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Last updated on August 21, 2018 Page 1 of 22 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 Repeated Dose Toxicity Studies o Chronic Toxicity Studies o Reproductive Toxicity Studies o Carcinogenicity studies o Inhalation Toxicity studies o Neurotoxicity 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) o Mouse Lymphoma Assay Environmental toxicity studies on aquatic and terrestrial organisms o Acute toxicity Studies o Acute immobilization test o Alga growth inhibition test o Lemna growth inhibition test 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 01-06-2018 to 18-07-2019 GLP/C- 097A/2018

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Page 1: List of GLP Certified Test Facilitiesdst.gov.in/sites/default/files/Certified Test Facilities 21082018.pdf · Certificate No. 1. International Institute of Biotechnology and Toxicology

Last updated on August 21, 2018 Page 1 of 22

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 Repeated Dose Toxicity Studies

o Chronic Toxicity Studies

o Reproductive Toxicity Studies

o Carcinogenicity studies

o Inhalation Toxicity studies

o Neurotoxicity 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)

o Mouse Lymphoma Assay

Environmental toxicity studies on

aquatic and terrestrial organisms

o Acute toxicity Studies

o Acute immobilization test

o Alga growth inhibition test

o Lemna growth inhibition test

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

01-06-2018

to

18-07-2019

GLP/C-

097A/2018

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Last updated on August 21, 2018 Page 2 of 22

Testing

Others

o Bioefficacy studies on Household

insect pests in the laboratory as per

WHOPES and other Standard

protocols

o ADME Studies

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 toxicity studies

Mutagenicity Studies

o Bacterial Reverse Mutation Test

(AMES Test)

o Micronucleus Assay (In Vitro and

In-vivo)

o Chromosomal Aberration Assay

(In-vitro)

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

05-06-2018

to

04-08-2019

GLP/C-

091A/2018

4. Jai Research Dr. L.U. Address: Jai Research Foundation, Near Physical-chemical Testing 05-08-2016 GLP/C-

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Last updated on August 21, 2018 Page 3 of 22

Foundation Sanghani,

Director-Quality

Assurance

Daman Ganga Bridge, N.H. No. 8,

Valvada - 396 105, Dist. Valsad (Gujarat)

Tel: +91-260 – 654 0242/3242/3243,

3291873

Fax: +91-22 – 66466119, 260-2707354

Email: jrf at jrfonline dot com

Toxicity Studies

o Acute Toxicity

o Sub-acute Toxicity

o Chronic Toxicity

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

to

04-08-2019 089/2016

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Last updated on August 21, 2018 Page 4 of 22

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

Acute Toxicity

Skin irritation/ corrosion

Eye irritation

Skin Sensitization

Dermal Toxicity

Inhalation Toxicity

Sub-acute/ Sub-chronic

Toxicity

Chronic Toxicity

Reproductive Toxicity

Carcinogenicity studies

Mutagenicity studies

Chromosomal Aberration

Test (In-vitro / In-vivo)

Micronucleus Assay (In-

vitro / In-vivo)

Bacterial Reverse Mutation

Assay (AMES Test)

Gene Mutation Test (In-

vitro)

Environmental toxicity studies on

aquatic & terrestrial organisms

Studies on behaviour in water, soil,

and air; bioaccumulation

07-11-2017 to

06-11-2020

GLP/C-

111/2017

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Last updated on August 21, 2018 Page 5 of 22

Biodegradability studies

Environmental Fate studies

Residue Studies

Analytical and Clinical Chemistry

Testing

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

Physical-chemical Testing

Toxicity studies o Acute Toxicity Studies

o Sub-acute Toxicity Studies

o Sub-chronic Toxicity Studies

o Chronic Toxicity Studies

o Developmental and

Reproductive Toxicity

o Carcinogenicity studies

o Local Tolerance studies

Mutagenicity studies

o AMES Test (In vitro)

o Chromosome Aberration

Test (In vitro)

o Micronucleus Test (In vivo)

Analytical and Clinical Chemistry

Testing

Others o Drug Metabolism &

Pharmacokinetic (DMPK)

o Safety Pharmacology

12-05-2018 to

11-05-2021

GLP/C-

117/2018

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)

Physical-chemical Studies

(Including 5 Batch Analysis)

Toxicity studies

o Acute Studies

o Acute Eye Irritation Studies

o Acute Skin Irritation Studies

15-03-2016 to

14-03-2019

GLP/C-

082/2016

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Last updated on August 21, 2018 Page 6 of 22

Fax: 91-20-6654 8799

Email: info at intoxlab dot com

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-

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

15-03-2016 to

14-03-2019

GLP/C-

081/2016

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Last updated on August 21, 2018 Page 7 of 22

testing

o Haematology and clinical

chemistry analysis for toxicity

studies

o Bio-analytical Studies (TK &

Antibody Estimations)

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

Mutagenicity Studies

o AMES Test

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

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

Toxicity Studies o Acute Toxicity

o Sub-acute Toxicity

o Chronic Toxicity

23-06-2018 to

22-06-2021

GLP/C-

120/2018

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Last updated on August 21, 2018 Page 8 of 22

Research

(NIPER)

Fax .: +91- 172-2214692

Email: ntc at niper dot ac dot in, tikoo at

niper dot ac dot in

12. R&D Center,

The Himalaya

Drug Company

Ms. Jayashree

Ullal, Test

Facility

Management

Address: R&D Center, The Himalaya

Drug Company, Makali, Bangalore-

562162 (Karnataka)

Tel: 0091- 80-23714444

Fax: 0091- 80-23714471

Mobile: 09980800031

Email: jayashree dot ullal at

himalayawellness dot com

Physical Chemical Testing

Toxicity Studies o Acute Toxicity

o Repeated dose 28 and 90 days

Toxicity

o Acute Dermal

o Repeated Dose Dermal

Mutagenicity Studies o AMES Test

Analytical and Clinical Chemistry

Testing

23-06-2018 to

22-06-2021

GLP/C-

118/2018

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

25-10-2016 to

24-10-2019

GLP/C-

094/2016

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Last updated on August 21, 2018 Page 9 of 22

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)

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

Mutagenicity Studies

o Bacterial Reverse Mutation Test

(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

12-01-2017 to

11-01-2020

GLP/C-

096/2016

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Last updated on August 21, 2018 Page 10 of 22

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)

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

Analytical and Clinical Chemistry

Testing

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

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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

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

23-09-2017 to

22-09-2020

GLP/C-

109/2017

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Last updated on August 21, 2018 Page 12 of 22

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

30-04-2018

to

29-04-2021

GLP/C-

115/2018

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 Toxicity

o Sub-acute Toxicity

o Sub-chronic Toxicity

o Chronic Toxicity

o Reproductive Toxicity

o Carcinogenicity Studies

o Phototoxicity Studies

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 Test (In vivo)

Analytical and clinical chemistry

testing

Others

o Safety Pharmacology

30-04-2018

to

29-04-2021

GLP/C-

116/2018

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Last updated on August 21, 2018 Page 13 of 22

o Pharmacokinetic Studies

o Tissue Distribution

21. Vanta

Bioscience

Limited

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

Email: tfm at vantabio dot com

Toxicity Studies o Acute Toxicity

o Sub-acute Toxicity

o Chronic Toxicity

o Reproductive Toxicity

o Inhalation Toxicity

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-WP2

(pKM 101)]

o Chromosomal Aberration Test (In-vitro/

In-vivo)

o Micronucleus Test (In-vitro/ In-vivo

using Human Lymphocytes)

o In-vitro cytotoxicity studies

Environmental Toxicity Studies on

Aquatic and Terrestrial Organisms o Earthworm Acute Toxicity Test

o Honey bees Acute Oral Toxicity Test

o Honey bees Acute Contact Toxicity

Test

Analytical and Clinical Chemistry

Testing

18-07-2018 to

17-07-2021

GLP/C-

125/2018

22. Vimta Labs

Limited

Dr. Upendra

Bhatnagar, Vice

President, Pre-

Clinical Division

Address: Vimta Labs Limited, Pre-

clinical Division, Life Sciences Facility,

Plot No. 5, MN Park, Genome Valley,

Turkapally, Shameerpet, Hyderabad-

500101 (Telangana)

Phone :- +9140-67404040

Fax:- +9140-39847708

Email: Upendra dot Bhatnagar at vimta

dot com

Physical Chemical Testing (including

Five Batch Analysis)

Toxicity Studies o Acute Toxicity

o Sub-acute Toxicity

o Chronic Toxicity

o Reproductive Toxicity

o Carcinogenicity Toxicity

Mutagenicity Studies o Bacterial Reverse Mutation Test

(AMES Test)

o Chromosomal Aberration Test (In-

vitro/ In-vivo)

06-09-2018 to

05-09-2021

GLP/C-

123/2018

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

o Mouse lymphoma Assay

Residue Studies

Analytical and Clinical Chemistry

Testing

Others o Safety Pharmacology

o Bioanalytical

o ADME (Absorption, metabolism and

distribution and elimination) Studies

o Biocompatibility studies

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

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

05-06-2017 to

04-06-2020

GLP/C-

102/2017

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Aquatic and Terrestrial organisms

Earthworm Reproduction Test

Fish Acute Toxicity Test

Analytical and Clinical Chemistry

Testing

Analysis of Biological Specimens

for Clinical Biochemistry,

Haematology, etc. for Toxicity

Studies

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

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

Toxicity Studies o Acute Toxicity

o Sub-acute Toxicity

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

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)

Residue Studies (Lab analysis only)

Analytical and Clinical Chemistry

Testing

13-06-2017 to

12-06-2020

GLP/C-

103/2017

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Last updated on August 21, 2018 Page 16 of 22

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

Mutagenicity Studies o Bacterial Reverse Mutation Test

(AMES Test)

o In-vivo Micronucleus Test

o In-vitro Chromosomal Aberration test

Analytical and Clinical Chemistry

Testing

Others

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

Email: mail at lailanutra dot in

research at lailanutra dot in

drgt at lailanutra dot in

Toxicity Studies

o Acute Toxicity

o Sub-acute Toxicity

o Sub-chronic Toxicity : 90-day

Oral

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

23-11-2017 to

22-11-2020

GLP/C-

112/2017

29.

Drug Safety

Assessment,

Novel Drug

Discovery and

Development

(NDDD), Lupin

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

Physical-chemical Testing

Toxicity Studies o Acute Toxicity

o Sub-acute Toxicity

o Chronic Toxicity

o Reproductive Toxicity

23-11-2017 to

22-11-2020

GLP/C-

110/2014

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Last updated on August 21, 2018 Page 17 of 22

Limited

(Research Park)

Fax: +91-20-66749563

Email: sharadsharma at lupinpharma dot

com

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

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

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

Private Limited

Dr. S.

Ramamoorthy,

Test Facility

Management

Address: Maddigatla Village, Boothpur

Mandal, Mahabubnagar – 509382

(Telangana)

Phone:+91-8542-231166

Email: ram dot murthy at Palamurbio dot

com

Physical Chemical Testing

Toxicity Studies o Acute Toxicity

o Sub-acute Toxicity

o Sub-chronic Toxicity

o Reproductive Toxicity

o Inhalation Toxicity

Mutagenicity Studies o Bacterial Reverse Mutation Test

o Chromosomal Aberration (In-vitro/

In-vivo)

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

o Cell Gene Mutation Assay

Environmental Toxicity Studies on

Aquatic and Terrestrial Organisms

Studies on behaviour in water, soil

and air; bioaccumulation

Residue Studies

Analytical and Clinical Chemistry

Testing

Others o Pharmacokinetic Study in Dogs and

20-05-2018 to

19-05-2021

GLP/C-

124/2018

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Maximum Tolerated Dose (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

Toxicity Studies

o Acute Toxicity

o Sub-acute Toxicity (upto 28 day)

Mutagenicity Studies

o AMES test

o Chromosomal Aberration Test (In-

vitro)

o Micronucleus Assay (In-vitro and

In-vivo)

Analytical and Clinical Chemistry

Testing

21-05-2018 to

20-05-2021

GLP/C-

119/2018

33. Natural

Remedies

Private Limited

Dr. C.V.

Chandrasekaran,

Test Facility

Management

Address: Plot No. 5B, Veerasandra

Industrial Area, Hosur Road, Electronic

City Post, Bangalore – 560100

(Karnataka)

Phone:+91-080-40209717

Email: cvc at naturalremedy dot com

Toxicity Studies o In vitro Sterioidogenesis assay

o In vitro Skin Irritation

o In vitro Skin Corrosion

o In vitro Eye Irritation

Mutagenicity Studies o Bacterial Reverse Mutation Test

o Chromosomal Aberration Test (In-

vitro)

o Micronucleus Test (In-vitro)

o Mammalian Cell Gene Mutation

Test (In-vitro)

08-06-2018 to

07-06-2021

GLP/C-

122/2018

34. Krish Biotech

Research

Private Limited

Dr. Raghib

Husain,

Test Facility

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

Physical chemical testing Including Five

Batch Analysis

Toxicity Studies

o Acute Toxicity

o Sub-acute Toxicity

o Sub-chronic Toxicity

o Neurotoxicity

o Inhalation Toxicity

o Developmental and Reproductive

Toxicity

Mutagenicity Studies o Bacterial Reverse Mutation Assay

(AMES Test)

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

o Chromosomal Aberration (In-vitro/

In-vivo)

Environmental toxicity studies on

08-06-2018 to

07-06-2021

GLP/C-

121/2018

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aquatic & terrestrial organisms using

Alga, Daphnia, Fish, Honeybees,

Silkworms, Earthworms and Birds

Residue Studies

Analytical and clinical chemistry testing

Bioanalytical Testing

Others

CNS Safety Studies

35. Bioscience

Research

Foundation

Dr. C.

Tamilselvan,

Test Facility

Management

Address: Bioscience Research

Foundation, Sengadu Village and Post,

Kandamangalam – 602 002,

Sriperumpudur Taluk, Kanchipuram

District (Tamilnadu), India

Phone: +91-44-27601082, 27601862

Email: brfchennai at gmail dot com

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/ In-

vivo)

o Chromosomal Aberration Assay (In-

vitro)

Environmental Toxicity Studies on

Aquatic and Terrestrial Organisms

Studies on Behavior in Water, Soil and

Air; Bioaccumulation

Residue Studies

Analytical and Clinical Chemistry

Testing

04-04-2016 to

03-04-2019

GLP/C-

084/2016

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

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

Mutagenicity Studies

o AMES Test (Bacterial Reverse

Mutation Assay)

21-02-2018 to

03-04-2019

GLP/C-

085A/2018

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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

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

Phone: +91-11-27667267, 27667860

Email: sridlhi at vsnl dot com

Physical Chemical Testing

Toxicity Studies

o Acute Toxicity

o Sub-acute Toxicity

o Sub-chronic/ Repeated Dose (90

days) Toxicity

o Inhalation Toxicity

Mutagenicity Studies

AMES Test

Analytical and Clinical Chemistry

Testing

26-12-2017 to

04-04-2019

GLP/C-

086A/2017

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

Toxicity Studies

o Acute Toxicity (Oral, Dermal)

o Sub-acute Toxicity (Oral)

o Skin irritation

o Eye irritation

o Dermal Toxicity

o Skin Sensitization

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

Physical-chemical Testing

Toxicity Studies

o Acute toxicity

o Sub-acute toxicity

o Skin sensitization

o In vitro Hematotoxicity assay (CFU-GM)

17-04-2017

to

16-04-2020

GLP/C-

099/2017

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Email: manu dot jaggi at daburresearch

dot in

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)

Analytical and Clinical Chemistry

Testing

Others

o Bio-analytical & DMPK

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)

Analytical and Clinical Chemistry

Testing

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

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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