LETTERS FOR ISSUE ON 09.04.2014
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 5222 / Approval Letter
2. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 010 / 6547 / Approval Letter
3. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5766 / Approval Letter
4. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5263 / Approval Letter
5. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 11169 / Approval Letter
6. / M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 1816 / Amendment Letter
7. / M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 6808 / Approval Letter
8. / M/s. Kemwell Biopharma Pvt. Ltd.,, Bangalore Rural-562123 / 3639 / Amendment Letter
9. / M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 7023 / Approval Letter
10. / M/s. Quest Life Sciecnes (P) Ltd., Chennai-600 045 / 3398 / Amendment Letter
11. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 5841 / Approval Letter
12. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 8576 / Approval Letter
13. / M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 5216 / Approval Letter
14. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 5429 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Cadila Pharmaceutical Ltd., Dholka-387 810, Ahmedabad / 12709 / Test Licence
2. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 7088 / Test Licence
3. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 5128 / Test Licence
4. / M/s. Manipal Acunova Ltd., Mangalore-575 001 / 10142 / Test Licence
5. / M/s. Om Sai Clinical Research Pvt. Ltd., Sangli-416 416, Maharsahtra / 12029 / Test Licence
6. / M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 7005 / Test Licence
7. / M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 7456 / Test Licence
8. / M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 7435 / Test Licence
9. / M/s. Windlas Healthcare Pvt. Ltd., Dehradun-248 110 / 7458 / Test Licence
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bard India Healthcare Pvt. Ltd. / 4300 / Approval (F-RC)
2. / M/s. Phoenix HC India Pvt. Ltd. / 63726 / Approval (F-RC)
3. / M/s. Maquet Medical India Pvt. Ltd. / 6693 / Approval (R-RC)
4. / M/s. Bard India Healthcare Pvt. Ltd. / 4300 / Approval (F-IL)
5. / M/s. Becton Dickinson India Pvt. Ltd. / 4311 / Approval (R-IL)
6. / M/s. Maquet Medical India Pvt. Ltd. / 6693 / Approval (R-IL)
7. / M/s. Depuy Medical Pvt. Ltd. / 1651 / Approval Letter
8. / M/s. Abbott Healthcare Pvt. Ltd. / 3731 / Approval Letter
9. / M/s. Johnson & Johnson Ltd. / 7341 / Approval Letter
10. / Office Memorandum
The Deputy Drugs Controller (I), Mumbai
The Deputy Drugs Controller (I), Gujarat
The Commissioner, Gujarat
The Joint Commissioner, Maharashtra / Nil / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Biocell Medicare / 7912 / Approval (IL)
2. / M/s. Becton Dickinson India Pvt. Ltd. / 5514 / Approval (IL)
3. / M/s. HLL Lifecare Limited. / 5546 / Approval (IL)
4. / M/s. POCT Services. / 8207 / Approval (IL)
5. / M/s. POCT Services. / 7270 / Approval (IL)
6. / M/s. P.O.C.T Services. / 5014 / Approval (IL)
7. / M/s. Polchem Hygiene Laboratories Pvt. Ltd / 5415 / Approval (IL)
8. / M/s. BioMerieux India Pvt. Ltd. / 6820 / Approval (E-IL)
9. / M/s. Bio-Rad Laboratories (India) Pvt. Ltd. / 7558 / Approval (TL)
10. / M/s. Qiagen India Pvt. Ltd. / 8385 / Approval (TL)
11. / M/s. Qiagen India Pvt. Ltd. / 7182 / Approval (TL)
12. / M/s. Diagast Gurgaon. / 6343 / Approval Letter
13. / M/s. DHR Holding India Pvt. Ltd. / 7709 / Approval Letter
14. / M/s. Limas Medical Devices & Diagnostics (P) Ltd. / 7479 / Clarification Letter
15. / M/s. Philips Electronics India Limited. / 7917 / Clarification Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Zim Lab Ltd. / 5731 / 9092 / Amendment Letter
2. / M/s Sun Pharma / 50966 / - / Approval Letter
3. / M/s Johnson & Johnson / 3596 / - / Approval Letter
4. / M/s Ipca Lab Ltd. / 2063 / 42671 / Letter
5. / M/s MSN Lab Ltd. / 29424,35580 / - / Approval Letter (2)
6. / M/s Lupin Ltd. / 757 / - / Approval Letter (2)
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / TROIKKA PHARMACEUTICALS LTD. / 53909 / CLARIFICATION LETTER
2. / FORUM PRODUCTS LTD. / 5618 / CLARIFICATION LETTER
3. / ARAMEX TRADING CO. / NIL / CLARIFICATION LETTER
4. / APC PHARAMCEUTICALS & CHEMICALS / 61873 / CLARIFICATION LETTER
5. / USV LTD. / 60341 / CLARIFICATION LETTER
6. / PFIZER PRODUCTS INDIA PVT. LTD. / 65094,2598,1415 / 3 CLARIFICATION LETTER
7. / NOVARTIS HEALTHCARE PVT. LTD. / 7327,8948,63880 / 3 CLARIFICATION LETTER
8. / FULFORD INDIA LTD. / 64303 / CLARIFICATION LETTER
9. / DSM NUTRITIONAL PRODUCTS INDIA PVT. LTD. / 47471,47482,
52652,1426,48399 / 5 CLARIFICATION LETTER
10. / G. LUCATOS & CO. / 7195,2801 / 2 CLARIFICATION LETTER
11. / CHANDRA BHAGAT PHARMA PVT. LTD. / 8942 / CLARIFICATION LETTER
12. / SHAH TC OVERSEAS PVT. LTD. / 7741,4865 / 2 CLARIFICATION LETTER
13. / MYLAN PHARMACEUTICALS PVT. LTD. / 62567 / CLARIFICATION LETTER
14. / SANOFI-SYNTHELABO INDIA LTD. / 60862 / CLARIFICATION LETTER
15. / UNICHEMIE INTERNATIONAL / 9803 / CLARIFICATION LETTER
16. / ADM AGRO INDUSTRIES INDIA PVT. LTD. / 1093 / CLARIFICATION LETTER
17. / GANGWAL CHEMICALS PVT. LTD. / 4965 / CLARIFICATION LETTER
18. / CADILA HELATHCARE LTD. / 5402 / CLARIFICATION LETTER
19. / ORGANON INDIA PVT.LTD. / 55166 / CLARIFICATION LETTER
20. / BOEHRINGER INGELHEIM INDIA PVT. LTD. / 5644 / CLARIFICATION LETTER
21. / GLAXOSMITHKLINE PHARMACEUTICALS LTD. / 1625 / CLARIFICATION LETTER
22. / BASF INDIA LTD. / 444 / CLARIFICATION LETTER
23. / BRISTOL MYERS SQUIBB INDIA PVT. LTD. / 8572 / CLARIFICATION LETTER
24. / MSD PHARMACEUTICALS PVT. LTD. / 5064 / CLARIFICATION LETTER
25. / SIGNET CHEMICAL CORPORATION PVT. LTD. / 9733 / CLARIFICATION LETTER
26. / RECKITT BENCKISER INDIA LTD. / 7334 / CLARIFICATION LETTER
27. / UCB INDIA PVT. LTD. / `9871,12106,9872 / 3 CLARIFICATION LETTER
28. / TATTVA PHARMA EXIM SERVICES / 9292 / CLARIFICATION LETTER
29. / BIOGEN IDEC INDIA PVT. LTD. / 63061 / CLARIFICATION LETTER
30. / BAXTER INDIA PVT. LTD. / 11908 / CLARIFICATION LETTER
31. / BIOCON LTD. / 57304,64689 / 2 CLARIFICATION LETTER
32. / NOVARTIS INDIA LTD. / 4288,8947 / 2 APPROVAL LETTER
33. / EASTERN CHEMICALS PVT. LTD. / 4019,4018 / 2 APPROVAL LETTER
34. / UNICHEMIE INTERNATIONAL / APPROVAL LETTER
35. / SAXDONS BITOECH PVT. LTD. / 3140 / APPROVAL LETTER
36. / SHAH TC OVERSEAS PVT. LTD. / 4027 / APPROVAL LETTER
37. / SANOFI INDIA LTD. / 914 / APPROVAL LETTER
38. / TARACO INTERNATIONAL / 6052 / APPROVAL LETTER
39. / ARUN & COMPANY / 2392 / APPROVAL LETTER
RULE-37
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / BIDDLE SAWYER LTD. / 7207 / CLARIFICATION LETTER
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. MSN Laboratories / - / Approval Letter
2. / M/s. Laila Pharmaceuticals / - / Clarification Letter
3. / M/s. Sanofi / - / Clarification Letter
4. / M/s. Pharmazz India / - / Approval Letter
5. / M/s. Dr. Reddy’s Lab. / - / Clarification Letter
6. / M/s. Venus Remedies / - / Clarification Letter
7. / M/s. Dishman Pharmaceuticals / - / Clarification Letter
8. / M/s. Lifecare Innovations / - / Clarification Letter
9. / M/s. Bharat Serum / - / Clarification Letter
10. / M/s. Emcure Pharmaceuticals / - / Clarification Letter
11. / Dr. Suruchi Hasija / - / Clarification Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Panacea Biotec Ltd / 10640 / Clarification letter
2 / M/s Indian Immunologicals Limited / 7308 / Clarification letter
3 / M/s Cadila Healthcare Ltd / 9361, 9360, 2295 / Approval letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Cadila Pharmaceuticals Limited / 10757 / Approval letter
2 / M/s Syngene International Ltd / 11803 / Approval letter
3 / M/s Baxter (India) Pvt Ltd / Approval letter
EXPORTS OF BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Semler Research Centre Pvt Limited / 6429 / Approval letter
2 / M/s Lambda Therapeutic Research Ltd / 8729 / Approval letter
3 / M/s Cliantha Research Ltd / 10383, 10385,10384, 10386, / Approval letter
4 / M/s Vimta Labs ltd / 8404 / Approval letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Serdia Pharmaceuticals (I) Pvt. Ltd., / 8616 / Letter
2. / M/s. Restech Pharma / Nil / Meeting Letter
3. / M/s. Naxpar Pharma / Nil / Meeting Letter
4. / M/s. D. M. Pharma / Nil / Meeting Letter
5. / M/s. BRD Medilabs / Nil / Meeting Letter
6. / M/s.Tee & Tee Health Care / Nil / Meeting Letter
7. / M/s. Rivpra Formulations / Nil / Meeting Letter
8. / M/s. Arion Healthcare / Nil / Meeting Letter
9. / M/s. Akums Drugs / Nil / Meeting Letter
10. / M/s. Noel Pharma / Nil / Meeting Letter
11. / M/s. Unix Biotech / Nil / Meeting Letter
12. / M/s. Windlas Biotech / Nil / Meeting Letter
13. / M/s.Cipla LTd., / Nil / Meeting Letter
14. / M/s. Logos Pharma / Nil / Meeting Letter
15. / M/s. Suncare Formulaitons / Nil / Meeting Letter
16. / M/s. Ravian Life Sciences / Nil / Meeting Letter
17. / M/s. Wallace Pharmaceuticals / Nil / Meeting Letter
18. / M/s. Swiss Garnier / Nil / Meeting Letter
19. / M/s. Aeon Drugs / Nil / Meeting Letter
20. / M/s. Phoenix Biologicals / Nil / Meeting Letter
21. / M/s. Sun Pharmaceuticals / Nil / Meeting Letter
22. / M/s. Psychotropics India / Nil / Meeting Letter
23. / M/s. RPG Life Sciences / Nil / Meeting Letter
24. / M/s. Pro Laboratories / Nil / Meeting Letter
25. / M/s. Acme Lifesciences / Nil / Meeting Letter
26. / M/s.CIAN Healthcare / Nil / Meeting Letter
27. / M/s. Micro Labs Ltd., / Nil / Meeting Letter
28. / M/s. AGIO Pharmaceuticals / Nil / Meeting Letter
29. / M/s. Alemic Pharmaceuticals / Nil / Meeting Letter
30. / M/s. Kaizen Pharmaceuticals / Nil / Meeting Letter
31. / M/s. Sain Medicaments / Nil / Meeting Letter
32. / M/s. Gen Pharma / Nil / Meeting Letter
33. / M/s. Noel Pharma / Nil / Meeting Letter
34. / M/s. Agron Remedies / Nil / Meeting Letter
35. / M/s. Rivpra Formulations / Nil / Meeting Letter
36. / M/s. Shiva Biogenetics / Nil / Meeting Letter
37. / M/s. MDC Pharmaceuticals / Nil / Meeting Letter
38. / M/s. Symbiotic Drugs / Nil / Meeting Letter
39. / M/s. Healer’s Labs / Nil / Meeting Letter
40. / M/s. Prim Research Laboratories / Nil / Meeting Letter
41. / M/s. Safetab Life Sciences / Nil / Meeting Letter
42. / M/s. GKM New Pharma / Nil / Meeting Letter
43. / M/s. Sozin Flora / Nil / Meeting Letter
WRITTEN CONFIRMATION
S. No / Firm Name / Type of Letter1. / M/s. SMS Pharmaceuticals Limited., / Letter
2. / M/s. Saurav Chemicals Ltd., / Letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Wockhardt Ltd., / 8148 / Approval Letter
2. / Wockhardt Limited / 8150 / Approval Letter
3. / Wockhardt Limited / 8149 / Approval Letter
4. / Wockhardt Limited / 8154 / Approval Letter
5. / Wockhardt Limited / 8152 / Approval Letter
6. / Wockhardt Limited / 8153 / Approval Letter
7. / Wockhardt Limited / 8151 / Approval Letter
8. / Ranbaxy Laboratories Ltd. / 8072 / Approval Letter
9. / Macleods Pharmaceuticals Limited / 8097 / Approval Letter
10. / Macleods Pharmaceuticals Limited. (M/S. Ciron Drugs & Pharmaceuticals Pvt. Ltd.) / 8123 / Approval Letter
11. / Mercury Laboratories Ltd. / 8200 / Approval Letter
12. / Medopharm / 8216 / Approval Letter
13. / LOK-BETA Pharmaceuticals(I) Pvt. Ltd. / 8214 / Approval Letter
14. / Shell-Life Sciences Pvt. Ltd. / 8056 / Approval Letter
15. / Piramal Enterprises Ltd. / 8056 / Approval Letter
16. / Haresh Oveta / 8187 / Approval Letter
17. / Haresh Oveta / 8188 / Approval Letter
18. / Harshada Corporation, / 8186 / Approval Letter
19. / Claris Otsuka Ltd. / 8403 / Approval Letter
20. / Dr. Reddys Laboratories Ltd. / 8448 / Approval Letter
21. / Meditech Pharmaceuticals / 8349 / Approval Letter
22. / Meditech Pharmaceuticals / 8348 / Approval Letter
23. / Farmachem Life Pvt. Ltd. / 8399 / Approval Letter
24. / Mehta Medicare Pvt. Ltd. / 8362 / Approval Letter
25. / Mehta Pharmaceutical Industries, / 8356 / Approval Letter
26. / Ruskin Chemipharm / 8392 / Approval Letter
27. / Sagar Rubber Products Pvt. Ltd. / 8398 / Approval Letter
28. / Pradipkumar Pharma Pvt. Ltd. / 8997 / Approval Letter
29. / Pradipkumar Pharma Pvt. Ltd. / 8396 / Approval Letter
30. / Pradipkumar & Co. / 8395 / Approval Letter