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Product Directory

Edition 3, 2011

Global Generic

This is the 3rd edition of the

Global Generic Product Directory


Although not quite as ground breaking as the first edition, this one has MORE products, MORE developers and generated MORE excitement. It is generally considered better than the first, which is great, as that is what we planned. If you have ideas on how we can keep improving our beloved directory, please do let us know. The business process is now even simpler:

Find a product you like in the directory

Go online to www.genericlicensing.com

Make contact with the developer

Genericlicensing Limited has been set up to help you do more business, more effectively.
We want you to have access to all the product data you need to license more products; that is why we are dedicated to keeping our database updated and finding new developers you might be interested in working with.

We want to be the first place you turn to when you think about a new product
We know you are a demanding user, so we're seeking new types and sources of data to add even more depth to our offering. We don't want you go anywhere else; that keeps us on our toes. Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!) We believe in data; you can believe in us.

Asa Cox
Founder, Genericlicensing Limited asa.cox@genericlicensing.com skype: asa_cox
Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy of the data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.

Contents
PRODUCTS
listed alphabetically (then by company)

COMPANIES
listed alphabetically (then by product)

AS - Azt Bac - But Cab - Cyt Eba - Eze Gab - Gri Hal - Hyp Iba - Ive Ket - Ket LC - Lys

........................ 2 31 ........................ 31 41 ........................ 41 79 ........................ 99 107 ........................ 122 132 ........................ 132 136 ........................ 136 147 ........................ 147 148 ........................ 151 167

Ache - Auro ........................ 276 - 301 Bata - Bors ........................ 306 - 347 Cadi - Cosc ........................ 351 - 372 Demo - Dyna ........................ 375 - 380 Efar - Euro Fada - Frat Gale - Grup IND - Jubi Labo - Lupi ........................ 384 - 392 ........................ 398 - 414 ........................ 416 - 428 ........................ 437 - 448 ........................ 465 - 470

Dac - Dyd ........................ 79 99 Fam - Fus ........................ 108 121

Hame - Herm ........................ 428 - 436 Kent - KRKA ........................ 450 - 461 Neog - Orch ........................ 474 - 486 PH&T - Prol ........................ 486 - 496 Rafa - Rusa Taro - Venu ........................ 499 - 504 ........................ 517 - 526 Sage - SunP ........................ 505 - 515 Wock - YSP ........................ 526 - 532

Mac - Myc ........................ 167 187 Nab - Nys ........................ 187 194 Oct - Ozy Pac - Pyr Que - Qui SA - Sum Tac - Tro Ura - Zal ........................ 194 206 ........................ 206 227 ........................ 227 230 ........................ 241 251 ........................ 251 266 ........................ 266 274

Rab - Rub ........................ 230 241

Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.

Listings By

PRODUCT

Global Generic
Product directory

PRODUCTS
Company Faromed Batavia Bioplus Bluepharm Helm IND Swift IND Swift Substipharm Tecnimede YSP YSP YSP YSP YSP Ache Laboratorios Eurofarma Hamelnrds Farmigea Farmigea Anglo-French Drugs & Industries Ltd Astron Batavia Bioplus Chhikara Pharma Dynamic Lifecare Eurofarma Eurofarma SuanFarma Substipharm Form Capsule - Pellets Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Solution - Oral Syrup Tablet Drops - Eye Drops - Eye Tablet Tablet - Film coated Tablet Tablet Tablet Tablet Gel - Topical Tablet Tablet Tablet Strength 500 mg 50mg, 100mg 25 mg, 50 mg, 100 mg 25 mg, 50 mg, 100 mg 50 mg, 100 mg 25mg 50mg 50 mg, 100 mg 50 mg, 100 mg 25mg 50mg 100mg 50 mg 50mg 5 mg/ml, 10 mg/ml 120 ml 200 mg, 400 mg 2% ( 10 ml) 0.1% + 0.25% (10 ml) 100 mg 100 mg 100mg 100 mg 100 mg 200 mg 30 mg 100 mg 100 mg 100 mg Format IOR CTD IOR CTD CTD NTA NTA CTD CTD ANDA ANDA ANDA CTD NTA IOR IOR CTD CTD CTD IOR CTD CTD IOR NTA IOR IOR IOR IOR CTD Dossier Status Ready Ready In-Dev Ready Ready In-Dev In-Dev Ready Ready In-Dev In-Dev In-Dev Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready In-Dev Ready Ready Ready Ready Ready Ready Approved Regulatory Country Status Austria IOR N/A Portugal Germany N/A N/A France Portugal N/A N/A N/A Taiwan Taiwan Brasil Brasil Germany Italy Italy India Spain IOR N/A INDIA India Brasil Brasil Spain France NRP IOR IOR PLG NRP IOR IOR PLG PLG IOR IOR IOR PLG Approved Approved Approved NRP PLG PLG Approved PLG IOR IOR Approved Approved Approved Approved PLG PLG

Molecule Name A S acid Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acarbose Acebrophylline Acebrophylline Acebutolol Aceclidine HCl Aceclidine HCl + Timolol Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac 2

IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)

GROW YOUR BUSINESS!


LICENSE OTC'S OR BIOSIMILARS 20 Top Company Profiles All seeking international partners No introduction fee's
GREG.KINSEY@GENERICLICENSING.COM
Research: groups of patents. Development: Approximately 50 products registered; about 20 further in development. Capacity: 3 manufacturing facilities cutting-edge, computer-controlled manufacturing technology including electronic batch recording. Quality: and transfer and inventory coverage. Responsiveness: Global supply chain management services. Marketing/ Distribution: Major generic player in UK and Israel; fully geared up to win tenders in Germany. Presence in several more markets worldwide via distribution partners.

We

target our goals. target our drugs. time our delivery

Interested in: Contract manufacturing Contract development/Co-development Out-licencing In-licencing Distribution EU-re-analyses/ release
For more information please visit www.dexcel.com

because timing is everything

Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk

GLOBAL GENERIC
PRODUCT DIRECTORY

FEATURED COMPANY
COmpaNY Name Wockhardt UK Ltd CiTY Wrexham COUNTRY UK
Wockhardt UK is a diverse pharmaceutical business, created from the merger of CP Pharmaceuticals and The Wallis Laboratory. We are a major supplier of healthcare products to the Retail Pharmacy, Hospital and Grocery sectors. With thriving Export and Contract Manufacturing Divisions also in place, this is an exciting time for Wockhardt UK. Contact: Ashish Kakabalia - Head of Pharmacy, GSL & Business Development email: Ashish.Kakabalia@wockhardt.co.uk Telephone: +44 (0) 1978 661261
Format
CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD Ready <2008 UK

Product
Cilostazol Cimetidine Ciprofloxacin Ciprofloxacin Ciprofloxacin Lactate Citalopram Citalopram Clarithromycin Clarithromycin Clopidrogel Desloratadine Desloratadine Desloratadine Diclofenac Diclofenac Diltiazem Diltiazem HCl Diosmin + Hesperidin Domperidone Donepezil Donepezil Doxazosin

Form
Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab

Strength
50 mg, 100 mg 100 mg, 200 mg, 400 mg, 800 mg 250 mg, 500 mg, 750 mg 250 mg, 500 mg 20 mg 250 mg, 500 mg 250 mg, 500 mg 75 mg 5 mg 250 mg, 500 mg, 750 mg 10 mg, 20 mg, 40 mg

In-Dev/ 1st Ready/App App Date


In-Dev Ready <2008

Country

Status
Ready Validation

Reg
DCP  None None None PL None PL None PL None None None None None None

Reg Date

MP SA
2.5 mg, 5 mg 5 mg 25 mg, 50 mg 60 mg 75 mg, 100 mg 180 mg 10 mg 5 mg, 10 mg 5 mg, 10 mg 450 mg + 50 mg

LY ON TA DA LE
Ready Ready Oct-08 Portugal App Greece UK UK UK Greece Greece Ready App Ready App Status Ready Ready Oct-08 In-Dev In-Dev Ready Ready App Ready App Ready Greece Portugal Greece Feb-09 Ready

Pilot Scale BE Pend.

Dec-09 Nov-08 Mar-08

Nov-08

PL None PL None Nov-08 Dec-09

GLOBAL GENERIC
PRODUCT DIRECTORY

FEATURED COMPANY
COmpaNY Name Hikma Pharmaceutials CiTY Amman COUNTRY Jordan
A fast-growing multinational group, specialized in manufacturing and marketing of generic, branded and licensed pharmaceutical products globally. Manufacturing operations are located in Jordan, Algeria, Egypt, Germany, Italy, Portugal, Saudi Arabia, Tunisia and USA. Active markets include MENA, USA and Europe. Profoundly working on expanding to new regions such as Australasia and South America. Contact: Contact Name email: bd@hikma.com Telephone: Contact Telephone Number
Format
CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD CTD Ready <2008 UK

Product
Cilostazol Cimetidine Ciprofloxacin Ciprofloxacin Ciprofloxacin Lactate Citalopram Citalopram Clarithromycin Clarithromycin Clopidrogel Desloratadine Desloratadine Desloratadine Diclofenac Diclofenac Diltiazem Diltiazem HCl Diosmin + Hesperidin Domperidone Donepezil Donepezil Doxazosin

Form
Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab Tab

Strength
50 mg, 100 mg 100 mg, 200 mg, 400 mg, 800 mg 250 mg, 500 mg, 750 mg 250 mg, 500 mg 20 mg 250 mg, 500 mg 250 mg, 500 mg 75 mg 5 mg 250 mg, 500 mg, 750 mg 10 mg, 20 mg, 40 mg

In-Dev/ 1st Ready/App App Date


In-Dev Ready <2008

Country

Status
Ready Validation

Reg
DCP  None None None PL None PL None PL None None None None None None

Reg Date

MP SA
2.5 mg, 5 mg 5 mg 25 mg, 50 mg 60 mg 75 mg, 100 mg 180 mg 10 mg 5 mg, 10 mg 5 mg, 10 mg 450 mg + 50 mg

LY ON TA DA LE
Ready Ready Oct-08 Portugal App Greece UK UK UK Greece Greece Ready App Ready App Status Ready Ready Oct-08 In-Dev In-Dev Ready Ready App Ready App Ready Greece Portugal Greece Feb-09 Ready

Pilot Scale BE Pend.

Dec-09 Nov-08 Mar-08

Nov-08

PL None PL None Nov-08 Dec-09

Listings By

COMPANY

Global Generic
Product directory

COMPANY
Molecule Name Acebrophylline Adapalene Alprazolam Ambroxol Amiloride + HCTZ Amiodarone Amlodipine Besilate Amoxicillin Atenolol Atenolol + Chlorthalidone Brimonidine Bromazepam Bromopride Bromopride Captopril Carbamazepine Carbidopa + Levodopa Carbocisteine Carvedilol Cefadroxil Monohydrate Chlorthalidone + Atenolol Ciprofloxacin Citalopram Cyclobenzaprine Desonide Dexamethasone + Tobramycin Diclofenac Diclofenac Form Solution - Oral Gel - Topical Tablet Solution - Oral Tablet Tablet Tablet Solution - Oral Tablet Tablet Solution Ophtalmic Tablet Drops Solution - Oral Tablet Tablet Tablet Solution - Oral Tablet Solution - Oral Tablet Tablet - Film coated Tablet - Film coated Tablet Cream Solution Ophtalmic Solution - Oral Gel - Topical Strength 5 mg/ml, 10 mg/ml 1% (30 g) 0.5 mg 3 mg/ml, 6 mg/ml 5 mg + 50 mg 200 mg 5 mg, 10 mg 50 mg / 5 ml, 400 mg / 10 ml 25 mg, 50 mg, 100 mg 50 mg + 12.5 mg, 100 mg + 50 mg 2 mg/ml 3 mg, 6 mg 4 mg/ml 1 mg/ml 25 mg, 50 mg 200 mg 25 mg + 250 mg 20 mg/ml, 50 mg/ml 3.125 mg, 6.25 mg, 12.5 mg, 25 mg 50 mg/ml, 100 mg/ml 12.5 mg + 50 mg, 50 mg + 100 mg 500 mg 20 mg 5 mg, 10 mg 5 mg/g (30 g) 1 mg + 3 mg / ml 15 mg/ml 10 mg/g Format IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR IOR Dossier Status Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Ready Approved Regulatory Country Status Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Brasil Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved Approved

Company Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios Ache Laboratorios

276

IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)

WE'LL DO THE WORK!


TAKE THE EFFORT OUT OF IN-LICENSING Give us a brief >> We agree a list of companies & products >> We get a licensing offer from them >> You take it from there
ASA.COX@GENERICLICENSING.COM

Services Offered
 

Regulatory filings, variations and license maintenance

Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA)




Manufacturing GMP inspection preparation


 

Manufacturing technical transfers Formulation development projects

Europe North America Australasia


Expertise is offered both in-house and through industry leading partners. Talk to us about your technical service requirements today.

CALL +44 (0)870 7524105


CLIENT.CARE@GENERICLICENSING.COM
Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.

Email: directory@genericlicensing.com or Phone: +44 8707524105

Copyright 2008-2011

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