LETTERS FOR ISSUE ON 18.06.2014
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / INTAS PHARMACEUTICALS LTD. / 20463 / CLARIFICATION LETTER
2. / NECTAR LIFESCIENCES LTD. / 21241 / CLARIFICATION LETTER
3. / ROCHE PRODCUTS INDIA PVT. LTD. / 20503 / CLARIFICATION LETTER
4. / HARESH CHEMICALS / 21218 / CLARIFICATION LETTER
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 18743 / Approval Letter
2. / M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 53467 / Approval Letter
3. / M/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 21784 / Approval Letter
4. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 15422 / Approval Letter
5. / M/s. Lupin Bioresearch Center, Pune-411 021 / 18513 / Approval Letter
6. / M/s. Lupin Bioresearch Center, Pune-411 021 / 19493 / Approval Letter
7. / M/s. Lupin Bioresearch Center, Pune-411 021 / 9776 / Approval Letter
8. / M/s. Micro Labs Limited, Bangalore-560 068 / 12116 / Amendment Letter
9. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 12168 / Approval Letter
10. / M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 23632 / Approval Letter
11. / M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 21953 / Approval Letter
12. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 15066 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 22154 / Test Licence
2. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 19958 / Test Licence
3. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 19959 / Test Licence
4. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 16062 / Test Licence
5. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 19619 / Test Licence
6. / M/s. Cipla Limited, Mumbai-400 008 / 20831 / Test Licence
7. / M/s. Cipla Limited, Mumbai-400 008 / 17257 / Test Licence
8. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560034 / 18769 / Test Licence
9. / M/s. Lupin Bioresearch Center, Pune-411 021 / 17178 / Test Licence
10. / M/s. Lupin Bioresearch Center, Pune-411 021 / 20763 / Test Licence
11. / M/s. OncoTherapies Ltd., Bangalore-560 076 / 18452 / Test Licence
12. / M/s. Semler Research Center, Bangalore-560078 / 17775 / Test Licence
13. / M/s. VerGo Clinicals, Goa-403 110 / 19874 / Test Licence
14. / M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 19459 / Test Licence
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Max Neeman / - / Clarification Letter
2. / M/s. MSD / 2051 / Additional sites Approval
3. / M/s. Pharmaleaf / 18105 / NDAC Follow-up letter
4. / M/s. Amgen / 14665 / Clarification Letter
5. / M/s. Biocad / - / NDAC Follow-up letter
EXPORT NOC
S. No / Firm Name / Diary No. / Type of Letter1. / M/s. Ranbaxy Laboratories Ltd. / 23325 / NOC
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Astra Zeneca Pharma India Ltd., / 15741 / Letter
2. / M/s. Ranbaxy Laboratories Ltd., / 17227 / Clarification Letter
3. / M/s. Ranbaxy Laboratories Ltd., / 42126 / Clarification Letter
4. / M/s. Adcock Ingram Healthcare Pvt. Ltd., / 42978 / Clarification Letter
5. / M/s. Fresenius Medical Care India Pvt. Ltd., / 22636 / Clarification Letter
6. / M/s. KNM Pharmachem / 10392 / Clarification Letter
7. / M/s. Bescoat / 30699 / Clarification Letter
8. / M/s. Takeda Pharmaceuticals India Pvt. Ltd., / 11527 / Clarification Letter
9. / M/s. Zoetis India Ltd., / 43357 / Letter
10. / M/s. Micro Labs Ltd., / 42686 / Clarification Letter
11. / M/s. Centaur Pharmaceuticals / 41228 / Clarification Letter
12. / M/s. Sanofi India Ltd., / 42133 / Letter
13. / M/s. Maral Labs, / 30651 / Clarification Letter
14. / M/s. Maral Labs, / 30651 / Clarification Letter
15. / M/s. Maral Labs, / 30651 / Clarification Letter
16. / M/s. Provimi Animal Nutrition India Pvt. Ltd., / 46751 / Clarification Letter
17. / M/s. Psychotropics India / 43463 / Clarification Letter
18. / M/s. Cipla Limited / 41305 / Clarification Letter
19. / M/s. Unibiotech Formulations / 43448 / Clarification Letter
20. / M/s. Unibiotech Formulations / 43445 / Clarification Letter
21. / M/s. Unibiotech Formulations / 43450 / Clarification Letter
22. / M/s. Unibiotech Formulations / 43442 / Clarification Letter
23. / M/s. Bayer Pharmaceuticals Pvt. Ltd., / 18237 / Letter
24. / M/s. Bayer Pharmaceuticals Pvt. Ltd., / 39352 / Clarification Letter
25. / M/s. Samrudh Pharmaceuticals Pvt. Ltd., / 40801 / Letter
26. / M/s. Samrudh Pharmaceuticals Pvt. Ltd., / 41274 / Letter
27. / M/s. Embiotic Laboratories (P) Ltd., / 43799 / Clarification Letter
28. / M/s. Prakruti Products Pvt. Ltd., / 42078 / Clarification Letter
29. / M/s. Promed Laboratories Pvt. Ltd., / 20258 / Clarification Letter
30. / M/s. Emcure Pharmaceuticals Ltd., / 40437 / Clarification Letter
31. / M/s. West Coast Pharmaceuticals Works Ltd., / 64074 / Clarification Letter
32. / M/s. Emcee Pharmaceuticals (P) Ltd., / 43029 / Clarification Letter
33. / M/s. Gurufcure / 41935 / Clarification Letter
34. / M/s. Bharti Life Sciences / 41278 / Clarification Letter
35. / M/s. Mepromax Lifesciences Pvt. Ltd., / 43247 / Clarification Letter
36. / M/s. Ravian Life Sciences Pvt. Ltd., / 5496 / Clarification Letter
37. / M/s. Alkem Laboratories Ltd., / 19498 / Clarification Letter
38. / M/s. Akums Drugs & Pharmaceuticals Ltd., / 37442 / Letter
39. / M/s. GlaxoSmithKline Pharmaceuticals Ltd., / 40859 / Clarification Letter
40. / M/s. Venus Remedies / 8521 / Clarification Letter
41. / M/s. Hetero Labs / 21370 / Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Bharat Serum and Vaccine Ltd / - / Clarification Letter
2. / M/s. UCB India Private Ltd. / - / Clarification Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Abbott Healthcare Ltd. / 18222 / Query Letter
2. / M/s. Biomet Orthopaedic India Pvt. Ltd. / FTS-2348 / Query Letter
3. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
4. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
5. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
6. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
7. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
8. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
9. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
10. / M/s. Edward Lifesciences (India) Pvt. Ltd. / 17625 / Query Letter
11. / M/s. India Medtronic Pvt. Ltd. / 14873 / Query Letter
12. / M/s. Spica Medical Equipment’s Pvt. Ltd. / 17144 / Query Letter
13. / M/s. Soham Enterprises. / Nil / Query Letter
14. / M/s. S. B. Medicare Pvt. Ltd. / 16491 / Query Letter
15. / M/s. Teleflex Medical Pvt. Ltd. / 8813 / Query Letter
16. / M/s. Wellness Concepts. / 6903 / Query Letter
17. / M/s. HI-Tech Medisyst Pvt. Ltd. / 17142 / Clarification Letter
18. / M/s. Biotronik Medical Devices India Pvt. Ltd. / 18128 / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Avantor Performance Materials India Ltd. / 18774 / Query Letter
2. / M/s. Beckman Coulter India Pvt. Ltd. / 19085 / Query Letter
3. / M/s. Kopran Laboratories Ltd. / 18542 / Query Letter
4. / M/s. Nihon Kohden India Pvt. Ltd. / 14107 / Query Letter
5. / M/s. Roche Diagnostics India Pvt. Ltd. / 13212 / Query Letter
6. / M/s. Roche Diagnostics India Pvt. Ltd. / 13213 / Query Letter
7. / M/s. Roche Diagnostics India Pvt. Ltd. / 13499 / Query Letter
8. / M/s. Roche Diagnostics India Pvt. Ltd. / 12334 / Query Letter
9. / M/s. Trivitron Healthcare Pvt. Ltd. / 19172 / Query Letter
10. / M/s Golden Harvest Industries / 20259 / Query Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Intas Pharmaceuticals Ltd / 20493 / Amendment Letter
2 / M/s Roche Product India Pvt, ltd / 15124 / Approval Letter
3 / M/s Sandor Medicaids Pvt, ltd / 10704 / Acknowledges Letter
4 / M/s Western Drugs Ltd / 14710 (fts no) / Clarification Letter
5 / M/s Novartis Healthcare Pvt, tld / 15261 / Acknowledges Letter
6 / M/s Novo Nordisk Pvt, Ltd / 23818 / Approval Letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Cadila Healthcare Ltd / 15324 / Clarification Letter
2 / M/s Sun Pharmaceuticals industries Ltd / 20460 / Approval Letter
3 / M/s Zee Laboratories Ltd / 20553 / Clarification Letter
4 / M/s Agila Specialties Pvt, ltd / 20557 / Approval Letter
5 / M/s MSD Wellcome Trust Hilleman Labortories Pvt, Ltd / 22900 / Approval Letter
6 / M/s Reliance Life Science Pvt, ltd / 20026 / Approval Letter
7 / M/s Lupin Ltd / 20576 / Approval Letter
8 / M/s Globion India Pvt, Ltd / 18696, 18694 / Approval Letter
9 / M/s USV Ltd / 18127 / Clarification Letter
10 / M/s Inbiopro Solution Pvt, ltd / 1034, 2216 (fts no) / Clarification Letter
11 / M/s Shantha Biotechnices Ltd / 22868 / Approval Letter
COSMETICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Premier Lifestyle Housing Pvt. Ltd, Maharashtra / 16092 / Deficiency Letter
2. / M/s. Dormir India Private Limited, Delhi / 15052 / Deficiency Letter
3. / M/s. Dormir India Private Limited, Delhi / 15050 / Deficiency Letter
4. / M/s. PZ Cussons India Private Limited, Mumbai / 16165 / Deficiency Letter
5. / M/s. Sunshine Electroplaters, Kerala / 14377 / Deficiency Letter
6. / M/s. Nuga Medical India Pvt. Ltd, Noida. / 17167 / Deficiency Letter
7. / M/s. Johnson & Johnson Limited, Mumbai / 12897, 16009 / Deficiency Letter
8. / M/s. Nails and Toes Services Pvt. Ltd, Mumbai / 14505 / Deficiency Letter
9. / M/s. SeaSoul Cosmeceuticals Private Limited, New Delhi / 14601 / Deficiency Letter
10. / M/s. Headstart International Pvt. Ltd, New Delhi / 14135 / Deficiency Letter