Beruflich Dokumente
Kultur Dokumente
S.No.
Test Facility
Contact Person
Areas of Expertise
International
Institute of
Biotechnology
and Toxicology
(IIBAT)
Dr. A. Ramesh,
Test Facility
Management
Physical-chemical testing
Toxicity studies
Mutagenicity studies
Environmental toxicity studies on
aquatic & terrestrial organisms
Studies on behavior in water, soil
and air; bioaccumulation
Residue studies
Studies on effects on mesocosoms
and natural ecosystems
Analytical and clinical chemistry
testing
Studies on natural enemies and
predators
Validity
period
Certificate
No.
* The Test Facility-International Institute of Biotechnology and Toxicology (IIBAT) was re-certified from July 19, 2010 - July 18, 2013 vide certificate No. GLP/C025. Further for grant of GLP re-certification from July 19, 2013 the facility was inspected and re-certification was not granted. IIBAT filed an appeal bearing No.
01/2014 against the decision, which has been disposed off by the Appellate Authority on July 22, 2015.
2.
3.
Mr. H.G.
GLP Laboratory,
Nemade
Gharda
Head Test
Chemicals
Facility
Limited
Management
Aurigene
Discovery
Technologies
Limited,
Hyderabad
Mr. CSN
Murthy, CEO &
Test Facility
Management
Physical-chemical Testing
(Including Five Batch Analysis)
05-08-2013
to
04-08-2016
GLP/C-053
Toxicity Studies
o Acute, Sub-acute and Sub-chronic
studies
Mutagenicity Studies
05-08-2013
o Bacterial Reverse Mutation Assay
to
(AMES Test)
04-08-2016
o Micronucleus Test (In-vivo)
Analytical and Clinical Chemistry
Testing
Others
GLP/C-051
Page 1 of 15
o Safety Pharmacology
(Neurobehavioral safety studies
in rodents)
o Toxicokinetic studies
Jai Research
Foundation
Dr. Abhay D.
Deshpande, Test Tel: 91-260 654 0242/3242/3243,
Facility
3291873
Management
Fax: 91-22 - 66466119
Email: jrf at jrfonline
Physical-chemical testing
Toxicity studies
o Acute, Sub acute, Sub chronic and
Chronic Studies
o Inhalation toxicity studies
o Reproductive studies,
Teratogenicity studies
o Skin Sensitization Studies
o Neurotoxicity Studies,
Immunotoxicity Studies
o Carcinogenicity Studies
o Endocrine disrupter assays
o In vitro skin corrosion test:
reconstructed human epidermis
test method
o In vitro skin irritation test
o Bovine corneal opacity and
permeability test for validation of
18-06-2015
test
to
Mutagenicity studies
04-08-2016
o Bacterial Reverse Mutation Assay
(AMES Test)
o Micronucleus Tests (In-vivo/ Invitro)
o Chromosomal Aberration Tests
(In-vivo/ In-vitro)
o Cell gene Mutation
o Endocrine disrupter assays
Environmental Toxicity Studies on
Aquatic and Terrestrial Organisms
o Fish: embryo toxicity test
o Fish: short-term toxicity test
on embryo and sac-fry
stages
Studies on Behaviour in Water, Soil
and Air : Bioaccumulation
Residue Studies
Analytical and clinical chemistry
GLP/C049A/2015
Page 2 of 15
5.
Orchid Research
Laboratories
Limited
Dr. B. Gopalan,
Chief Scientific
Officer
6.
Advinus
Therapeutics
Limited
Dr. S. Natesan,
Vice President
and Head,
Corporate
Quality
Assurance
testing
Others
o Impurity profile and five batch
analysis
o Bio analytical and Toxicokinetics
o Drug metabolism &
Pharmacokinetics and tissue
distribution
o Safety pharmacology
Physical-chemical Testing
Toxicity Studies
o Acute toxicity studies
o Sub-acute toxicity studies
o Sub-chronic toxicity studies
o Reproductive toxicity
studies
GLP/C25-05-2014 to
Mutagenicity Studies
060/2014
24-05-2017
o AMES Test
o Chromosomal aberration test
(in-vitro/in-vivo)
o Micronucleus assay (invitro/in-vivo)
Analytical and Clinical Chemistry
Testing
Physical-chemical testing
Toxicity studies
Acute Toxicity
Skin Sensitization studies
Sub-acute/Sub-chronic
GLP/CToxicity studies
07-11-2014 to
065/2014
Chronic Toxicity studies
06-11-2017
Reproductive
Toxicity
studies
Carcinogenicity studies
Inhalation Toxicity studies
Mutagenicity studies
Chromosomal
Aberration
Test (In-vitro & In-vivo)
Page 3 of 15
7.
Zydus Research
Centre, Cadila
Healthcare
Limited
Dr. Mukul R.
Jain,
Tel: 91-2717-250802, 250803, 250803,
Sr. General
250804, 250805
Manager
(Pharmacology &
Toxicology)
Fax: 91-2717-250606
8.
Intox Private
Limited, Pune
AMES Test
Gene Mutation Test (Invitro)
Environmental toxicity studies on
aquatic & terrestrial organisms
o Ecotoxicology studies
Studies on behaviour in water, soil,
and air; bioaccumulation
Biodegradability studies
Environmental Fate studies
Residue studies
Analytical and clinical chemistry
testing
Others
o
Bioanalytical and
toxicokinetics
o
Drug metabolism &
pharmacokinetics and tissue
distribution
o
Safety Pharmacology
Toxicity studies (Acute, Sub-acute,
Sub-chronic and Chronic toxicity
Studies, Reproductive studies,
Carcinogenicity studies
Mutagenicity studies
Analytical and Clinical Chemistry
Testing
Others (Drug Metabolism &
Pharmacokinetic Studies, Safety
Pharmacology Studies)
Physical-chemical testing
Toxicity studies
o Acute Toxicity Studies (Oral,
Dermal, Inhalation, Parenteral
routes), Skin irritation/
Sensitization, Eye irritation
o Sub-acute Toxicity Studies (14
12-05-2012 to GLP/C-040
11-05-2015
15-03-2013 to GLP/C-048
14-03-2016
Page 4 of 15
Fax: 91-20-22923643
Email: intox at vsnl dot com
9.
Toxicity studies
o Acute Studies (Oral, dermal, eye
irritation, Skin irritation, skin
sensitization)
o Sub- acute Studies (Oral, IV)
o Sub-chronic Studies (Oral, IV)
15-03-2013 to GLP/C-045
Mutagenicity Studies
14-03-2016
o Bacterial Reverse Mutation Assay
(Ames Test)
Analytical and clinical chemistry
testing
10.
Torrent
Pharmaceuticals Dr. Deepa Joshi,
Limited, Torrent Test Facility
Research Centre, Management
Gandhinagar
Ahmedabad Airport-Gandhinagar
Highway, Near Indira Bridge, Village
Bhat-382 428, Dist. Gandhinagar,
Gujarat, India
Tel: 0091- 79-23969100
Fax .: 009179- 23969135
Toxicity studies
o Acute toxicity studies (Single dose
toxicity studies)
20-08-2013 to GLP/C-052
o Sub-acute/ Short term toxicity
19-08-2016
studies (14 days and 28 days
repeated dose toxicity studies,
Skin Sensitization Test)
o Sub Chronic toxicity studies (3
Page 5 of 15
Email:
11.
12.
13.
GLP Test
Facility, Ranbaxy
Research
Laboratories,
Gurgaon
Dr. V. M.
Shingatgeri
Test Facility
Management
The National
Address: The National Toxicology Centre ,
Toxicology
National Institute of Pharmaceutical
Centre,
Education and Research (NIPER), SectorNational Institute
of Pharmaceutical Dr. K.K. Bhutani 67,S.A.S Nagar (Mohali),Punjab-160062
Education and
Director (Offg.)
Tel: 0091-172-2214682-87
Research
(NIPER), SectorFax .: 0091- 172-2214692
67,S.A.S Nagar
Email: dircetor at niper dot ac dot in
(Mohali),Punjab160062
Address: GLP test facility, The Himalaya
Dr. Shyam
Drug Company, Makali, Bangalore-562123
Ramakrishnan,
GLP test facility,
Tel: 0091- 80-23714444
Test Facility
The Himalaya
Fax .: 0091- 80-23714471
Drug Company,
Management,
Email: shyam dot r at himalayawellness
Makali,
The Himalaya
dot com
Bangalore-562123 Drug Company,
Makali,
Toxicity Studies
o Acute toxicity
o Repeated Dose toxicity
o Abnormal toxicity
o Local Tolerance
o Pyrogen Testing
o Specific toxicity
o Immunogenicity
Mutagenicity Studies
o AMES test
o Chromosome Aberration test (Invitro/ In-vivo)
o Micronucleus Assay (In-vivo)
Others
o Safety Pharmacology
Physical-Chemical Testing
(Stability Testing)
Toxicity studieso Acute toxicity studies, Repeated
dose (28 days, 90 days) toxicity
studies
Mutagenicity studies-
03-10-2013 to GLP/C-054
02-10-2016
23-06-2012 to GLP/C-041
22-06-2015
23-06-2012 to GLP/C-043
22-06-2015
Page 6 of 15
Bangalore562123
14.
Indian Institute of
Toxicology, Pune
15.
Dr. V. K.
Syngene
Satheesh, Test
International
Facility
Ltd. , Bangalore
Management
GLP/C25-10-2013 to
055/2013
24-10-2016
Page 7 of 15
Others
o Bio analytical (TK analysis)
for pre-clinical studies
16.
RCC
Laboratories
India Private
Limited,
Hyderabad.
Dr. R.
Ravikrishnan,
Test Facility
Management
Address:
Genome Valley, Turkapally,
Shameerpet (Mandal), Ranga Reddy
District,
Hyderabad-500 078
Tel: 0091- 40-23480422
Fax .: 0091- 40-23480420
Email: rajaram.ravikrishnan at rccltd dot
in
17.
Sa-Ford, Taloja,
District, Raigad,
Maharashtra
Dr. Prabhu
Daivasigamani,
Test Facility
Management
Address:
Sa Ford, Plot No. V-10,
MIDC Industrial Area,
Taloja, Distt. Raigad,
Maharashtra- 410 208, India
Tel: 0091- 22-64564403
Fax: 0091- 22-27411722
Email: pd at sa-ford dot com
Toxicity Studies
o Acute Toxicity Studies
o Sub- acute Toxicity Studies
o Chronic Toxicity Studies
o Reproductive Toxicity Studies
o Carcinogenicity Studies
o Inhalation toxicity and Skin
sensitization studies
Mutagenicity Studies
o AMES Test
o Micronucleus Assay (in-vivo)
o Chromosome Aberration Test
(in-vitro/in-vivo)
Analytical and Clinical Chemistry
Testing
GLP/C04-04-2014 to
059/2014
03-04-2017
Page 8 of 15
18.
Address:
Industries R & D Centre,
Udaisagar Road, Udaipur- 313001,
Rajasthan.
Tel: 91-9124301642
Fax: 91-294-2491946
Email:- a.mittal at piind dot com
Physical-Chemical Testing
(Including 5 batch analysis)
Toxicity Studies
o Acute and Sub-acute Studies (28
and 90 days)
o Chronic toxicity
o Acute inhalation toxicity
o Reproductive & developmental
toxicity (Male fertility study and
Teratology study)
Mutagenicity Studies
o Bacterial Reverse Mutation Assay
GLP/C23-09-2014 to
(AMES Test)
064/2014
22-09-2017
o Micronucleus Test (In-vivo/In
Vitro)
o Chromosomal Aberration test (Invivo/In Vitro)
o NRU Phototoxicity test
Environmental Toxicity Studies on
Aquatic and Terrestrial Organisms
o Acute toxicity
o Acute immobilization test
o Alga growth inhibition test
o Honey Bees toxicity test
Analytical and Clinical Chemistry
Testing
19.
Bioneeds India
Private Limited,
Bangalore Rural
District,
Karnataka.
GLP/C05-09-2014 to
063/2014
04-09-2017
Page 9 of 15
20.
21.
22.
Upasi Tea
Research
Foundation,
Valparai,
Distt.
Coimbatore, TN
GLP Testing
Facility,
Syngenta
Biosciences Pvt.
Ltd., Goa.
Sun Pharma
Advanced
Research
Company Ltd.,
Vadodara
Dr. B.
Radhakrishnan,
Director
Dr.
Rajendra
Hosmani,
Test Facility
Management
Residue Studies
Tel:+91-4253-235301, 235303
Fax:+91-04253-235302
Email: director at upasitearesearch dot
org
Address: GLP Testing Facility, Syngenta
Biosciences Pvt. Ltd., Santa Monica
Works, Corlim Ilhas - 403 110, (Goa)
Tel.+91 832 2490500, 832 2490506
Fax +91 832 2490561
GLP/C09-02-2015 to
069/2015
08-02-2018
30-04-2015
to
29-04-2018
GLP/C071/2015
Dr. Atul
Vekariya,
Assistant
Manager, Quality Tel.+91-265-26615500 , 6615600
Fax: +91-0265 2354897
Assurance Unit
Email: atul dot vekariya at sunpharma dot
com
Toxicity studies
o Acute, sub acute and chronic (14, 30
and 90, 180 days)
o Reproductive studies
o Carcinogenicity
o Phototoxicity
o Inhalation toxicity
o Immunogenicity (MEST and GPMT)
o Local Tolerance (Ocular and Dermal)
o Intracutaneous testing
30-04-2015
Mutagenicity studies
to
o Bacterial Reverse Mutation assay
29-04-2018
(AMES test)
o Chromosomal Aberration Test (In vitro)
o Micronucleus Assay (In vivo)
Analytical and clinical chemistry
testing
Others
o Safety Pharmacology Studies
o Pharmacokinetic Studies
o Tissue Distribution Studies
GLP/C070/2015
Page 10 of 15
23.
Vanta
Bioscience,
Tamil Nadu.
Dr. V. Amalan
Stanley,
Test Facility
Management
24.
Vimta Labs
Limited,
Hyderabad.
25.
Toxicity studies
o Acute studies
o Sub-acute studies
o Sub-chronic and Chronic
studies
o Reproduction Toxicity studies
(segment 1)
18-07-2012 to GLP/C-042
Mutagenicity studies
17-07-2015
o Bacterial Reverse Mutation
assay (Ames Test)
o In vivo micronucleus test
o In vitro chromosome aberration
test
Analytical and clinical chemistry
testing
Toxicity studies
o Acute studies
o Sub-acute studies
o Sub-chronic and Chronic
toxicity studies
Mutagenicity studies
o AMES Test
o In vivo and in-vitro Mouse
micronucleus test
o In vivo and in-vitro
chromosome aberration test
o Mouse lymphoma assay
Analytical and Clinical Chemistry
Testing
Others
o Pharmacokinetic Studies
Physical-Chemical Testing
06-09-2012 to GLP/C-044
05-09-2015
10-04-2013 to GLP/C-047
09-04-2016
Page 11 of 15
26.
27.
28.
29.
Dr. Manu
Venus Medicine
Choudhary, Test
Research Centre,
Facility
Baddi
Management
Vishaktata
Parikshan: GLP
Anuroop
Suvidha, Toxicity
Testing: GLP
Dr. K.C. Gupta,
Test Facility,
Test Facility
CSIR- Indian
Management
Institute of
Toxicology
Research (IITR),
Lucknow
Centre for
Toxicology and
Developmental
Research
(CEFT), Chennai
Dr. Praveen S
Hushangabade,
Test Facility
Management
Dr. S.
Thanikachalam,
Test Facility
Management
23-07-2013 to GLP/C-050
22-07-2016
Toxicity Studies
o Acute toxicity studies
GLP/Co Sub-acute toxicity studies
05-06-2014 to
058/2014
Mutagenicity Studies
04-06-2017
o Chromosomal Aberration test
(In-vivo)
o Micronucleus Assay (In-vivo)
Toxicity Studies
o Acute toxicity studies
o Sub-acute toxicity studies
o Reproductive toxicity studies
GLP/C13-06-2014 to
061/2014
Mutagenicity Studies
12-06-2017
o AMES Test
o Micronucleus Assay (In-vivo)
Analytical and clinical chemistry
testing
Toxicity Studies
o Acute toxicity studies
o Dermal irritation /Corrosion
o Eye irritation
o Skin sensitization
GLP/Co Repeated oral toxicity studies 17-09-2014 to
062/2014
16-09-2017
Mutagenicity Studies
o Bacterial
Reverse
Mutation
Assay (AMES Test)
o Micronucleus Assay (In-vivo)
o Chromosomal Aberration test
(In-vitro)
Page 12 of 15
Analytical
testing
30.
31.
32.
33.
Laila
Nutraceuticals
Research &
Development
Centre,
Vijayawada
Drug Safety
Assessment,
Noval Drug
Discovery and
Development,
Lupin Limited
(Research Park),
Pune
Lambda
Therapeutic
Research
Limited,
Ahmedabad
Palamur
Biosciences
Private Limited,
Mahabubnagar
Mr. Kiran
Bhupathiraju,
CEO
Dr. Sharad K.
Sharma, Deputy
TFM
Mr. Manoj K.
Patel, HeadQuality
Assurance Unit
Dr. S.
Ramamoorthy,
Test Facility
Management
and
clinical
chemistry
Toxicity Studies
o Acute Toxicity studies
o Sub-acute Toxicity studies
Analytical and clinical chemistry
testing
Others
o Drug Metabolism &
Pharmacokinetics (DMPK)
studies
o Toxicokinetic Bioanalysis
Physical-chemical Testing
Toxicity Studies
o Acute Toxicity studies
o Sub-acute Toxicity Studies
o Chronic Toxicity
o Reproductive Toxicity
Mutagenicity Studies
o AMES Test
o Micronucleus Assay (In-vitro &
In-vivo)
o Chromosomal Aberration test
(In-vitro & In-vivo)
Analytical and Clinical Chemistry
testing
Others
o CNS Safety Studies
GLP/C23-11-2014 to
066/2014
22-11-2017
GLP/C23-11-2014 to
067/2014
22-11-2017
GLP/C25-11-2014 to
068/2014
24-11-2017
Toxicity Studies
GLP/Co Acute oral, dermal toxicity study 20-05-2015 to 072/2015
19-05-2018
in rats
o Acute
Dermal
irritation
Page 13 of 15
Phone:+91-8542-231166
Email: ram dot murthy at Palamurbio dot
com
34.
GLP Compliant
Laboratory,
Jubilant Biosys
Limited,
Bangalore
Dr. Mullangi
Ramesh, Test
Facility
Management
35.
Toxicity Studies
o Acute toxicity studies and Sub-acute
toxicity studies
Mutagenicity Studies
o AMES test
o Chromosomal aberration test (In
GLP/C21-05-2015 to
Vitro)
073/2015
20-05-2018
o Micronucleus Assay (In Vivo)
Analytical and clinical chemistry
testing
o Analytical Method Validation
o Bioanalytical Method Validation
o Clinical Chemistry Analysis
GLP/CToxicity Studies
08-06-2015 to
074/2015
o In vitro reproductive toxicity study
07-06-2018
o Sterioidogenesis assay: Testosterone
Page 14 of 15
Management
560100 (Karnataka)
Phone:+91-080-40209717
Email: cvc at naturalremedy dot com
36.
Dr. Raghib
Krish Biotech
Husain,
Research Private Test Facility
Limited, Kalyani Management
and Oestrogen
Mutagenicity Studies
o Micronucleus Test (In Vitro)
o Mammalian Cell Gene Mutation Test
(In vitro)
o Chromosomal aberration test (In
Vitro)
o Bacterial Reverse Mutation Test
Page 15 of 15