USFDA Approved Plant List

List of companies having USFDA, MHRA, Health Canada, TGA & other Certifications Pune Sr. No 1

Name of the Company

Name of the Certification

M/s. Emcure Pharmaceuticals Ltd., Emcure House, T-184, MIDC, Bhosari, Pune

US FDA/UK MHRA/WHO/ Medicines control Council(MCC), South Africa

2

M/s. Cipla Ltd., Kurkumbh, Pune M/s. Okasa Pharma Pvt. Ltd., L-2, Additional MIDC, Satara

US FDA/ MHRA/ Therapeutic Control Council (South Africa)/ WHO/ ANVISA (Brazil) WHO/

3

4

M/s. Mediorals Laboratories Pvt. Ltd., J4/2, Additional MIDC, Satara

SIDC- State Institute for Drug Control, Slovak Republic CAPA- Ministry of Health & Population, Egypt TGA- Therapeutic Goods Administration, Australia APVMA- Australian Presticides & Veterinary Medicines Authority, Australia Health Ministry Council of GCC States. National Institute for the Surveillance of Drugs & Food, Columbia National Drug Authority, Uganda Ministry of Health Tanzania Food & Drug Authority, Tanzania Pharmacy Medicines & Poisons Board of Malawi Medicine Control Council, Republic of South Africa Ministry of Health, Ghana Food and Drug Control Centre, Libya MCC- Medicines Control Council, South Africa WHO PIC/S- Pharmaceutical inspection convention, Slovak Republic TGA- Therapeutic Goods Administration, Australia NDA- National Drug Authority, Uganda Pliva, Croatia MHRA - Medicines And Healthcare Products Regulatory Agency (UK) TFDA- Tanzania Food And Drugs Authority Republic of NAMIBIA- Ministry of health and social services, Namibia Pantex, Holland Biofarm, Poland Biofarm, Poland

Aurangabad Sr. Name of the Company No 1. M/s. Ajanta Pharma Ltd., B-4/5/6, MIDC, Paithan, Aurangabad 2. M/s. Ajanta Pharma Ltd., 31-0, midc, Chikalthana, Aurangabad 3. M/s. Atra Pharma Ltd,

Name of the Certification WHO WHO WHO/ ISO

H-19, MIDC, Waluj, Aurangabad 4. M/s. Baxter (I) Ltd., B-15/2, MIDC, Waluj, Aurangabad 5. M/s. Concept Pharma Ltd., A-28/3, MIDC, Chikhalthana, Aurangabad 6. M/s. Universal Prophylatic Pvt. Ltd., K117, MIDC, Waluj, Aurangabad 7. M/s. Encore Health care Pvt. Ltd., D-5, MIDC, Paithan, Aurangabad 8. M/s. FDC Ltd, B-8, MIDC, Waluj, Aurangabad 9. M/s. Herman Finochem Ltd., E-9, MIDC, Chikalthana, Aurangabad 10. M/s. Herman Finochem Ltd., A-100/2, MIDC, Shendra, Aurangabad 11. M/s. J. K. Ansell Pvt. Ltd., G-35 & 36, MIDC, Waluj, Aurangabad 12. M/s. Johnson & Johnson Ltd., B-14, MIDC, Waluj, Aurangabad 13. M/s. Lupin Ltd., A-28/1, MIDC, Chikalthana, Aurangabad 14. M/s. Midas Care Pharma F-106, MIDC, Aurangabad 15. M/s. Navketan Pharma F-106, MIDC, Aurangabad 16. M/s. Navketan Research Laboratory F107 & 8, MIDC, Waluj, Aurangabad 17. M/s. Savera Pharma Ltd., H-39 & 40, MIDC, Waluj 18. M/s. Shreya Life Sciences Pvt. Ltd., MIDC, Waluj, Aurangabad 19. M/s. Wockhardt Ltd., L-1, MIDC, Chikalthana, Aurangabad 20. M/s. Wockhardt Ltd., B-15/2, MIDC, Chikalthana, Aurangabad 21. M/s. Wockhardt Ltd., H-14/2, MIDC, Chikalthana, Aurangabad 22. M/s. Wockhardt Ltd., B-14/2,(EOU), Chikalthana, Aurangabad 23. M/s. Midas Care Pharmaceutical Pvt. ltd., B-16, MIDC, Waluj, Aurangabad 24. M/s. Orchid Chemical & Pharmace. Ltd., 25. M/s. Indoco Remedies B-20, MIDC, Waluj, Aurangabad

WHO/ ISO/ South Africa NCC WHO/ Kango WHO/ WHO/ WHO/ USFDA/ MHRA WHO/ USFDA/ HEALTH CANADA/ TGA/ France and Japan WHO/ USFDA/ COS WHO/ SABS & CEMARK/ ISO WHO WHO WHO/ MHRA WHO WHO WHO/ ISO WHO WHO/ USFDA/ MHRA WHO/ USFDA/ MHRA WHO WHO/ USFDA/ MHRA WHO/ MHRA USFDA/ MHRA WHO/ USFDA/ Uganda & Ukrain

Kokan Sr. No 1. 2. 3. 4. 5. 6. 7.

Name of the Company

Name of the Certification

M/s. Glaxo Smith Cline Pharmaceuticals Ltd, Second Pokharan Rd, Thane

MHRA

M/s. Watsone Pharma, Unit No. K-7, Ambarnath M/s. Watsone Pharma, Unit No. N-15, Ambarnath M/s. Watsone Pharma, Dombivali M/s. Centor Pharmaceuticals, Ambarnath M/s. Lupin Ltd., T-142, MIDC, Tarapur M/s. Aarti Drugs Ltd., E-21,22 MIDC, Tarapur

USFDA/IMB/WHO USFDA/EDQM/WHO USFDA/ EDQM /WHO USFDA/ WHO USFDA USFDA

8. 9. 10. 11. 12.

13. 14. 15.

16. 17. 18. 19. 20. 21. 22.

M/s. Aarti Drugs Ltd., G-60, MIDC, Tarapur M/s. Aarti Industries E-50, MIDC, Tarapur M/s. Calexy Pharma Pvt. Ltd., MIDC, Tarapur M/s. RPG Life Science, MIDC, Thane, Belapur Rd, Navi Mumbai M/s. Sandoz Pvt. Ltd., 8/a-2, 8-B, TTC Industrial Area, Kalave Bridge, Village Dighe, Navi Mumbai M/s. Sandoz Pvt. Ltd., MIDC, Plot No D31, 32 Navi Mumbai M/s. USV Ltd, B-1/8, MIDC, Lote parshuram , Khed, Ratnagiri M/s. Adlar Mediquipe Pvt. Ltd., Muradapur, Hatis, Sangameshvar, Ratnagiri M/s. Unichem Laboratories Ltd., 99, MIDC Area, Dhatav, Roha, Dist- Raigad M/s. Cipla Ltd., Unit-I, A-33, MIDC, Patalganga, Dist- Raigad M/s. Cipla Ltd., Unit-II, A-42, MIDC, Patalganga, Dist- Raigad M/s. M. J. Biopharm Pvt. ltd., Plot No L/7, MIDC Indl. Area, Taloja, Raigad M/s. Kopran Ltd., Savroli Village, TalKhalapur, Dist- Raigad M/s. Kopran Ltd., MIDC, Mahad, DistRaigad M/s. Milan Laboratories (India), Plot No 63-67, JCIE Ltd, Kamothe, Panvel, Dist- Raigad

USFDA USFDA USFDA/ EDQM TGA USFDA/ TGA

USFDA USFDA/Berlin Health Authority Germany/ TGA ISO 13485, 2003/CE

USFDA/ TGA USFDA/MHRA/Health Canada/ TGA/MCC/Anvisa MHRA/TGA/Slovak Republic MHRA/MCC TGA/ Health Canada/ Yemen/ MCC MHRA MHRA

Nashik Sr. No 1

2

3

4 5 6 7

Name of the Company

Name of the Certification

M/s. Sun Pharma. Industries Ltd. A-7/A/8, MIDC Industrial area Nagpur, Ahmednagar, M/s. Matrix Laboratories Ltd. F-4, F-12, MIDC, Malegaon, Sinner, Nashik M/s Megafine Pharma (P) Ltd. 31-35, & 48-51/201, village Lakhmapur, Dindori, Nashik-422 202. M/s. Glenmark Pharmaceuticals Ltd., E 37/39, MIDC, Satpur, Nashik M/s. Genom Biotech Pvt. Ltd., D 121 & 123, Malegaon MIDC, Sinnar M/s. Glaxo Smithkline Pharmaceuticals Ltd, A10, MIDC, Ambad, Nashik M/s. Maxheal Pharmaceuticals (India) 95/6, MIDC, Satpur, Nashik

US FDA/ WHO GMP

US FDA/ TGA/MHRA/ WHO GMP

US FDA/ WHO GMP/ ISO 9000, 9001, 2000, 14001, 2004 South Africa, MCC Colombia, ANVISA Brazil WHO GMP/ ISO 9001, 2000 WHO GMP WHO GMP

Amravati Sr. No

Name of the Company

Name of the Certification

1

Nil

Nil

Nagpur Sr. No 1

Name of the Company

Name of the Certification

M/s. Zim Laboratories Ltd.,

ISO 9001: 2000 NAFDAC Lagos