasse 60B, 4057 Basel,
Switzerland.
Details of Composition:-
Composition as Quantity
Composition as per
S. Composition as per CoPP
Quantity certificate of Quantity
No per reg letter (issued by
analysis
Swiss medic)
1. Highly 40 mg Standardized panax 40mg Standardized 40mg
concentrated, ginseng extract G115 panax ginseng
Standardized extract G115
ginseng extract pharmaton
G115
2. Dimethylaminoeth 26.0mg 2- 26.00mg Dimethylaminoe 26.0mg
anol Bitrarate Dimethylaminoethan thanol
Pharmaton ol bitratrate hydrogentartrate
3. Vitamin A USP 4000 IU Vitamin A Palmitate 4000 IU Vitamin A 4000IU
concentrate, oily
form
4. Vitamin B1 USP 2.0mg Thiamine 2.0mg Thiamine nitrate 2.0mg
mononitrate
5. Vitamin B2 USP 1.0mg Riboflavin 1.0mg Riboflavin 2.0mg
6. Vitamin B6 USP 1.0mg Pyridoxine 1.0mg Pyridoxine 1.0mg
hydrochloride hydrochloride
7. Vitamin B12 1.0mcg Cyanocobalamin 1.0mcg Cyanocobalamin 1.0mcg
8. Vitamin C USP 60.0mg Ascorbic Acid 60.0mg Ascorbic Acid 60.0mg
9. Vitamin D USP 400IU Ergocalciferol 400IU Ergocalciferol 400IU
10. Vitamin E 10.0mg D,l-alpha-tecopheryl 10.0mg All-rac-alpha- 10.0mg
Acetate Tocopheryl
acetate
11. Nicotinamide (PP) 15.0mg Nicotinamide 15.0mg Nicotinamide 15.0mg
USP
12. Calcium 10.0mg Calcium Pantothenate 10.0mg Calcium 10.0mg
Pantothenate USP Pantothenate
13. Iron USP 10.0mg Iron 10.0mg Dried ferrous 10.0mg
sulfate
14. Calcium USP 90.3mg Calcium 90.30mg Calcium 90.3mg
hydrogen
phosphate,
anhydrous
15. Phosphorus USP 70.0mg Phosphorus 69.9mg Phosphor 70.0mg
16. Fluorine 0.2mg Fluor 0.20mg Calcium 0.2mg
fluoride
17. Copper USP 1.0mg Copper 1.0mg Copper (II) 1.0mg
Sulfate, dried
18. Potassium DAB 8.0mg Potassium 8.0mg Potassium 8.0mg
sulfate
19. Manganese USP 1.0mg Manganese 1.0mg Manganese (II) 1.0mg
sulfate,
monohydrate
20. Magnesium USP 10.0mg Magnesium 10.0mg Magnesium 10.0mg
sulfate, dried
21. Zinc USP 1.0mg Zinc 1.0mg Zinc oxide 1.0mg
22. Choline, inositol, 66.0mg - -
linoleic acid and
linolenic acid
23. Rutin (rutoside) 20.0mg Rutoside 20.0mg
trihydrate
24. Lecithin 50.0mg
25. Soyabean oil 16.0mg
Decision:- Registration Board deferred the case for detail deliberation in next Board
meeting.
B. VETERINARY CASES.
Case No.03:- Registration of Drugs under the Drugs Act, 1976-Inspection Report of
Manufacturer Abroad.
The Registration Board in its various meetings approved following products of M/s.
Ghazi Brothers, Karachi, manufactured by M/s. HebeiYuanzheng Pharmaceutical Co. Ltd.,
Shijiazhuang City, Hebei Province, China subject to inspection of manufacturer abroad as per
import policy and verification of storage facility (where applicable) as per detailed mentioned
against each:-
S. Name of Name of Drugs/ Decontrolled/ Shelf Decision/ Remarks
No. Importer/ Composition & Packs Size Life (in Italic)
Manufacturer Meeting
1. M/s. Ghazi Sinozene Powder 2.36g 5 years Approved.
Brothers, for Injection 23.6g As per CoPP the composition is
Karachi. / Each sachet DiminazeneDiaceturate………..1.05g
M/s. contains:- while Antipyrine is shown as inactive
HebeiYuanzheng Diminazeneaceturat ingredient and Phenazone is not
Pharmaceuticale …..1.05g mentioned.
Co. Ltd., Phenazone..1.31g Moreover Pack size mentioned in
Shijiazhuang (Through sub- FSC 2.36g/sachet.
City, Hebei committee
Province, China.constituted in M-
237)
2. -do- Isomedium Powder 1gm sachet 03years Approved.
for parental
administration
Each sachet
contains:-
Isometamedium
Chloride
th
| 990
Hydrochloride ….1g
(M-251)
With reference to above products following details are submitted:

(i) In compliance, inspection of the manufacturer abroad M/s. Hebei Yuanzheng
Pharmaceutical Co. Ltd., Shijiazhuang City, Hebei Province, China was carried out by
the nominated panel comprising Mr. Abdul Sattar Soomro, Director, Drug Testing
Laboratory, Karachi/Member Drug Registration Board & Mr. Khalid Mehmood,
Federal Inspector of Drugs, DRAP, Islamabad on 04th& 05th April, 2017 and the panel
rated the manufacturing facility as "good" (recommended), recommending only seven
other veterinary drugs (liquid injectable & oral suspension) excluding the above
mentioned sachet.
(ii) The panel further, reported that “both of the above products are not in free sale in the
country of origin as admitted by the management. The panel stated to have inspected
the sachet section as per mandate, recommending it only/if subject to provision of free
sale certificate (FSC) of above products in the country of origin which has not been
found on the day of inspection.
(iii) Now the firm has submitted fresh valid and legalized original CoPP/ Free Sale
Certificate issued by Chinese Authorities for the above products for which inspection
panel has reported to be not in free sale in country of origin. The observations on the
CoPP submitted by the firm are mentioned in the remarks column of above table
against each product.
(iv) The complete address of manufacturer and product license holder as per new CoPP
submitted is as under.
M/s. HebeiYuanzheng Pharmaceutical Co., Ltd., No. 16 Liuyuan Road,
Chang,An District, Shijiazhuang City, Hebei Province, China.
(v) The finish product specifications for the above products are not mentioned in minutes.
However the firm vide letter informed that the firm has claimed specification of
innovator.
(vi) The local storage facility of M/s. Ghazi Brothers, Karachi has already been verified by
the concerned area FID.
meeting.
Case No. 04:- Request of M/S. Decent Pharma, Rawat, Islamabad/Registration of

Drugs under the Drugs Act, 1976.
Registration Board in its 237th meeting held on 26-02-2013 constituted a sub-
committee for evaluation of application of veterinary products for ensuring completion of
codal formalities. The Board further authorized its Chairman, Registration Board for taking
decision on recommendations of the committee following the 10 products per section policy.
The sub-committee in its meeting held on 25-04-2013 deferred following product of
M/s. Decent Pharma, Rawat, Islamabad as per detailed mentioned alongside for therapeutic
justification for formulation:
S. Name of Name of drug(s) & Decontrolled/ Shelf Life
No Manufacturer/ Composition with Demanded Packs Size
Importer MRP.
1. M/s. Decent Pharma, Tribiotic Oral Powder 100gm 02 years
National Industrial Zone Each 100g powder contains:- 250gm
Rawat. Islamabad. Amoxicillin Trihydrate..20g 500gm
Lincomycin HCI……...8.8g 1Kg
Spectinomycin 2HCI…8.8g 5Kg
(Antibacterial). 10Kg
25Kg
Subsequently M/s. Decent Pharma, Rawat, Islamabad submitted various documents
relating to specification & usage of individual components of the above drugs combination.
The above compositions are me-too drugs.
The case was again discussed in its 267th meeting of Registration Board and decided
to refer the case for further evaluation and recommendations of Dr. Qurban Ali. The expert
opinion of Dr. Qurban Ali is as under:-
S. Name of Name of drug(s) & Comments of Dr. Qurban Ali
No Applicant Composition
1. M/s. Decent Tribiotic Oral Powder The product is combination of antibiotics
Pharma, National Each 100g powder contains:- used for a number of bacterial infections in
Industrial Zone Amoxicillin Trihydrate..20g food producing and pet animals.
Rawat. Islamabad. Lincomycin HCI……...8.8g
Spectinomycin 2HCI…8.8g Amoxicillin given orally is stable in
(Antibacterial). gastrointestinal tract with higher absorption
than naturally occurring Penicillins.
Furthermore, residues in liver, kidney,
muscle and fats are depleted.
Lincomycin hydrochloride is bacteriostatic
and is rarely used in humans due to high
likelihood of severe gastrointestinal
disturbance; instead Clindamycin (7-Chloro
derivative of Lincomycin) is used in human
medicicne as an alternative to Penicillins. Its
antibacterial spectrum is similar to
erythromycin.
Primarily bacteriostatic, Spectinomycin in
used in human medicine as an alternative to
Ceftriaxone and other beta-lactams almost
exclusively for rectal and genital
gomorrhoea with 95% cure rate. In livestock
production, Spectinomycin is usually
administered with Lincomycin for a variety
of infections and as preventative therapy.
The referred product in combination form is
me-too product also; thus is a fair candidate
for registration and is Recommend for
approval for veterinary use.
The Registration Board in its 278th meeting deferred the case form confirmation of
latest GMP status of the firm from QA&LT Division as the firm production was suspended
by the Central Licensing Board in its 260th meeting. Subsequently the Central Licensing
Board in its 264th meeting considered the panel inspection report dated 31st May, 2018 and
07th June, 2018. The production was resumed vide QA & LT letter dated 18th September,
2018.
meeting.
Case No. 05:- ISSUANCE OF REGISTRATION LETTER

The Registration Board in its 277th meeting considered request of M/s. Orient Traders
International, Karachi regarding transfer of registration of following veterinary products from
M/s. Orient Animal Health (Pvt) Ltd, Karachi to M/s. Orient Traders International, Karachi
and change of manufacturer.
S.No Name of drug(s) Composition. Remarks
1. Levaveto-15 Injectable Solution Packs size are taken for minutes
Per ml contains:- 236th meeting 10ml, 30ml,50ml,
Levamisole Hydrochloride……...150mg 100ml, 250ml, 500ml.
Sodium Hypophosphite…….…..0.50mg Firm requested for grant of 100ml
Ammonium Acetate…………….....5mg pack among the approved pack
Hydrochloric Acid…………….....pH3.5 sizes.
Propylene Glycol……………..….0.1ml
Registration Board, inter alia, took following decisions:

Approved following product in favor of M/s. Orient Traders International, Karachi
with the details mentioned there under subject to import policy for finished drugs:-
a) Levaveto-15 Injectable Solution
Manufacturer:
M/s. LaboratoiresBiove, 3 Rue de Lorraine, 62510 Arques, France.
M/s. V.M.D. Hoge, Mauw 900, 2370, Arendonk, Belgium.
Shelf life 36 months.
The Board further directed that as per practice only active ingredients are to be
mentioned on registration certificates.
The Board further directed that as per practice only active ingredients are to be
mentioned on registration certificates.
With reference to above decision, the following facts were considered:-
(i) Levaveto-15 Injectable Solution, the composition in the CoPP is mentioned as
“Levamisole (as hydrochloride)” 128mg/ml while the registration letter mention
the composition as Levamisole HCL…150mg. In registration letter the
composition of the base is proposed to be mentioned as per CoPP.
(ii) The products are on free sale in Belgium & France, therefore the exemption from
the inspection can be considered as per import policy for such drugs.
(iii) The firm has provided revised Form-5A having composition in accordance with
Free Sale Certificate issued by French Authority as per following details.
Levaveto-15 Injectable Solution
Per ml contains:-
Levamisole(as hydrochloride)……...128mg
The Registration letter has been issued with composition in accordance with Free Sale
Certificate.
meeting.
Case No.06:- Request of M/s. Ras Pharmaceuticals (Pvt) Ltd., Multan for
Corrections/Change of Composition of already Registered Veterinary
Drugs.
M/s. Ras Pharmaceuticals (Pvt) Ltd., Multan has requested for corrections/change of
composition of their following registered drugs as per details mentioned against each:-
S. Regn. Product Composition Demanded Composition Me-too Product
No No. Approved as per Initial
in 253rd meeting Registration.
1. 079860 CA SUPER Oral Powder C.A Super Oral Powder Medi CA
Each 100gm contains:- Each 1000gm contains:- Powder
Acetylsalicylic Acetylsalicylic Acid ……200gm (Regn.No.02657
Acid……….22.2g Ascorbic 8) M/s. Medi-
Ascorbic Acid………...…600gm Vet (Pvt) Ltd.,
Acid………...….666gm Lahore.
2. 079861 ONEVIT Oral Powder Onevit Oral Powder NO-BAC Oral
Each 100gm contains:- Each gm contains:- Water Soluble
Oxytetraycline HCL.…10gm Oxytetraycline HCI USP Powder
Neomycin Sulphate…..10gm …….100mg (Regn.No.03502
Vitamin A……...75000IU Neomycin Sulphate USP 0) M/s. Sanna
Vitamin D3……….50000IU ….100mg Laboratories,
Vitamin E……..0.25gm Vitamin A B.P…….…750IU Faisalabad.
Vitamin B 1……….0.1gm Vitamin D3 B.P……500IU
Vitamin B2……....0.12gm Vitamin E B.P…...2.5mg
Vitamin…B6…….0.12gm Vitamin K3
Vitamin B12……….0.75g B.P……………3.5mg
Vitamin C…….50gm Vitamin B1 B.P………1.0mg
Calcium Vitamin B2 B.P……....1.2mg
Pantopatheante…..10gm Vitamin B6 B.P………1.2mg
Folic Acid……...0.030gm Vitamin B12 B.P……7.5mcg
Nicotinic Acid…...0.15gm Folic Acid B.P……….0.3mg
dLMethionine………3gm Calcium Pantopatheante B.P
L-Lysine………….5gm ……………...7.5gm
Nicotinic Acid B.P…1.50mg
Vitamin C B.P……..10mg
dLMethionine B.P……30mg
L-Lysine B.P………50mg
3. 079871 CINARAS Oral Liquid Cinaras Oral Liquid Cina T.S. Oral
Each 100ml contains:- Each ml contains:- Suspension
Cinoxin……….0.75g Enrofloxacin (Regn.No.03145
Sulphamethoxy pyridazine (Cinoxin)…….75mg 6) M/s. Vety
……...0.75g SulphamethoxyPyridazine.75mg Care
Sulphamethazine…...5g Sulphamethazine……50mg Pharmaceuticals,
Trimethoprim…2.50gm Trimethoprim………….25mg Islamabad.
4. 079870 MYCOSTOP Oral Liquid Mycostop Oral Liquid PneumpLiquid
Each 100ml contains:- Each ml contains:- (Regn.No.05888
Tylosin Tartrate……...10gm Tylosin Tartrate…...100mg 2) M/s. Attabak
Doxycycline HCL…...20gm Doxycycline HCI (USP) Pharmaceuticals,
ColistinSulphate….500MIU …200mg Islamabad.
Bromhexine HCL…..5gm ColistinSulphate…..450,000IU
Bromhexine HCI……....4mg
The firm deposited fee of Rs.20,000 x 4 = Rs. 60,000/ and submitted revised Form-5
as per me-too already registered products.
meeting.
Registration-III Section
Case No. 7: Extension in contract manufacturing permission along with change in
contract manufacturer applied by M/s Well Care, Sargodha
M/s Well Care Pharmaceuticals, Sargodha have applied for extension in contract
manufacturing permission along with change in contract manufacturer from M/s Medley
Pharmaceuticals to M/s Seraph Pharmaceuticals, Islamabad for following products.
S. Name of Existing New Reg. No. Name of drug(s) & Date of Remarks
No. Applicant Manufacturer Manufacturer Composition application,
Diary No. &
Form
1. M/s Well M/s Medley M/s Seraph 031958 Fitral Tablet 40mg 19-10-2018 The
Care Pharmaceut Pharmaceutic Each enteric coated 959 DD R- product is
Pharmaceut ical, Wah als, tablet contains: III available in
ical, Cantt. Islamabad Pantoprazole (as Fee USP.
Islamabad Sodium Rs.50,000/-
Sesquihydrate)....40mg 22-04-2016
2. -do- -do- -do- 031984 Meta-Q Tablets 19-10-2018 The
500mg 956 DD R- product is
Each film coated tablet III available in
contains: Fee USP.
Levofloxacin (as Rs.50,000/-
hemihydrate)…500mg 22-04-2016
3. -do- -do- -do- 031983 Meta-Q Tablets 19-10-2018 The
contains: Fee USP.
Levofloxacin (as Rs.50,000/-
hemihydrate)…250mg 22-04-2016
4. -do- -do- -do- 031973 Alphacip Tablet 19-10-2018 The
contains: Fee USP.
Ciprofloxacin (as Rs.50,000/- The firm
HCl)…..500mg 22-04-2016 has
requested
to change
the brand
name to
Gracip.
5. -do- -do- -do- 031972 Alphacip Tablet 19-10-2018 The
contains: Fee USP.
Ciprofloxacin (as HCl) Rs.50,000/- The firm
…..250mg 22-04-2016 has
requested
to change
the brand
name to
Gracip.
Background of the case:
The previous permission was valid till 31-05-2011 as per documents submitted by the firm.
However, interim extensions were granted by the Federal Governemnt / DRAP ’s Policy
Board and now it is valid till 31-08-2013 as documented in minutes of 238th meeting of
Registration Board.
The firm applied for extension in contract manufacturing permission with fee of Rs.50,000/-
per product dated 15-04-2013. The case was considered in 238th meeting of Registration
Board and was deferred since the request of firm does not fall under present contract
policy.
The firm has then applied for change in contract manufacturer from M/s Medley to
M/s Wenovo Pharmaceuticals in the year 2016 and deposited fee of Rs.50,000/- for each
product dated 22-04-2016 without providing the previous contract manufacturing permission.
Now the firm has requested for change in contract manufacturer from M/s Medley to M/s
Seraph Pharmaceuticals in the same fee as deposited in the year 2016.
a) Application/Form 5
b) Fee of Rs.50,000/- for each product dated 22-04-2016.
b) Copy of contract manufacturing agreement between M/s. Well Care Pharmaceutical,
Sargodha and M/s Seraph Pharmaceuticals, Islamabad dated 27-06-2018.
c) Latest GMP inspection report of M/s Seraph Pharmaceuticals, Islamabad (dated 11-
06-2018) concluding that panel unanimously recommended issuance of GMP
certificate.
d) DML of both contract giver (applied for renewal on 05-06-2014) and acceptor (12-
06-2017).
e) Evidence of approval of Tablet (general) verified from GMP certificate (M/s Seraph
Pharmaceuticals, Islamabad).
M/s Well Care Pharmaceuticals has not submitted section approval letter. However
they have submitted copy of approval of layout plan showing that firm possesses capsule,
oral liquid syrup, dry powder suspension, powder repacking and liquid repacking sections.
Decision: Registration Board deferred the case for detail deliberation in next Board
meeting.
Case No. 8: Extension in contract manufacturing permission applied by M/s Werrick,

Islamabad
M/s Werrick Pharmaceuticals, Islamabad have applied for extension in contract
manufacturing permission from M/s Scotmann Pharmaceuticals, Islamabad for following
products.
S. Name of Applicant Existing Reg. No. Name of drug(s) & Date of Date of initial
No. Manufacturer Composition application, registration
Diary No. & renewal
& Form submitted
1. M/s Werrick M/s Scotmann 050728 Ciprin 100mg Infusion 16-05- Initial
Pharmaceutical, Pharmaceutical, Each ml contains:- 2018 registration:
Islamabad Islamabad. Ciprofloxacin…..2mg Dy.519 24-09-2008
Manufacturer’s DD (R-III) Renewal
Specification) Fee applied:
Rs.50000/- 02-07-2013
30-4-2018 Rs.10,000/-
2. -do- -do- 050729 Ciprin 200mg Infusion -do- -do-
Each ml contains:-
Ciprofloxacin…..2mg
(Manufacturer’s
Specification)
3. -do- -do- 050730 Brodin 500mg Infusion -do- -do-
Each Ml contains:-
Levofloxacin…….5mg
(Manufacturer’s
Specification)
4. -do- -do- 050732 Menidazole 500mg infusion -do- -do-
Each ml contains:
Metronidazole…..5mg
(BP Specification)
5. -do- -do- 050731 Ofloxin 200mg Infusion -do- -do-
Each ml contains:
Ofloxacin……….2mg
(Manufacturer’s
Specification)
6. -do- -do- 056857 Flamex Injection -do- Initial
Each 3ml contains: registration:
Dicfenac Sodium …75mg 13-07-2009
(BP Specification) Renewal
applied: 10-
07-2014
(Rs.10,000/-
7. -do- -do- 056858 Inovit Injection -do- -do-
Each ml Contains:
Mecobalamine…….500mcg
(Scotmann Specification)
8. -do- -do- 056863 Streight Injection -do- -do-
Each 10ml ampoule
Contain:
Isosorbide Dinitrate
………10mg
Scotmann Specification)
9. -do- -do- 063447 Zip Injection -do- Initial
Each ml Contains: registration:
Ziprasidone as Mesylate 08-07-2010
Trihydrate………20mg Renewal
(Manufacturer’s applied: 17-
Specification) 06-2015
(Rs.10,000/-
10. -do- -do- 063448 Clacin IV Infusion -do- -do-
Each Vial contain:
Clarithromycin….500mg

The previous permission was valid till 30-06-2010 & 31-12-2010 as per documents submitted
by the firm. However, interim extensions were granted by the Federal Governemnt / DRAP’s
Policy Board and now it is valid till 31-08-2013 as documented in minutes of 238th meeting
of Registration Board.
The firm applied for extension in contract manufacturing permission with fee of Rs.50,000/-
per product dated 15-04-2013. The case was considered in 238th meeting of Registration
Board and was deferred since the request of firm does not fall under present contract
policy.
The firm has then applied for renewal of above mentioned products as per details
mentioned in last column above. Now the firm has applied for extension in contract
manufacturing permission from Scotmann Pharmaceuticals and deposited fee of Rs.50,000/-
for each product dated 30-04-2018.
a) Application/Form 5
b) Fee of Rs.50,000/- for each product.
c) Contract manufacturing agreement between M/s. Werrick Pharmaceutical, Islamabad
and M/s Scotmann Pharmaceuticals, Islamabad dated 26-04-2018.
d) Latest GMP inspection report of M/s Scotmann Pharmaceuticals, Islamabad (dated
14-09-2017 & 21-09-2017) concluding that panel unanimously recommended issuance
of GMP certificate.
meeting.
Case No. 9: Extension in contract manufacturing permission applied by M/s Wilson,
Islamabad
M/s Wilson Pharmaceuticals, Islamabad have applied for extension in contract
manufacturing permission from M/s Scotmann Pharmaceuticals, Islamabad for following
products.
S. Name of Existing Reg. No. Name of drug(s) & Date of Date of initial
No. Applicant Manufacturer Composition application, registration
Diary No. & & renewal
Form submitted
1. M/s Wilson M/s 050722 Mytil 100mg Infusion 16-05-2018 Initial
Pharmaceuti Scotmann Each ml Contains Dy. No. 519 registration
cal, Pharmaceuti Ciprofloxacin…..2mg DD (R-III) 24-9-2008
Islamabad cal, (Manufactuer’s Fee Renewal
Islamabad. Specification) Rs.50000/- applied:
09-5-2018 03-7-2013
Rs.10,000/
2. -do- -do- 050723 Mytil 200 Infusion -do- -do-
Each ml contains
Ciprofloxacin…..2mg
(Mfg.Specification)
3. -do- -do- 050724 Protektin 500mg Infusion -do- -do-
Each ml contains:
Levofloxacin …..5mg
(Mfg.Specification)
4. -do- -do- 050725 Wiloxin 200mg Infusion -do- -do-
Ofloxacin…….2mg
(Mfg.Specification)
5. -do- -do- 050726 Metazaole 500mg Infusion -do- -do-
Each ml contains:
Metronidazole….5mg
(BP Specification)
6. -do- -do- 050727 Peptinil 50mg Injection -do- -do-
Each 2ml Contains:
Ranitidine HCl….50mg
(Mfg.Specification)

The previous permission was valid till 30-06-2010 as per documents submitted by the firm.
However, interim extensions were granted by the Federal Governemnt / DRAP ’s Policy
Board and now it is valid till 31-08-2013 as documented in minutes of 238th meeting of
Registration Board. The firm applied for extension in contract manufacturing permission with
fee of Rs.50,000/- per product dated 15-04-2013. The case was considered in 238th meeting
of Registration Board and was deferred since the request of firm does not fall under present
contract policy. The firm has then applied for renewal of above mentioned products as per
details mentioned in last column above. Now the firm has applied for extension in contract
manufacturing permission from Scotmann Pharmaceuticals and deposited fee of Rs.50,000/-
for each product dated 09-05-2018.
c) Application/Form 5
d) Fee of Rs.50,000/- for each product.
c) Contract manufacturing agreement between M/s. Wilson Pharmaceutical, Islamabad
and M/s Scotmann Pharmaceuticals, Islamabad dated 16-04-2018.
d) Latest GMP inspection report of M/s Scotmann Pharmaceuticals, Islamabad (dated
14-09-2017 & 21-09-2017) concluding that panel unanimously recommended issuance
of GMP certificate.
meeting.
Registration-IV Section
Case No.10: Pending Registration letter of M/s. Z-Jan Pharmaceuticals, Hattar

M/s. Z-Jan Pharmaceutical, Hattar had applied for the registration of following drugs in
various registration board meetings, details are as under : -
S. Name of Drug and Price Pack Meeting Registration Remarks
No. Composition Size Board Decision
i. Gel-K-Zole. Rs.250/60 M-202 Deferred till As per available hard copy
Each gram contains:- ml the installation decision is rejected while
Ketoconazole…..20mg. of HVAC. in soft copy minutes the
product is deferred.
ii. Nalfin Injection 20mg. Rs. 350.00 M-218 Deferred for  As per provided
Each ml contains:- 1mlx5’s policy inspection reported dated
Nalbuphine………20mg. (Narcotic 07-08-2018 the firm do
Section). not possess Psychotropic
Injection Section,
however, firm possess
liquid general injection
section.
 Firm submitted
differential fee Rs.12000/-
 Undertakings not
provided.
iii. Nalfin Injection 10mg. Rs. 250.00 M-218 Deferred for -do-
Each ml ampoule 1mlx5’s policy
contains:- (Narcotic
Nalbuphine……..10mg. Section).
iv. Tram Injection. Rs. 190.00 M-218 Deferred for -do-
Each 2ml ampoule 5’s policy
contains:- (Narcotic
Tramadol HCl…..100mg. Section).
v. Cefobact Injection 2gm. Rs. 530.00 M-218 Deferred for  In 218th meeting,
Each vial contains:- 1’s the product was approved
Cefoperazone as Sodium clarification of in the strength as
……2gm. formulation. under: -
Sulbactum as Sodium
Cefoperazone as Sodium
……….2gm.
……2gm.
Sulbactum as Sodium
……….2gm.
 Whereas in form 5 it is
mentioned as: -
Cefoperazone as
Sodium……1gm.
Sulbactum as
Sodium……….1gm.
 The firm posses Dry
Powder Injection
Section.
 Undertakings are not
provided.
Decision: Registration Board decided to:-
i. Defer the product at S.No.1 for confirmation of status from original minutes
of Registration Board Meeting (M-202);
ii. Approve the products at S.No.2-4. Fee shall be verified as per procedure
adopted in 284th meeting.
iii. Defer the product at S.No.5 for confirmation of composition from dossier.
Case No.11: Pending Registration letter of M/s. Navegal Laboratories, Hattar.

M/s. Navegal Laboratories, Hattar had applied for the registration of following drugs in
various registration board meetings, details are as under : -
S.No. Name of Drug and Composition Price Pack Size Meeting Registration Board
Decision
1. Dizen 2mg Tablets Rs. 1.00 M-225 Approved
Each tablet contains:- per tablet 3x10’s
Diazepam……………2mg
(Benzodiazepine)
2. Dizen 5mg Tablets Rs. 2.00 M-225 Approved
Each tablet contains:- per tablet 3x10’s
Diazepam……………5mg
(Benzodiazepine)
3. Ropirol Tablets 1 mg. Rs.35.5/tablet. M-237 Approved
Each Tablet Contains:- 2x10
Ropinirole (as HCl) .…..1 mg.
(Navegal Specification)
4. Ropirol Tablets 2 mg. Rs.45.00/tablet. M-237 Approved
Each Tablet contains:- 2x10
Ropinirole (as HCl) ………..2 mg.
5. Rivatin Capsules 3 mg. Rs.140.25/capsule. M-237 Approved
Each Capsule Contains:- 3x10
Rivastigmine (as tartrate)…….3 mg.
6. Rivatin Capsules 4.5 mg. Rs.140.25/capsule M-237 Approved
Each Capsule Contains:- 3x10
Rivastigmine (as tartrate) ……4.5 mg.
7. Racit 40mg Capsules Rs. 210/ per M-242 Approved
Each capsule capsule 4x7’s.
contains:-
Atomoxetine HCl 45.60mg equivalent
to Atomoxetine…...40mg
8. Xolpi 10mg Tablets Each tablet Rs.16.00 2x10’s M-246 Approved
contains:- Zolpidem
Hemitartrate….10mg (Imidazopyridine)
Decision: Registration Board decided to:-
i. Defer the products at S.No.1-2 in above-referred case for submission
of differential fee of PKR=12000/-;
ii. Approve the products at S.No.3-8. Fee shall be verified as per
procedure adopted in 284th meeting.
Case No.12: Request of M/s. Zaynoon Pharmaceuticals, Peshawar For Grant of Afresh
Registration.
The Registration Board, in 276th meeting held on 22ND- 25TH November, 2017, declared
registration of all drugs of M/s. Zaynoon Pharmaceuticals, Peshawar invalid due to invalidity
of DML declared by CLB (vide 249th meeting). However, the firm was issued afresh DML
No. 000358 by way of formulation, dated 11-04-2017. Management of the firm has now
applied for registration of following products on form-5 with fee of Rs.20,000/- each as per
details mentioned below:
S.No. Brand Name, Dy.No./Date Evidence of Section Approval, Last
Composition and & Availability in Inspection Report &
(Reg.No) Demanded RRAs and DML
Price/ Pack Metoo Status
Provided by
Firm
1. Zayfen Suspension. Rs.14.00 Bruphene Approval of Liquid
Each 5ml contains:- Rs.18.00 Suspension of Syrup
Ibuprofen……………….100mg 60ml M/s. Abbott Section: 13-04-2017
(B.P Specification) 90ml Karachi Last Inspection
Reg. No.064409 report: 11-01-2018
DML: 11-04-2017
(Flag- A)
2. Nafpol 6 Plus Suspension. Rs.15.00 Calpol 6 Plus -do-
Each 5ml contains:- 60ml Suspension
Paracetamol……………250mg. M/s. GSK
(BP Specification)
Reg. No.064410
3. Zaycid Suspension. Rs.18.00 Mylanta -do-
Each 5ml contains:- 120ml Antacid
Aluminium Hydroxide….....215mg. Original Oral
Magnesium Hydroxide……….80mg. Liquid Bottle of
Simethicone…………………..25mg. M/s. Johnson &
(USP Specification) Johnson
Reg. No.064411 Karachi
The firm has provided copies of challan of Rs.20,000/- for each product. They have requested
to re-register the above products accordingly.
As per information obtain from QA&LT Division, based on critical observation made by FID
querying routine GMP inspection on 11-10-2018, a panel has been constituted for thorough
inspection of the firm for verification of observation.
S.No. Observations
1. The air curtain was not working at the male change room entrance.
2. The management has placed a basin in the change room which is advised to be
removed.
3. Raw material store is very small and the passage to liquid section is also from the
receiving area for materials; which needs to be separated by some partition.
4. The firm is also advised to provide the quarantine for the received materials.
5. The raw material testing record was seen randomly but regretted to state the record
was not up-to-date although QC released tags found placed on all the raw material
but the data is not traceable in the QC lab.
6. Improvement is advised in the condition of the dispensing room.
7. The management is advised to change the balance in the dispensing room.
8. The management is advised to control the humidity before dispensing the Raw
Material.
9. The flooring in the liquid section is in very bad condition and needs immediate
improvement; especially the washing area needs replacement of tiles.
10. The management is using used bottles which should be immediately stopped as
already advised in the last inspection.
11. In the QC Lab the record is not maintained and loose papers are being used for the
recording of the test results; the management is directed to use ledgers for the data so
it can be kept in safe custody.
12. HPLC is not in working condition, it is a very old model and needs to be replaced.
13. The management is also advised to follow official testing methods for the testing of
their registered products and should buy recent official books which are mandatory
for the development of their QC methods.
14. The SOP for stability testing are not satisfactory.
15. The capacity of the Stability Chamber was also not sufficient for their registered
products.
16. The HPLC operator also needs training.
17. The management is advised to appoint the full time QA in-Charge with sufficient
experience.
18. The management is advised to immediately do the following;
a) Calibration of all the equipment.
b) Preparation and up-gradation of all the SOPs of Production and QC
c) Purchase of official books (latest edition) and preparation of testing method
accordingly.
d) Up-gradation of HPLC.
e) Adaptation of official testing method.
f) Training of staff.
g) Appointment of QA staff as per rules.
Decision: Registration Board deferred the above-referred case till the firm complies
with GMP requirements.
Registration–V Section
Case No. 13: Correction in minutes of 283rd meeting of Registration Board.
Name of firm Product name and Demanded Decision Remarks

composition MRP/Pack
size
M/s Wilshire Xerbas tablet 10mg 1’s, Approved with Correction in
laboratories Each film coated tablet 5’s,10’s,20’s innovator’s formulation solicited as
124/1, Quid-e- contains: , 30’s, 50’s; specification. per innovator
Azam Industrial Solifenacin As per SRO Each tablet contains 10
Estate, Kot succinate….10mg mg solifenacin succinate,
Lakhpat, Lahore. corresponding to 7.5 mg
solifenacin.
Xerbas tablet 5mg 1’s, Approved with Correction in
-do- Each film coated tablet 5’s,10’s,20’s innovator’s formulation solicited as
contains: , 30’s, 50’s; specification. per innovator
Solifenacin As per SRO
succinate….5mg Each tablet contains 5
mg solifenacin succinate,
corresponding to 3.8 mg
solifenacin.
Decision: Registration Board noted the correction in minutes as proposed in last

column.
Export Facilitation Desk
Case No.14. Registration of Drugs of M/s. Unison Chemical Works, Araian-15km,

Raiwind Road, Lahore for Export purpose.
Firm has applied for registration of drug(s) only for export purpose as per
following details:
Sr.# Name of Drug(s) Generic/RRA Status Diary No. Fee with
date
I II III IV
01. Unisoft Tablets 5mg/60mg Rhilor-D Tablets by M/s Dy No.87-PE&R-
Each tablet contains: Pharmatec Pakistan (Pvt) (EFD) 08.11.2018
Loratadine……………………...5mg ltd. Rs.20,000/-
Pseudoephedrine Hydrochloride…60mg (Reg. No. 032555)
Details of requirements as per SOP (approved by Registration Board in its M- 283meeting) and the
documents submitted by the firm are as under:-
Sr.# Requirements As Per SOP Submitted documents (Ref. File.No. 1-
5/2018-PE&R-EFD-DRAP(M-18-
PRVC))
01. Application on Form 5/Form 5D/ form5F (CTD) with Application on form-5 with fee slips of
required fee as per relevant SRO. PKR 20,000/-
02. Copy of approved section from CLB or Panel Approval of relevant section verified
Inspection Report for Renewal of DML as evidence of from section approval issued by
approved sections for DML before 2005. licensing division, dated 25.08.2010.
03. Copy of last inspection report conducted by DRAP Last GMP Inspection Report dated
within last 12 months. 06.08.2018.
Conclusion: Good level of GMP
compliance
GMP Certificate issued on14.09.2018.
04. An undertaking that applied registration is exclusively provided
for export purpose and will not be sold in Pakistan.
05. Evidence of generic / approval status by Reference As stated vide column III of above table
Regulatory Authorities for applied formulation. In
cases where the formulations are neither generic nor
approved by Reference Regulatory Authorities,
applicant will provide evidence of approval status of
applied formulation by regulatory authority of
importing country.
06. Copy of DML along with its renewal status. Copy of DML renewed on 31-05-2014
07. An undertaking that the proposed names/ label/ color provided
do not resemble with already registered brands in
importing country. In case of resemblance/similarity
with already registered drug product in importing
country, the applicant will be liable to change
immediately.
Decision: Registration Board approved the grant of registration for “Unisoft

Tablets 5mg/60mg”, exclusively for export purpose, subject to the
following conditions:
 Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No objection certificate from concerned DRAP office.
 Manufacturer will also furnish export documents endorsed from
custom authorities (if required for any query) in order to ensure the
export of the product.
Division of Biological Evaluation & Research
Item No. 1: Imported Human Biologicals from Non-reference countries.
1. Name of Importer M/s. AGP Limited B-23-C, S.I.T.E., Karachi
Detail of DSL Copy of DSL No. 0427 valid till 21-09-2019
Name of Manufacturer Manufacturer & Product License Holder
M/s Biocon Limited,
Special Economic Zone, Plot No.2, 3, 4 & 5 Phase
IV,Bommasandra – Jigani Link Road,Bommasandra
Post,Bengaluru – 560 099, India.
Applicant for Certificate
M/s. Mylan Pharmaceuticals Pvt Ltd.,
Plot No.1-A/2, MIDC Industrial Estate, Taloja, Panvel, Dist-
Raigad, Maharashtra – 410208.
Brand Name +Dosage Form + ABEVMY® 100
Strength Bevacizumab Injection (r-DNA Origin) 100mg/4ml vial
Concentrate for solution for Intravenous (I.V) infusion
Single use vial 4mL Vial
Bevacizumab (r-DNA origin)………………….100mg
Monosodium phosphate monohydrate USP …...23.20mg
Disodium phosphate anhydrous USP …...4.80mg
Trehalose dehydrate USP ……240mg
Polysorbate 20 USP ……1.60mg
Water for Injection(s) USP ……q.s
Finished product specifications Store at 2-80C
Approval status of this product Avastin by M/s Roch
in Reference countries
Pharmacological Group Monoclonal antibody/ Anticancer
Shelf life 2 Years
International Availability of this India
product
Similar Product already Avastin by M/s Roch
Fee submitted AD Bio Dy. No.834/2018 dated 8-6-2018.
Rs.100,000/- dated 31-5-2018.
Demanded Price/ Pack size PKR 28,800/- 100mg/4ml vial
General documentation 1. Legalized Certificate of Pharmaceutical Product (CoPP) No.
DCD/CR-311/Spl.Cell-I/2017-18 valid up to 16-01-2020.
2. Original Letter of Authorization signed between M/s Mylan
Pharmaceuticals Pvt. Ltd, India and M/s AGP Ltd, Pakistan
dated 22-01-2018.
3. Copy of legalized GMP No. DCD/CR-1010/SPL. CL-1/2016-
2017 dated 14 Nov 2016 and valid up to 22-09-2018.
Remarks of Evaluator Details of biosimilarity are included below.
(Khurram Khalid AD)
2. Name of Importer M/s. AGP Limited B-23-C, S.I.T.E., Karachi
Name of Manufacturer Manufacturer & Product License Holder
M/s Biocon Limited,
Special Economic Zone,Plot No.2, 3, 4 & 5 Phase
IV,Bommasandra – Jigani Link Road,Bommasandra
Post,Bengaluru – 560 099, India.
Applicant for Certificate
M/s. Mylan Pharmaceuticals Pvt Ltd.,
Plot No.1-A/2, MIDC Industrial Estate, Taloja, Panvel, Dist-
Raigad, Maharashtra – 410208.
Brand Name +Dosage Form + ABEVMY® 400
Strength Bevacizumab Injection (r-DNA Origin) 400mg/16ml vial
Concentrate for solution for Intravenous (I.V) infusion Single use
vial
16ml Vial
Bevacizumab (r-DNA origin)…………………..400mg
Monosodium phosphate monohydrate USP …....92.80mg
Disodium phosphate anhydrous USP …...19.20mg
Trehalose dehydrate USP ……960mg
Polysorbate 20 USP ……6.40mg
Water for Injection (s) USP ……q.s
Finished product specifications Store at 2-80C
Approval status of this product Avastin by M/s Roch
in Reference countries
Pharmacological Group Monoclonal antibody/ Anticancer
Shelf life 2 Years
International Availability of this India
product
Similar Product already Avastin by M/s Roch
Dy No & Date of application, R&I Dy.No.20391dated 06-06-2018.
Fee submitted AD Bio Dy. No.835/2018 dated 8-6-2018
Rs.100,000/- dated31-05-2018.
Demanded Price/ Pack size PKR 114,500/- 16ml Vial
General documentation 1. Attested Legalized Certificate of Pharmaceutical Product
(CoPP) No.DCD/CR-311/Spl.Cell-I/2017-18 valid up to 16-
01-2020.
2. Original Letter of Authorization signed between M/s Mylan
Pharmaceuticals Pvt. Ltd, India and M/s AGP Ltd, Pakistan
dated 22-01-2018.
Remarks of Evaluator Details of biosimilarity are included below.
(Khurram Khalid AD)
Biosimilarity data provided by the Firm is among Bevacizumab, EU Avastin& US Avastin
WHO Biosimilarity Data Submitted by the firm
Guidelines
Quality Comparison i. Primary Sequence Identity byPeptide Mass Fingerprinting (R-
1. Physicochemical PMF), Intact Mass and HC/LC Mass.
Characterization ii. Intact Mass and HC and LC mass of Antibody.
iii. Peptide Mass Fingerprinting (PMF) by LC-ESI-MS
iv. Sequence confirmation between MYL-1402O and Avastin®
established by utilizing a combination of two proteolytic
enzymes (endoproteinase Glu-C and trypsin). Trypsin.
v. Disulphide bridging - Non reduced peptide mass fingerprinting
(non-reduced PMF)
vi. Secondary structure estimation from FT-IR analysis
vii. Extrinsic Fluorescence analysis using bis-ANS dye
viii. Hydrogen-Deuterium exchange (HDX) using Mass Spectrometry
ix. Glycan analysis using NP-HPLC
x. Purity of monomer and presence of HMWP by SEC-HPLC
xi. Percent oxidation estimation from reduced Peptide mass
fingerprinting
2. Biological Activity i. ELISA
ii. VEGF binding (ELISA)
iii. Inhibition of proliferation assay using HUVEC (Human Umbilical
Vein Endothelial Cell) cells
iv. FcγRIIa receptor binding
3. Immunochemical i. FcγRIIIa receptor binding
properties ii. FcγRIa receptor binding
iii. C1q binding assay
iv. Impurities Reduced CE-SDS - Low molecular weight impurities
v. Stability Studies The firm has submitted the stability study
Non-clinical Comparison Toxicology/ Pharmacotoxicolgy:
i. In-vitro Studies i. Single doseacute toxicitystudy in swiss Albinomice&New
ii. In-vivo Studies Zealandwhite rabbits
a. Biological/ ii. 28-day repeatdose toxicitystudy in Cynomolgusmonkey.
Pharmacodynamic iii. Four-weekrepeat dosecomparativetoxicity study in swiss Albino
activity mice
b. Non- clinical toxicity iv. 90-day repeat dose toxicitystudy in New Zealand white rabbits.
as determined in one Comparative in-vitroPrimary Pharmacodynamics:
repeat dose toxicity i. Inhibition ofVEGF- inducedproliferation byHUVECs
study ii. VEGF-165binding assay&FcγRIa bindingassay by ELISA.
iii. No secondary pharmacodynamics studies have been performed.
iv. A designated comparative single dose pharmacokinetic study of
Bevacizumab and Avastin®not conducted. However,
comparative toxicokinetic evaluation and exposureare
performed during repeat-dose toxicology studies in Swiss
Albino mice, New Zealand, White rabbits and in cynomolgus
monkeys.
v. Results and reports of toxicology study.
Clinical Comparison A Phase I randomized, single center, double-blind, 3-parallel-arm clinical
trial; Bevacizumab &EU- and US-approved Avastin®.
 Total: 111 Healthy malevolunteers
 Mylan’s Bevacizumab(n=37),
 US-approved Avastin®(n=37) and
 EU-approved Avastin®(n=37)
A Phase IIIdouble blind,randomized, activecontrolled, parallel
design,comparative pk, efficacy,safety and immunogenicitystudy of myl-
1402o andavastin®, both incombination with xeloxchemotherapy in
patientswith metastatic colorectalcancer.
Mylan’s Bevacizumab(n=68)
Avastin® (n=68)
Decision: Keeping in view the biosimilarity data and submitted CoPPs indicating the products
are available in country of origin; Registration Board approved the products subject to compliance
of current import policy for finished drugs.
Item No. 2: Imported veterinary biologicals form Non-reference countries.

1. Name of Importer M/s Vet Line International, 55/S, 1st Floor Main Shadman
Market, Lahore
DSL details License to sell drug as Distributor renewed upto: 11-02-2019
Name of Manufacturer M/s Lanzhou Bio-Pharmaceutical Factory of China Animal
Husbandry Industry Co., Ltd.
No. 2, Yanchang Road, Lanzhou City, Gansu Province, China
Brand Name +Dosage Form + Foot and Mouth Disease Trivalent Vaccine,
Strength Inactivated (Type O, Type A and Asia 1)
FMD virus strain O/HB/HK/99……….≥ 107.0TCID50 before
inactivation
AF/72………≥ 107.0TCID50 before inactivation
Asia-1/XJ/KLMY/04………≥ 107.0TCID50 before inactivation
Potency:
The efficacy of one dose vaccine against FMD virus
O/HB/HK/99 strain, AF/72 strain and Asia-1/XJ/KLMY/04
strain shall be at least 6PD50.
Finished product specifications As per innovator specification.
Shelf life 2 years at 2-80C
Products already registered in Arriah-Vac of M/s Mustafa Brothers, Faisalabad
Pakistan
Demanded Price / Pack size Decontrolled/ 50ml/Bottle
General documentation Valid legalized GMP certificate no. (2015) GMP 20 dated 08-
05-2017 valid till 13-1-2020
Original Valid legalized FSC dated 24-12-2014
Remarks of Evaluator  Quantitative composition is not mentioned in FSC, only
serotypes are mentioned. The above mentioned
composition is taken from Form-5A & Certificate of
Analysis.
 The firm has provided accelerated stability of 35 days
indicating that the potency of type O and Asia 1 strains
becomes less than 6PD50 at 35 day time point.
Decision:- Keeping in view the valid legalized GMP and FSC, Registration Board
approved the product subject to compliance of current Import policy for finished drugs. The
firm will submit valid legalized FSC with composition and same will be verified during
inspection of manufacturer abroad. Registration Board has authorized its Chairman for
issuance of registration letter after confirmation of composition.
Item No. 3: Miscellaneous/ deferred Cases.

1. Extension of permission for contract manufacturing of products applied by M/s
Werrick Pharmaceuticals, Islamabad deferred in 285th meeting of Registration
Board.
M/s Werrick Pharmaceuticals, Islamabad applied for the extension in permission for
contract manufacturing of following registered products by M/s Scotmann Pharmaceuticals,
Islamabad:
Sr. Reg. No. Contract Giver & Contract Brand Name & composition Contract
No. Acceptor Validity
1. 036096 M/s Werrick Pharmaceuticals, Cell-aid Depot Injection 50mcg 31-08-2018
Islamabad Each vial contains:
M/s Scotmann Interferon alpha-2b long
Pharmaceuticals. Islamabad acting…50mcg
5. 035798 M/s Werrick Pharmaceuticals, Cell-aid Injection Alfa 2a 31-08-2018

Islamabad Each ml contains:
M/s Scotmann Interferon alpha-2a….…….3Miu
Pharmaceuticals. Islamabad
6. 035799 M/s Werrick Pharmaceuticals, Cell-aid Injection Alfa 2b 31-08-2018
Islamabad
M/s Scotmann Each ml contains:
Pharmaceuticals. Islamabad Interferon alpha-2b….…….3Miu
Islamabad Each ampoule contains:
Pharmaceuticals, Islamabad acting….150mcg
8. 072853 M/s Werrick Pharmaceuticals, Anti-B Vaccine 10mcg 31-08-2013
Islamabad Contains:
M/s Scotmann Hepatitis B Surface
Pharmaceuticals, Islamabad Antigen……10mcg
9. 072854 M/s Werrick Pharmaceuticals, Anti-B Vaccine 20mcg 31-08-2013
Islamabad Contains:
M/s Scotmann Hepatitis B Surface
Pharmaceuticals, Islamabad Antigen……20mcg
10. 066508 M/s Werrick Pharmaceuticals, Genrate Injection 1000IU 31-08-2013
Islamabad Each pre-filled syringe contains:
M/s Scotmann Pharmaceuticals, Epoetin alfa…..10000IU
Islamabad
a. Application for extension of contract manufacturing
b. Fee challan of Rs. 50000/-
c. Copy of initial registration letter/ contract manufacturing letter
d. Copy of last renewal submission
e. For products at sr. no. 1-6, copy of approval letter for extension in contract
manufacturing permission dated 12-04-2017 indicating extension was granted upto
31-08-2018.
f. For products at sr. no. 7-10, contract was valid till 31-08-2013. No further extension
approval is submitted by the firm.
g. Copy of GMP inspection report conducted on 10-10-2018&17-10-2018
Registration Board decided as follows:
“Registration Board deferred the case for verification of renewal applications of
above products submitted by the firm.”
The case was referred to RRR section for verification of renewal submission. Renewal
section then referred the case to R-III section for verification of any extension in contract
permission. The response is recorded as under:
“The products mentioned vide para-1/n were registered on contract manufacturing basis.
The permission was valid till 30-06-2010. Later on, interim extensions wwere granted by
Federal Government/ DRAP’s Policy Board till 31-08-2013. The firm has then applied for
extension in contract manufacturing permission with fee of Rs. 50000/- for each product
dated 15-04-2013. The case was considered in 238th meeting and were referred to Biological
Directorate by the Registration Board. Copy of minutes of 238th meeting is placed on the file
verifying/ confirming the fee submitted by the firm.
The firm has not applied for extension/ any other post registration variation in this section
afterwards as per record available in this section. However, the firm has submitted the
evidence of renewal applications of the said products.”
In this context, it is submitted that as per minutes of meeting, aforementioned products were
referred to DBER but this division has no record of receiving the said applications of 2013. In
2015, the firm submitted the application for extension in contract manufacturing permission
for products at sr. no. 1 to 7 along with fee of Rs. 50000/- for each product. The case for
products at sr. no. 1-6 was taken up in 267th meeting and the permission was extended till 31-
08-2018 but the product at sr. no. 7 was inadvertently missed for inclusion in the agenda. For
products at sr. no. 8-10, DBER has no record neither of 2013 nor afterwards.
Now the firm has applied for extension in contract permission for all the products.
Decision: Registration Board deferred the case for detailed deliberation in next
meeting.
Werrick Pharmaceuticals, Islamabad.
M/s Werrick Pharmaceuticals, Islamabad applied for the extension in permission of
contract manufacturing of following human biologicals. The details of the products are as
follows:
Sr. Contract Giver & Reg. No. Brand Name & Composition Date of Initial Date of last
No. Contract Accepter Reg. renewal
submission
1. M/s Werrick 056859 Oxaparin Injection 20mg 13-07-2009 10-07-2014
Pharmaceuticals, Each 0.2ml contains:
Islamabad. Enoxaparin Sodium…20mg
2. 056860 Oxaparin Injection 40mg 13-07-2009 10-07-2014
M/s Scotmann Each 0.4ml contains:
Pharmaceuticals, Enoxaparin Sodium…40mg
3. Islamabad 056861 Oxaparin Injection 60mg 13-07-2009 10-07-2014
Enoxaparin Sodium…60mg
4. 056862 Oxaparin Injection 80mg 13-07-2009 10-07-2014
Enoxaparin Sodium…80mg
The firm has submitted following documents for each product:
c. Copy of initial registration letter/ contract manufacturing letter
d. Copy of last renewal submission.
e. Contract was valid till 31-08-2013. No further extension approval is submitted by the
firm.
f. Copy of GMP inspection report conducted on 10-10-2018 & 17-10-2018
The permission was valid till 30-06-2010. Later on, interim extensions were granted by
referred to DBER but this division has no record of receiving the said applications of 2013
nor afterwards. Now the firm has applied for extension in contract permission for above
products.
meeting.
Wilson’s Pharmaceuticals, Islamabad.
M/s Wilson’s Pharmaceuticals, Islamabad applied for the extension in permission of
contract manufacturing of following human biologicals. The details of the products are as
follows:
Sr. Contract Giver & Reg. No. Brand Name & Composition Date of Initial Date of last
No. Contract Accepter Reg. renewal
submission
1 M/s Wilson’s 056917 Enox Injection 20mg 16-12-2009 21-11-2014
Pharmaceuticals, Each 0.2ml contains:
Islamabad Enoxaprin Sodium…20mg
2 056918 Enox Injection 40mg 16-12-2009 21-11-2014
M/s Scotmann Each 0.4ml contains:
Pharmaceuticals, Enoxaprin Sodium…40mg
3 Islamabad 056919 Enox Injection 60mg 16-12-2009 21-11-2014
Enoxaprin Sodium…60mg
4 056920 Oxaparin Injection 80mg 16-12-2009 21-11-2014
Enoxaprin Sodium…80mg
The firm has submitted following documents for each product:
c. Copy of initial contract manufacturing permission certificate
d. Copy of last renewal submission.
e. Contract manufacturing certificate was valid till 31-08-2013. No further extension
approval is submitted by the firm.
f. Copy of GMP inspection report conducted on 10-10-2018 & 17-10-2018
The permission was valid till 30-06-2010. Later on, interim extensions were granted by
referred to DBER but this division has no record of receiving the said applications of 2013
nor afterwards. Now the firm has applied for extension in contract permission for above
products.
Moreover, M/s Scotmann Pharmaceuticals, Islamabad has already applied for the transfer of
registration of above products and M/s Wilson’s Pharmaceuticals, Islamabad has given the
NOC for transfer of registration from their name to M/s Scotmann Pharmaceuticals,
Islamabad.
meeting.
The meeting ended with the vote of thanks to and from the Chair.

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MINUTES OF 286th MEETING OF REGISTRATION BOARD

HELD ON 14th to 16th NOVEMBER, 2018

Item Detail of Item Pages

 RRR Section …………… …………. ……….. (686-746)

 Export Facilitation Desk……… ……… ……. (747-749)

V. Division of Biological Evaluation & Research 750 – 803

Drug Regulatory Authority of Pakistan

Dr. Muhammad Akram, Reprentative of Animal Husbandry Commissioner attended

Decision: Registration Board confirmed the minutes of 285th meeting of

Case No.01: Constitution of Post Registration Variation Committee (PRVC).

Decision: Registration Board noticed that the powers delegated to Chairman

Furthermore, job of power delegation is entrusted and related to the ex-

Moreover, performance and functions of the Board executed through its

Keeping in view the rule position explained above and performance

A committee to ensure availability of life saving drugs is working on directions of the

A. Shortage of Following Drugs as reported by Sheikh Zayed Hospital, R.Y. Khan:-

PROCEEDING OF THE MEETING:-

B. Shortage of Drugs as reported by CDC, Punjab vide letter dated 08.09.2018:-

PROCEEDING OF THE MEETING:-

C. Shortage of Drugs as reported by CDC, Punjab vide letter dated 10.08.2018

D. Non-Availability of Vaccines (MMR/Hepatitis-A) as reported by Shifa International

S. No. Item Short Since Reason of Non-Availability

F. Discontinuation of Supply of Humatrope 5mg (15IU) Injections

PROCEEDING OF THE MEETING:-

H. Priority consideration of formulations due to shortage in market.

a. Polystyrene Sodium Sulfonate Resin-Powder Sachet & Jar:

Pharmaceutical Evaluation Cell

4. Name and Address of the KANEL PHARMACEUTICALS.

7. Name and Address of the Kanel Pharmaceuticals, Plot#6-road SS-3.National Indust.

GMP status Last inspection dated 13-02-2018 confirms good level of

GMP status Last inspection dated 13-02-2018 confirms good level of

Approval status of product in Could not be confirmed

Me-too status Ectafin Injection 1gm IV by Hi-Medic Pharmaceuticals (Pvt)

442. Name and address of manufacturer / M/s Venus Pharma Lahore

1. NO-SPA 40 mg solution for injection by Sanofi Aventis

recommended renewal of DML.

Approval status of product in VELOSEF 500mg Injection by M/s APOTHECON (USFDA

Approval status of product in VELOSEF 1000mg Injection by M/s APOTHECON

Approval Status of Product in Bambuterol juice 1mg/ml by AstraZaneca

Sr. No Section No. of products No. of molecules

Approval status of product in MHRA Approved

620. Name and address of Manufacturer / M/s Shaheen Pharmaceuticals.

Approval status of product in Reference

Approval status of product in Reference

Approval status of product in Reference

Approval status of product in Reference

Approval status of product in Reference

Approval status of product in Reference

Approval status of product in Reference

Remarks of the Evaluator  Approved formulation in MHRA contains Ibuprofen

b. Local manufacturing applications of priority categories defined by Registration

Approval status of product in Reference FEMARA 2.5 mg Tablet by M/s Novartis

c. Import Applications of Priority Categories Defined by Registration Board in its

RS10A3P 101.86% 92.3% 93.2% 88.6%

a. New Cases (Human)

Sole Agency Agreement: Notarized copy of Sole agency

Sole Agency Agreement: Notarized copy of Sole agency

Sole Agency Agreement: Notarized copy of Sole agency

Comparison of Chromatographic conditions:

Manufacturing Date 20-1-2017 20-2-2017 20-3-2017

Sr.# Deficiency/Observation Response by Pharma

Decision: Deferred for stability study data as per zone IV-A.

Batch No. 096B17 097B17 098B17