List of GLP certified Test Facilities in National GLP Programme S.No. Test Facility Contact Person Test Facility Details Areas of Expertise . 1 International Institute of Biotechnology and Toxicology (IIBAT) 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 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. From July 19, 2013 until further orders of Hon’ble High Court of Madras & as per GLP/C-025 NGCMA’s Document No. GLP-108 & GLP-113 * * The GLP certificate No. GLP/C-025 has been kept alive till further orders of the Hon’ble High Court of Madras in the Writ Petition No. 27191 of 2015, filed by International Institute of Biotechnology and Toxicology (IIBAT) against National GLP Compliance Monitoring Authority (NGCMA), Union of India and others. 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 Address: B-27/29, MIDC-Phase I, Dombivli (East)–421 203 Dist. Thane, Maharashtra State, India Tel: 91- 251-2430580 , Fax: 91-251-2430581 Email: hgnemade at gharda dot com Address: Bollaram Road, Miyapur, Hyderabad-500 049, Andhra Pradesh Tel: 91-40-44657777 Fax: 91-40-44657438 Email: murthy_csn at aurigene dot com 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 o Bacterial Reverse Mutation Assay 05-08-2013 (AMES Test) to o Micronucleus Test (In-vivo) 04-08-2016 Analytical and Clinical Chemistry Testing Others o Safety Pharmacology GLP/C-051 Page 1 of 17 (Neurobehavioral safety studies in rodents) o Toxicokinetic studies Address: Jai Research Foundation, Near Daman Ganga Bridge, N.H. No. 8, Valvada - 396 108, Dist. Valsad (Gujrat) 4. 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 test 18-06-2015 Mutagenicity studies to o Bacterial Reverse Mutation Assay 04-08-2016 (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 testing GLP/C049A/2015 Page 2 of 17 5. Orchid Research Laboratories Limited Dr. B. Gopalan, Chief Scientific Officer Address: Orchid Chemicals and Pharmaceuticals Limited, # 476, Old Mahabalipuram Road, Sholinganallur, Chennai-600 019, India Tel: 91-44- 24502246, 24501474 Fax: 91-44 - 24501396 Email: research at orchidpharma dot com 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 Address: Plot Nos. 21 & 22, Phase-II , Post Box No. 5813, Peenya Industrial Area, Bangalore-560 058, India 6. Advinus Therapeutics Limited Dr. S. Natesan, Vice President and Head, Corporate Quality Assurance Tel: 91-80-28394959, 28397338 Fax: 91-80-28394015, 28396023 Email: info at advinus dot com Physical-chemical testing Toxicity studies Acute Toxicity Skin Sensitization studies Sub-acute/Sub-chronic Toxicity studies GLP/C07-11-2014 to Chronic Toxicity studies 065/2014 Reproductive Toxicity 06-11-2017 studies Carcinogenicity studies Inhalation Toxicity studies Mutagenicity studies Chromosomal Aberration Test (In-vitro & In-vivo) Micronucleus Assay (In- Page 3 of 17 vitro & In-vivo) 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 Address: Zydus Research Centre, Sarkhej-Bavala National Highway No. 8A, Moraiya, Aahmedabad-382 213, Gujarat, India 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 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 GLP/Co Bacterial Reverse Mutation 12-05-2015 to Test (AMES Test) 076/2015 11-05-2018 o Chromosome Aberration Test (In vitro and In vivo) o Micronucleus Test (In vivo) Analytical and Clinical Chemistry Testing Others o Drug Metabolism & Pharmacokinetic (DMPK) o Safety Pharmacology Page 4 of 17 Address: 375, Urawade, Tal-Mulshi, Distt. Pune - 412 115 (Maharashtra), India 8. Intox Private Limited Dr. P.Y. Naik, Director & CEO Tel: 91-20-6654 8700 (30 lines) Fax: 91-20-6654 8799 Email: info at intoxlab dot com 9. Laboratory Animal Research Services (LARS), Reliance Life Sciences Private Limited Address: Laboratory Animal Research Services (LARS), Reliance Life Sciences Dr. S. Harinarayan Rao, Private Limited, Dhirubhai Ambani Life Sciences Centre, R-282, Thane-Belapur Associate Road, Rabale, Navi Mumbai-400 701, Research Maharashtra, India Director 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, Perinatal 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/ Invitro) 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 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 GLP/C15-03-2016 to 082/2016 14-03-2019 GLP/C15-03-2016 to 081/2016 14-03-2019 Page 5 of 17 Tel: +91-22-3911 8500-05 Fax: +91-22-39118099 Email: hari.rao at relbio dot com 10. Torrent Pharmaceuticals Dr. Deepa Joshi, Limited, Torrent Test Facility Research Centre, Management Gandhinagar Address: Ahmedabad AirportGandhinagar Highway, Near Indira Bridge, Village Bhat-382 428, Dist. Gandhinagar, Gujarat, India Tel: 0091- 79-23969100 Fax .: 009179- 23969135 Email: glptrc at torrentpharma dot com, Deepajoshi at torrentpharma dot com 11. GLP Test Facility, Sun Pharmaceutical Industries Ltd., Gurgaon Dr. V. M. Shingatgeri, Test Facility Management Address: GLP Test Facility, Sun Pharmaceutical Industries Ltd., Sarhaul, Sector 18, Udyog Vihar, Industrial Area, Gurgaon -122015 (Haryana) Tel: 0091- 124-2397541 Fax .: 0091- 124-4037263 Email: VYAS.SHINGATGERI at ranbaxy dot com Mutagenicity Studies o AMES Test o Chromosomal Aberration Test (Invitro) o Micronucleus Assay (In-vitro/ Invivo) 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) Toxicity studies o Acute toxicity studies (Single dose toxicity studies) o Sub-acute/ Short term toxicity studies (14 days and 28 days repeated dose toxicity studies, Skin Sensitization Test) o Sub Chronic toxicity studies (3 20-08-2013 to GLP/C-052 and 6 months repeated dose 19-08-2016 toxicity studies) Mutagenicity Studies o In-vivo Mammalian Micronucleus Test Analytical and clinical chemistry testing Physical-chemical testing (Stability studies only) 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 13-8-2015 to 02-10-2016 GLP/C054A/2015 Page 6 of 17 12. National Toxicology Centre, National Institute of Pharmaceutical Education and Research (NIPER), Mohali Dr. K.K. Bhutani Director (Offg.) Address: National Toxicology Centre , National Institute of Pharmaceutical Education and Research (NIPER), Sector-67,S.A.S Nagar (Mohali),Punjab160062 13. Toxicity Studies (Acute, Sub-acute and chronic toxicity studies) GLP/C23-06-2015 to 077/2015 22-06-2018 Physical-Chemical Testing Toxicity studieso Acute Toxicity Studies o Repeated dose 28 days and 90 days Toxicity Studies Mutagenicity studieso Bacterial Reverse Mutation Test (AMES Test) Analytical and Clinical chemistry testing GLP/C23-06-2015 to 078/2015 22-06-2018 Tel: 0091-172-2214682-87 Fax .: 0091- 172-2214692 Email: dircetor at niper dot ac dot in Address: R&D Center, The Himalaya Drug Company, Makali, Bangalore-562123 R&D Center, The Himalaya Drug Company, Bangalore Ms. Jayashree Ullal, Test Facility Management Tel: 0091- 80-23714444 Fax: 0091- 80-23714471 Mobile: 09980800031 Email: jayashree dot ullal at himalayawellness dot com 14. Indian Institute of Toxicology, Pune o AMES Test o Chromosome Aberration Test (Invitro and In-vivo) o Micronucleus Assay (In-vivo) Others o Safety Pharmacology Dr. V.M. Bhide, Test Facility Management Address: Indian Institute of Toxicology, 32 A/1, Hadapsar Industrial Estate, Pune (Maharashtra)-411 013, India Tel: 0091- 20-26819962 Fax .: 0091- 20-26819962 Email: iitoxicology at gmail dot com Toxicity Studies o Acute Studies (Oral, Parenteral, Dermal, Inhalation, Dermal Irritation/ Corrosion, Eye Irritation/ Corrosion, Skin Sensitization Test) o Sub- acute Studies 16-04-2013 to GLP/C-046 o Chronic Studies 15-04-2016 Mutagenicity Studies o Bacterial Reverse Mutation Assay (Ames Test) o Mammalian Erythrocyte Micronucleus Test o In vivo/ in vitro Mammalian Page 7 of 17 Chromosome Aberration Test 15. Dr. V. K. Syngene Satheesh, Test International Facility Ltd. , Bangalore Management Address: Syngene International Ltd Biocon Park, Plot No.2&3, Bommasandra IV Phase, Jigani Link Road, Bangalore-560099 Tel: 0091- 80-28083879 Fax .: 0091- 80-40143150 Email: Satheesh.Velath at syngeneintl dot com 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 Physical-Chemical Testing o Characterisation o Five batch analysis o Analytical method development & validation o Stability and Homogeneity testing o Dose confirmation analysis Toxicity Studies o Acute toxicity o Sub-chronic toxicity o Chronic toxicity o Local tolerance, Skin irritation, Guinea pig maximization studies o Reproductive and development toxicity o Neurotoxicity studies Mutagenicity Studies o Bacterial Reverse Mutation Assay (AMES test) o Micronucleus test (In vivo) o Chromosome aberration (Invitro) Others o Bio analytical (TK analysis) for pre-clinical studies GLP/C25-10-2013 to 055/2013 24-10-2016 Physical –Chemical Testing (including five batch analysis) Toxicity Studies o Acute, Sub acute o Chronic, Subchronic o Reproductive, Inhalation GLP/C12-01-2014 to o Carcinogenicity 056/2014 11-01-2017 Mutagenicity Studies o AMES test o Chromosome Aberration (Invitro/ In-vivo) o Micronucleus Assay (Invitro/ In-vivo) o Mouse Lymphoma Assay Page 8 of 17 Physical-chemical Testing (Including 5-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 o 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/C27-11-2015 to 059A/2015 03-04-2017 Physical –Chemical Testing (Including 5 batch Analysis) GLP/C05-09-2014 to 063/2014 04-09-2017 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) GLP/C23-09-2014 to 064/2014 22-09-2017 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 18. 19. Dr. Anuj Kumar R & D Center, Mittal, Vice P I Industries President R&D Limited, Udaipur and Test Facility Management Bioneeds India Private Limited, Bangalore Rural District, Karnataka. Dr. S.N. Vinaya Babu, Test Facility Management Address: R & D Centre, P I Industries Limited, Udaisagar Road, Udaipur- 313001, Rajasthan. Tel: 91-9124301642 Fax: 91-294-2491946 Email:- a.mittal at piind dot com Address: Bioneeds India Private Limited, Devarahosahally, Sompura Hobli, NH-4, Nelamangala Tq. Bangalore Rural District-56211, Karnataka. Tel: +91-816-2243751-54 Fax: +91-816-2243755 Email: snvinaybabu at gmail dot com, vinaybabu at bioneeds dot in Environmental Toxicity Studies on Aquatic and Terrestrial Organisms Analytical and Clinical Chemistry Testing Residue Studies (Lab Analysis only) Page 9 of 17 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 Dr. Trinada Rao Chitturi, Test Facility Management Mutagenicity Studies o Bacterial Reverse Mutation Assay (AMES Test) 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 Address: UPASI Tea Research Foundation, Tea Research Institute, Nirar Dam BPO, Valparai-642127, Coimbatore District, (Tamil Nadu) Residue Studies Physical –Chemical Testing Others o Analytical Chemistry Testing 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 30-04-2015 to 29-04-2018 GLP/C070/2015 Email: rajendra.hosmani at syngenta dot com Address: Sun Pharma Advanced Research Company Ltd., SPARC Ltd., Village Tandalja, Vadodara-390020, (Gujarat) and SPARC Ltd., 907/4 GIDC, Makarpura, Vadodara-390010 (Gujarat) Toxicity studies o Acute, sub acute and chronic (14, 30 and 90, 180 days) o Reproductive studies o Carcinogenicity o Phototoxicity Page 10 of 17 Tel:- +91-265-26615500 Fax: +91-0265 – 2354897 Mobile: +91-9824410098 Email: chitturi dot rao at sunpharma dot com 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) Analytical and clinical chemistry testing Others o Safety Pharmacology Studies o Pharmacokinetic Studies o Tissue Distribution Studies 23. Vanta Bioscience, Gummindipundi, Tamil Nadu. Dr. V. Amalan Stanley, Test Facility Management Address: Vanta Bioscience (A division of Kemin Industris South Asia Private Limited), K2, 11th Cross street, SIPCOT Industries Estate, Gummidipundi, Tamil Nadu- 601201. Tel :- +91-44-67910-300/329/306/303 Fax:- +91-44-4220-2810 Email: amalan.stanley at vantabio dot com, tfm at vantabio dot com 24. Vimta Labs Limited, Hyderabad. Dr. Nitin Shetty, Vice President & Facility Head, Pre-Clinical Division Address: Vimta Labs Limited, Life Sciences Facility, Plot No. 5, Alexandria Knowledge Park, Genome Valley, Turkapally, Shameerpet, Hyderabad-500 078. 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 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 using Human Lymphocytes and In vivo) o Chromosome Aberration Test (In vitro and In vivo) Analytical and clinical chemistry testing Toxicity studies o Acute Toxicity Studies o Sub-acute Toxicity Studies o Chronic Toxicity Studies o Reproductive Toxicity Studies o Carcinogenicity Studies Mutagenicity studies GLP/C18-07-2015 to 079/2015 17-07-2018 GLP/C06-09-2015 to 080/2015 05-09-2018 Page 11 of 17 Fax:- +9140-39847708 Email: nitin.shetty at vimta dot com 25. Indofil Industries Dr. J G Limited Chandorkar Address: Indofil Industries Limited, Research & Development Centre, Off Swami Vivekanand Road, Azad Nagar, Sandoz Baug P.O. Thane – 400 607 (Maharashtra), India 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 o Phone :- +9140-67404040 GLP/CPhysical-Chemical Testing (Including 10-04-2016 to 083/2016 09-04-2019 5 Batch Analysis) Phone: 022- 67999100 Email: jchandorkar-icc at modi dot com 26. Dr. Manu Venus Medicine Choudhary, Test Research Centre, Facility Baddi Management Address: Venus Medicine Research Centre, Venus Remedies Limited, Hill Top Industrial Estate, Jharmajri EPIP, Phase I (Extension), Bhatoli Kalan, Baddi – 173205 (Himachal Pradesh), India Phone: +91-1795-302003, 302004 Physical-Chemical Testing (Stability Testing Only) Analytical Chemistry Testing 23-07-2013 to GLP/C-050 22-07-2016 E-mail: research at venusremedies dot com 27. Vishaktata Parikshan: GLP Anuroop Suvidha, Toxicity Testing: GLP Test Facility, CSIR- Indian Institute of Toxicology Professor Alok Dhawan, Test Facility Management Address: Vishaktata Parikshan: GLP Anuroop Suvidha, Toxicity Testing: GLP Test Facility, CSIR- Indian Institute of Toxicology Research (IITR), Post Box No. 80, Mahatma Gandhi Marg, Lucknow – 226 001 (Uttar Pradesh), India Phone: +91-522-2621856, 2628227 Toxicity Studies o Acute Toxicity Studies o Sub-acute Toxicity Studies GLP/C04-04-2016 to Mutagenicity Studies 058A/2016 o Chromosomal Aberration Test (In- 04-06-2017 vivo) o Micronucleus Assay (In-vivo) Environmental Toxicity Studies on Page 12 of 17 Research (IITR) Aquatic and Terrestrial organisms Fax: +91-522-2628227, 2611547 E-mail: tfm.glp at iitr dot res dot in director at iitrindia dot org 28. 29. 30. 31. Vivo Bio Tech Ltd., Pregnapur, Medak District Dr. Praveen S Hushangabade, Test Facility Management Address: Sy # No.: 349/A, 350A, 351, 356/3A, Pregnapur Village – 502311, Gejwal Mandal, Medak District, Telangana Phone: +91-845-4210411 Fax: +91-40-27803612 E-mail: pravin at vivobio dot com Address: Centre for Toxicology and Developmental Research (CEFT), No. 1, Centre for Ramachandra Nagar, Sri Ramachandra Dr. Yogeshkumar Toxicology and University, Porur, Chennai – 600116 Murkunde, Test Developmental Facility Research Mobile: 09841342435 Management (CEFT), Chennai Email: ceft at sriramachandra dot edu dot in Laila Nutraceuticals Research & Development Centre, Vijayawada Mr. Kiran Bhupathiraju, CEO Drug Safety Assessment, Noval Drug Discovery and Development, Dr. Sharad K. Sharma, Deputy TFM Address: Laila Nutraceuticals Research & Development Centre, Survey No:181/2, JRD Tata Industrial Estate, Kanuru – 520007, Vijayawada (Andhra Pradesh) Phone:+91-866-6636666 Email: mail at lailanutra dot in research at lailanutra dot in Address: Drug Safety Assessment, Noval Drug Discovery and Development, Lupin Limited (Research Park), 46A/47A, Nande Village, Mulshi Taluka, Pune-412115 (Maharashtra) Toxicity Studies o Acute toxicity studies o Sub-acute toxicity studies o Reproductive toxicity studies Mutagenicity Studies 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 o Repeated oral toxicity studies Mutagenicity Studies o Bacterial Reverse Mutation Assay (AMES Test) o Micronucleus Assay (In-vivo) o Chromosomal Aberration test (In-vitro) Analytical and clinical chemistry testing 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 GLP/C13-06-2014 to 061/2014 12-06-2017 GLP/C17-09-2014 to 062/2014 16-09-2017 GLP/C23-11-2014 to 066/2014 22-11-2017 GLP/C23-11-2014 to 067/2014 22-11-2017 Page 13 of 17 Lupin Limited (Research Park), Pune 32. Lambda Therapeutic Research Limited, Ahmedabad Phone:+91-20-66749100 Fax: +91-20-66749563 Email: sharadsharma at lupinpharma dot com Mr. Manoj K. Patel, HeadQuality Assurance Unit Address: Lambda Therapeutic Research Limited, Plot No. 38, Nr. Silver Oak Club, S.G. Highway, Gota, Ahmedabad – 380061 (Gujarat) Phone:+91-079-40402374 Email: manojkpatel at lambda-cro dot com 33. Palamur Biosciences Private Limited, Mahabubnagar Dr. S. Ramamoorthy, Test Facility Management Address: Technology Research Park, SVS Medical College Campus, Yenugonda, Mahabubnagar – 509002 (Telangana) Phone:+91-8542-231166 Email: ram dot murthy at Palamurbio dot com 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 Analytical and Clinical Chemistry testing Others o Bio-analysis o Pharmacokinetic analysis GLP/C25-11-2014 to 068/2014 24-11-2017 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 GLP/Co Acute Skin sensitization study in 20-05-2015 to 072/2015 Guinea Pigs 19-05-2018 o 28 days Repeated oral dose toxicity studies in rats 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 Page 14 of 17 typhimurium o Mammalian Cell gene mutation test (In vivo) Analytical and clinical chemistry testing Others o Pharmacokinetic study in dogs 34. GLP Compliant Laboratory, Jubilant Biosys Limited, Bangalore 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 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 35. Dr. C.V. Natural Remedies Chandrasekaran, Private Limited, Test Facility Bangalore 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 36. Dr. Raghib Krish Biotech Husain, Research Private Test Facility Limited, Kalyani Management Address: 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 Toxicity Studies o In vitro reproductive toxicity study o Sterioidogenesis assay: Testosterone and Oestrogen Mutagenicity Studies GLP/C08-06-2015 to o Micronucleus Test (In Vitro) 074/2015 o Mammalian Cell Gene Mutation Test 07-06-2018 (In vitro) o Chromosomal aberration test (In Vitro) o Bacterial Reverse Mutation Test Physical chemical testing Toxicity Studies o Acute toxicity study GLP/C08-06-2015 to Mutagenicity Studies 075/2015 o Micronucleus Assay (In-vitro/In-vivo) 07-06-2018 o AMES test (In-vitro/ In-vivo) Environmental toxicity studies on aquatic & terrestrial organisms using Page 15 of 17 fish, honeybees, alga, daphnia and earthworm. Analytical and clinical chemistry testing 37. Bioscience Research Foundation Address: Bioscience Reserarch Foundation, Sengadu Village and Post, Kandamangalam – 602 002, Dr. C. Sriperumpudur Taluk, Kanchipuram Tamilselvan, Test District (Tamilnadu), India Facility Management Phone: +91-44-27601082, 27601862 Email: brfchennai at gmail dot com 38. Dr. S.S. GLR Murugan, Test Laboratories Pvt. Facility Ltd. 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 Email: siva dot murugan at glrlabs dot com 39. Toxicology Centre, Shriram Dr. K.M. Chacko, Address: Toxicology Centre, Shriram Institute for Industrial Research (A unit Physical-chemical Testing Toxicity Studies o Acute Toxicity o Skin Sensitization o Repeated Dose (28&90-day) Toxicity o Reproduction/ Developmental Toxicity Screening Mutagenicity Studies o AMES Test o Micronucleus Assay (In-vitro/ Invivo) o Chromosomal Aberration Assay (Invitro) Environmental Toxicity Studies on Aquatic and Terrestrial Organisms Studies on Behavior in Water, Soil and Air; Bioaccumulation Residue Studies Analytical and Clinical Chemistry Testing Toxicity Studies o Acute Toxicity o Acute Eye Irritation/ Corrosion o Acute Dermal Irritation/ Corrosion o Repeat Dose 28-day Toxicity o Skin Sensitization Mutagenicity Studies o AMES Test (Bacterial Reverse Mutation Assay) o Micronucleus Assay (In-vivo) o Chromosome Aberration Test (Invitro) o Comet Assay o Cytotoxicity Toxicity Studies o Acute Toxicity Studies GLP/C04-04-2016 to 084/2016 03-04-2019 GLP/C04-04-2016 to 085/2016 03-04-2019 05-04-2016 to GLP/C04-04-2019 Page 16 of 17 Institute for Industrial Research Director & Test Facility Management of Shriram Scientific and Industrial Research Foundation), 19, University Road, Delhi – 110 017, India Phone: +91-11-27667267, 27667860 Sub-acute Toxicity Studies Sub-chronic/ Repeated Dose (90 days) Toxicity Studies o Inhalation Toxicity Studies Analytical and Clinical Chemistry Testing o o 086/2016 Email: sridlhi at vsnl dot com Page 17 of 17