LETTERS FOR ISSUE ON 03.03.2015
Global Clinical Trial
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Boehringer / 50377/50964 / PA/Additional sites Approval
2. / M/s. Eli Lilly / 1997 / Addiitonal sites Approval/ Clarification Letter
3. / M/s. PRA / 44943/44942 / PA Approval Letter
4. / M/s. Novartis / 3246 / Amendment in TL Approval
5. / M/s. Roche / 2838 / Change in PI Approval
6. / M/s. Sanofi / 3676 / Clarification Letter
7. / M/s. Manipal Acunova / 2254 / TL Approval Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Novartis Healthcare / 1834, 45814 / 67969 / TL, Deficiency Letter
2. / M/s Pfizer Products India / 45165 / 66956 / Deficiency Letter
3. / M/s Torrent / 50198 / 75792 / TL
4. / M/s Shilpa Medicare Ltd. / - / 74852 / Deficiency Letter
5. / M/s Lincoln Pharmaceuticals / 49156 / 74026 / Deficiency Letter
6. / M/s Troikaa Pharmaceuticals / 2051 / 3449 / BE NOC
7. / Glenmark Generics Ltd. / 1893 / 2923 / BE NOC, TL
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 3481 / Clarification Letter
2. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 3877 / Test Licence
3. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 5321 / Approval Letter
4. / M/s. APL Research Center, Hyderabad-500 038 / 3821 / Clarification Letter
5. / M/s. APL Research Center, Hyderabad-500 038 / 3491 / Clarification Letter
6. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 3492 / Approval Letter
7. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 3796 / Approval Letter
8. / M/s. Athena Drug Delivery Solutions Pvt. Ltd., Dist. Thane, Maharashtra-421 501 / 2604 / Approval Letter
9. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 3490 / Clarification Letter
10. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 3648 / Approval Letter
11. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 3480 / Approval Letter
12. / M/s. Cipla Ltd., Mumbai-400 013 / 3583 / Clarification Letter
13. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4123 / Approval Letter
14. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 3590 / Approval Letter
15. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5836 / Approval Letter
16. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5837 / Approval Letter
17. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 4770 / Test Licence
18. / M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 4609 / Amendment Letter
19. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 5179 / Amendment Letter
20. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 4379 / Clarification Letter
21. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 4380 / Clarification Letter
22. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 5692 / Approval Letter
23. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 5505 / Test Licence
24. / M/s. Jubilant Generics Ltd., Noida-201 301, UP / 5833 / Test Licence
25. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 3655 / Clarification Letter
26. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 51079 / Test Licence
27. / M/s. Lupin Limited (Research Park), Pune-412 115 / 3874 / Approval Letter
28. / M/s. Manipal Acunova Limited, Manipal -576104 / 3878 / Test Licence
29. / M/s. Manipal Acunova Ltd., Mangalore-575 001 / 3879 / Test Licence
30. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 5127 / Approval Letter
31. / M/s. Semler Research Center, Bangalore-560078 / 49931 / Approval Letter
32. / M/s. Semler Research Center, Bangalore-560078 / 4015 / Approval Letter
33. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 1635 / Amendment Letter
34. / M/s. Sun Pharma Advanced Research Company Ltd., Vadodara-390 020 / 3999 / Approval Letter
35. / M/s. Sun Pharma Advanced Research Company Ltd., Vadodara-390 020 / 3522 / Approval Letter
36. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 3691 / Approval Letter
37. / M/s. VerGo Pharma Research Pvt. Ltd. (Div- VerGo Clinicals), Goa-403 110 / 3382 / Approval Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Max Neeman / - / Clarification Letter
2. / M/s. Pfizer / 49471 / Clarification Letter
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Ipca laboratories Limited / 2931 / Approval Letter
2. / Alkem Laboratories Ltd. / 3575 / Approval Letter
3. / Alkem Laboratories Ltd. / 3576 / Approval Letter
4. / Neon Laboratories / 3614 / Approval Letter
5. / Pratistha Pharma / 3485 / Approval Letter
6. / Sagar Rubber Products Pvt. Ltd. / 3484 / Approval Letter
7. / Eastern Chemicals (Mumbai) Pvt. Ltd. / 3494 / Approval Letter
8. / Inspira Bio Pharm Pvt. Ltd. / 3610 / Approval Letter
9. / Nectar Lifesciences Ltd. (Unit-II) / 3619 / Approval Letter
10. / Symbio Generrics India Pvt. Ltd. / 3495 / Approval Letter
11. / Neon Laboratories Ltd. / 3615 / Approval Letter
12. / United Biotech Pvt. Ltd. / 3694 / Approval Letter
13. / DSM Sinochem Pharmaceuticals India Pv.t Ltd. / 3759 / Approval Letter
14. / Ranbaxy Laboratories Ltd. / 3717 / Approval Letter
15. / Aristo Pharmaceuticals Pvt. Ltd. / 3634 / Approval Letter
16. / Kantilal Manilal & Co. Pvt. Ltd., / 3683 / Approval Letter
17. / Central Drug House / 3682 / Approval Letter
18. / Central Drug House / 3681 / Approval Letter
19. / Fresenius Kabi Oncology Ltd. / 3626 / Approval Letter
20. / Fresenius Kabi Oncology Ltd. / 3627 / Approval Letter
21. / Aristo Pharmaceuticals Pvt. Ltd. / 3635 / Approval Letter
22. / Cadila Healthcare Ltd. / 3743 / Approval Letter
23. / Khushbu Impex / 3747 / Approval Letter
24. / Excipients House / 3645 / Approval Letter
25. / Brenntag Ingredients (India) Pvt. Ltd. / 3684 / Approval Letter
26. / Symbiotec Pharmalab Limited / 3755 / Approval Letter
27. / Symbiotec Pharmalab Limited / 3756 / Approval Letter
28. / Symbiotec Pharmalab Limited / 3757 / Approval Letter
29. / Ranbaxy Laboratories Ltd. / 3718 / Approval Letter
30. / Indi Pharma Pvt. Ltd. / 3729 / Approval Letter
31. / Jagsonpal Pharmaceuticals Ltd. / 3633 / Approval Letter
32. / Zydus Healthcare / 3742 / Approval Letter
33. / Sentiss Pharma Pvt. Ltd. / 4033 / Approval Letter
34. / Anantco Enterprises Pvt. Ltd. / 4164 / Approval Letter
35. / C.J. shah & Co. / 2128 / Approval Letter
36. / Pulse Pharma / 2054 / Approval Letter
37. / Emil Pharmaceuticals Industries Pvt. Ltd. / 2201 / Approval Letter
38. / Ranbaxy Laboratories ltd. / 2219 / Approval Letter
39. / Neon Laboratories ltd. / 3616,3617 / Approval Letter
40. / Galentic Pharma / 3478 / Approval Letter
41. / Central Drug House / 3389 / Approval Letter
42. / Biocon Ltd. / 3580 / Approval Letter
43. / Sanofi-synthelabo India ltd. / 43158 / Approval Letter
44. / Novartis India Ltd. / 35535,39417 / Approval Letter
45. / Glaxo Smith Kline Pharmaceuticals Ltd / 4292 / Approval Letter
46. / Win Medicare Pvt. Ltd. / nil / Approval Letter
47. / MSD pharmaceuticals Pvt. ltd. / 78 / Amended Letter
48. / Bayer Zydus Pharma Pvt. Ltd. / 48621 / Amended Letter
49. / Novartis Healthcare Pvt. Ltd. / 4041 / Amended Letter
REGISTRATION
S.no. / Name of applicant / Diary no. / Type of letter1. / Anantco enterprises pvt. Ltd. / 1336,42400 / Approval letter/clarification letter
2. / Dpb antibiotics pvt. Ltd. / 2749 / Approval letter
3. / Max neeman medical international ltd. / 2676 / Approval letter
4. / Chephis corpoartion / 2393 / Approval letter
5. / Ethachem / 47444 / Approval letter
6. / Bluestream manufacutring services pvt. Ltd. / 50794 / Approval letter
7. / Paviour pharmaceuti cals pvt. Ltd. / 3409 / Amended letter
8. / Roche products india pvt. Ltd. / 3620 / Amended letter
9. / Besins healthcare india pvt. Ltd. / 4751 / Amended letter
10. / Novartis healthcare pvt. Ltd. / 4041 / Amended letter
11. / Bayer pharmaceutical pvt. Ld. / 3822 / Amended letter
12. / Chephis corporation / 48174 / Amended letter
13. / Pfizer products india pvt. Ltd. / 50773 / Clarification letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Hetero Drugs Ltd / Clarification letter
2 / M/s Roche Product India Pvt, ltd / 535 / Clarification letter
3 / M/s Novartis Healthcare ltd / 43923 / Clarification letter
4 / Dr. Reddy Labortories / 35088 / Clarification letter
5 / M/s Sanofi Synthelabo India ltd / 4283 / Clarification letter
6 / M/s GSk Pharmaceuticals Ltd / 46225, 28522 / Clarification letter
7 / M/s Wyeth ltd / 2554 / Clarification letter
8 / M/s Eli Lilly and Company India Pvt, ltd / 3278 / Clarification letter
9 / M/s Sanofi Pasteur India Pvt, ltd / 4963 / Clarification letter
10 / M/s Wockhardt ltd / 10112, 6882 / Approval letter
11 / M/s Boehringer Ingelheim India Pvt, ltd / 51374 / Approval letter
12 / M/s Intervet India Pvt, ltd / 77038 (fts no) / Approval letter
13 / M/s Ranbaxy Laboratories ltd / 32583 (fts no) / Approval letter
14 / M/s Vins Bioproducts ltd / 76822 (fts no) / Approval letter
15 / M/s Baxter India pvt , ltd / Approval letter
16 / M/s Intas Pharmaceutical ltd / 18688, 18689, / Approval letter
17 / M/s Bharat Serum and vaccine ltd / 28769 / Approval letter
18 / M/s Merck Specialities pvt, ltd / 3976 / Approval letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Bard India Healthcare Pvt. Ltd. / 47674 / Query Letter
2. / M/s. Smith & Nephew Healthcare Pvt. Ltd. / 47836 / Query Letter
3. / M/s. Stericat Gutsrings Pvt. Ltd. / 42568 / Letter