LETTERS FOR ISSUE ON 06.05.2014
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. BiogenIdec / 8474 / TL Approval Letter
2. / M/s. Sanofi / - / Clarification Letter
3. / M/s. Klinera / 10331/6989/6990 / Change in PI & Additional site Approval Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s GlaxoSmithKline Pharmaceuticals Ltd / Clarification Letter
2 / M/s Bio-Med (P) Ltd / 3621 / Clarification Letter
3 / M/s Intervet Pvt Ltd / 6449 / Clarification Letter
4 / M/s HLL Biotech Ltd / Clarification Letter
5 / M/S Intas pharmaceuticals Ltd / 18010 (fts no) / Clarification Letter
EXPORT OF BIOLOGICALS SAMPLES
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Cliantha research Ltd / 16707, 16708, 14511, 14809, 16231, 14510 / Approval Letter
2 / M/s Kemwell / 17419 / Approval Letter
3 / M/s Ratim research Ltd / 12220 / Approval Letter
4 / M/s Lambda Therapeutic Research Ltd / 15845 / Approval Letter
5 / M/s GVK Biosciences Pvt, Ltd / 13776 / Approval Letter
6 / M/s Accutest research Laboratories Ltd / 14810 / Approval Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Fresenius Medical Care India Pvt. Ltd., / 8255 / Clarification Letter
2. / M/s. Akums Drugs & Pharmaceuticals Ltd., / 16124 / Approval Letter
3. / M/s. Torrent Pharmaceuticals Pvt. Ltd., / 708 / Approval Letter
4. / M/s. Coastal Medicare Pvt. Ltd., / 43624 / Clarification Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Abbott Healthcare Pvt. Ltd. / 8280 / Approval (F-RC)
2. / M/s. Johnson & Johnson Ltd. / 55826 / Approval (F-RC)
3. / M/s. Johnson & Johnson Ltd. / 8424 / Approval (F-RC)
4. / M/s. Johnson& Johnson Ltd. / 55618 / Approval (F-RC)
5. / M/s. Boston Scientific India Pvt. Ltd. / 64236 / Approval (E-RC)
6. / M/s. Becton Dickinson India Pvt. Ltd. / 56268 / Approval (E-RC)
7. / M/s. Covidien Healthcare India Pvt. Ltd. / 57007 / Approval (E-RC)
8. / M/s. Advance Therapeutics Pvt. Ltd. / 10377 / Approval (F-IL)
9. / M/s. Abbott Healthcare Pvt. Ltd. / 27197 / Approval (F-IL)
10. / M/s. Hester Diagnostics Pvt. Ltd. / 10405 / Approval (F-IL)
11. / M/s. Innvolution Healthcare Pvt. Ltd. / 9130 / Approval (F-IL)
12. / M/s. Prathosh Medico. / 9129 / Approval (F-IL)
13. / M/s. Becton Dickinson India Pvt. Ltd. / 56268 / Approval (E-IL)
14. / M/s. Phoenix Cardio Care India Pvt. Ltd. / 9514 / Approval (E-IL)
15. / M/s. Innvolution Healthcare Pvt. Ltd. / 8711 / Approval (E-IL)
16. / The Joint Commissioner, Pune (CLAA)
The Deputy Drugs Controller (I), Mumbai (CLAA)
(M/s. Action Medical Marketing Pvt. Ltd.) / FTS-18270 / Approval Letter
17. / The Drugs Controller, Orissa (CLAA)
The Deputy Drugs Controller (I), Kolkata (CLAA)
(M/s. I.F.G.L. Refractories Ltd.) / FTS-17988 / Approval Letter
18. / The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Ahmedabad (CLAA)
(M/s. MIV Therapeutics (I) Pvt. Ltd.) / FTS-15675 / Approval Letter
19. / The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Ahmedabad (CLAA)
(M/s. Smith Medimed Pvt. Ltd.) / FTS-8203 / Approval Letter
20. / The Drugs Controller & Licensing Authority, Jaipur (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Vitromed Healthcare, Jaipur) / FTS-16113 / Approval Letter
21. / M/s. Becton Dickinson India Pvt. Ltd. / 9994 / Query Letter
22. / M/s. Becton Dickinson India Pvt. Ltd. / 45629 / Query Letter
23. / M/s. Clinicare (India) Pvt. Ltd. / 64911 / Query Letter
24. / M/s. Cipla Ltd. / 10957 / Query Letter
25. / M/s. Cipla Ltd. / 10956 / Query Letter
26. / M/s. Globe Biomedicals. / Nil / Query Letter
27. / M/s. Johnson & Johnson Ltd. / 59006 / Query Letter
28. / M/s. Johnson & Johnson Ltd. / 60050 / Query Letter
29. / M/s. IntasMedi Devices Ltd.
All Port offices of CDSCO / Nil / Query Letter
30. / M/s. India Medtronic Pvt. Ltd. / 62059 / Query Letter
31. / M/s. Medi Plus India Ltd. / 12997 / Query Letter
32. / M/s. SandorMedicaids Pvt. Ltd. / 56460 / Query Letter
33. / M/s. J.K. Ansell Ltd. / 9796 / Query Letter
34. / M/s. J.Mitra& Bros. / 9517 / Clarification Letter
35. / M/s. Nanz Med Science Pharma (P) Ltd. / 10462 / Clarification Letter
36. / M/s. Terumo Penpol Ltd. / 2710 / Clarification Letter
37. / Dr. V. Bhujanga Rao. / FTS-14357 / Clarification Letter
38. / The Drugs Controller & Licensing Authority, Jaipur (CLAA)
(M/s. Dr. Surgical, Rajasthan) / FTS-72148 / Query Letter
39. / M/s. La-Med Healthcare Pvt. Ltd., Faridabad (CLAA) / FTS-16105 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Becton Dickinson India Pvt. Ltd. / 8728 / Approval (IL)
2. / M/s. Rapha Diagnostics Pvt. Ltd. / 9934 / Approval (IL)
3. / M/s. Thermo Fisher Scientific India Pvt. Ltd. / 8569 / Approval (IL)
4. / M/s. Abbott Healthcare Pvt. Ltd. / 9721 / Approval (E-IL)
5. / M/s. Avantor Performance Materials India Ltd. / 9980 / Approval (TL)
6. / M/s. Bio State. / 10332 / Approval (TL)
7. / M/s. Roche Diagnostics India Pvt. Ltd. / 10452 / Approval (TL)
8. / M/s. M M Trading Company. / 12328 / Query Letter
9. / M/s. Pammvi Exports Pvt. Ltd. / 9288 / Query Letter
10. / M/s. Roche Diagnostic India Pvt. Ltd. / 63032 / Query Letter
11. / M/s. Roche Diagnostic India Pvt. Ltd. / 10454 / Query Letter
12. / M/s. Roche Diagnostic India Pvt. Ltd. / 60333 / Query Letter
13. / M/s. Roche Diagnostic India Pvt. Ltd. / 60290 / Query Letter
14. / M/s. Sri Balaji Enterprises. / 13323 / Query Letter
15. / M/s. Vinay Brothers (Diagnostics). / 10752 / Query Letter
16.
17.
COSMETICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. JCKRC SPA Destination Private Limited, Mumbai / 9121 / Approval Letter
2. / M/s. Aluxure Bio Sciences International Private Limited, Rajasthan / 11869 / Approval Letter
3. / M/s. Forever Living Imports (I) Private Limited, Mumbai / 6701 / Approval Letter
4. / M/s. Argus Cosmetics Limited, Tamil Nadu / 7839 / Approval Letter
5. / M/s. Emerald Isle Luxe Private Limited, Mumbai / 9272 / Approval Letter
6. / M/s. Glosel India Impex Pvt. Ltd, Chennai / 12511 / Approval Letter
7. / Dr. A S Clinic Pvt. Ltd, New Delhi / 10391 / Approval Letter
8. / M/s. Nutra Skyn Care, Mumbai / 12605 / Approval Letter
9. / M/s. J L Morison India Limited, Mumbai / 8490, 8491 / Approval Letter
10. / M/s. Sohum autogas systems Private Limited, Pune / 10695 / Approval Letter
11. / M/s. ASI International Private, New Delhi / 11361 / Approval Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Actavis Pharma Development Centre Pvt Ltd / 13352, 20945 / Approval Letter
2. / Actavis Pharma Development Centre Pvt Ltd / 13353, 20944 / Approval Letter
3. / Actavis Pharma Development Centre Pvt Ltd / 13360, 20937 / Approval Letter
4. / Agila Specialties Pvt Ltd / 12889, 19895 / Approval Letter
5. / Alembic Pharmaceuticals Ltd / 13548, 20573 / Approval Letter
6. / Alembic Pharmaceuticals Ltd / 13549, 20572 / Approval Letter
7. / Alkem Laboratories Ltd / 13461, 20886 / Approval Letter
8. / Alkem Laboratories Ltd / 13462, 20893 / Approval Letter
9. / Alphamed Formulations Pvt Ltd / 13043, 19791 / Approval Letter
10. / Alphamed Formulations Pvt Ltd / 13042, 19793 / Approval Letter
11. / APL Research Centre / 13145, 20830 / Approval Letter
12. / Apotex Research Pvt Ltd / 13470, 20878 / Approval Letter
13. / Apotex Research Pvt Ltd / 13469, 20882 / Approval Letter
14. / Apotex Research Pvt Ltd / 13468, 20884 / Approval Letter
15. / Apotex Research Pvt Ltd / 12908, 19940 / Approval Letter
16. / Apotex Research Pvt Ltd / 12909, 19939 / Approval Letter
17. / Apotex Research Pvt Ltd. / 13471, 20873 / Approval Letter
18. / Apotex Research Pvt Ltd. / 13472, 20869 / Approval Letter
19. / Apotex Research Pvt Ltd. / 13473, 20864 / Approval Letter
20. / Apotex Research Pvt Ltd. / 13474, 20860 / Approval Letter
21. / Cadila Healthcare Limited / 13300, 20017 / Approval Letter
22. / Cadila Healthcare Limited / 13301, 20018 / Approval Letter
23. / Cadila Healthcare Limited / 13311, 20013 / Approval Letter
24. / Cipla Ltd / 13573, 20460 / Approval Letter
25. / Cipla Ltd / 13574, 20456 / Approval Letter
26. / Cipla Ltd / 13575, 20453 / Approval Letter
27. / Cipla Ltd / 13576, 20478 / Approval Letter
28. / Cipla Ltd / 13577, 20476 / Approval Letter
29. / Cipla Ltd / 13578, 20473 / Approval Letter
30. / Cipla Ltd / 13579, 20470 / Approval Letter
31. / Cipla Ltd / 13580, 20467 / Approval Letter
32. / Cipla Ltd / 13582, 20490 / Approval Letter
33. / Cipla Ltd / 13583, 20484 / Approval Letter
34. / Cipla Ltd / 13584, 20482 / Approval Letter
35. / Cipla Ltd / 13581, 20464 / Approval Letter
36. / Cipla Ltd / 12812, 19441 / Approval Letter
37. / Cipla Ltd / 12814, 19436 / Approval Letter
38. / Cipla Ltd / 12816, 19433 / Approval Letter
39. / Cipla Ltd / 12815, 19431 / Approval Letter
40. / Dr. Reddy’s Laboratories Ltd / 13378, 20818 / Approval Letter
41. / Glenmark Generics Ltd / 13045, 19774 / Approval Letter
42. / Glenmark Generics Ltd / 13057, 19768 / Approval Letter
43. / Glenmark Generics Ltd / 13044, 19776 / Approval Letter
44. / Granules India Ltd / 13535, 20908 / Approval Letter
45. / Inventia Healthcare Pvt Ltd / 12892, 19892 / Approval Letter
46. / Ipca Laboratories Ltd / 13456, 20902 / Approval Letter
47. / Ipca Laboratories Ltd / 13458, 20898 / Approval Letter
48. / Ipca Laboratories Ltd / 13457, 20900 / Approval Letter
49. / Ipca Laboratories Ltd / 13459, 20897 / Approval Letter
50. / Ipca Laboratories Ltd / 13460, 20895 / Approval Letter
51. / Ipca Laboratories Ltd / 13455, 20909 / Approval Letter
52. / Ipca Laboratories Ltd / 13074, 19898 / Approval Letter
53. / Ipca Laboratories Ltd / 13073, 19899 / Approval Letter
54. / Jubilant Life Sciences Ltd / 13559, 20578 / Approval Letter
55. / Jubilant Life Sciences Ltd / 13560, 20568 / Approval Letter
56. / Jubilant Life Sciences Ltd / 13561, 20566 / Approval Letter
57. / Jubilant Life Sciences Ltd / 13562, 20563 / Approval Letter
58. / Jubilant Life Sciences Ltd / 13563, 20560 / Approval Letter
59. / Jubilant Life Sciences Ltd / 13567, 20558 / Approval Letter
60. / Lupin Ltd / 13505, 20850 / Approval Letter
61. / Lupin Ltd / 13513, 20813 / Approval Letter
62. / Lupin Ltd / 13512, 20836 / Approval Letter
63. / Lupin Ltd / 13507, 20846 / Approval Letter
64. / Lupin Ltd / 13508, 20843 / Approval Letter
65. / Lupin Ltd / 13509, 20842 / Approval Letter
66. / Lupin Ltd / 13510, 20840 / Approval Letter
67. / Lupin Ltd / 13511, 20839 / Approval Letter
68. / Lupin Ltd / 13506, 20847 / Approval Letter
69. / MSN Laboratories Pvt Ltd / 12868, 19964 / Approval Letter
70. / MSN Laboratories Pvt Ltd / 12865, 19963 / Approval Letter
71. / MSN Laboratories Pvt Ltd / 12863, 19965 / Approval Letter
72. / Par Formulations Pvt Ld / 12933, 19962 / Approval Letter
73. / Par Formulations Pvt Ld / 12910, 19961 / Approval Letter
74. / Par Formulations Pvt Ld / 12928, 19960 / Approval Letter
75. / Par Formulations Pvt Ld / 12929, 19959 / Approval Letter
76. / RA ChemPharma Ltd / 13380, 20576 / Approval Letter
77. / Ranbaxy Laboratories Ltd / 13409, 20929 / Approval Letter
78. / Ranbaxy Laboratories Ltd / 13419, 20913 / Approval Letter
79. / Ranbaxy Laboratories Ltd / 13418, 20914 / Approval Letter
80. / Ranbaxy Laboratories Ltd / 13416, 20918 / Approval Letter
81. / Ranbaxy Laboratories Ltd / 13415, 20920 / Approval Letter
82. / Ranbaxy Laboratories Ltd / 13414, 20921 / Approval Letter
83. / Ranbaxy Laboratories Ltd / 13413, 20923 / Approval Letter
84. / Ranbaxy Laboratories Ltd / 13412, 20924 / Approval Letter
85. / Ranbaxy Laboratories Ltd / 13411, 20926 / Approval Letter
86. / Ranbaxy Laboratories Ltd / 13410, 20928 / Approval Letter
87. / Ranbaxy Laboratories Ltd / 13420, 20912 / Approval Letter
88. / Ranbaxy Laboratories Ltd / 13454, 20910 / Approval Letter
89. / Ranbaxy Laboratories Ltd / 13421, 20911 / Approval Letter
90. / Ranbaxy Laboratories Ltd / 13417, 20916 / Approval Letter
91. / Sentiss Pharma Pvt Ltd / 13007, 19936 / Approval Letter
92. / Shasun Pharmaceuticals Ltd / 13322, 20827 / Approval Letter
93. / Sitec Labs Pvt Ltd / 13392, 20906 / Approval Letter
94. / Sitec Labs Pvt Ltd / 13393, 20904 / Approval Letter
95. / Sun Pharma / 13351, 20942 / Approval Letter
96. / Suven Life Sciences / 13362, 20932 / Approval Letter
97. / Suven Life Sciences / 13361, 20933 / Approval Letter
98. / Unichem Lab Ltd / 13056, 19782 / Approval Letter
99. / Unichem Lab Ltd / 13055, 19784 / Approval Letter
100. / Unichem Lab Ltd / 13054, 19785 / Approval Letter
101. / Unique Pharmaceutical Laboratories / 13333, 20441 / Approval Letter
102. / Watson Pharma Pvt. Ltd / 13379, 20881 / Approval Letter
103. / Tevapharm India Pvt Ltd / 17262, 25781, 12139, 18328, 17261, 25992, 9660, 14996 / Deficiency Letter
104. / Encube Ethicals Pvt Ltd / 14258, 21752 / Deficiency Letter
105. / Lupin Ltd / 18409, 27649 / Amendment Letter
106. / Orbicular Pharmaceutical Technologies Pvt Ltd / 17665, 26473 / Amendment Letter
107. / Polypeptide Laboratories Pvt Ltd / 18649, 27865 / Amendment Letter
108. / Ranbaxy Laboratories Ltd / 17632, 26454 / Amendment Letter
109. / Resonance Laboratories Pvt Ltd / 17703, 26759 / Amendment Letter
110. / Resonance Laboratories Pvt Ltd / 18364, 27593 / Amendment Letter
111. / Strides Arcolab Ltd / 18365, 27582 / Amendment Letter
WRITTEN CONFIRMATION