LETTERS FOR ISSUE ON 14.08.2014
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Aarti Drugs Ltd. / WC Letter
2 / M/s. Titan Laboratories Pvt. Ltd. / WC Letter
BE NOC FOR EXPORT
(2nd List)
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 31053 / Approval Letter
2. / M/s. APL Research Center, Hyderabad-500 090 / 21299 / Rejection Letter
3. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 31301 / Approval Letter
4. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 32555 / Approval Letter
5. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 22272 / Approval Letter
6. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 31556 / Approval Letter
7. / M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 33048 / Approval Letter
8. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 31521 / Approval Letter
9. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 31531 / Approval Letter
10. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 31467 / Approval Letter
11. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 31174 / Approval Letter
12. / M/s. Lupin Bioresearch Center, Pune-411 021 / 32182 / Approval Letter
13. / M/s. Lupin Bioresearch Center, Pune-411 021 / 31098 / Approval Letter
14. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600059 / 33767 / Approval Letter
15. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 33768 / Amendment Letter
16. / M/s. Norwich Clinical Services Pvt. Ltd., Bangalore-560 034 / 32144 / Approval Letter
17. / M/s. Novel Clinical Research (India) Pvt. Ltd., Karnataka-560 069 / 32153 / Approval Letter
18. / M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500 037 / 33130 / Approval Letter
19. / M/s. Ranbaxy Laboratories Ltd., New Delhi / 32011 / Approval Letter
20. / M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 33869 / Approval Letter
21. / M/s. Semler Research Center, Bangalore-560078 / 33106 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 31267 / Test Licence
2. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 31910 / Test Licence
3. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 31693 / Test Licence
4. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 27643 / Test Licence
5. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 30631 / Test Licence
6. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 31251 / Test Licence
7. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 31919 / Test Licence
8. / M/s. Jubilant Generics Limited, Noida-201 301, UP / 32868 / Test Licence
9. / M/s. Lupin Bioresearch Center, Pune-411 021 / 22492 / Test Licence
10. / M/s. Manipal Acunova Ltd., Manipal AcuNova KMC CPU, Mangalore-575 001 / 33179 / Test Licence
11. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 29435 / Test Licence
12. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 31507 / Test Licence
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Aristo Pharmaceuticals Ltd., / 16466 / Clarification Letter
2. / M/s. Lifecare Formulations Pvt. Ltd., / 42082 / Letter
3. / M/s. Acme Lifesciences / 16728 / Letter
4. / M/s. Suncare Formulations Pvt. Ltd., / 43145 / Letter
5. / M/s. Prim Research Laboratories, / 43342 / Letter
6. / M/s. Sozin Flora Pharma, 41547 / 41547 / Letter
7. / M/s. Rivpra Formulations Pvt. Ltd., / 43592 / Letter
8. / M/s. Psychotropics India Ltd., / 48544 / Letter
9. / M/s. Psychotropics India Ltd., / 43471 / Letter
10. / M/s. Ravian Life Sciences Pvt. Ltd., / 16240 / Letter
11. / M/s. Pro Laboratories Pvt. Ltd., / 49904 / Letter
12. / M/s. MDC Pharmaceuticals Pvt. Ltd., / 47577 / Letter
13. / M/s. Akums Drugs & Pharmaceuticals Ltd., / 46719 / Letter
14. / M/s. BRD Medilabs, / 49052 / Letter
15. / M/s. Gelnova Laboratories (I) Pvt. Ltd., / 43298 / Letter
16. / M/s. Safetab Life Sciences / 42637 / Letter
17. / M/s. Ranbaxy Laboratories Ltd., / 48739 / Letter
18. / M/s. Orbit Lifesciences Pvt. Ltd., / 42613 / Clarification Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Edwards Lifesciences (India) Pvt. Ltd. / 24241 / Approval (F-RC)
2. / M/s. Johnson & Johnson Ltd. / 23056 / Approval (F-RC)
3. / M/s. Johnson & Johnson Ltd. / 23056 / Approval (F-IL)
4. / M/s. Stryker India Pvt. Ltd. / 60406 / Approval (F-RC)
5. / M/s. St. Jude Medical India Pvt. Ltd. / 21070 / Approval (R-RC)
6. / M/s. St. Jude Medical India Pvt. Ltd. / 21070 / Approval (R-IL)
7. / M/s. Event Medi Systems. / 29017 / Query Letter
8. / M/s. St. Jude Medical India Pvt. Ltd. / 27015 / Query Letter
9. / M/s. Surya Surgicals Ltd. / 25812 / Letter
10. / Under Secretary, Nirman Bhawan. / FTS-44009 / Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Roche Diagnostics India Pvt. Ltd. / 32578 / Approval (RC)
2. / M/s. Roche Diagnostics India Pvt. Ltd. / 32578 / Approval (IL)
3. / M/s. BioSystems Diagnostics Pvt. Ltd. / 24155 / Approval (IL)
4. / M/s. Beckman Coulter India Pvt. Ltd. / 25088 / Approval (IL)
5. / M/s. BioMerieux India Pvt. Ltd. / 26136 / Approval (E-IL)
6. / M/s. Apex Surgicals. / 26454 / Approval (TL)
7. / M/s. Ajay Medical Agency. / 24974 / Approval (TL)
8. / M/s. Becton Dickinson India Pvt. Ltd. / 24903 / Approval (TL)
9. / M/s. Beckman Coulter India Pvt. Ltd. / 27099 / Approval (TL)
10. / M/s. Beckman Coulter India Pvt. Ltd. / 27099 / Approval (TL)
11. / M/s. Beckman Coulter India Pvt. Ltd. / 27100 / Approval (TL)
12. / M/s. Roche Diagnostics India Pvt. Ltd. / 27919 / Approval (TL)
13. / M/s. U.R. Biomedical Pvt. Ltd. / 25927 / Approval (TL)
14. / M/s. Roche Diagnostics India Pvt. Ltd. / Nil / Approval Letter
15. / M/s. Becton Dickinson India Pvt. Ltd. / 27122 / Query Letter
16. / M/s. RMD Mediaids Pvt. Ltd. / 22350 / Approval Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s GSK Pharmaceuticals ltd / 25092 / Clarification letter
2 / M/s Dr. Reddy’s Laboratories ltd / 26099 / Clarificat ion letter
3 / M/s GSK Aisa Pvt, ltd / 22145, 22144 / Clarification letter
4 / M/s EliLilly and company (india) pvt, ltd / 12771 / Clarification letter
5 / M/s Cliantha Reserch Ltd / 28745 / Clarification letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy./No. / STATUS1 / M/s M.J. Biopharma Pvt, Ltd / 48618 (fts no) / Approval letter
2 / M/s Lupin Ltd / 48618 (fts no) / Approval letter
3 / M/s Intas Pharmaceuticals ltd / 29859 / Approval letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Agila Specialties Pvt Ltd / 31813, 46970 / Approval Letter
2. / Agila Specialties Pvt Ltd / 31814, 46965 / Approval Letter
3. / Ajanta Pharma Ltd / 32044, 47389 / Approval Letter
4. / Ajanta Pharma Ltd / 35045, 47365 / Approval Letter
5. / Ajanta Pharma Ltd / 32046, 47380 / Approval Letter
6. / Ajanta Pharma Ltd / 32048, 47371 / Approval Letter
7. / Alkem Laboratories Ltd. / 32091, 47504 / Approval Letter
8. / Cipla Ltd / 31810, 46994 / Approval Letter
9. / Cipla Ltd / 31811, 46976 / Approval Letter
10. / Cipla Ltd / 31824, 46950 / Approval Letter
11. / Cipla Ltd / 31825, 46947 / Approval Letter
12. / Cipla Ltd / 31830, 46817 / Approval Letter
13. / Cipla Ltd / 31831, 46860 / Approval Letter
14. / Cipla Ltd / 31832, 46866 / Approval Letter
15. / Cipla Ltd / 31833, 46874 / Approval Letter
16. / Cipla Ltd / 31834, 46903 / Approval Letter
17. / Cipla Ltd / 31835, 46911 / Approval Letter
18. / Cipla Ltd / 31836, 46856 / Approval Letter
19. / Cipla Ltd / 31837, 46916 / Approval Letter
20. / Cipla Ltd / 31838, 46845 / Approval Letter
21. / Cipla Ltd / 31839, 46850 / Approval Letter
22. / Cipla Ltd / 31840, 46836 / Approval Letter
23. / Cipla Ltd / 31842, 46822 / Approval Letter
24. / Cipla Ltd / 32117, 47535 / Approval Letter
25. / Cipla Ltd / 32118, 47530 / Approval Letter
26. / Cipla Ltd / 32119, 47531 / Approval Letter
27. / Cipla Ltd / 32120, 47534 / Approval Letter
28. / Cipla Ltd / 32121, 47506 / Approval Letter
29. / Cipla Ltd / 32122, 47496 / Approval Letter
30. / Cipla Ltd / 32123, 47499 / Approval Letter
31. / Cipla Ltd / 32124, 47502 / Approval Letter
32. / Cipla Ltd / 32125, 47553 / Approval Letter
33. / Cipla Ltd / 32126, 47560 / Approval Letter
34. / Cipla Ltd / 32127, 47563 / Approval Letter
35. / Cipla Ltd / 32128, 47567 / Approval Letter
36. / Cipla Ltd / 32109, 47544 / Approval Letter
37. / Cipla Ltd / 32110, 47545 / Approval Letter
38. / Cipla Ltd / 32111, 47547 / Approval Letter
39. / Cipla Ltd / 32112, 47550 / Approval Letter
40. / Cipla Ltd / 32113, 47491 / Approval Letter
41. / Cipla Ltd / 32114, 47542 / Approval Letter
42. / Cipla Ltd / 32115, 47540 / Approval Letter
43. / Cipla Ltd / 32116, 47537 / Approval Letter
44. / Dr. Reddy’s Laboratories Ltd. / 32057, 47286 / Approval Letter
45. / Dr. Reddy’s Laboratories Ltd. / 32058, 47281 / Approval Letter
46. / Dr. Reddy’s Laboratories Ltd. / 32059, 47278 / Approval Letter
47. / FDC Ltd / 32196, 47273 / Approval Letter
48. / FDC Ltd / 32195, 47191 / Approval Letter
49. / Fresenius Kabi Oncology Ltd / 32083, 47356 / Approval Letter
50. / Getz Pharma Research Pvt Ltd / 31789, 47011 / Approval Letter
51. / Getz Pharma Research Pvt Ltd / 31790, 47039 / Approval Letter
52. / Getz Pharma Research Pvt Ltd / 31792, 47042 / Approval Letter
53. / Getz Pharma Research Pvt Ltd / 31793, 47040 / Approval Letter
54. / Getz Pharma Research Pvt. Ltd / 32056, 47294 / Approval Letter
55. / Getz Pharma Research Pvt. Ltd / 32060, 47373 / Approval Letter
56. / Getz Pharma Research Pvt. Ltd / 32061, 47368 / Approval Letter
57. / Lupin Ltd / 32164, 47517 / Approval Letter
58. / Lupin Ltd / 32165, 47516 / Approval Letter
59. / Lupin Ltd / 32166, 47515 / Approval Letter
60. / Lupin Ltd / 32167, 47514 / Approval Letter
61. / Lupin Ltd / 32168, 47513 / Approval Letter
62. / Mylan Laboratories Ltd / 32197, 47262 / Approval Letter
63. / Mylan Laboratories Ltd / 32198, 47422 / Approval Letter
64. / RA Chem Pharma Ltd / 32037, 47464 / Approval Letter
65. / Sun Pharmaceutical Industries Ltd / 32084, 47324 / Approval Letter
66. / Sun Pharmaceutical Industries Ltd / 32085, 47299 / Approval Letter
67. / Torrent Pharmaceuticals Ltd / 32075, 47363 / Approval Letter
68. / Torrent Pharmaceuticals Ltd / 32076, 47359 / Approval Letter
69. / Unique Pharmaceutical Laboratories / 31812, 46972 / Approval Letter
70. / Vimta Labs Ltd / 32190, 47200 / Approval Letter
71. / Vimta Labs Ltd / 32191, 47428 / Approval Letter
72. / Vimta Labs Ltd / 32192, 47427 / Approval Letter
73. / Mylan Laboratories Ltd / 32199, 47418 / Approval Letter
74. / Mylan Laboratories Ltd / 32200, 47414 / Approval Letter
75. / Mylan Laboratories Ltd / 32201, 47240 / Approval Letter
76. / Johnson and Johnson Ltd / 32205, 47433 / Approval Letter
77. / Johnson and Johnson Ltd / 32206, 47439 / Approval Letter
78. / Johnson and Johnson Ltd / 32207, 47467 / Approval Letter
79. / Johnson and Johnson Ltd / 32212, 47471 / Approval Letter
80. / Johnson and Johnson Ltd / 32213, 47475 / Approval Letter
81. / Johnson and Johnson Ltd / 32213, 47430 / Approval Letter
82. / Actavis Pharma Development Centre Pvt. Ltd / 32229, 47466 / Approval Letter
83. / Actavis Pharma Development Centre Pvt. Ltd / 32230, 47458 / Approval Letter
84. / Actavis Pharma Development Centre Pvt. Ltd / 32231, 47498 / Approval Letter
85. / Actavis Pharma Development Centre Pvt. Ltd / 32232, 47493 / Approval Letter
86. / Actavis Pharma Development Centre Pvt. Ltd / 32233, 47489 / Approval Letter
87. / Actavis Pharma Development Centre Pvt. Ltd / 32234, 47472 / Approval Letter
88. / Sanofi-Synthelabo (India) Ltd. / 32251, 47387 / Approval Letter
89. / Sanofi-Synthelabo (India) Ltd. / 32252, 47376 / Approval Letter
90. / Emcure Pharmaceuticals Ltd / 32253, 47469 / Approval Letter
91. / Hospira Healthcare India Pvt. Ltd / 32254, 47392 / Approval Letter
92. / Hospira Healthcare India Pvt. Ltd / 32255, 47395 / Approval Letter