list of glp certified test facilitiesdst.gov.in/sites/default/files/certified test facilities...dr....

Last updated on March 12, 2018 of 23

List of GLP Certified Test Facilities

S.No. Test Facility Contact Person Test Facility Details Areas of Expertise Validity period

Certificate No.

1.

International Institute of Biotechnology and Toxicology

Dr. A. Ramesh, Test Facility Management

Address: Padappai-601301, Kancheepuram District, Tamil Nadu, India Tel: +91-44-27174246, 27174266 Fax: +91-44-27174455 Email: director at iibat dot com

Physical-chemical Testing (including Five Batch Analysis)

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 studies

Mutagenicity Studies o Bacterial Reverse Mutation Test

(AMES Test) o Chromosomal Aberration Test (In

vitro and In vivo) o Micronucleus Test (In vitro and In

vivo) using Human Lymphocytes o Mouse Lymphoma Assay

Environmental toxicity studies on aquatic and terrestrial organisms o Acute toxicity Studies (Earthworm,

Fish, Chicken, Pigeon) o Acute immobilization test o Alga growth inhibition test o Lemna growth inhibition test o Mesocosm studies o Honey Bees toxicity test o Reproduction toxicity Studies

(Daphnia, Earthworm) Studies on behavior in water soil and

air: bioaccumulation o Biodegradability studies o Environmental Fate studies o Metabolism & translocation,

Absorption Residue Studies Studies on effects on mesocosms and

natural ecosystems Analytical and Clinical Chemistry

19-07-2016 to 18-07-2019

GLP/C-097/2017


Testing Others

o Bioefficacy studies on Household insect pests in the laboratory as per WHOPES and other Standard protocols

2.

GLP Laboratory, Gharda Chemicals Limited

Mr. H.G. Nemade, Head & Test Facility Management

Address: GLP Laboratory, Gharda Chemicals Limited, B-27/29, MIDC, Phase I, Dombivli (East)–421203, Dist. Thane, (Maharashtra), India Tel: 91- 251-2430580 Fax: 91-251-2430581 Email: hgnemade at gharda dot com

Physical-chemical Testing (Including Five Batch Analysis)

05-08-2016 to 04-08-2019

GLP/C-090/2016

3.

Aurigene Discovery Technologies Limited

Mr. CSN Murthy, CEO & Test Facility Management

Address: Aurigene Discovery Technologies Limited, Bollaram Road, Miyapur, Hyderabad-500049 (Telangana) Tel: +91-40-44657777 Fax: +91-40-44657438 Email: murthy_csn at aurigene dot com

Toxicity Studies o Acute Toxicity o Sub-acute Toxicity o Chronic Toxicity o Sub-chronic studies


(AMES Test) o Micronucleus Assay (In-vivo)

Analytical and Clinical Chemistry Testing

Others o Safety Pharmacology o Analytical Method Validation

Studies o Dose Formulation Analysis o Drug Metabolism &

Pharmacokinetic Studies o Tissue Distribution Studies o Bioanalytical Method Validation

Studies o Bioanalysis o Toxicokinetic Analysis

05-08-2016 to 04-08-2019

GLP/C-091/2016

4. Jai Research Foundation

Dr. L.U. Sanghani, Director-Quality Assurance

Address: Jai Research Foundation, Near Daman Ganga Bridge, N.H. No. 8, Valvada - 396 105, Dist. Valsad (Gujarat)

Tel: +91-260 – 654 0242/3242/3243,

Physical-chemical Testing Toxicity Studies

o Acute Toxicity o Sub-acute Toxicity o Chronic Toxicity

05-08-2016 to 04-08-2019

GLP/C-089/2016


3291873

Fax: +91-22 – 66466119, 260-2707354 Email: jrf at jrfonline dot com

o Sub-chronic Toxicity o Inhalation Toxicity studies o Reproductive Studies o Skin Sensitization Studies o Neurotoxicity Studies o Teratogenicity Studies o Immunotoxicity Studies o Endocrine Disruptor Assays o Carcinogenicity Studies o In vitro Skin Corrosion Test:

Reconstructed Human Epidermis Test

o In vitro Skin Irritation Test o Bovine Corneal Opacity and

Permeability Test for Validation of Test

Mutagenicity studies o Bacterial Reverse Mutation Assay

(AMES Test) o Micronucleus Test (In-vivo & In-

vitro) o Chromosomal Aberration Test (In-

vivo & In-vitro) o Cell gene Mutation o Endocrine Disrupter assay

Environmental Toxicity Studies on Aquatic and Terrestrial Organisms o Alga Growth Inhibition Test o Daphnia Acute Immobilization

Test o Acute Fish Toxicity o Acute Oral and Contract Toxicity

Test to Honeybee o Acute Earthworm Toxicity Test o Avian Acute Oral and Dietary

Toxicity Study o Earthworm and Daphnia

Reproduction Toxicity Test 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

Testing Others

o Impurity profile and Five Batch Analyses

o Bio-analytical and Toxicokinetics o Drug metabolism &

Pharmacokinetics and Tissue Distribution

o Safety pharmacology

5.

Eurofins Advinus Limited

Dr. S. Natesan, Vice President and Head, Corporate Quality Assurance

Address: Plot Nos. 21 & 22, Phase-II , Post Box No. 5813, Peenya Industrial Area, Bangalore-560 058, India

Tel: 91-80-28394959, 28397338

Fax: 91-80-28394015, 28396023

Email: info at advinus dot com

Physical-chemical Testing including Five batch analysis

Toxicity studies o Acute Toxicity o Skin irritation/ corrosion o Eye irritation o Skin Sensitization o Dermal Toxicity o Inhalation Toxicity o Sub-acute/ Sub-chronic

Toxicity o Chronic Toxicity o Reproductive Toxicity o Carcinogenicity studies

Mutagenicity studies o Chromosomal Aberration

Test (In-vitro / In-vivo) o Micronucleus Assay (In-

vitro / In-vivo) o Bacterial Reverse Mutation

Assay (AMES Test) o Gene Mutation Test (In-

vitro) Environmental toxicity studies on

aquatic & terrestrial organisms Studies on behaviour in water, soil,

and air; bioaccumulation o Biodegradability studies o Environmental Fate studies

Residue Studies Analytical and Clinical Chemistry

Testing

07-11-2017 to 06-11-2020

GLP/C-111/2017


Others o Bioanalytical and

Toxicokinetics o Drug Metabolism and

Pharmacokinetics & Tissue Distribution

o Safety Pharmacology o PK and Immunogenicity

Analysis of Biologics

6.

Zydus Research Centre (Cadila Healthcare Limited)

Dr. Mukul R. Jain, Sr. General Manager (Pharmacology & Toxicology)

Address: Zydus Research Centre, Sarkhej-Bavala National Highway No. 8A, Moraiya, Aahmedabad-382 213, Gujarat, India

Tel: 91-2717-250802, 250803, 250803, 250804, 250805

Fax: 91-2717-250606

Email: zrc at zyduscadila dot com

Toxicity studies o Acute Toxicity Studies o Sub-acute Toxicity Studies o Sub-chronic Toxicity Studies o Chronic Toxicity Studies o Reproductive Toxicity

Studies o Carcinogenicity studies

Mutagenicity studies o Bacterial Reverse Mutation

Test (AMES Test) o Chromosome Aberration

Test (In vitro and In vivo) o Micronucleus Test (In vivo)


Others o Drug Metabolism &

Pharmacokinetic (DMPK) o Safety Pharmacology

12-05-2015 to 11-05-2018

GLP/C-076/2015

7. Intox Private Limited

Dr. P.Y. Naik, Director & CEO

Address: 375, Urawade, Tal-Mulshi, Distt. Pune - 412 115 (Maharashtra), India

Tel: 91-20-6654 8700 (30 lines)

Fax: 91-20-6654 8799

Email: info at intoxlab dot com

Physical-chemical Studies (Including 5 Batch Analysis)

Toxicity studies o Acute Studies o Acute Eye Irritation Studies o Acute Skin Irritation Studies o Acute Skin Sensitization Studies o Sub-acute (14, 28, 90 days)

Toxicity Studies o Chronic Toxicity Studies o Reproductive Toxicity Studies

(Pre-natal Developmental Toxicity, Fertility Studies, Peri-

15-03-2016 to 14-03-2019

GLP/C-082/2016


natal and Post-natal Studies, Multi-generation Studies)

o Toxicokinetic Studies Mutagenicity studies

o AMES Test o Chromosomal Aberration Test

(In-vivo/ In-vitro) o Micronucleus Assay (In-vivo/ In-

vitro) o In-vitro Sister Chromatid

Exchange o In-vitro Mammalian Cell Gene

Mutation Test Environmental Toxicity Studies on

Aquatic and Terrestrial Organisms Studies on Behavior in Water, Soil

and Air; Bioaccumulation Residue Studies Analytical and Clinical Chemistry

Testing

8.

Laboratory Animal Research Services (LARS), Reliance Life Sciences Private Limited

Dr. Ramnath R L, Test Facility Management

Address: Laboratory Animal Research Services (LARS), Reliance Life Sciences Private Limited, Dhirubhai Ambani Life Sciences Centre, R-282, Thane-Belapur Road, Rabale, Navi Mumbai-400 701, Maharashtra, India

Tel: +91-22-4067 8515

Fax: +91-22-4067 8099

Mobile: +91 90040 80460

Email: ramnath dot l at relbio dot com

Toxicity studies o Acute Toxicity Studies o Acute Eye Irritation Studies o Acute Skin Irritation Studies o Acute Skin Sensitization Studies o Sub- acute Toxicity Studies

(7,14,28-days) o Sub-chronic Toxicity Studies

Mutagenicity Studies o AMES Test o Chromosomal Aberration Test (In-

vitro) o Micronucleus Assay (In-vitro/ In-

vivo) o In-vitro cytotoxicity Studies

Analytical and clinical chemistry testing o Haematology and clinical

chemistry analysis for toxicity studies

o Bio-analytical Studies (TK & Antibody Estimations)

15-03-2016 to 14-03-2019

GLP/C-081/2016


9.

Torrent Pharmaceuticals Limited :Torrent Research Centre

Dr. Deepa Joshi, Test Facility Management

Address: Torrent Pharmaceuticals Limited :Torrent Research Centre, Ahmedabad Airport-Gandhinagar Highway, Near Indira Bridge, Village Bhat-382 428, Dist. Gandhinagar, (Gujarat)

Tel: +91- 79-23969100 Fax .: +91-79- 23969135 Email: glptrc at torrentpharma dot com, Deepajoshi at torrentpharma dot com

Toxicity studies o Acute Toxicity o Sub-acute/ Short Term Toxicity

(14 days and 28 days) o Chronic Toxicity (6 Months) o Sub-chronic Toxicity (3 Months) o Skin Sensitization Test o Dermal Toxicity

Mutagenicity Studies o Mammalian Micronucleus Test

(In-vivo) Analytical and Clinical Chemistry

Testing

20-08-2016 to 19-08-2019

GLP/C-092/2016

10.

GLP Test Facility, Sun Pharmaceutical Industries Limited

Dr. Arshad Khuroo, Test Facility Management

Address: GLP Test Facility, Sun Pharmaceutical Industries Limited, Research & Development Centre, Plot No. GP - 5, HSIDC, Sector - 18, Old Delhi – Gurgaon Road, Gurgaon -122015 (Haryana) Tel: +91- 124-4231001/5 Fax .: +91- 124-4231002 Email: arshad dot khuroo at sunpharma dot com

o Mutagenicity Studies o AMES Test

o Others o Toxicokinetics o Drug Metabolism and

Pharmacokinetics o Bio-analytical (including Bio-

analytical Method Validation)

03-10-2016 to 02-10-2019

GLP/C-095/2016

11.

National Toxicology Centre, National Institute of Pharmaceutical Education and Research (NIPER)

Prof. K.B. Tikoo, Management

Address: National Toxicology Centre , National Institute of Pharmaceutical Education and Research (NIPER), Sector-67,S.A.S Nagar (Mohali),Punjab-160062 Tel: +91-172-2292049, 2214692 Fax .: +91- 172-2214692 Email: ntc at niper dot ac dot in, tikoo at niper dot ac dot in

Toxicity Studies (Acute, Sub-acute and chronic toxicity studies)

23-06-2015 to 22-06-2018

GLP/C-077/2015

12. R&D Center, The Himalaya Drug Company

Ms. Jayashree Ullal, Test Facility Management

Address: R&D Center, The Himalaya Drug Company, Makali, Bangalore-562123

Physical-Chemical Testing Toxicity studies-

o Acute Toxicity Studies o Repeated dose 28 days and 90

23-06-2015 to 22-06-2018

GLP/C-078/2015


Tel: 0091- 80-23714444 Fax: 0091- 80-23714471 Mobile: 09980800031 Email: jayashree dot ullal at himalayawellness dot com

days Toxicity Studies Mutagenicity studies-

o Bacterial Reverse Mutation Test (AMES Test)

Analytical and Clinical chemistry testing

13. Indian Institute of Toxicology

Dr. V.M. Bhide, Test Facility Management

Address: Indian Institute of Toxicology, 32 A/1, Hadapsar Industrial Estate, Pune - 411 013 (Maharashtra), India

Tel: +91- 20-26819961 Fax .: +91- 20-26819962 Mobile: +91-9822031109 Email: iitoxicology at gmail dot com

Toxicity Studies o Acute Toxicity o Sub- acute Toxicity o Chronic Toxicity o Sub-chronic Toxicity o Skin Sensitization o Inhalation Studies

16-04-2016 to 15-04-2019

GLP/C-087/2016

14. Syngene International Limited

Dr. V. K. Satheesh, Test Facility Management

Address: Biocon Park, Plot No. 2&3, Bommasandra IV Phase, Jigani Link Road, Bangalore-560099 Tel: +91- 80-2808 3879 Fax .: +91- 80-4014 3150 Email: Satheesh dot velath at syngeneintl dot com

Physical-chemical testing o Characterization o 5 Batch analysis o Analytical Method Development &

Validation o Stability and Homogeneity Testing o Dose Confirmation Analysis

Toxicity Studies o Acute Toxicity

Acute Oral Toxicity Acute Dermal Toxicity Acute Inhalation Toxicity Acute Dermal

Irritation/Corrosion Acute Eye Irritation/Corrosion G. Pig Maximization-

Magnusson & Kligman and Buhler Method

Local tolerance tests Local lymph node assay

o Sub-acute/Sub-chronic Toxicity 7 day Repeat Dose Toxicity 14 day Repeat Dose Toxicity 28 day Repeat Dose Toxicity 42 day Repeat Dose Toxicity 90 day Repeat Dose Toxicity

o Chronic Toxicity (Repeated Dose Toxicity Studies)

25-10-2016 to 24-10-2019

GLP/C-094/2016


Developmental and Reproductive Toxicity

SEG – I : Male and Female Fertility study

SEG – II : Embryo-fetal Toxicity or Developmental Toxicity

SEG – III : Pre and Post –natal and Maternal Toxicity


(Ames) o Chromosome Aberration Test (In-

vitro & In-vivo) o Micronucleus Assay (In vitro & In-

vivo) Analytical and clinical chemistry testing Others

o Bioanalysis o Method Development o Method Validation o Sample Analysis

15.

RCC Laboratories India Private Limited

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 dot ravikrishnan at rcclabs dot com

Physical-chemical testing (including Five batch analysis)

Toxicity studies o Acute Toxicity Studies o Repeated Dose Toxicity (7, 14, 28, 90

Days) studies o Chronic Toxicity Studies o Reproductive Toxicity Studies o Carcinogenicity studies o Inhalation Toxicity studies o Skin Irritation/ Corrosion Test (In

vitro) o Local Lymph Node Assay (LLNA) o Pyrogen Test o Bacterial Endotoxin Test (BET)

Mutagenicity studies o Bacterial Reverse Mutation Test

(AMES Test) o Chromosome Aberration Test (In-

vitro/In-vivo) o Micronucleus Assay (In-vitro/In-vivo) o Mouse Lymphoma Assay (MLA)

12-01-2017 to 11-01-2020

GLP/C-096/2016


Residue Analysis o Lab Analysis only

Environmental toxicity studies on aquatic and terrestrial organisms

Analytical and clinical chemistry testing

16. Sa-Ford

Dr. Mital Ravalji, Test Facility Management

Address: Sa Ford, Plot No. V-10, MIDC Industrial Area, Taloja, Distt. Raigad, Maharashtra- 410 208, India Tel: +91- 22-64564400 Fax: +91- 22-27411722 Email: tfm at sa-ford dot com

Physical-chemical Testing (Including 5-Batch Analysis)

Toxicity Studies o Acute Toxicity o Sub- acute Toxicity o Sub-chronic Toxicity o Chronic Toxicity o Reproductive Toxicity o Carcinogenicity Studies o Inhalation toxicity studies o Skin sensitization studies

Mutagenicity Studies o AMES Test o Micronucleus Assay (in-vitro/in-

vivo) o Chromosome Aberration Test (in-

vitro/in-vivo) o Mouse Lymphoma Assay


04-04-2017 to 03-04-2020

GLP/C-101/2017

17. R & D Center, PI Industries

Dr. Anuj Kumar Mittal, Vice President R&D and Test Facility Management

Address: R & D Center, PI Industries, Udaisagar Road, Udaipur- 313001, Rajasthan Tel: 91-9124301642 Fax: 91-294-2491946 Email:- a.mittal at piind dot com

Physical –Chemical Testing Including Five Batch Analysis

05-09-2017 to 04-09-2020

GLP/C-104/2017

18. Bioneeds India Private Limited

Dr. S.N. Vinaya Babu, Test Facility Management

Address: Bioneeds India Private Limited, Devarahosahally, Sompura Hobli, NH-4, Nelamangala Taluk. Bangalore Rural District-562111, Karnataka Tel: +91-816-2243751-54 Fax: +91-816-2243755 Email: snvinaybabu at gmail dot com, vinaybabu at bioneeds dot in

Physical-Chemical Testing Including Five Batch Analysis

Toxicity Studies o Acute Toxicity o Sub-acute Toxicity o Chronic Toxicity o Inhalation Toxicity o Reproductive and Developmental

23-09-2017 to 22-09-2020

GLP/C-109/2017


Toxicity o Local Lymph Node Assay o Neurotoxicity

Mutagenicity Studies o Bacterial Reverse Mutation Test o Micronucleus Test (In-vivo / In-

vitro) o Chromosome Aberration Test (In-

vivo / In-vitro) o In-vitro Mammalian Cell Gene

Mutation Test Using HPRT and XPRT Genes

Environmental Toxicity Studies on Aquatic and Terrestrial Organisms o Acute Fish Toxicity Test o Acute Immobilization Test in

Daphnia o Avian Acute Oral and Dietary

Toxicity Test o Acute Oral and Contact Toxicity

Test in Honey Bee o Fish-embryo Toxicity Test o Earthworm and Daphnia

Reproduction Toxicity Test o Acute Silkworm Toxicity Test o Acute Trichogramma Toxicity

Test Residue Studies Analytical and Clinical Chemistry

Testing Others

o Bioanalytical Studies o Toxicokinetics Studies o Biocompatibility Studies o In-vitro 3T3 NRU Photo

Toxicity Test o Mouse Lymphoma Assay o In-vitro Skin Absorption Study o Bovine Corneal Opacity and

Permeability Test o In-vitro Skin Irritation:

Reconstructed Human Epidermis Test


o In-vitro Ocular Irritation Test o In Chemico Skin Sensitization:

Direct Peptide Reactivity Assay o Cytotoxicity Assay

19.

GLP Testing Facility, Syngenta Biosciences Pvt. Ltd.

Dr. Rajendra Hosmani, Test Facility Management

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

Email: rajendra dot hosmani at syngenta dot com

Physical –Chemical Testing Others

o Analytical Chemistry Testing

30-04-2015 to 29-04-2018

GLP/C-071/2015

20.

Sun Pharma Advanced Research Company Ltd.

Dr. Trinada Rao Chitturi, Test Facility Management

Address: Sun Pharma Advanced Research Company Ltd., SPARC Ltd., Village Tandalja, Vadodara-390020, (Gujarat) and SPARC Ltd., 907/4 GIDC, Makarpura, Vadodara-390010 (Gujarat) Tel:- +91-265-26615500 Fax: +91-0265 – 2354897 Mobile: +91-9824410098 Email: chitturi dot rao 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

Mutagenicity studies o Bacterial Reverse Mutation assay

(AMES test) o Chromosomal Aberration Test (In vitro) o Micronucleus Assay (In vivo)


Others o Safety Pharmacology Studies o Pharmacokinetic Studies o Tissue Distribution Studies

30-04-2015 to 29-04-2018

GLP/C-070/2015

21.

Vanta Bioscience Limited (formerly Vanta Bioscience)

Dr. Vyas M. Shingatgeri, Test Facility Management

Address: Vanta Bioscience Limited, K2 B, 11th Cross Street, SIPCOT Industrial Complex, Gummidipundi, Tamil Nadu- 601201.

Tel :- +91-44-67910-300/329/306/303 Fax:- +91-44-4220-2810

Toxicity studies o Acute Toxicity Studies o Sub-acute Toxicity Studies o Chronic Toxicity Studies o Reproductive Toxicity studies o In vitro Skin Corrosion using

31-07-2017 to 17-07-2018

GLP/C-079A/2017


Email: tfm at vantabio dot com

Episkin Model o In vitro Skin Irritation using

Episkin Model Mutagenicity studies

o Bacterial Reverse Mutation Test (AMES Test), including E.coli and TA97a

o Micronucleus Test (In vitro and In vivo) using Human Lymphocytes

o Chromosome Aberration Test (In vitro and In vivo)


22. Vimta Labs Limited

Dr. Upendra Bhatnagar, Vice President, Pre-Clinical Division

Address: Vimta Labs Limited, Life Sciences Facility, Plot No. 5, Alexandria Knowledge Park, Genome Valley, Turkapally, Shameerpet, Hyderabad-500 078.

Phone :- +9140-67404040

Fax:- +9140-39847708 Email: Upendra dot Bhatnagar at vimta dot com

Toxicity studies o Acute Toxicity Studies o Sub-acute Toxicity Studies o Chronic Toxicity Studies o Reproductive Toxicity Studies o Carcinogenicity Studies

Mutagenicity studies o AMES Test (Bacterial Reverse

Mutation Assay) o Chromosome Aberration Test

(In vitro and In vivo) o Mouse Lymphoma Assay o Micronucleus Test (In vitro and

In vivo) Analytical and Clinical Chemistry

Testing Others

o Bio-analytical o Pharmacokinetics o Safety Pharmacology

06-09-2015 to 05-09-2018

GLP/C-080/2015

23. Indofil Industries Limited

Dr. J G Chandorkar

Address: Indofil Industries Limited, Research & Development Centre, Off Swami Vivekanand Road, Azad Nagar, Sandoz Baug P.O. Thane – 400 607 (Maharashtra), India Phone: 022- 67999100 Email: jchandorkar-icc at modi dot com

Physical-Chemical Testing (Including 5 Batch Analysis)

10-04-2016 to 09-04-2019

GLP/C-083/2016


24. Venus Medicine Research Center

Dr. Manu Chaudhary, Test Facility Management

Address: Venus Medicine Research Center, Hill Top Industrial Estate, Jharmajri EPIP, Phase I (Extension), Bhatoli Kalan, Baddi – 173205, Solan (Himachal Pradesh), India Phone: +91-1795-302100, 302101 Fax: +91-1795-271272, 271270 E-mail: research at venusremedies dot com

Physical-chemical Testing (Stability Testing Study)

Toxicity Studies o Acute Toxicity (Oral/Dermal) o Sub-acute Toxicity (Oral/Dermal)

23-07-2016 to 22-07-2019

GLP/C-088/2016

25.

Toxicity Testing: GLP Test Facility, CSIR- Indian Institute of Toxicology Research

Professor Alok Dhawan, Test Facility Management

Address: Toxicity Testing: GLP Test Facility, CSIR- Indian Institute of Toxicology Research , Gheru Campus, Sarojini Nagar Industrial Area, Kanpur Road, Lucknow – 226 008 (Uttar Pradesh) Phone: +91-522-2476051/57, 2476091 Fax: +91-522-2611547 E-mail: tfm.glp at iitr dot res dot in

o Toxicity Studies o Acute Toxicity o Sub-acute Toxicity o Chronic Toxicity o Sub-chronic Toxicity o Primary Skin Irritation and Skin

Sensitization Studies Mutagenicity Studies

o Chromosomal Aberration Test (In-vivo/ In-vitro)

o Micronucleus Assay (In-vivo/ In-vitro)

Environmental Toxicity Studies on Aquatic and Terrestrial organisms

o Earthworm Reproduction Test o Fish Acute Toxicity Test


o Analysis of Biological Specimens for Clinical Biochemistry, Haematology, etc. for Toxicity Studies

05-06-2017 to 04-06-2020

GLP/C-102/2017

26. Vivo Bio Tech Ltd.

Dr. Atoshi Mukherjee, Test Facility Management

Address: Sy # No.: 349/A, Pregnapur Village – 502311, Gajwel Mandal, Siddipet District (Telangana) Phone: +91-8454244599 Fax: +91-40-27803612 E-mail: amukherjee at vivobio dot com

o Physical-chemical Testing (Including Five Batch Analysis)

o Determination of active ingredient content, pH, Density, Dissociation Constant, UV visible absorption spectrum, Colour, Odour, Physical state, Validation of analytical method

o Toxicity Studies o Acute Toxicity o Sub-acute Toxicity

13-06-2017 to 12-06-2020

GLP/C-103/2017


o Repeat dose 90-day Toxicity o Reproduction Toxicity o In-vitro 3T3 NRU Assay o MTT Assay o Hen’s Egg Test Chorioallantoic

Membrane (HET-CAM) Test o Mutagenicity Studies

o AMES Test o Micronucleus Assay (In –vitro/

In-vivo) o Cell Gene Mutation Assay (In-

vitro) o Cytotoxicity Assay (In-vitro) o Mammalian Chromosome

Aberration Test (In-vitro) o Mammalian Bone Marrow

Chromosome Aberration Test (In-vivo)

o Residue Studies (Lab analysis only) o Analytical and Clinical Chemistry

Testing

27.

Centre for Toxicology and Developmental Research (CEFTE)

Dr. Yogesh kumar Murkunde, Test Facility Management

Address: Centre for Toxicology and Developmental Research (CEFTE), No. 1, Ramachandra Nagar, Sri Ramachandra University, Porur, Chennai – 600116 (Tamil Nadu) Mobile: 09841342435 Email: ceft at sriramachandra dot edu dot in

Toxicity Studies o Acute Toxicity o Dermal Irritation/ Corrosion o Eye Irritation o Skin Sensitization o Repeated Dose Toxicity o In-vitro Cytotoxicity


(AMES Test) o In-vivo Micronucleus Test o In-vitro Chromosomal Aberration test


Others o Bioanalytical Testing – Ligand

Binding Assay

17-09-2017 to 16-09-2020

GLP/C-105/2017

28.

Laila Nutraceuticals Research & Development Center

Dr. G. Trimurtulu

Address: Survey No:181/2, JRD Tata Industrial Estate, Kanuru – 520007, Vijayawada (Andhra Pradesh) Phone:+91-866-6636666

Toxicity Studies o Acute Toxicity o Sub-acute Toxicity o Sub-chronic Toxicity : 90-day

Oral

23-11-2017 to 22-11-2020

GLP/C-112/2017


Email: mail at lailanutra dot in research at lailanutra dot in drgt at lailanutra dot in

o Reproductive Toxicity Mutagenicity Studies

o Chromosomal Aberration Test (In-vitro)

o Micronucleus Assay (In-vitro/ In-vivo)

o AMES Test Analytical and Clinical Chemistry Testing Others

o Drug Metabolism & Pharmacokinetics (DMPK) Studies

o Toxicokinetic & Bioanalysis

29.

Drug Safety Assessment, Novel Drug Discovery and Development (NDDD), Lupin Limited (Research Park)

Dr. Sharad K. Sharma, Deputy TFM

Address: Drug Safety Assessment, Novel Drug Discovery and Development (NDDD), Lupin Limited (Research Park), 46A/47A, Nande Village, Mulshi Taluka, Pune-412115 (Maharashtra) Phone: +91-20-66749100 Fax: +91-20-66749563 Email: sharadsharma at lupinpharma dot

com

Physical-chemical Testing Toxicity Studies

o Acute Toxicity o Sub-acute Toxicity o Chronic Toxicity o Reproductive Toxicity o Phototoxicity Studies

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 Respiratory and CNS Safety Studies

23-11-2017 to 22-11-2020

GLP/C-110/2014

30.

Lambda Therapeutic Research Limited

Mr. Manoj K. Patel, Head-Quality Assurance Unit

Address: Lambda Therapeutic Research Limited, Survey No. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmedabad – 382481 (Gujarat) Phone:+91-079-40202374 Email: manojkpatel at lambda-cro dot com

o Analytical Chemistry Testing o Analysis of samples from safety/

Toxicokinetic studies, In-vitro and In-vivo studies

o Pharmacokinetics and statistical analysis of safety (Toxicology)/ Toxicokinetic studies

25-11-2017 to 24-11-2020

GLP/C-113/2017

31. Palamur Biosciences

Dr. S. Ramamoorthy,

Address: Technology Research Park, SVS Medical College Campus,

o Physical Chemical Testing (including five batch analysis)

02-08-2017 to 19-05-2018 GLP/C-


Private Limited Test Facility Management

Yenugonda, Mahabubnagar – 509002 (Telangana) Phone:+91-8542-231166 Email: ram dot murthy at Palamurbio dot com

o Toxicity Studies o Acute oral, dermal toxicity study

in rats o Acute Dermal irritation

/Corrosion study in New Zealand Rabbits

o Acute Eye irritation/ corrosion study in New Zealand Rabbits

o Acute Inhalation toxicity study in rats

o Acute Skin sensitization study in Guinea Pigs

o 28 days Repeated oral dose toxicity studies in rats

o Sub-acute Toxicity (repeated 28 days)

o Sub-chronic Toxicity (repeated 90 days including Beagle Dog)

o Inhalation Toxicity (repeated 28 days)

o Reproductive Toxicity Study Screening Test

o Mutagenicity Studies o Mammalian Erythrocyte

Micronucleus test in mice o Mammalian Chromosomal

Aberration test (In-vitro) using CHOK1 cell line

o Bacterial Reverse Mutation Assay in Salmonella typhimurium

o Mammalian Cell gene mutation test (In vivo)

o Micronucleus Assay (In vitro) o Chromosomal Aberration Test

(In vivo/ In vitro – Human Lymphocytes)

o Environmental toxicity studies on aquatic and terrestrial organisms

o Acute Earthworm Toxicity Study in Eisenia Foetida

o Earthworm Reproduction Toxicity Study in Eisenia Foetida

072A/2017


o Acute Avian Oral Toxicity Study in Japanese Quail

o Acute Avian Oral Toxicity Study in Pigeon

o Avian Dietary Toxicity Study in Japanese Quail

o Acute Toxicity Study in Freshwater Fish (Poecilia Reticulata)

o Acute Toxicity Study in Freshwater Fish (Brachydaniorerio)

o Acute Contact Toxicity Study in Honeybee

o Acute Oral Toxicity Study in Honeybee

o Acute Immobilization Toxicity Study in Daphnia magna

o Growth Inhibition test in Lemna gibba (Duckweed)

o Growth Inhibition Study in Green Algae (Pseudokirchneriella subcapitata)

o Studies on behaviour in water, soil and air; bioaccumulation

o Residue Studies (Lab analysis only) o Analytical and clinical chemistry

testing o Others

o Pharmacokinetic study in dogs o MTD studies in dogs

32.

GLP Compliant Laboratory, Jubilant Biosys Limited

Dr. Mullangi Ramesh, Test Facility Management

Address: 96, Industrial Suburb, 2nd Stage, Yeshwanthpur, Bangalore – 560022 (Karnataka) Phone:+91-80-66628339 Email: mullangi underscore ramesh at jubilantinnovation dot com

o Toxicity Studies o Acute toxicity studies and Sub-acute

toxicity studies o Mutagenicity Studies

o AMES test o Chromosomal aberration test (In

Vitro) o Micronucleus Assay (In Vivo)

o Analytical and clinical chemistry testing

o Analytical Method Validation

21-05-2015 to 20-05-2018

GLP/C-073/2015


o Bioanalytical Method Validation o Clinical Chemistry Analysis

33. Natural Remedies Private Limited

Dr. C.V. Chandrasekaran, Test Facility Management

Address: Plot No. 5B, Veerasandra Industrial Area, 19 KM Stone, Hosur Road, Electronic City Post, Bangalore – 560100 (Karnataka) Phone:+91-080-40209717 Email: cvc at naturalremedy dot com

o Toxicity Studies o In vitro reproductive toxicity study o Sterioidogenesis assay: Testosterone

and Oestrogen o In vitro Skin Irritation o In vitro Skin Corrosion o In vitro Eye Irritation

o 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

01-08-2017 to 07-06-2018

GLP/C-074A/2017

34. Krish Biotech Research Private Limited

Dr. Raghib Husain, Test Facility Management

Address: Krish Biotech Research Private Limited, T-1, QK-17 (Part) WBIIDC, Kalyani, Phase III, Nadia – 741235 (West Bengal) Phone:+91-33-25824472 Fax: +91-33-71081012 Email: raghib dot h at krishbiotech dot com

o Physical chemical testing (Including Five Batch Analysis)

o Toxicity Studies o Acute Toxicity o Sub-acute Toxicity o Sub-chronic Toxicity o Neurotoxicity Studies/ CNS Safety

Studies o Inhalation Toxicity o Developmental and Reproductive

Toxicity o Mutagenicity Studies

o Micronucleus Assay (In-vitro/In-vivo) o Chromosomal Aberration Assay (In-

vitro/In-vivo) o Bacterial Reverse Mutation Assay

(AMES Test) o Environmental toxicity studies on

aquatic & terrestrial organisms o Residue Studies o Analytical and clinical chemistry testing

01-08-2017 to 07-06-2018

GLP/C-075B/ 2017

35. Bioscience Research Foundation

Dr. C. Tamilselvan, Test Facility Management

Address: Bioscience Research Foundation, Sengadu Village and Post, Kandamangalam – 602 002, Sriperumpudur Taluk, Kanchipuram

o Physical-chemical Testing o Toxicity Studies

o Acute Toxicity o Skin Sensitization

04-04-2016 to 03-04-2019

GLP/C-084/2016


District (Tamilnadu), India Phone: +91-44-27601082, 27601862 Email: brfchennai at gmail dot com

o Repeated Dose (28&90-day) Toxicity

o Reproduction/ Developmental Toxicity Screening

o Mutagenicity Studies o AMES Test o Micronucleus Assay (In-vitro/ In-

vivo) o Chromosomal Aberration Assay (In-

vitro) o Environmental Toxicity Studies on

Aquatic and Terrestrial Organisms o Studies on Behavior in Water, Soil and

Air; Bioaccumulation o Residue Studies o Analytical and Clinical Chemistry

Testing

36. GLR Laboratories Pvt. Ltd.

Dr. J.S.I. Rajkumar, Test Facility Management

Address: GLR Laboratories Pvt. Ltd., No. 444, Gokulam Street, Phase II, Plot 19, Ganesh Nagar, Asisi Nagar, Madhavaram, Chennai – 600 060 (Tamilnadu), India Phone: +91-44-25552358 Mobile:+91-9940570504 Email: rajkumarjs at glrlabs dot com

o Toxicity Studies o Acute Toxicity o Acute Eye Irritation/ Corrosion o Acute Dermal Irritation/

Corrosion o Repeat Dose 28-day Toxicity o Skin Sensitization o 90-days Repeated/ Systemic

Toxicity Test o Implantation Test

o Mutagenicity Studies o AMES Test (Bacterial Reverse

Mutation Assay) o Micronucleus Assay (In-vivo) o Chromosome Aberration Test (In-

vitro) o Comet Assay o Cytotoxicity o Mammalian Cell Gene Mutation

Assay/ Mouse Lymphoma Assay

21-02-2018 to 03-04-2019

GLP/C-085A/2018

37.

Toxicology Centre, Shriram Institute for Industrial Research

Dr. K.M. Chacko, Director & Test Facility Management

Address: Toxicology Centre, Shriram Institute for Industrial Research (A unit of Shriram Scientific and Industrial Research Foundation), 19, University Road, Delhi – 110 017, India

o Physical Chemical Testing o Toxicity Studies

o Acute Toxicity o Sub-acute Toxicity o Sub-chronic/ Repeated Dose (90

days) Toxicity

26-12-2017 to 04-04-2019

GLP/C-086A/2017


Phone: +91-11-27667267, 27667860 Email: sridlhi at vsnl dot com

o Inhalation Toxicity o Mutagenicity Studies

o AMES Test o Analytical and Clinical Chemistry

Testing

38.

Micro Therapeutic Research Labs Pvt. Ltd.

Dr. V. Selvaraj, Test Facility Management

Address: Micro Therapeutic Research Labs Pvt. Ltd., 50/51, Third Street, Balaji Nagar, Padi, Chennai – 600050 (Tamilnadu) Phone: +91-44-26548475, 26543424 Mobile: +91-9444384262 Email: ganesan at microtheraps dot com

o Toxicity Studies o Acute Toxicity (Oral, Dermal) o Sub-acute Toxicity (Oral) o Skin irritation o Eye irritation o Dermal Toxicity o Skin Sensitization

o Mutagenicity Studies o AMES Test o Chromosomal Aberration Test

(In- vitro) o Micronucleus Assay (In-vivo)

22-07-2016 to 21-07-2019

GLP/C-093/2016

39. Ross Lifescience Private Limited

Dr. Kedar Deobhankar, Chief Executive Officer & Test Facility Management

Address: Ross Lifescience Private Limited, Plot No. 96, Sector No. 10, PCNTDA, Bhosari, Pune – 411026 (Maharashtra) Phone: +91-20-66357725 Email: kedar at rosslife dot net

Physical-chemical Testing (including Five Batch analysis)

Environmental Toxicity Studies on Aquatic and Terrestrial Organisms

17-04-2017 to 16-04-2020

GLP/C-098/2017

40. Dabur Research Foundation

Dr. Manu Jaggi, Chief Scientific Officer & Test Facility Management

Address: Dabur Research Foundation (A research organization promoted by the Promoters of Dabur Group) 22, Site IV, Sahibabad Ghaziabad – 201010 (Uttar Pradesh) Phone: +91-120-3378610 Email: manu dot jaggi at daburresearch dot in

Physical-chemical Testing Toxicity Studies o Acute toxicity o Sub-acute toxicity o Skin sensitization o In vitro Hematotoxicity assay (CFU-GM) o In vitro Irritation study (HET-CAM) o In vitro Skin Corrosion - RHE test

(EpiSkinTM) Mutagenicity Studies o AMES Test o Chromosomal Aberration Assay (In

vitro) o Micronucleus Assay (In vivo)


Others o Bio-analytical & DMPK

17-04-2017 to 16-04-2020

GLP/C-099/2017


41. Anthem Biosciences Private Limited

Dr. Prasad Shivarudraiah, Head- Preclinical Research Development

Address: Anthem Biosciences Private Limited, No. 49, Canara Bank Road, Bommasandra Industrial Area, Phase I Bommasandra, Hosur Road, Bangalore – 560099 (Karnataka) Phone: +91-80-66724000, 66724046 Fax: +91-80-66724020 Mobile: +91-9741223861 Email: Prasad dot s at anthembio dot com

Physical-chemical Testing Toxicity Studies o Acute Toxicity o Sub-acute Toxicity o Sub-chronic Toxicity o Chronic Toxicity

Mutagenicity Studies o Bacterial Reverse Mutation Assay

(AMES test) o Chromosomal Aberration Test (In vitro

& In vivo) o Micronucleus Test (In vitro & In vivo)


Others o Dose confirmation, Homogeneity and

stability testing o Bio-analytical studies o Toxicokinetics o Drug Metabolism and Pharmacokinetics

(DMPK) studies

17-04-2017 to 16-04-2020

GLP/C-100/2017

42. Meghmani Organics Ltd.

Mr. Bhavesh R. Vyas, Test Facility Management

Address: Meghmani Organics Ltd., Plot No. 402 to 404 & 452, Village Chharodi – 382170, Taluka: Sanand, District: Ahmedabad (Gujarat) Mobile: +91-9099939289 Email: bhavesh dot vyas at Meghmani dot com

Physical-chemical Testing Including Five Batch Analysis

18-10-2017 to 17-10-2020

GLP/C-106/2017

43. Sipra Labs Limited

Dr. V. Satyamarauama, Test Facility Management

Address: Sipra Labs Limited, Industrial Estate, Balanagar, Hyderabad – 500037 (Telangana) Phone: +91-040-23802004 Email: sipra at sipralabs dot com

Toxicity Studies o Acute Toxicity o Sub-acute Toxicity o Chronic Toxicity

18-10-2017 to 17-10-2020

GLP/C-107/2017

44. CSIR – Central Drug Research Institute

Dr. Madhu Dikshit, Director

Address: CSIR – Central Drug Research Institute, Sector 10, Jankipuram Extension, Lucknow – 226031 (Uttar Pradesh) Phone: +91 0522- 2772450 Email: director at cdri dot res dot in

Toxicity Studies o Acute Toxicity

Others o Safety Pharmacology

18-10-2017 to 17-10-2020

GLP/C-108/2017


45.

JDM Scientific Research Organization Private Limited

Mr. Joy Paiza, Test Facility Management

Address: JDM Scientific Research Organization Private Limited, Block No. 58, Village: Lasundra, Taluka: Savli, District : Vadodara – 391775 (Gujarat) Phone: +91-9099995351 Email: info at jdmresearch dot com

Physical-chemical Testing Including Five Batch Analysis

21-02-2018 to 20-02-2021

GLP/C-114/2018

list of glp certified test facilitiesdst.gov.in/sites/default/files/certified test facilities...dr....

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