LETTERS FOR ISSUE ON 17.02.2014
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / SHAH TC OVERSEAS PVT. LTD. / 45958 / CLARIFICATION LETTER
2. / PARENTERAL DRUGS (INDIA) LIMITED / CLARIFICATION LETTER
3. / UNIPHARMA / 2854 / CLARIFICATION LETTER
4. / NOVARTIS HEALTHCARE PVT. LTD / 4289 / CLARIFICATION LETTER
5. / ALLIANCE PHARMA AGENCIES / 53717 / CLARIFICATION LETTER
6. / UNICHEMIE INTERNATIONAL / 59485 / CLARIFICATION LETTER
7. / UNICHEMIE INTERNATIONAL / 28548, 32724 / CLARIFICATION LETTER
8. / GENERIX LIFESCIENCES PVT. LTD / 61829 / CLARIFICATION LETTER
9. / RECKITT BENCKISER INDIA LIMITED / 53414 / CLARIFICATION LETTER
SHELF LIFE
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / STRIDES ARCOLAB LIMITED / 2760 / CLARIFICATION LETTER
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Cadila Healthcare Ltd. / 3038 / APPROVAL LETTER
2. / Agila Specialties Pvt. Ltd. / 2955 / APPROVAL LETTER
3. / C.J. Shah & Co. / 2950 / APPROVAL LETTER
4. / C.J. Shah & Co. / 2951 / APPROVAL LETTER
5. / C.J. Shah & Co. / 2952 / APPROVAL LETTER
6. / C.J. Shah & Co. / 2953 / APPROVAL LETTER
7. / Vyali International / 2887 / APPROVAL LETTER
8. / Vyali International / 2885 / APPROVAL LETTER
9. / Vyali International / 2884 / APPROVAL LETTER
10. / Vyali International / 2889 / APPROVAL LETTER
11. / Vyali International / 2886 / APPROVAL LETTER
12. / Vyali InternationaL / 2888 / APPROVAL LETTER
13. / Ankur Drugs & Pharma Ltd. / 2888 / APPROVAL LETTER
14. / Imex Overseas / 2987 / APPROVAL LETTER
15. / Farmachem Life Pvt. Ltd. / 2895 / APPROVAL LETTER
16. / Harshada Corporation / 2901 / APPROVAL LETTER
17. / Harshada Corporation / 2899 / APPROVAL LETTER
18. / Harshada Corporation / 2900 / APPROVAL LETTER
19. / Harshada Corporation / 2902 / APPROVAL LETTER
20. / Harshada Corporation / 2896 / APPROVAL LETTER
21. / Harshada Corporation / 2898 / APPROVAL LETTER
22. / Harshada Corporation / 2897 / APPROVAL LETTER
23. / Ruskin Chemipharm / 2890 / APPROVAL LETTER
24. / Ruskin Chemipharm / 2894 / APPROVAL LETTER
25. / Ruskin Chemipharm / 2893 / APPROVAL LETTER
26. / Ruskin Chemipharm / 2892 / APPROVAL LETTER
27. / Ruskin Chemipharm / 2891 / APPROVAL LETTER
28. / Astrazeneca Pharma India Ltd. / 3371 / APPROVAL LETTER
29. / Dupen Laboratories Pvt. Ltd. / 3699 / APPROVAL LETTER
30. / Cipla Ltd. / 5116 / APPROVAL LETTER
31. / Boehringer Ingelheim India Pvt. Ltd. / 48292 / APPROVAL LETTER
32. / Boehringer Ingelheim India Pvt. Ltd / 48289 / APPROVAL LETTER
33. / Boehringer Ingelheim India Pvt. Ltd. / 48287 / APPROVAL LETTER
34. / Boehringer Ingelheim India Pvt. Ltd. / 48290 / APPROVAL LETTER
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Actimus Biosciences Pvt. Ltd., Visakhapatnam-530 003 / 1530 / Approval Letter
2. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 63073 / Approval Letter
3. / M/s. APL Research Centre, Hyderabad-500 090 / 64607 / Approval Letter
4. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 63203 / Approval Letter
5. / M/s. BA Research India Ltd., Ahmedabad-380 054 / 58763 / Clarification Letter
6. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 63434 / Approval Letter
7. / M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 33247 / Clarification Letter
8. / M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 9456 / Clarification Letter
9. / M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 9101 / Clarification Letter
10. / M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 1050 / Clarification Letter
11. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 2584 / Approval Letter
12. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 2806 / Approval Letter
13. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 64240 / Approval Letter
14. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 26204 / Clarification Letter
15. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 49611 / Clarification Letter
16. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 12263 / Clarification Letter
17. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 63580 / Approval Letter
18. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 64621 / Approval Letter
19. / M/s. Mylan Laboratories Ltd., Medak District -502 325, AP / 61660 / Clarification Letter
20. / M/s. Natco Pharma Ltd., Hyderabad-500 033 / 54877 / Clarification Letter
21. / M/s. QPS Bioserve India (P) Ltd., Hyderabad – 500 037 / 49877 / Clarification Letter
22. / M/s. QPS Bioserve India (P) Ltd., Hyderabad – 500 037 / 58060 / Clarification Letter
23. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 16448 / Clarification Letter
24. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 1649 / Approval Letter
25. / M/s. Troikaa Pharmaceuticals Ltd., Ahmedabad-380 054 / 63814 / Approval Letter
26. / M/s. Unichem Laboratories Ltd., Mumbai-400 102 / 10549 / Clarification Letter
27. / M/s. Unichem Laboratories Ltd., Mumbai-400 102 / 40029 / Clarification Letter
28. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 41207 / Clarification Letter
29. / M/s.Orchid Healthcare., Tamil Nadu / 29842 / Clarification Letter
30. / M/s.Semler Research Center Pvt. Ltd., Bangalore 560 078 / 52377 / Clarification Letter
31. / M/s. APL Research Centre, Hyderabad-500 090 / 21922 / NDAC Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 53576 / Test Licence
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Abbott Medical Optics Pvt. Ltd. / 41983 / Clarification Letter
2. / M/s. Baxter (India) Pvt. Ltd. / 65211 / Clarification Letter
3. / M/s. Carl Zesis India (Bangalore) Pvt. Ltd. / 53187 / Clarification Letter
4. / M/s. MN Solutions. / 2907 / Clarification Letter
5. / M/s. Angiplast Pvt. Ltd. (CLAA) / FTS-700 / Clarification Letter
6. / The Joint Commissioner, Thane (CLAA)
M/s. Sure International Pvt. Ltd., Thane (CLAA) / FTS-5760 / Clarification Letter
7. / The Joint Commissioner, Pune (CLAA)
M/s. S.H Pitkar Orthotools Pvt. Ltd., Pune (CLAA) / FTS-88688 / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Immunoshop India Pvt. Ltd. / 61795 / Clarification Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Sun Pharmaceuticals Ltd., / 38411 / Approval Letter
2. / M/s. Axa Parenteral Ltd., / 42227 / Clarification Letter
3. / M/s. Franco-Indian Remedies Pvt. Ltd., / 54319 / Clarification Letter
4. / M/s. Franco-Indian Remedies Pvt. Ltd., / 54318 / Clarification Letter
5. / M/s. Kaizen Pharmaceuticals Ltd., / 49236 / Clarification Letter
6. / M/s. Moraceae Pharmaceuticals Pvt. Ltd., / 48211 / Clarification Letter
7. / M/s. Pfizer Ltd., / 49431 / Letter
8. / M/s. Rivpra Formulations Pvt. Ltd., / 43628 / Clarification Letter
9. / M/s. Ravenbhel Healthcare Pvt .Ltd., / 66384 / Clarification Letter
10. / M/s. Naxper Pharma Pvt. Ltd., / 42183 / Clarification Letter
11. / M/s. MSD Pharmaceuticals / 16690 / Clarification Letter
12. / M/s. Hema Laboratories (P) Ltd., / 43300 / Clarification Letter
13. / M/s. Indchemic Health Specialities Pvt. Ltd., / 48585 / Clarification Letter
14. / M/s. Stadmed Pvt. Ltd., / 77088 / Clarification Letter
15. / M/s. Stadmed Pvt. Ltd., / 77088 / Clarification Letter
16. / M/s. Stadmed Pvt. Ltd., / 77088 / Clarification Letter
17. / M/s. Stadmed Pvt. Ltd., / 77088 / Clarification Letter
18. / M/s. Stadmed Pvt. Ltd., / 77088 / Clarification Letter
19. / M/s. Synokem Pharmaceuticals Pvt. Ltd., / 42941 / Clarification Letter
20. / M/s. Torrent Pharmaceuticals Pvt. Ltd., / 44439 / Clarification Letter
21. / M/s. UCB India Pvt. Ltd., / 2299 / Letter
22. / M/s. Suncare Formulations Pvt. Ltd., / 43147 / Clarification Letter
23. / M/s. Zim Laboratories / 41584 / Clarification Letter
24. / M/s. Bescoat / 64102 / Clarification Letter
25. / M/s. Maxheal Pharmaceuticals (I) Ltd., / 84911 / Letter
26. / M/s. Allergan India Pvt. Ltd., / 54919 / Clarification Letter
27. / M/s. BRD Medilabs / 49046 / Clarification Letter
28. / M/s. Purnima Pharmaceuticals (P) Ltd., / 77667 / Letter
29. / M/s. GKM New Pharma / 42054 / Clarification Letter
30. / M/s. Vivimed Labs Ltd., / 42469 / Clarification Letter
31. / M/s. Astral SterilTech Pvt. Ltd., / 42193 / Clarification Letter
32. / M/s. Kaptab Pharmaceuticals / 135 / Clarification Letter
33. / M/s. Biogenetic Drugs Pvt. Ltd., / 82926 / Clarification Letter
VACCINE DIVISION
Sr. No. / Company Name / Dy. No. / STATUS1 / M/s GlaxoSmithKline Asia Pvt Ltd / 2707, 170,36500 / Approval letter
2 / M/s Cadila Healthcare Limited / 840 / Approval letter
3 / M/s Novartis Healthcare Pvt, Ltd / 840 / Approval letter
4 / M/s Lupin Ltd / 56831 / Approval letter
5 / M/s Gland Pharma Ltd / 63950 / Approval letter
7 / M/s Serum Institute of India Ltd / 2587 / Approval letter
8 / M/s Chiron Behring Vaccine Pvt, ltd / 728 / Approval letter
9 / M/s LG Life Sciences India Pvt, ltd / 4637 / Clarification Letter
10 / M/s Johnson & Johnson Ltd / 58213 / Approval letter
11 / M/s Venkatshwara Hatcheries Pvt, Tld / 2870, 2868, 2870 / Approval letter
BIOLOGICAL DIVISION
Sr. No. / Company Name / Dy. No. / STATUS1 / M/s Cadila Healthcare Limited / 378, 1802 / Approval letter
2 / M/s Reliance Life Sciences PVt, Ltd / 64848 / Approval letter
3 / M/s Biocon Ltd / 1111, 4161 (fts no) / Approval letter
4 / M/s Intas Pharmaceuticals Ltd / 1520, 1518,1519 / Approval letter
5 / M/s United States Pharmacopeia India Pvt, ltd / 64779 / Approval , Clarification Letter,
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Actavis Pharma Development Centre Pvt Ltd / 4617, 7173 / Approval Letter
2. / Actavis Pharma Development Centre Pvt Ltd / 4618, 7175 / Approval Letter
3. / Actavis Pharma Development Centre Pvt Ltd / 4619, 7177 / Approval Letter
4. / Actavis Pharma Development Centre Pvt Ltd / 4649, 7121 / Approval Letter
5. / Actavis Pharma Development Centre Pvt Ltd / 4631, 6948 / Approval Letter
6. / Actavis Pharma Development Centre Pvt Ltd / 4650, 7119 / Approval Letter
7. / Actavis Pharma Development Centre Pvt Ltd / 4630, 7181 / Approval Letter
8. / Actavis Pharma Development Centre Pvt Ltd / 4620, 7179 / Approval Letter
9. / Actavis Pharma Development Centre Pvt Ltd / 4651, 7140 / Approval Letter
10. / Actavis Pharma Development Centre Pvt Ltd / 4648, 7114 / Approval Letter
11. / Actavis Pharma Development Centre Pvt Ltd / 4647, 7093 / Approval Letter
12. / Actavis Pharma Development Centre Pvt Ltd / 4646, 7071 / Approval Letter
13. / Actavis Pharma Development Centre Pvt Ltd / 4635, 7041 / Approval Letter
14. / Actavis Pharma Development Centre Pvt Ltd / 4634, 7037 / Approval Letter
15. / Actavis Pharma Development Centre Pvt Ltd / 4633, 7027 / Approval Letter
16. / Actavis Pharma Development Centre Pvt Ltd / 4632, 7005 / Approval Letter
17. / Agila Specialties Pvt. Ltd / 4139, 6513 / Approval Letter
18. / Agila Specialties Pvt. Ltd. / 4137, 6500 / Approval Letter
19. / Ajanta Pharma Ltd / 3891, 6143 / Approval Letter
20. / Ajanta Pharma Ltd / 4086, 6378 / Approval Letter
21. / Ajanta Pharma Ltd / 4570, 7168 / Approval Letter
22. / Ajanta Pharma Ltd / 4569, 7166 / Approval Letter
23. / Ajanta Pharma Ltd / 4568, 7164 / Approval Letter
24. / Ajanta Pharma Ltd / 4566, 7085 / Approval Letter
25. / Alembic Pharmaceuticals Ltd / 4314, 6637 / Approval Letter
26. / Alembic Pharmaceuticals Ltd / 4315, 6636 / Approval Letter
27. / Alembic Pharmaceuticals Ltd / 4316, 6634 / Approval Letter
28. / Alembic Pharmaceuticals Ltd / 4317, 6632 / Approval Letter
29. / Alembic Pharmaceuticals Ltd / 4318, 6630 / Approval Letter
30. / Alembic Pharmaceuticals Ltd / 4319, 6727 / Approval Letter
31. / Alembic Pharmaceuticals Ltd / 4313, 6640 / Approval Letter
32. / Alembic Pharmaceuticals Ltd / 4306, 6774 / Approval Letter
33. / Alembic Pharmaceuticals Ltd / 4307, 6777 / Approval Letter
34. / Alembic Pharmaceuticals Ltd / 4308, 6778 / Approval Letter
35. / Alembic Pharmaceuticals Ltd / 4309, 6781 / Approval Letter
36. / Alembic Pharmaceuticals Ltd / 4507, 6924 / Approval Letter
37. / Alembic Pharmaceuticals Ltd / 4509, 6929 / Approval Letter
38. / Alembic Pharmaceuticals Ltd / 4508, 6936 / Approval Letter
39. / Alembic Pharmaceuticals Ltd / 4514, 6946 / Approval Letter
40. / Alembic Pharmaceuticals Ltd / 4513, 6961 / Approval Letter
41. / Alembic Pharmaceuticals Ltd / 4512, 6963 / Approval Letter
42. / Alembic Pharmaceuticals Ltd / 4522, 6965 / Approval Letter