LETTERS FOR ISSUE ON 25.03.2015
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 5648 / Approval Letter
2. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 6111 / Approval Letter
3. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 6368 / Test Licence
4. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 4881 / Clarification Letter
5. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 7370 / Clarification Letter
6. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 6182 / Approval Letter
7. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 5533 / Clarification Letter
8. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 4372 / Clarification Letter
9. / M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 5975 / Approval Letter
10. / M/s. APL Reserch Center, Hyderabad-500 038 / 7312 / Clarification Letter
11. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 6105 / Approval Letter
12. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 5619 / Test Licence
13. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 6477 / Clarification Letter
14. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 51273 / Approval Letter
15. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 50211 / Approval Letter
16. / M/s. Bio Scientific Research Laboratories (India) Pvt. Ltd., Dist. Thane-401 104 / 6599 / Test Licence
17. / M/s. Bio Scientific Research Laboratories (India) Pvt. Ltd., Dist. Thane-401 104 / 6598 / Test Licence
18. / M/s. Cipla Ltd., Mumbai-400 013 / 6240 / Clarification Letter
19. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5711 / Approval Letter
20. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5725 / Approval Letter
21. / M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 6088 / Approval Letter
22. / M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 6086 / Approval Letter
23. / M/s. Dr. Reddy's Laboratories Ltd., Hyderabad-500 016 / 6361 / Clarification Letter
24. / M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 5710 / Approval Letter
25. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 6491 / Clarification Letter
26. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 6492 / Clarification Letter
27. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 6490 / Clarification Letter
28. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 6287 / Approval Letter
29. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 6699 / Test Licence
30. / M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 5866 / Clarification Letter
31. / M/s. LifeSan Clinical Research, Mumbai-400 055 / 6251 / Clarification Letter
32. / M/s. Lupin Bioresearch Center, Pune-411 021 / 5781 / Clarification Letter
33. / M/s. Lupin Limited (Research Park), Pune-412 115 / 46023 (8137) / Rejection Letter
34. / M/s. Lupin Limited (Research Park), Pune-412 115 / 6254 / Approval Letter
35. / M/s. Lupin Limited (Research Park), Pune-412 115 / 6255 / Approval Letter
36. / M/s. Lupin Limited (Research Park), Pune-412 115 / 6253 / Approval Letter
37. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 6307 / Approval Letter
38. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 6663 / Approval Letter
39. / M/s. Manipal Acunova Ltd., Mangalore-575 001 / 6184 / Approval Letter
40. / M/s. Manipal Acunova Ltd., Mangalore-575 001 / 5665 / Test Licence
41. / M/s. Mankind Pharma Limited, New Delhi-110 020 / 6455 / Test Licence
42. / M/s. MSN Laboratories Ltd., Hyderabad-500 018 / 6272 / Test Licence
43. / M/s. MSN Laboratories Ltd., Hyderabad-500 018 / 6250 / Test Licence
44. / M/s. Mylan Laboratories Limited, Hyderabad-500 062 / 6348 / Approval Letter
45. / M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 6952 / Test Licence
46. / M/s. Novel Clinical Research (India) Pvt. Ltd., Karnataka-560 069 / 5974 / Approval Letter
47. / M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 6186 / Test Licence
48. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 6175 / Approval Letter
49. / M/s. RA Chem Pharma Ltd., Hyderabad-500 037 / 48332 / Rejection Letter
50. / M/s. RA Chem Pharma Ltd., Hyderabad-500 037 / 5747 / Clarification Letter
51. / M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 6091 / Approval Letter
52. / M/s. Semler Research Center, Bangalore-560078 / 5726 / Approval Letter
53. / M/s. Semler Research Center, Bangalore-560078 / 6628 / Approval Letter
54. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 6311 / Approval Letter
55. / M/s. Strides Arcolab Ltd., Bangalore -560076 / 6576 / Test Licence
56. / M/s. Sun Pharma Advanced Research Company Ltd., Vadodara-390 020 / 4287 / Rejection Letter
57. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 6063 / Rejection Letter
58. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 5523 / Clarification Letter
59. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 5951 / Approval Letter
60. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 5970 / Clarification Letter
61. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 059 / 1986 / Amendment Letter
62. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 5732 / Test Licence
63. / M/s. Unichem Laboratories Ltd., Mumbai-400 102 / 3018 / Approval Letter
64. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 5734 / Clarification Letter
65. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 3098 / Approval Letter
66. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 6236 / Approval Letter
67. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 6532 / Test Licence
68. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 969 / Test Licence
69. / M/s. VerGo Pharma Research Pvt. Ltd. (Div- VerGo Clinicals), Goa-403 110 / 6362 / Test Licence
70. / M/s. Vimta Labs Ltd., Hyderabad-500051 / 6237 / Clarification Letter
71. / M/s. Vimta Labs Ltd., Hyderabad-500051 / 3880 / Amendment Letter
72. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 5860 / Approval Letter
73. / M/s. Wockhardt Limited, Aurangabad-431 006 / 6662 / Approval Letter
74. / M/s. Wockhardt Limited, Aurangabad-431 006 / 3277 / Test Licence
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Advanced Bionics India Private Limited / 49251 / Approval Letter
2. / M/s. Johnson & Johnson Ltd., / 49759 / RC+ F-10
3. / M/s. Biotronik Medical devices pvt Ltd., / 51340 / Approval Letter
4. / M/s. Biotronik Medical Devices India Pvt ltd., / 48164 / RC+F-10
5. / M/s. Phoenix Medicare Pvt Ltd. / 46764 / RC+F-10
6. / M/s. Baxter (India) Pvt Ltd., / 5182 / Approval Letter
7. / M/s. Terumo India Pvt ltd., / 47321 / RC+F-10
8. / M/s. Baxter(India) Pvt ltd., / 6762 / Query Letter
9. / M/s. Devine Meditech / FTS 74229 / CLLA
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Abbott Healthcare Pvt Ltd., / 44604 / F-10
2. / M/s. Transasia Bio Medicals Limited / 45533 / F-10
3 / .M/s Siemens Limited / 1579 / F-10
4. / M/s Siemens Limited / 850 / F-10
5. / M/s. Labx / 1256 / F-10
6. / M/s Roche Diagnostics India Pvt ltd. / 50402 / F-10
7. / M/s Roche Diagnostics India Pvt Ltd., / 2618 / End-F-10
8. / M/s DSS Imagetech Pvt Ltd., / 50247 / End-10
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Claris Injectable Ltd., C/o. M/s. Claris Otsuka Pvt. Ltd., Gujarat / 11118 / Approval
02 / M/s. Claris Injectable Ltd., Gujarat / 11121, 11119 / Approval
03 / M/s. Fresenius Kabi India Ltd., Pune / 11020, 12389 / Approval
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Innova Pharmactive Pvt. Ltd., Nagpur, Maharashtra. / WC Certificate
EXPORT NOC
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Alivira animal health limited, thane / Letter
2. / M/s.Claris life sciences Pvt. limited, Gujarat / Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s Optimus Drugs (P) Limited / - / Query Letter
2. / Dndi (Dr. Bhawna Sharma) / - / Meeting Notice 07.04.2015 Antimicrobial & Antiviral)
3. / Dr. Soumya Swaminathan, Director, National Institute of Research in Tuberculosis / - / Meeting Notice 07.04.2015 Antimicrobial & Antiviral)
4. / M/s. Bharat Serum / - / Meeting Notice 07.04.2015 Antimicrobial & Antiviral)
5. / Dr. Avanth Kumar / - / Tamoxifen
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Modi mundi / - / - / SEC Letter
2. / M/s Zim Labs / - / - / SEC Letter
3. / M/s Intas / - / - / SEC Letter
4. / M/s Novarits / - / - / SEC Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. KemwellBiopharmaPvt. Ltd., / Nil / SEC Letter
2. / M/s. Pfizer Ltd., / Nil / SEC Letter
3. / M/s. Cadila Pharmaceuticals / Nil / SEC Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Novartis / 3500/5716/7499 / Change in PI / Amendment in Export NOC / TL Approval Letters
2. / M/s. MSD / 5494 / Letter
3. / M/s. Quintiles / 4333 / Change in PI Approval
4. / M/s. PRA / 5039/6078 / Clarification Letter
5. / M/s. Excel Life Sciences / 5985 / Clarification Letter
REGSTRATION
S.NO. / Name of applicant / DIARY NO. / TYPE OF LETTER1. / PFIZER PRODUCTS INDIA PVT. LTD. / 48725 / CLARIFICATION LETTER
2. / PHARMA ACTION HELATH CARE PV.T LTD. / 50469 / CLARIFICATION LETTER
3. / EASTERN CHEMICALS CORPORATION / 995 / CLARIFICATION LETTER
4. / MSD PHARMACEUTICAL PVT. LTD. / 6664 / CLARIFICATION LETTER
5. / TATTVA PHARMA EXIM SERVICES / 28088,5652 / 02 CLARIFICATION LETTER
6. / CENTAUR CHEM / 637 / CLARIFICATION LETTER
7. / WOCKHARDT LTD. / 41937 / CLARIFICATION LETTER
8. / BAYER PHARMACEUTICALS PV. LTD. / 40431 / CLARIFICATION LETTER
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / INDOCO REMEDIES LTD. / 6597 / CLARIFICATION LETTER
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Bharat Biotech International Ltd / Clarification letter
2 / M/s Bayer Pharmaceuticals Pvt, ltd / 48626 / Clarification letter
3 / M/s Novartis Healthcare Ltd / 50589, 51095 / Clarification letter
4 / M/s Nexus Clinical research India ltd / 48294 / Clarification letter
5 / M/s Boehringer Ingelheim India Pvt, ltd / 5351 / Clarification letter
6 / M/s Roche Product India Pvt, ltd / 21174, 50286 / Clarification letter
7 / M/s Johnson & Johnson ltd / 48233 / Clarification letter
8 / M/s Novo Nordisk India Pvt, ltd / 48706 / Clarification letter
9 / M/s Eli Lilly and Company India Pvt, ltd / 1958 / Clarification letter
10 / M/s Intervet India Pvt ,ltd / 4760 / Clarification letter
11 / M/s Virchow Biotech Pvt ltd / 12974 (fts no) / Approval letter
12 / M/s Reliance life science pvt, ltd / 5831 / Approval letter
13 / M/s Merck Specialties pvt, ltd / 5913 / Acknowledge letter
14 / M/s Accutest research laboratories pvt, ltd / 5853 / Amendment letter