New List of GLP Approved Labs

8/15/2019 New List of GLP Approved Labs

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List of GLP certified Test Facilities in National GLP Programme

S.No. Test Facility Contact Person Test Facility Details Areas of ExpertiseValidity

period

Certificate

No.

1.

InternationalInstitute ofBiotechnologyand Toxicology(IIBAT)

Dr. A. Ramesh,Test FacilityManagement

Address: Padappai-601301, KancheepuramDistrict, Tamil Nadu, IndiaTel: 91-44-27174246, 27174266Fax: 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, soiland air; bioaccumulation

Residue studies

Studies on effects on mesocosoms

and natural ecosystems

Analytical and clinical chemistry

testing

Studies on natural enemies and

predators

* *

* The Test Facility-International Institute of Biotechnology and Toxicology (IIBAT) was re-certified from July 19, 2010 - July 18, 2013 vide certificate No. GLP/C-025. 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.

GLP Laboratory,GhardaChemicalsLimited

Mr. H.G. NemadeHead TestFacilityManagement

Address: B-27/29, MIDC-Phase I,Dombivli (East)–421 203 Dist. Thane,Maharashtra State, IndiaTel: 91- 251-2430580 ,Fax: 91-251-2430581

Email: hgnemade at gharda dot com

Physical-chemical Testing (Including Five Batch Analysis)

05-08-2013to04-08-2016

GLP/C-053

3.

AurigeneDiscoveryTechnologiesLimited,Hyderabad

Mr. CSNMurthy, CEO &Test FacilityManagement

Address: Bollaram Road, Miyapur,Hyderabad-500 049, Andhra PradeshTel: 91-40-44657777Fax: 91-40-44657438Email: murthy_csn at aurigene dot com

Toxicity Studieso

Acute, Sub-acute and Sub-chronicstudies

Mutagenicity Studieso

Bacterial Reverse Mutation Assay(AMES Test)

o

Micronucleus Test (In-vivo)

Analytical and Clinical Chemistry

Testing

Others

05-08-2013to04-08-2016

GLP/C-051


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o Safety Pharmacology(Neurobehavioral safety studiesin rodents)

o

Toxicokinetic studies

4.Jai ResearchFoundation

Dr. Abhay D.Deshpande, TestFacilityManagement

Address: Jai Research Foundation, Near

Daman Ganga Bridge, N.H. No. 8,Valvada - 396 108, Dist. Valsad (Gujrat)

Tel: 91-260 – 654 0242/3242/3243,

3291873

Fax: 91-22 - 66466119Email: jrf at jrfonline


Toxicity studieso

Acute, Sub acute, Sub chronic and

Chronic Studieso

Inhalation toxicity studieso

Reproductive studies,Teratogenicity studies

o

Skin Sensitization Studieso Neurotoxicity Studies,

Immunotoxicity Studieso

Carcinogenicity Studieso Endocrine disrupter assayso In vitro skin corrosion test:

reconstructed human epidermistest method

o

In vitro skin irritation testo

Bovine corneal opacity and permeability test for validation oftest

Mutagenicity studieso Bacterial Reverse Mutation Assay

(AMES Test)o

Micronucleus Tests ( In-vivo/ In-vitro)

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

o

Cell gene Mutation

o

Endocrine disrupter assays Environmental Toxicity Studies on

Aquatic and Terrestrial Organismso

Fish: embryo toxicity testo

Fish: short-term toxicity teston embryo and sac-frystages

Studies on Behaviour in Water, Soiland Air : Bioaccumulation

Residue Studies


18-06-2015to04-08-2016

GLP/C-

049A/2015


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testing

Otherso Impurity profile and five batchanalysiso

Bio analytical and Toxicokineticso

Drug metabolism &Pharmacokinetics and tissuedistribution

o

Safety pharmacology

5.Orchid ResearchLaboratoriesLimited

Dr. B. Gopalan,Chief ScientificOfficer

Address: Orchid Chemicals andPharmaceuticals Limited,# 476, Old Mahabalipuram Road,Sholinganallur,Chennai-600 019,India Tel: 91-44- 24502246, 24501474

Fax: 91-44 - 24501396Email: research at orchidpharma dot com

Physical-chemical Testing

Toxicity Studieso

Acute toxicity studieso

Sub-acute toxicity studieso

Sub-chronic toxicity studieso

Reproductive toxicitystudies

Mutagenicity Studieso AMES Testo

Chromosomal aberration test

(in-vitro/in-vivo)o

Micronucleus assay (in-vitro/in-vivo)


Testing

25-05-2014 to24-05-2017

GLP/C-

060/2014

6.

AdvinusTherapeuticsLimited

Dr. S. Natesan,Vice Presidentand Head,CorporateQualityAssurance

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


Toxicity studies

Acute Toxicity

Skin Sensitization studies

Sub-acute/Sub-chronic

Toxicity studies

Chronic Toxicity studies

Reproductive Toxicity

studies

Carcinogenicity studies

Inhalation Toxicity studies


Chromosomal Aberration

Test ( In-vitro & In-vivo)

07-11-2014 to06-11-2017

GLP/C-065/2014


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Micronucleus Assay ( In-

vitro & In-vivo)

AMES Test

Gene Mutation Test ( In-

vitro)


aquatic & terrestrial organisms

o

Ecotoxicology studies Studies on behaviour in water, soil,

and air; bioaccumulation

Biodegradability studies

Environmental Fate studies

Residue studies


testing

Otherso

Bioanalytical andtoxicokinetics

o

Drug metabolism & pharmacokinetics and tissuedistribution

o

Safety Pharmacology

7.

Zydus ResearchCentre, CadilaHealthcareLimited

Dr. Mukul R.Jain,Sr. GeneralManager(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 (Acute, Sub-acute,Sub-chronic and Chronic toxicityStudies, Reproductive studies,Carcinogenicity studies



Testing

Others (Drug Metabolism &

Pharmacokinetic Studies, SafetyPharmacology Studies)

12-05-2012 to11-05-2015

GLP/C-040

8.Intox PrivateLimited, Pune

Dr. P.Y. Naik,Director & CEO

Address: 375, Urawade, PirangutUrawade Road, Tal. Mulshi, Distt. Pune(Maharashtra)-412 108, India

Tel: 91-20-22923633, 22923643


Toxicity studieso

Acute Toxicity Studies (Oral,Dermal, Inhalation, Parenteralroutes), Skin irritation/Sensitization, Eye irritation

o Sub-acute Toxicity Studies (14

15-03-2013 to14-03-2016

GLP/C-048


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Fax: 91-20-22923643

Email: intox at vsnl dot com

days, 28 days – Oral, Dermal,Inhalation, Parenteral routes)

o Chronic Toxicity Studies (90days)o Reproductive Toxicity Studies

Mutagenicity studieso


o

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

o Micronucleus Assay (In-vivo/ In-

vitro)o

In-vitro sister chromatidexchange

o In-vitro mammalian cell gene

mutation test

Environmental Toxicity Studies on

Aquatic and Terrestrial Organisms


testing

9.

LaboratoryAnimal ResearchServices(L.A.R.S.),Reliance LifeSciences PrivateLimited

Dr. S.Harinarayan Rao,AssociateResearchDirector

Address: Laboratory Animal ResearchServices (L.A.R.S.), Reliance LifeSciences Private Limited, DhirubhaiAmbani Life Sciences Centre, R 282,Thane-Belapur Road, Rabale, NaviMumbai-400 701, Maharashtra, India

Tel: 0091-22-3911 8500-05

Fax: 0091-22-39118099

Email: hari.rao at relbio dot com

Toxicity studieso Acute Studies (Oral, dermal, eye

irritation, Skin irritation, skinsensitization)

o Sub- acute Studies (Oral, IV)o

Sub-chronic Studies (Oral, IV)


Bacterial Reverse Mutation Assay(Ames Test)


testing

15-03-2013 to14-03-2016

GLP/C-045

10.

TorrentPharmaceuticalsLimited, TorrentResearch Centre,Gandhinagar

Dr. Deepa Joshi,Test FacilityManagement

Ahmedabad Airport-GandhinagarHighway, Near Indira Bridge, VillageBhat-382 428, Dist. Gandhinagar,Gujarat, India

Tel: 0091- 79-23969100Fax .: 009179- 23969135

Toxicity studieso Acute toxicity studies (Single dose

toxicity studies)o

Sub-acute/ Short term toxicitystudies (14 days and 28 daysrepeated dose toxicity studies,Skin Sensitization Test)

o Sub Chronic toxicity studies (3

20-08-2013 to19-08-2016

GLP/C-052


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Email: and 6 months repeated dosetoxicity studies)


In-vivo Mammalian MicronucleusTest


testing

11.

GLP TestFacility, RanbaxyResearchLaboratories,Gurgaon

Dr. V. M.ShingatgeriTest FacilityManagement

GLP Test Facility, Ranbaxy ResearchLaboratories, Research and DevelopmentCentre, Sarhaul, Sector 18,Udyog Vihar, Industrial Area,Gurgaon (Haryana)-122015

Tel: 0091- 124-2397541Fax .: 0091- 124-4037263Email: VYAS.SHINGATGERI atranbaxy dot com

Physical-chemical testing (Stabilitystudies only)

Toxicity Studieso Acute toxicityo

Repeated Dose toxicityo

Abnormal toxicityo Local Toleranceo

Pyrogen Testingo Specific toxicityo

Immunogenicity


AMES testo

Chromosome Aberration test (In-vitro/ In-vivo)

o

Micronucleus Assay (In-vivo)

Otherso

Safety Pharmacology

03-10-2013 to02-10-2016

GLP/C-054

12.

The NationalToxicology

Centre, National Instituteof PharmaceuticalEducation andResearch

(NIPER), Sector-67,S.A.S Nagar(Mohali),Punjab-160062

Dr. K.K. BhutaniDirector (Offg.)

Address: The National Toxicology Centre , National Institute of PharmaceuticalEducation and Research (NIPER), Sector-

67,S.A.S Nagar (Mohali),Punjab-160062

Tel: 0091-172-2214682-87

Fax .: 0091- 172-2214692Email: dircetor at niper dot ac dot in

Toxicity Studies (Acute, Sub-acuteand chronic toxicity studies)

23-06-2012 to22-06-2015

GLP/C-041

13.

GLP test facility,The HimalayaDrug Company,Makali,Bangalore-562123

Dr. ShyamRamakrishnan,Test FacilityManagement,The HimalayaDrug Company,Makali,

Address: GLP test facility, The HimalayaDrug Company, Makali, Bangalore-562123

Tel: 0091- 80-23714444Fax .: 0091- 80-23714471Email: shyam dot r at himalayawellnessdot com

Physical-Chemical Testing

(Stability Testing)

Toxicity studies-o

Acute toxicity studies, Repeateddose (28 days, 90 days) toxicitystudies

Mutagenicity studies-

23-06-2012 to22-06-2015

GLP/C-043


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Bangalore-562123

o Bacterial reverse mutation tests(AMES test)

Analytical and Clinical chemistry

testing

14.Indian Institute ofToxicology, Pune

Dr. V.M. Bhide,Test FacilityManagement

Address: Indian Institute of Toxicology, 32A/1, Hadapsar Industrial Estate, Pune

(Maharashtra)-411 013, India

Tel: 0091- 20-26819962Fax .: 0091- 20-26819962Email: iit at pn2 dot vsnl dot net dot in

Toxicity Studieso Acute Studies (Oral, Parenteral,

Dermal, Inhalation, Dermal

Irritation/ Corrosion, EyeIrritation/ Corrosion, SkinSensitization Test)

o Sub- acute Studieso

Chronic Studies


Bacterial Reverse Mutation Assay(Ames Test)

o Mammalian ErythrocyteMicronucleus Test

o In vivo/ in vitro Mammalian

Chromosome Aberration Test

16-04-2013 to15-04-2016

GLP/C-046

15.

Syngene

InternationalLtd. , Bangalore

Dr. V. K.Satheesh, TestFacilityManagement

Address: Syngene International Ltd BioconPark, Plot No.2&3, Bommasandra IV Phase,Jigani Link Road, Bangalore-560099

Tel: 0091- 80-28083879Fax .: 0091- 80-40143150Email: Satheesh.Velath at syngeneintldot com

Physical-Chemical Testingo Characterisationo

Five batch analysiso Analytical method

development & validationo Stability and Homogeneity

testingo

Dose confirmation analysis

Toxicity Studieso

Acute toxicityo

Sub-chronic toxicityo

Chronic toxicityo

Local tolerance, Skinirritation, Guinea pigmaximization studies

o Reproductive and

development toxicityo Neurotoxicity studies


Bacterial Reverse MutationAssay (AMES test)

o

Micronucleus test (In vivo)

25-10-2013 to24-10-2016

GLP/C-

055/2013


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o Chromosome aberration (In-vitro)

Otherso

Bio analytical (TK analysis)for pre-clinical studies

16.

RCCLaboratoriesIndia PrivateLimited,Hyderabad.

Dr. R.Ravikrishnan,Test FacilityManagement

Address:Genome Valley, Turkapally,Shameerpet (Mandal), Ranga ReddyDistrict,Hyderabad-500 078Tel: 0091- 40-23480422Fax .: 0091- 40-23480420Email: rajaram.ravikrishnan at rccltd dotin

Physical –Chemical Testing (including five batch analysis)

Toxicity Studies

o

Acute, Sub acuteo

Chronic, Subchronico

Reproductive, Inhalationo Carcinogenicity


AMES testo Chromosome Aberration (In-

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

vitro/ In-vivo)o Mouse Lymphoma Assay


Aquatic and Terrestrial Organisms Analytical and Clinical Chemistry

Testing

Residue Studies (Lab Analysis only)

12-01-2014 to11-01-2017

GLP/C-

056/2014

17.Sa-Ford, Taloja,District, Raigad,Maharashtra

Dr. PrabhuDaivasigamani,Test FacilityManagement

Address:Sa Ford, Plot No. V-10,MIDC Industrial Area,

Taloja, Distt. Raigad,Maharashtra- 410 208, IndiaTel: 0091- 22-64564403Fax: 0091- 22-27411722Email: pd at sa-ford dot com

Toxicity Studieso

Acute Toxicity Studieso Sub- acute Toxicity Studieso

Chronic Toxicity Studieso

Reproductive Toxicity Studieso Carcinogenicity Studieso

Inhalation toxicity and Skinsensitization studies

Mutagenicity Studieso AMES Test

o Micronucleus Assay (in-vivo)o Chromosome Aberration Test

(in-vitro/in-vivo) Analytical and Clinical Chemistry

Testing

04-04-2014 to03-04-2017

GLP/C-

059/2014


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18.R & D Center,P I IndustriesLimited, Udaipur.

Dr. Anuj KumarMittal, VicePresident R&Dand Test FacilityManagement

Address:Industries R & D Centre,

Udaisagar Road, Udaipur- 313001,Rajasthan.Tel: 91-9124301642Fax: 91-294-2491946Email:- a.mittal at piind dot com

Physical –Chemical Testing

(Including 5 batch Analysis)

05-09-2014 to04-09-2017

GLP/C-

063/2014

19.

Bioneeds IndiaPrivate Limited,Bangalore RuralDistrict,Karnataka.

Dr. S.N. VinayaBabu,

Test FacilityManagement

Address: Bioneeds India Private Limited,Devarahosahally, Sompura Hobli, NH-4,

Nelamangala Tq. Bangalore RuralDistrict-56211, 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 5 batch analysis) Toxicity Studies

o

Acute and Sub-acute Studies (28and 90 days)

o

Chronic toxicityo Acute inhalation toxicityo

Reproductive & developmentaltoxicity (Male fertility study andTeratology study)



o

Micronucleus Test ( In-vivo/InVitro)

o

Chromosomal Aberration test ( In-vivo/In Vitro)

o

NRU Phototoxicity test


Aquatic and Terrestrial Organismso

Acute toxicityo Acute immobilization testo Alga growth inhibition testo

Honey Bees toxicity test


Testing

23-09-2014 to

22-09-2017

GLP/C-

064/2014


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20.

Upasi TeaResearchFoundation,Valparai,Distt.Coimbatore, TN

Dr. B.Radhakrishnan,Director

Address: UPASI Tea Research

Foundation, Tea Research Institute, Nirar

Dam BPO, Valparai-642127, Coimbatore

District, (Tamil Nadu)

Tel:+91-4253-235301, 235303Fax:+91-04253-235302

Email: director at upasitearesearch dotorg

Residue Studies09-02-2015 to08-02-2018

GLP/C-

069/2015

21.

GLP TestingFacility,SyngentaBiosciences Pvt.Ltd., Goa.

Dr.RajendraHosmani,Test FacilityManagement

Address: GLP Testing Facility, SyngentaBiosciences Pvt. Ltd., Santa MonicaWorks, Corlim Ilhas - 403 110, (Goa)

Tel.+91 832 2490500, 832 2490506

Fax +91 832 2490561

Email: rajendra.hosmani at syngenta dotcom

Physical –Chemical Testing

Otherso Analytical Chemistry Testing

30-04-2015to29-04-2018

GLP/C-071/2015

22.

Sun PharmaAdvancedResearchCompany Ltd.,Vadodara

Dr. AtulVekariya,AssistantManager, QualityAssurance Unit

Address: Sun Pharma AdvancedResearch Company Ltd., SPARC Ltd.,Village Tandalja, Vadodara-390020,(Gujarat) and SPARC Ltd., 907/4 GIDC,Makarpura, Vadodara-390010 (Gujarat)

Tel.+91-265-26615500 , 6615600Fax: +91-0265 – 2354897Email: atul dot vekariya at sunpharma dotcom

Toxicity studieso

Acute, sub acute and chronic (14, 30and 90, 180 days)

o Reproductive studieso

Carcinogenicityo Phototoxicityo

Inhalation toxicityo Immunogenicity (MEST and GPMT)o

Local Tolerance (Ocular and Dermal)o Intracutaneous testing


o

Bacterial Reverse Mutation assay(AMES test)

o

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


testing

Otherso

Safety Pharmacology Studieso

Pharmacokinetic Studieso

Tissue Distribution Studies

30-04-2015to29-04-2018

GLP/C-070/2015


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23.VantaBioscience,

Tamil Nadu.

Dr. V. AmalanStanley,Test Facility

Management

Address: Vanta Bioscience (A divisionof Kemin Industris South Asia PrivateLimited), K2, 11th Cross street, SIPCOTIndustries Estate, Gummidipundi, Tamil

Nadu- 601201.

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

Email: amalan.stanley at vantabio dotcom,

tfm at vantabio dot com

Toxicity studieso

Acute studieso Sub-acute studieso

Sub-chronic and Chronicstudies

o Reproduction Toxicity studies

(segment 1)


o

Bacterial Reverse Mutationassay (Ames Test)

o In vivo micronucleus testo

In vitro chromosome aberrationtest


testing

18-07-2012 to17-07-2015

GLP/C-042

24.Vimta LabsLimited,Hyderabad.

Dr. Nitin Shetty,Vice President &Facility Head,Pre-ClinicalDivision

Address: Vimta Labs Limited, LifeSciences Facility, Plot No. 5, AlexandriaKnowledge Park, Genome Valley,Turkapally, Shameerpet, Hyderabad-500

078.

Phone :- +9140-67404040

Fax:- +9140-39847708

Email: nitin.shetty at vimta dot com

Toxicity studieso

Acute studieso

Sub-acute studieso

Sub-chronic and Chronictoxicity studies

Mutagenicity studieso

AMES Testo In vivo and in-vitro Mouse

micronucleus testo

In vivo and in-vitrochromosome aberration test

o Mouse lymphoma assay


Testing

Otherso

Pharmacokinetic Studies

06-09-2012 to05-09-2015

GLP/C-044

25.Indofil IndustriesLimited

Dr. J GChandorkar

Address: Indofil Industries Limited,Research & Development Centre, OffSwami Vivekanand Road, Azad Nagar,Sandoz Baug P.O. Thane (Maharashtra),India – 400607Phone: 022- 67999100Email: jchandorkar-icc at modi dot com

Physical-Chemical Testing10-04-2013 to09-04-2016

GLP/C-047


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26.Venus MedicineResearch Centre,Baddi

Dr. ManuChoudhary, TestFacilityManagement

Address: Venus Medicine ResearchCentre, Venus Remedies Limited, HillTop Industrial Estate, Jharmajri EPIP,Phase I (Extension), Bhatoli Kalan, Baddi(Himachal Pradesh), India – 173205Phone: +91-1795-302003, 302004E-mail: research at venusremedies dotcom

Physical-Chemical Testing (Stability

Testing Only)

Analytical Chemistry Testing

23-07-2013 to22-07-2016

GLP/C-050

27.

VishaktataParikshan: GLPAnuroopSuvidha, ToxicityTesting: GLPTest Facility,CSIR- IndianInstitute ofToxicologyResearch (IITR),

Lucknow

Dr. K.C. Gupta,Test FacilityManagement

Address: Vishaktata Parikshan: GLPAnuroop Suvidha, Toxicity Testing: GLPTest Facility, CSIR- Indian Institute ofToxicology Research (IITR), Post Box

No. 80, Mahatma Gandhi Marg,Lucknow – 226001 (Uttar Pradesh), India

Phone: +91-522-2621856, 2628227Fax: +91-522-2628227, 2611547E-mail: tfm.glp at iitr dot res dot in,

director at iitrindia dot org

Toxicity Studies o


Sub-acute toxicity studies

Mutagenicity Studies o

Chromosomal Aberration test( In-vivo)

o Micronucleus Assay ( In-vivo)

05-06-2014 to04-06-2017

GLP/C-058/2014

28.Vivo Bio TechLtd., Pregnapur,Medak District

Dr. Praveen SHushangabade,Test FacilityManagement

Address: Sy # No.: 349/A, 350A, 351,356/3A, Pregnapur Village – 502311,Gejwal Mandal, Medak District,Telangana

Phone: +91-845-4210411Fax: +91-40-27803612E-mail: pravin at vivobio dot com

Toxicity Studies o


Sub-acute toxicity studieso

Reproductive toxicity studies

Mutagenicity Studies o AMES Testo

Micronucleus Assay ( In-vivo)


testing

13-06-2014 to12-06-2017

GLP/C-061/2014

29.

Centre forToxicology andDevelopmentalResearch(CEFT), Chennai

Dr. S.Thanikachalam,Test FacilityManagement

Address: Centre for Toxicology andDevelopmental Research (CEFT), No. 1,Ramachandra Nagar, Sri RamachandraUniversity, Porur, Chennai – 600116

Mobile: 09840048269Email: ceft at sriramachandra dot edu dotin

Toxicity Studies o


Dermal irritation /Corrosiono Eye irritationo Skin sensitizationo

Repeated oral toxicity studies

Mutagenicity Studies o Bacterial Reverse Mutation

Assay (AMES Test)o

Micronucleus Assay ( In-vivo) o

Chromosomal Aberration test( In-vitro)

17-09-2014 to16-09-2017

GLP/C-062/2014


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testing

30.

Laila NutraceuticalsResearch &Development

Centre,Vijayawada

Mr. KiranBhupathiraju,

CEO

Address: Laila Nutraceuticals Research& Development Centre, Survey

No:181/2, JRD Tata Industrial Estate,Kanuru – 520007, Vijayawada (AndhraPradesh)

Phone:+91-866-6636666Email: mail at lailanutra dot in

research at lailanutra dot in

Toxicity Studieso

Acute Toxicity studieso Sub-acute Toxicity studies

Analytical and clinical chemistrytesting

Others

o

Drug Metabolism &Pharmacokinetics (DMPK)studies

o Toxicokinetic Bioanalysis

23-11-2014 to22-11-2017

GLP/C-066/2014

31.

Drug SafetyAssessment,

Noval Drug

Discovery andDevelopment,Lupin Limited(Research Park),Pune

Dr. Sharad K.

Sharma, DeputyTFM

Address: Drug Safety Assessment, Noval Drug Discovery and Development,Lupin Limited (Research Park),46A/47A, Nande Village, Mulshi Taluka,

Pune-412115 (Maharashtra) Phone:+91-20-66749100Fax: +91-20-66749563Email: sharadsharma at lupinpharma dot

com

Physical-chemical Testing

Toxicity Studies o

Acute Toxicity studieso Sub-acute Toxicity Studieso

Chronic Toxicityo

Reproductive Toxicity


AMES Testo

Micronucleus Assay ( In-vitro & In-vivo)

o

Chromosomal Aberration test( In-vitro & In-vivo)


testing

Others

o CNS Safety Studies

23-11-2014 to22-11-2017

GLP/C-

067/2014

32.

LambdaTherapeuticResearchLimited,Ahmedabad

Mr. Manoj K.Patel, Head-QualityAssurance Unit

Address: Lambda Therapeutic ResearchLimited, Plot No. 38, Nr. Silver OakClub, S.G. Highway, Gota, Ahmedabad –380061 (Gujarat)

Phone:+91-079-40402374

Email: manojkpatel at lambda-cro dotcom


testing

Others

o

Bio-analysis

o Pharmacokinetic analysis

25-11-2014 to24-11-2017

GLP/C-068/2014

33.

PalamurBiosciencesPrivate Limited,Mahabubnagar

Dr. S.Ramamoorthy,Test FacilityManagement

Address: Technology Research Park,SVS Medical College Campus,Yenugonda, Mahabubnagar – 509002(Telangana)

Toxicity Studies o

Acute oral, dermal toxicity studyin rats

o

Acute Dermal irritation

20-05-2015 to19-05-2018

GLP/C-072/2015


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Phone:+91-8542-231166

Email: ram dot murthy at Palamurbio dotcom

/Corrosion study in NewZealand Rabbits

o Acute Eye irritation/ corrosionstudy in New Zealand Rabbits

o Acute Inhalation toxicity study inrats

o

Acute Skin sensitization study inGuinea Pigs

o

28 days Repeated oral dosetoxicity studies in rats


Mammalian ErythrocyteMicronucleus test in mice

o

Mammalian ChromosomalAberration test ( In-vitro) usingCHOK1 cell line

o Bacterial Reverse MutationAssay in Salmonellatyphimurium

o Mammalian Cell gene mutation

test (In vivo) Analytical and clinical chemistry

testing

Others

o Pharmacokinetic study in dogs

34.

GLP CompliantLaboratory,

Jubilant BiosysLimited,Bangalore

Dr. Mullangi

Ramesh, TestFacilityManagement

Address: 96, Industrial Suburb, 2nd Stage, Yeshwanthpur, Bangalore –560022(Karnataka)

Phone:+91-80-66628339

Email: mullangi underscore ramesh at jubilantinnovation dot com

Toxicity Studieso Acute toxicity studies and Sub-acute

toxicity studies

Mutagenicity Studieso AMES testo

Chromosomal aberration test ( In

Vitro)o

Micronucleus Assay ( In Vivo)


testingo

Analytical Method Validation o

Bioanalytical Method Validation o

Clinical Chemistry Analysis

21-05-2015 to20-05-2018

GLP/C-

073/2015

35. Natural RemediesPrivate Limited,Bangalore

Dr. C.V.Chandrasekaran,Test Facility

Address: Plot No. 5B, VeerasandraIndustrial Area, 19 KM Stone, HosurRoad, Electronic City Post, Bangalore –

Toxicity Studieso In vitro reproductive toxicity studyo

Sterioidogenesis assay: Testosterone

08-06-2015 to07-06-2018

GLP/C-074/2015


15/15

Page 15 of 15

Management 560100 (Karnataka)

Phone:+91-080-40209717

Email: cvc at naturalremedy dot com

and Oestrogen

Mutagenicity Studieso Micronucleus Test ( In Vitro)o

Mammalian Cell Gene Mutation Test( In vitro)

o Chromosomal aberration test ( In

Vitro)o Bacterial Reverse Mutation Test

36.Krish BiotechResearch PrivateLimited, Kalyani

Dr. RaghibHusain,Test FacilityManagement

Address: T-1, QK-17 (Part) WBIIDC,Kalyani, Phase III, Nadia – 741235(West Bengal)

Phone:+91-33-25824472Fax: +91-33-71081012

Email: raghib dot h at krishbiotech dotcom

Physical chemical testing

Toxicity Studieso Acute toxicity study


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


aquatic & terrestrial organisms using

fish, honeybees, alga, daphnia and

earthworm.

Analytical and clinical chemistry testing

08-06-2015 to07-06-2018

GLP/C-075/2015

New List of GLP Approved Labs

Documents

Transcript of New List of GLP Approved Labs