LETTERS FOR ISSUE ON 23.06.2014
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Biogen Idec / 7521/17358/12101 / Clarification Letter/PA Approval Letter
2. / M/s. Quintiles / 4604 / Clarification Letter
3. / M/s. INC Research / 10007 / PA Approval Letter
4. / M/s. Excel Life Sciences / 15199 / CT NOC Approval Letter
5. / M/s. Novartis / 15768 / Additional sites Approval letter
6. / M/s. Inventiv / 64101 / Change in PI Approval
7. / M/s. PPD / 18427/18897 / Change in PI Approval Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 21778 / Approval Letter
2. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 20271 / Approval Letter
3. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 22273 / Approval Letter
4. / M/s. Drug Monitoring Research Institute (P) Ltd., Navi Mumbai-400 701 / 25205 / Approval Letter
5. / M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 20253 / Approval Letter
6. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 17222 / Approval Letter
7. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 19531 / Approval Letter
8. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 20427 / Approval Letter
9. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 7550 / Approval Letter
10. / M/s. Lupin Bioresearch Center, Pune-411 021 / 20422 / Approval Letter
11. / M/s. Lupin Bioresearch Center, Pune-411 021 / 20190 / Approval Letter
12. / M/s. Lupin Bioresearch Center, Pune-411 021 / 20227 / Approval Letter
13. / M/s. Lupin Bioresearch Center, Pune-411 021 / 20421 / Approval Letter
14. / M/s. Lupin Bioresearch Center, Pune-411 021 / 20419 / Approval Letter
15. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 20639 / Approval Letter
16. / M/s. QPS Bioserve India (P) Ltd., Andhra Pradesh / 21251 / Approval Letter
17. / M/s. Synapse Labs Pvt. Ltd., Pune-411 014 / 19526 / Clarification Letter
18. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 22305 / Approval Letter
19. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 19456 / Clarification Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 19816 / Test Licence
2. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 21219 / Test Licence
3. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 20378 / Test Licence
4. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 21182 / Test Licence
5. / M/s. Alkem Laboratories Ltd., Dist: Raigad -410208 / 19997 / Test Licence
6. / M/s. Aristo Pharmaceuticals Pvt. Ltd., Mumbai-400 053 / 21313 / Test Licence
7. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 20413 / Test Licence
8. / M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 19521 / Test Licence
9. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 21141 / Test Licence
10. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 20643 / Test Licence
11. / M/s. Novartis Healthcare Pvt. Ltd., Mumbai-400 018 / 22003 / Test Licence
12. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 20294 / Test Licence
13. / M/s. Wockhardt Limited, Mumbai-400 051 / 20836 / Test Licence
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Panacea Biotech Ltd / 22808, 1190 / Clarification Letter
2 / M/s Intas Pharmaceuticals Ltd / 18376 / Clarification Letter
3 / M/s Bio-Med (p) Ltd / 12903 / Clarification Letter
4 / M/s Novartis Healthcare Pvt, ltd / 20822, 9790 / Clarification Letter
5 / Dr. Reddy Laboratories / Clarification Letter
6 / M/s Ceva (I) Pvt, ltd / 13196 / Clarification Letter
7 / M/s Sanofi-Synthelabo India Ltd / 19414 / Approval Letter
8 / M/s Zoetis India Ltd / 25364 / Clarification Letter
9 / M/s Hipra (I) Ltd / 12729 / Clarification Letter
10 / M/s Gennova Biopharmaceuticals Ltd / 64690, 18945 / Approval Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / RUSHI CORPORATION / 11434 / APPROVAL LETTER
2. / DSM NUTRITIONAL PRODUCTS INDIA PV.T LTD. / 22672 / APPROVAL LETTER
3. / G.C. CHEMIE PHARMIE LTD. / 12732 / APPROVAL LETTER
4. / SHAH TC OVERSEAS PVT. LTD. / 10233 / CLARIFICATION LETTER
5. / RUSKIN CHEMIPHARM / 17810 / CLARIFICATION LETTER
6. / COSMOS INTERNATIONAL / 12302 / CLARIFICATION LETTER
7. / CHEMET / 12114 / CLARIFICATION LETTER
8. / SIGN PHARMA TRADE SERVICES PVT. LTD. / 20452 / CLARIFICATION LETTER
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / The State Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Degania Medical Devices Pvt. Ltd.) / FTS-35185 / Approval Letter
2. / M/s. Apothecaries Pvt. Ltd. / 20650 / Query Letter
3. / M/s. Biorad Medisys Pvt. Ltd. / 52562 / Letter
4. / M/s. Biomet Orthopaedic India Pvt. Ltd. / Nil / Query Letter
5. / M/s. Boston Scientific India Pvt. Ltd. / 18600 / Letter
6. / M/s. Heart Care Pharma Services Pvt. Ltd. / 6074 / Letter
7. / M/s. Reckitt Benckiser (India) Ltd. / 18295 / Query Letter
8. / M/s. Cook India Medical Devices Pvt. Ltd. / 369 / Letter
9. / M/s. Johnson & Johnson Ltd. / 23417 / Letter
10. / M/s. Meril Life Sciences India Pvt. Ltd. / 9543 / Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Atheneses DX Pvt. Ltd. / 18998 / Approval (E-IL)
2. / M/s. Werfen Medical India Pvt. Ltd. / 19086 / Approval (E-IL)
3. / M/s. Ypsomed India Pvt. Ltd. / 20299 / Query Letter
BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Biovet Pvt, Ltd / 3991 / Clarification Letter
2 / M/s Biological E. Ltd / 35203 (fts no) / Approval Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Sun Phramaceuticals Industries Ltd / Clarification Letter
2 / M/s Wyeth Ltd / 10576 / Clarification Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Troikaa Pharmaceuticals Ltd., / 10197 / Letter
2. / M/s. Sun Pharmaceuticals Industries Ltd., / 22084 / 2 Amendment Letter
COSMETICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Tradelinks International, Mumbai / 14945 / Approval Letter
2. / M/s. Valeo Nutra Pvt. Ltd, Mumbai / 17987 / Approval Letter
3. / M/s. Hindustan Unilever Limited, Mumbai / 16298 / Deficiency Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Actavis Pharma Development Centre Pvt Ltd / 21932, 32570 / Approval Letter
2. / AET Laboratories Pvt. Ltd / 21684, 32333 / Approval Letter
3. / AET Laboratories Pvt. Ltd / 21685, 32294 / Approval Letter
4. / Agila Specialties Pvt Ltd / 21941, 32684 / Approval Letter
5. / Agila Specialties Pvt Ltd / 21942, 32686 / Approval Letter
6. / Agila Specialties Pvt Ltd / 21943, 32689 / Approval Letter
7. / Alembic Pharmaceuticals Ltd / 21878, 32654 / Approval Letter
8. / Alembic Pharmaceuticals Ltd / 21879, 32651 / Approval Letter
9. / Alembic Pharmaceuticals Ltd / 21880, 32710 / Approval Letter
10. / Alembic Pharmaceuticals Ltd / 21881, 32711 / Approval Letter
11. / Alembic Pharmaceuticals Ltd / 21882, 32712 / Approval Letter
12. / Alembic Pharmaceuticals Ltd / 21883, 32713 / Approval Letter
13. / Alembic Pharmaceuticals Ltd / 21884, 32715 / Approval Letter
14. / Alembic Pharmaceuticals Ltd / 21885, 32716 / Approval Letter
15. / Alembic Pharmaceuticals Ltd / 21886, 32664 / Approval Letter
16. / Alembic Pharmaceuticals Ltd / 21887, 32648 / Approval Letter
17. / Alembic Pharmaceuticals Ltd / 21888, 32646 / Approval Letter
18. / Alembic Pharmaceuticals Ltd / 21889, 32645 / Approval Letter
19. / Alembic Pharmaceuticals Ltd / 21890, 32643 / Approval Letter
20. / Alembic Pharmaceuticals Ltd / 21891, 32560 / Approval Letter
21. / Alembic Pharmaceuticals Ltd / 21892, 32662 / Approval Letter
22. / Alembic Pharmaceuticals Ltd / 21893, 32520 / Approval Letter
23. / Alembic Pharmaceuticals Ltd / 21894, 32522 / Approval Letter
24. / Alembic Pharmaceuticals Ltd / 21895, 32526 / Approval Letter
25. / Alembic Pharmaceuticals Ltd / 21896, 32527 / Approval Letter
26. / Alembic Pharmaceuticals Ltd / 21897, 32533 / Approval Letter
27. / Alembic Pharmaceuticals Ltd / 21898, 32535 / Approval Letter
28. / Amneal Pharmaceuticals Co. (I) Pvt. Ltd / 21758, 32346 / Approval Letter
29. / Amneal Pharmaceuticals Co. (I) Pvt. Ltd / 21759, 32350 / Approval Letter
30. / APL Research Centre / 21753, 32360 / Approval Letter
31. / APL Research Centre / 21754, 32357 / Approval Letter
32. / APL Research Centre / 21755, 32355 / Approval Letter
33. / Cipla Ltd / 21663, 32322 / Approval Letter
34. / Cipla Ltd / 21664, 32326 / Approval Letter
35. / Cipla Ltd / 21665, 32317 / Approval Letter
36. / Cipla Ltd / 21672, 32306 / Approval Letter
37. / Dr. Reddy’s Laboratories Ltd / 21666, 32310 / Approval Letter
38. / Enem Nostrum Remedies Pvt Ltd / 21976, 32657 / Approval Letter
39. / FTF Pharma Pvt Ltd / 21977, 32660 / Approval Letter
40. / Genevo Development Services Ltd / 21810, 32721 / Approval Letter
41. / Getz Pharma Research Pvt. Ltd / 21856, 32259 / Approval Letter
42. / Hetero Labs Ltd / 21693, 32339 / Approval Letter
43. / HLL Lifecare Ltd / 21949, 32605 / Approval Letter
44. / Lupin Ltd / 21966, 32622 / Approval Letter
45. / Lupin Ltd / 21967, 32626 / Approval Letter
46. / Lupin Ltd / 21968, 32632 / Approval Letter
47. / Lupin Ltd / 21969, 32635 / Approval Letter
48. / Lupin Ltd / 21970, 32638 / Approval Letter
49. / Lupin Ltd / 21971, 32641 / Approval Letter
50. / Lupin Ltd / 21972, 32644 / Approval Letter
51. / Lupin Ltd / 21973, 32647 / Approval Letter
52. / Lupin Ltd / 21974, 32650 / Approval Letter
53. / Lupin Ltd / 21975, 32655 / Approval Letter
54. / Malladi Drugs & Pharmaceuticals Ltd / 21808, 32665 / Approval Letter
55. / Malladi Drugs & Pharmaceuticals Ltd / 21809, 32680 / Approval Letter
56. / Naprod Life Sciences Pvt Ltd / 21944, 32691 / Approval Letter
57. / Novartis Healthcare Pvt Ltd / 21956, 32615 / Approval Letter
58. / Novartis Healthcare Pvt Ltd / 21957, 32613 / Approval Letter
59. / Optimus Generics Ltd / 21817, 32659 / Approval Letter
60. / Optium Generics Ltd / 21818, 32658 / Approval Letter
61. / Ranbaxy Laboratories Ltd / 21945, 32695 / Approval Letter
62. / Ranbaxy Laboratories Ltd / 21946, 32698 / Approval Letter
63. / Ranbaxy Laboratories Ltd / 21947, 32701 / Approval Letter
64. / Ranbaxy Laboratories Ltd / 21948, 32595 / Approval Letter
65. / Torrent Pharmaceuticals Ltd / 21678, 32303 / Approval Letter
66. / Torrent Pharmaceuticals Ltd / 21679, 32300 / Approval Letter