Letters for Issue On20.10.2014

LETTERS FOR ISSUE ON20.10.2014

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Asiatic / 38899 / Clarification Letter
2. / M/s. BIOCAD / 39406 / Clarification Letter
3. / M/s. BMS / 39419 / Clarification Letter
4. / M/s. Novartis / 28697/38135/41526 / Export NOC Approval/TL Approval
5. / M/s. Boehringer / 30384 / Change in PI Approval
6. / M/s.Parexel / 33358 / Clarification Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Carl Zeiss India (Bangalore) Pvt. Ltd. / 30403 / Query Letter
M/s. Regenerative Medical Services Pvt. Ltd. / 30302 / Query Letter
M/s. Venus Medical Products. / 19863 / Query Letter
M/s. Translumina Therapeutics. / FTS-54196 / Query Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Dazzle Bio Systems Pvt. Ltd. / 36987 / Query Letter
M/s. Diasorin Trivitron Healthcare Pvt. Ltd. / 33693 / Query Letter
M/s. KHC Healthcare India Pvt. Ltd. / 33629 / Query Letter
M/s. Medispec India Ltd. / 37091 / Letter
M/s. Sandor Medicaids Pvt. Ltd. / 35332 / Query Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 34877 / Rejection Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 40820 / Test Licence
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 40835 / Test Licence
M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 42086 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 42338 / Test Licence
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 23770 / Approval Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 42281 / Approval Letter
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 30663 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42155 / Clarification Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42157 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42158 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42159 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42330 / Test Licence
M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 48854 / Additional Study Centre
M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 41029 / Rejection Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 39477 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 37718 / Rejection Letter
M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 39471 / Amendment Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 42317 / Approval Letter
M/s. Lupin Limited (Research Park), Pune-411 042 / 42319 / Approval Letter
M/s. Manipal Acunova Ltd., Manipal-576 104 / 41658 / Clarification Letter
M/s. QPS Bioserve Clinical Research Pvt. Ltd., Hyderabad-500 037 / 42349 / Clarification Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 41968 / Clarification Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 41968 / Clarification Letter
M/s. Wockhardt Limited, Aurangabad-431 210 / 10216 / Approval Letter

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
1. / ActavisPharma Development Centre Pvt. Ltd / 40765,59872 / Approval Letter
2. / ActavisPharma Development Centre Pvt. Ltd / 40766, 59871 / Approval Letter
3. / ActavisPharma Development Centre Pvt. Ltd / 40767, 59869 / Approval Letter
4. / ActavisPharma Development Centre Pvt. Ltd / 40768, 59867 / Approval Letter
5. / ActavisPharma Development Centre Pvt. Ltd / 40769, 59863 / Approval Letter
6. / ActavisPharma Development Centre Pvt. Ltd / 40764, 59874 / Approval Letter
7. / Aizant Drug Research Solutions Pvt Ltd / 40652, 60035 / Approval Letter
8. / Akums Drugs & Pharmaceuticals Ltd / 40785, 60068 / Approval Letter
9. / Alkem Laboratories Ltd / 40719, 59794 / Approval Letter
10. / Alkem Laboratories Ltd / 40718, 59795 / Approval Letter
11. / Alkem Laboratories Ltd / 40722, 59791 / Approval Letter
12. / Alkem Laboratories Ltd / 40721, 59792 / Approval Letter
13. / Alkem Laboratories Ltd / 40720, 59793 / Approval Letter
14. / Alkem Laboratories Ltd / 60303, 40992 / Approval Letter
15. / Alkem Laboratories Ltd / 40993, 60302 / Approval Letter
16. / Alkem Laboratories Ltd / 40994, 60298 / Approval Letter
17. / APL Research Centre / 40677, 59935 / Approval Letter
18. / APL Research Centre / 40680, 59934 / Approval Letter
19. / APL Research Centre / 40679, 59941 / Approval Letter
20. / APL Research Centre / 40678, 60021 / Approval Letter
21. / APL Research Centre / 40681, 59790 / Approval Letter
22. / APL Research Centre / 40675, 59938 / Approval Letter
23. / APL Research Centre / 40676, 59937 / Approval Letter
24. / APL Research Centre / 40674, 59936 / Approval Letter
25. / Cipla Ltd / 40698, 59788 / Approval Letter
26. / Dr. Reddy’s Laboratories Ltd / 40699, 59843 / Approval Letter
27. / Dr. Reddy’s Laboratories Ltd / 40700,59840 / Approval Letter
28. / Dr. Reddy’s Laboratories Ltd / 40701, 59836 / Approval Letter
29. / Dr. Reddy’s Laboratories Ltd / 40694, 59833 / Approval Letter
30. / Dr. Reddy’s Laboratories Ltd / 40695, 59817 / Approval Letter
31. / Dr. Reddy’s Laboratories Ltd / 40696, 59813 / Approval Letter
32. / Dr. Reddy’s Laboratories Ltd / 40697, 59810 / Approval Letter
33. / Emcure Pharmaceuticals Ltd / 40642, 60076 / Approval Letter
34. / Emcure Pharmaceuticals Ltd / 40645, 60090 / Approval Letter
35. / Emcure Pharmaceuticals Ltd / 40644, 60085 / Approval Letter
36. / Emcure Pharmaceuticals Ltd / 40643, 60081 / Approval Letter
37. / Glenmark Generics Ltd / 40942, 60194 / Approval Letter
38. / Glenmark Generics Ltd / 40943, 60188 / Approval Letter
39. / Glenmark Generics Ltd / 40944, 60186 / Approval Letter
40. / Glenmark Generics Ltd / 40941, 60195 / Approval Letter
41. / Glenmark Generics Ltd / 40938, 60202 / Approval Letter
42. / Glenmark Generics Ltd / 40939, 60200 / Approval Letter
43. / Glenmark Generics Ltd / 40940, 60198 / Approval Letter
44. / Indoco Remedies Ltd / 40653, 59933 / Approval Letter
45. / Indoco Remedies Ltd / 40654, 59932 / Approval Letter
46. / Indoco Remedies Ltd / 40655, 59931 / Approval Letter
47. / Indoco Remedies Ltd / 40656, 59925 / Approval Letter
48. / Indoco Remedies Ltd / 40657, 59924 / Approval Letter
49. / Indoco Remedies Ltd / 40658, 59923 / Approval Letter
50. / Indoco Remedies Ltd / 40659, 59922 / Approval Letter
51. / Intas Pharmaceuticals Ltd / 41000, 60150 / Approval Letter
52. / Intas Pharmaceuticals Ltd / 41005, 60151 / Approval Letter
53. / Intas Pharmaceuticals Ltd / 41004, 60153 / Approval Letter
54. / Intas Pharmaceuticals Ltd / 41003, 60155 / Approval Letter
55. / Intas Pharmaceuticals Ltd / 41002, 60158 / Approval Letter
56. / Intas Pharmaceuticals Ltd / 41001, 60159 / Approval Letter
57. / Jubilant Generics Ltd / 40762, 60034 / Approval Letter
58. / Jubilant Generics Ltd / 40763, 59918 / Approval Letter
59. / Lupin Ltd / 40740, 60024 / Approval Letter
60. / Lupin Ltd / 40741, 60026 / Approval Letter
61. / Lupin Ltd / 40733, 60028 / Approval Letter
62. / Macleods Pharmaceuticals Ltd / 40761, 60032 / Approval Letter
63. / Macleods Pharmaceuticals Ltd / 40760, 60030 / Approval Letter
64. / Macleods Pharmaceuticals Ltd / 40426, 59501 / Approval Letter
65. / Micro Labs Ltd / 40868, 60229 / Approval Letter
66. / Micro Labs Ltd / 40867, 60233 / Approval Letter
67. / Micro Labs Ltd / 40870, 60224 / Approval Letter
68. / Micro Labs Ltd / 40866, 60234 / Approval Letter
69. / Micro Labs Ltd / 40869, 60227 / Approval Letter
70. / Novartis Healthcare Pvt Ltd / 40715, 60095 / Approval Letter
71. / Novartis Healthcare Pvt Ltd / 40714, 60072 / Approval Letter
72. / Novartis Healthcare Pvt Ltd / 40716, 60099 / Approval Letter
73. / Ranbaxy Laboratories Ltd / 40918, 60219 / Approval Letter
74. / Suven Life Sciences Limited / 40947, 60201 / Approval Letter
75. / Suven Life Sciences Limited / 40946, 60204 / Approval Letter
76. / Syngene International Limited / 40887, 60271 / Approval Letter
77. / Syngene International Limited / 40886, 60268 / Approval Letter
78. / Syngene International Limited / 40884, 60057 / Approval Letter
79. / Syngene International Limited / 40885, 60054 / Approval Letter
80. / Syngene International Limited / 40858, 60197 / Approval Letter
81. / Torrent Pharmaceuticals Ltd / 40632, 60012 / Approval Letter
82. / Torrent Pharmaceuticals Ltd / 40633, 60008 / Approval Letter
83. / Torrent Pharmaceuticals Ltd / 40634, 60005 / Approval Letter
84. / Torrent Pharmaceuticals Ltd / 40635, 60001 / Approval Letter
85. / Torrent Pharmaceuticals Ltd / 40636, 59999 / Approval Letter
86. / Torrent Pharmaceuticals Ltd / 40637, 59995 / Approval Letter
87. / Torrent Pharmaceuticals Ltd / 40638, 59990 / Approval Letter
88. / Torrent Pharmaceuticals Ltd / 40639, 59986 / Approval Letter
89. / Torrent Pharmaceuticals Ltd / 40641, 59939 / Approval Letter
90. / Torrent Pharmaceuticals Ltd / 40986, 60245 / Approval Letter
91. / Torrent Pharmaceuticals Ltd / 40987, 60254 / Approval Letter
92. / Torrent Pharmaceuticals Ltd / 40982, 60257 / Approval Letter
93. / Torrent Pharmaceuticals Ltd / 40981, 60262 / Approval Letter
94. / Torrent Pharmaceuticals Ltd / 40980, 60264 / Approval Letter
95. / Torrent Pharmaceuticals Ltd / 40988, 60266 / Approval Letter
96. / Torrent Pharmaceuticals Ltd / 40985, 60250 / Approval Letter
97. / Torrent Pharmaceuticals Ltd / 40984, 60242 / Approval Letter
98. / Torrent Pharmaceuticals Ltd / 40983, 60239 / Approval Letter
99. / Watson Pharma Pvt Ltd / 40783, 59808 / Approval Letter
100. / Watson Pharma Pvt Ltd / 40784, 59804 / Approval Letter
101. / Zydus Hospira Oncology Pvt. Ltd / 40729, 59789 / Approval Letter
102. / Zydus Hospira Oncology Pvt. Ltd / 40730, 59920 / Approval Letter
103. / Zydus Hospira Oncology Pvt. Ltd / 40731, 59921 / Approval Letter
104. / Zydus Hospira Oncology Pvt. Ltd / 40732, 59919 / Approval Letter

WRITTEN CONFIRMATION

INTERNATIONAL CELL

S. No / Firm Name / Type of Letter
1-3 / M/s. Cipla Ltd., / Letter
4. / M/s. Lupin Limited., / Letter
5. / M/s. Symbiotec Pharma Labs Limited., / Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Lincoln Pharmaceuticals Ltd., / 29293 / 43335 / Deficiency Letter
M/s Intas / - / - / Letter
M/s GSK / - / - / Letter
M/s Troikaa / - / - / Letter

VACCINE DIVISION

S. No. / COMPANY NAME / Dy. No. / STATUS
1 / M/s Shantha Biotechnices Ltd / 39383 / Approval Letter
2 / M/s VHB Life Sciences Ltd / 21789 / Clarification Letter
3 / M/s Panacea Biotech Ltd / 29101 / Clarification Letter
4 / M/s Hestero Drugs Ltd / 25886, 30300 / Clarification Letter
5 / M/s Optimus Pharma Consulting / Approval Letter
6 / M/s Novo Nordisk India Pvt, ltd / Clarification Letter
8 / M/s Novartis Healthcare Pvt, ltd / 20752 / Clarification Letter
9 / M/s Intas Pharmaceuticals Ltd / 37468 / Clarification Letter
10 / M/s Wochardt ltd / 5786 / Approval Letter
11 / M/s Sanofi-Synthelabo India Ltd / 26928 / Clarification Letter
12 / M/s GSK Pharmaceuticals ltd / 23016, 28522, 40179, 6200 / Clarification Letter & Approval Letter
13 / M/s Bristol Myers Squibb India Pvt, ltd / 21478 / Clarification Letter
14 / M/s Serum Institute of India Ltd / 40582 / Approval Letter
15 / M/s Agila Specialties Pvt, ltd / 38004 / Approval Letter
16 / M/s Cadila Healthcare ltd / 40114 / Approval Letter
17 / M/s Symmetrix Biotech Pvt, ltd / 32828 / Approval Letter
18 / M/s Lupin Ltd / 36773 / Clarification Letter
19 / M/s Reliance Life Sciences Pvt, ltd / 10004 / Clarification Letter
20 / M/s VINS Bioproducts Ltd / 47965(fts no) / Approval letter

REGISTRAION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
APOTHECARIES PVT. LTD / 21219 / Clarification letter
SANOFI-SYNTHELABO IDNIA LTD. / 36967 / Clarification letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Maya clinical / - / NDAC Meeting Letter
2. / M/s. Novartis / - / NDAC Meeting Letter
3. / M/s. Novo Nordisk / - / NDAC Meeting Letter
4. / M/s. Kendle / - / NDAC Meeting Letter

WRITTEN CONFIRMATION

S. No / Firm Name / Type of Letter
1. / M/s. Andhra Medi Pharma India Pvt. Limited., / WC Letter

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 42098 / Approval Letter
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 42087 / Test Licence
M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 42368 / Test Licence
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 42337 / Approval Letter
M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 42282 / Approval Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 41582 / Approval Letter
M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 27216 / Rejection Letter
M/s. Biocon Limited, Bangalore-560 100 / 41698 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42168 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42183 / Test Licence
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42161 / Test Licence
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 42335 / Approval Letter
M/s. Jubilant Generics Ltd., Noida-201 301, UP / 42470 / Test Licence
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 42241 / Approval Letter
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 39663 / Test Licence
M/s. Lupin Limited (Research Park), Pune-411 042 / 42321 / Approval Letter
M/s. MSN Laboratories Ltd., Hyderabad-500 018 / 39210 / Test Licence
M/s. MSN Laboratories Pvt. Ltd., Medak District, Telangana / 42220 / Approval Letter
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 41989 / Clarification Letter
M/s. Raptim Research Ltd., Navi Mumbai-400 701 / 42296 / Test Licence
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 42170 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 42169 / Test Licence
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 24918 / Rejection Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 25727 / Rejection Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 24919 / Rejection Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 26448 / Rejection Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 25729 / Rejection Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 42261 / Approval Letter
M/s. Wockhardt Limited, Aurangabad-431 006 / 29147 / Rejection Letter