LETTERS FOR ISSUE ON 28.08.2014
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Swati Spentose Private Limited. / WC Letter
EXPORT NOC
INTERNATIONAL CELL
S. No / Firm Name / Type of Letter1. / M/s. Ray Chemicals Private Limited. / Letter
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 / 29417 / Amendment Letter
2. / M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 20751 / Amendment Letter
3. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 28692 / Amendment Letter
4. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 32750 / Approval Letter
5. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 10653 / Approval Letter
6. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 13838 / Approval Letter
7. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 32527 / Amendment Letter
8. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 32173 / Amendment Letter
9. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 7843 / Rejection Letter
10. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 32636 / Amendment Letter
11. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 32635 / Amendment Letter
12. / M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 29981 / Approval Letter
13. / M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 29984 / Approval Letter
14. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 30103 / Amendment Letter
15. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 22038 / Amendment Letter
16. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 32819 / Amendment Letter
17. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 25976 / Approval Letter
18. / M/s. Hetero Labs Ltd., Hyderabad-500 018 / 32562 / Approval Letter
19. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 31940 / Amendment Letter
20. / M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 14399 / Amendment Letter
21. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 22730 / Approval Letter
22. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 / 29759 / Amendment Letter
23. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560034 / 32807 / Approval Letter
24. / M/s. Lupin Bioresearch Center, Pune-411 021 / 25369 / Clarification Letter
25. / M/s. Lupin Bioresearch Center, Pune-411 021 / 16399 / Approval Letter
26. / M/s. Mylan Laboratories Limited, Secunderabad / 25133 / Amendment Letter
27. / M/s. Mylan Laboratories Limited, Secunderabad / 31135 / Amendment Letter
28. / M/s. Quest Life Sciences (P) Ltd., Chennai-600045 / 21608 / Approval Letter
29. / M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 25391 / Additional Study Centre
30. / M/s. Semler Research Center Pvt. Ltd., Bangalore-560078 / 13623 / Approval Letter
31. / M/s. Semler Research Center, Bangalore-560078 / 33427 / Approval Letter
32. / M/s. Sipra Labs Limited, Hyderabad-500 018 / 34334 / Approval Letter
33. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 33618 / Approval Letter
34. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 26992 / Amendment Letter
35. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 18421 / Amendment Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Famy Care Ltd., Mumbai-400 001 / 22637 / Test Licence
2. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 30353 / Test Licence
3. / M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 32479 / Test Licence
4. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 26409 / Test Licence
5. / M/s. Lupin Bioresearch Center, Pune-411 021 / 29549 / Test Licence
6. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 30769 / Test Licence
7. / M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015 / 25254 / Test Licence
8. / M/s. Semler Research Center, Bangalore-560078 / 34880 / Test Licence
9. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 24488 / Test Licence
10. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 32622 / Test Licence
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Dr. P.V.Dave. / - / Query Letter
2. / M/s Hetero Labs Ltd. / - / BE NOC Letter (2)
3. / M/s Akums Drugs and Pharmaceuticals Ltd. / - / Query Letter
4. / M/s. Biogen Idec Biotech India / - / Approval Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Creative Health Care Pvt. Ltd., / 42909 / Clarification Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Ranbaxy Laboratories Ltd., / 7050 / 10963 / Deficiency Letter
2. / M/s GlaxoSmithkline Pharmaceuticals Ltd., / 26122 / 38455 / Deficiency Letter
3. / M/s CD Pharma India Pvt. Ltd., / 16727 / 25159 / Deficiency Letter
4. / Torrent Pharmaceuticals Ltd., / 5306 / 8456 / Deficiency Letter
5. / M/s Cipla Ltd., / 26270 / - / BE NOC Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Bharat Biotech International Ltd / 28027 / Clarification letter
2 / M/s GSK Asia Pvt, Limited / 31630, 28728 / Approval Letter
3 / M/s Globion India Pvt, Ltd / 23831 / Approval Letter
5 / M/s Johnson & Johnson Ltd / 44902, 28093 / Approval Letter
6 / M/s Reliance Life Sciences Pvt, Ltd / 26949 / Acknowledge Letter
7 / M/s Intas Pharmaceuticals Ltd / 13842 / Approval Letter
8 / Dr. Reddy’s Laboratories Ltd / 41751 / Approval Letter
9 / M/s Biogen Idec Biotech India Pvt, ltd / Clarification letter
10 / M/s Wockhardt Ltd / 22767 / Clarification letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Biological E. Ltd / 24198 / Approval Letter
2 / M/s Cadila Healthcare Ltd / 43694, 42154 / Approval Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Aarti Drugs Ltd / 32202, 47224 / Approval Letter
2. / Aarti Drugs Ltd / 32203, 47203 / Approval Letter
3. / Aarti Drugs Ltd / 32209, 47479 / Approval Letter
4. / Aarti Drugs Ltd / 32210, 47482 / Approval Letter
5. / Aarti Drugs Ltd / 32211, 47486 / Approval Letter
6. / Alembic Pharmaceuticals Ltd / 33384, 49174 / Approval Letter
7. / APL Research Centre / 33419, 49255 / Approval Letter
8. / APL Research Centre / 33420, 49098 / Approval Letter
9. / APL Research Centre / 33421, 49256 / Approval Letter
10. / APL Research Centre / 33422, 49092 / Approval Letter
11. / Athena Drug Delivery Solutions Pvt. Ltd. / 33265, 48837 / Approval Letter
12. / Bayer Pharmaceuticals Pvt. Ltd / 33359, 49219 / Approval Letter
13. / Cadila Pharmaceutical Limited / 33314, 49182 / Approval Letter
14. / Cadila Pharmaceutical Limited / 33315, 49179 / Approval Letter
15. / Celogen Life Sciences and Technologies Pvt Ltd / 33333, 49079 / Approval Letter
16. / Cipla Ltd / 31841, 46833 / Approval Letter
17. / Cipla Ltd / 31829, 46828 / Approval Letter
18. / Cipla Ltd / 32888, 48381 / Approval Letter
19. / Dr. Reddy’s Laboratories Ltd / 33385, 49222 / Approval Letter
20. / Dr. Reddy’s Laboratories Ltd / 33386, 49224 / Approval Letter
21. / Emcure Pharmaceuticals Ltd / 33268, 48967 / Approval Letter
22. / Emcure Pharmaceuticals Ltd / 33269, 48961 / Approval Letter
23. / Hetero Labs Ltd / 33304, 48725 / Approval Letter
24. / Hetero Labs Ltd / 33305, 48717 / Approval Letter
25. / Johnson and Johnson Ltd / 33408, 49236 / Approval Letter
26. / Johnson and Johnson Ltd / 33409, 49230 / Approval Letter
27. / Johnson and Johnson Ltd / 33410, 49234 / Approval Letter
28. / Johnson and Johnson Ltd / 33411, 49227 / Approval Letter
29. / Johnson and Johnson Ltd / 33412, 49242 / Approval Letter
30. / Lupin Ltd / 33374, 49078 / Approval Letter
31. / Lupin Ltd / 33375, 49077 / Approval Letter
32. / Lupin Ltd / 33376, 49076 / Approval Letter
33. / Lupin Ltd / 33377, 49075 / Approval Letter
34. / Lupin Ltd / 33378, 49074 / Approval Letter
35. / Lupin Ltd / 33379, 49073 / Approval Letter
36. / Lupin Ltd / 33380, 49072 / Approval Letter
37. / Lupin Ltd / 33381, 49071 / Approval Letter
38. / Lupin Ltd / 33382, 49070 / Approval Letter
39. / Lupin Ltd / 33383, 49069 / Approval Letter
40. / Macleods Pharmaceuticals Ltd / 33292, 48877 / Approval Letter
41. / Macleods Pharmaceuticals Ltd / 33293, 48875 / Approval Letter
42. / Medreich Ltd / 33360, 49168 / Approval Letter
43. / Novartis Healthcare Pvt Ltd / 33270, 48771 / Approval Letter
44. / Novartis Healthcare Pvt Ltd / 33271, 48767 / Approval Letter
45. / Novartis Healthcare Pvt Ltd / 33272, 48764 / Approval Letter
46. / Novartis Healthcare Pvt Ltd / 33273, 48761 / Approval Letter
47. / Novartis Healthcare Pvt Ltd / 33274, 48760 / Approval Letter
48. / Novartis Healthcare Pvt Ltd / 33275, 48758 / Approval Letter
49. / Ranbaxy Laboratories Ltd / 33458, 49197 / Approval Letter
50. / Raptim Research Ltd / 33465, 49204 / Approval Letter
51. / Sharon Bio-Medicine Ltd / 33291, 48846 / Approval Letter
52. / Sun Pharmaceutical Industries Ltd / 33390, 49210 / Approval Letter
53. / Syngene International Limited / 33334, 49258 / Approval Letter
54. / Syngene International Limited / 33335, 49259 / Approval Letter
55. / Teva India Pvt. Ltd / 33329, 49190 / Approval Letter
56. / Teva India Pvt. Ltd / 33330, 49085 / Approval Letter
57. / Teva India Pvt. Ltd / 33331, 49083 / Approval Letter
58. / Tevapharm India Pvt. Ltd / 33280, 48781 / Approval Letter
59. / Tevapharm India Pvt. Ltd / 33281, 48778 / Approval Letter
60. / Tevapharm India Pvt. Ltd / 33282, 48776 / Approval Letter
61. / Tevapharm India Pvt. Ltd / 33283, 48802 / Approval Letter
62. / Tevapharm India Pvt. Ltd / 33284, 48798 / Approval Letter
63. / Tevapharm India Pvt. Ltd / 33285, 48796 / Approval Letter
64. / Tevapharm India Pvt. Ltd / 33286, 48794 / Approval Letter
65. / Tevapharm India Pvt. Ltd / 33287, 48791 / Approval Letter
66. / Tevapharm India Pvt. Ltd / 33288, 48790 / Approval Letter
67. / Tevapharm India Pvt. Ltd / 33289, 48786 / Approval Letter
68. / Tevapharm India Pvt. Ltd / 33290, 48783 / Approval Letter
69. / VerGo Pharma Research Laboratories Pvt Ltd / 33332, 49080 / Approval Letter
70. / Watson Pharma Pvt. Ltd / 33296, 48710 / Approval Letter
71. / Watson Pharma Pvt. Ltd / 33297, 48708 / Approval Letter
72. / Watson Pharma Pvt. Ltd / 33298, 48705 / Approval Letter
73. / Watson Pharma Pvt. Ltd / 33299, 48700 / Approval Letter
74. / Watson Pharma Pvt. Ltd / 33300, 48696 / Approval Letter
75. / Watson Pharma Pvt. Ltd / 33301, 48702 / Approval Letter
76. / Watson Pharma Pvt. Ltd / 33302, 48697 / Approval Letter
77. / Watson Pharma Pvt. Ltd / 33303, 48692 / Approval Letter
78. / Watson Pharma Pvt. Ltd / 33306, 48688 / Approval Letter
79. / Zoetis Pharmaceutical Research Pvt Ltd / 33321, 49252 / Approval Letter
80. / Zoetis Pharmaceutical Research Pvt Ltd / 33322, 49247 / Approval Letter
81. / Zoetis Pharmaceutical Research Pvt Ltd / 33323, 49249 / Approval Letter
82. / Zoetis Pharmaceutical Research Pvt Ltd / 33324, 49251 / Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Johnson & Johnson Ltd. / 24996 / Approval (F-RC)
2. / M/s. Johnson & Johnson Ltd. / 24996 / Approval (F-IL)
3. / M/s. Covidien Healthcare India Pvt. Ltd. / 22982 / Approval (R-E-RC)
4. / M/s. Covidien Healthcare India Pvt. Ltd. / 22982 / Approval (R-E-IL)
5. / M/s. Coral Healthcare Pvt. Ltd. / 28769 / Approval (F-IL)
6. / M/s. Depuy Medical Pvt. Ltd. / 28450 / Approval (F-IL)
7. / M/s. Bangalore Surgicals. / 26614 / Approval (R-IL)
8. / M/s. Exactech India (P) Ltd. / 30970 / Approval (R-IL)
9. / M/s. Emergo (India) Consulting Pvt. Ltd. / 27037 / Approval Letter
10. / M/s. Clairvoyance Consulting. / 30170 / Letter
11. / M/s. Access Devices. / 17655 / Query Letter
12. / M/s. Johnson & Johnson Ltd. / 26651 / Letter
13. / M/s. MN Solutions. / 12790 / Query Letter
14. / M/s. Smith & Nephew Healthcare Pvt. Ltd. / 28455 / Letter
15. / M/s. Baxter (India) Pvt. Ltd. / 29449 / Query Letter
16. / M/s. Johnson & Johnson Ltd. / 27746 / Query Letter
17. / M/s. Stryker India Pvt. Ltd. / 28020 / Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Biogenix Inc. / 27453 / Approval (IL)
2. / M/s. Sysmex India (P) Ltd. / 26184 / Approval (IL)
3. / M/s. Roche Diagnostics India Pvt. Ltd. / 28686 / Approval (E-IL)
4. / M/s. Aiikya E-Systems India Pvt. Ltd. / 27031 / Query Letter
5. / M/s. Instrumentations Laboratory India Pvt. Ltd. / 27525 / Query Letter
6. / M/s. Inclen Trust International. / 8755 / Clarification Letter
7. / M/s. Biogenuix Medsystems Pvt. Ltd. / 28334 / Query Letter
8. / The Deputy Drugs Controller, Ahmedabad.
The Commissioner, Gujarat. / Nil / Letter
COSMETICS DIVISION