LETTERS FOR ISSUE ON 21.04.2014
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 9655 / Clarification Letter
2. / M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 9656 / Clarification Letter
3. / M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 6355 / Clarification Letter
4. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 3429 / Amendment Letter
5. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 9014 / Approval Letter
6. / M/s. Biocon Limited, Bangalore-560 100 / 3192 / Amendment Letter
7. / M/s. Biocon Ltd., Bangalore-560 100 / 7554 / Clarification Letter
8. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6441 / Approval Letter
9. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6226 / Approval Letter
10. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 5281 / Approval Letter
11. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 6875 / Approval Letter
12. / M/s. Ethics Bio Lab Pvt. Ltd., Pallikaranai, Chennai-600 100 / 8853 / Approval Letter
13. / M/s. Fortis Clinical Research Ltd., Faridabad-121 002 / 5414 / Amendment Letter
14. / M/s. Fortis Clinical Research Ltd., Faridabad-121 002 / 9415 / Approval Letter
15. / M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 15246 / Approval Letter
16. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 15710 / Additional Study Centre
17. / M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 6321 / Approval Letter
18. / M/s. Jubilant Life Sciences Ltd, Noida, 201301, UP / 3644 / Amendment Letter
19. / M/s. Kemwell Biopharma Pvt. Ltd., Bangalore-562 123 / 15820 / Approval Letter
20. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 5884 / Approval Letter
21. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 6274 / Approval Letter
22. / M/s. Mylan Laboratories Limited, Secunderabad / 732 / Amendment Letter
23. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 8726 / Approval Letter
24. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 3819 / Approval Letter
25. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 5750 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 12058 / Test Licence
2. / M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 9389 / Test Licence
3. / M/s. Lok-Beta Pharmaceuticals (I) Pvt Ltd, West Mumbai-400080 / 4681 / Test Licence
4. / M/s. Semler Research Center Pvt. Ltd., Bangalore-560078 / 9959 / Test Licence
5. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 12354 / Test Licence
6. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 7856 / Test Licence
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Abhayam Pharmaceuticals / 10834, 16813 / Approval Letter
2. / Actavis Pharma Development Centre Pvt. Ltd / 10928, 16786 / Approval Letter
3. / Actavis Pharma Development Centre Pvt. Ltd / 10927, 16789 / Approval Letter
4. / Actavis Pharma Development Centre Pvt. Ltd / 10926, 16792 / Approval Letter
5. / Actavis Pharma Development Centre Pvt. Ltd / 10925, 16796 / Approval Letter
6. / Actavis Pharma Development Centre Pvt. Ltd / 10924, 16798 / Approval Letter
7. / Actavis Pharma Development Centre Pvt. Ltd / 10786, 16799 / Approval Letter
8. / Actavis Pharma Development Centre Pvt. Ltd / 10785, 16820 / Approval Letter
9. / Actavis Pharma Development Centre Pvt. Ltd / 10791, 16687 / Approval Letter
10. / Actavis Pharma Development Centre Pvt. Ltd / 10792, 16690 / Approval Letter
11. / Agila Specialties Pvt. Ltd / 10890, 16737 / Approval Letter
12. / Agila Specialties Pvt. Ltd. / 10891, 16733 / Approval Letter
13. / Aizant Drug Research Solutions Pvt. Ltd. / 10827, 16812 / Approval Letter
14. / Akorn India Pvt Ltd / 10733, 16266 / Approval Letter
15. / Dr. Reddy’s Laboratories Ltd / 10752, 16807 / Approval Letter
16. / Dr. Reddy’s Laboratories Ltd / 10850, 18614 / Approval Letter
17. / Dr. Reddy’s Laboratories Ltd / 10851, 16815 / Approval Letter
18. / Dr. Reddy’s Laboratories Ltd / 10857, 16816 / Approval Letter
19. / Dr. Reddy’s Laboratories Ltd / 10858, 16817 / Approval Letter
20. / Dr. Reddy’s Laboratories Ltd / 10859, 16818 / Approval Letter
21. / Dr. Reddy’s Laboratories Ltd / 10860, 16819 / Approval Letter
22. / Emcure Pharmaceuticals Ltd. / 10916, 16699 / Approval Letter
23. / Emcure Pharmaceuticals Ltd. / 10917, 16695 / Approval Letter
24. / Emcure Pharmaceuticals Ltd. / 10915, 16692 / Approval Letter
25. / Emcure Pharmaceuticals Ltd. / 10918, 16688 / Approval Letter
26. / Emcure Pharmaceuticals Ltd. / 10920, 16685 / Approval Letter
27. / Glenmark Generics Ltd / 10943, 16800 / Approval Letter
28. / Glenmark Generics Ltd / 10944, 16871 / Approval Letter
29. / Glenmark Generics Ltd / 10947, 16874 / Approval Letter
30. / Glenmark Generics Ltd / 10948, 16876 / Approval Letter
31. / Glenmark Pharmaceuticals Ltd / 10942, 16801 / Approval Letter
32. / Glenmark Pharmaceuticals Ltd / 10941, 16802 / Approval Letter
33. / Hospira Healthcare India Pvt. Ltd / 10904, 16717 / Approval Letter
34. / Intas Pharmaceuticals Ltd / 10745, 16822 / Approval Letter
35. / Intas Pharmaceuticals Ltd / 10746, 16826 / Approval Letter
36. / Intas Pharmaceuticals Ltd / 10748, 16834 / Approval Letter
37. / Johnson and Johnson Ltd / 10824, 16810 / Approval Letter
38. / Johnson and Johnson Ltd / 10825,16811 / Approval Letter
39. / Mylan Laboratories Ltd / 10789, 16880 / Approval Letter
40. / Mylan Laboratories Ltd / 10788, 16882 / Approval Letter
41. / Sequent Research Ltd / 10901, 16706 / Approval Letter
42. / Takeda Pharmaceuticals India Pvt. Ltd. / 10888, 16754 / Approval Letter
43. / Unichem Laboratories Ltd / 10885, 16763 / Approval Letter
44. / Unichem Laboratories Ltd / 10884, 16772 / Approval Letter
45. / Unichem Laboratories Ltd / 10883, 16803 / Approval Letter
46. / Unique Pharmaceutical Laboratories. / 10813, 16703 / Approval Letter
47. / Unique Pharmaceutical Laboratories. / 10798, 16693 / Approval Letter
48. / Unique Pharmaceutical Laboratories. / 10797, 16697 / Approval Letter
49. / Unique Pharmaceutical Laboratories. / 10812, 16805 / Approval Letter
50. / Unique Pharmaceutical Laboratories. / 10814, 16806 / Approval Letter
51. / Unique Pharmaceutical Laboratories. / 10815, 16808 / Approval Letter
52. / Unique Pharmaceutical Laboratories. / 10823, 16809 / Approval Letter
53. / Vimta Labs Ltd / 10787, 16804 / Approval Letter
54. / Astral SteriTech Pvt Ltd / 11704, 17839 / Deficiency Letter
55. / Cipla Ltd / 9297, 14231 / Deficiency Letter
56. / Claris Otsuka Ltd / 9972, 15307 / Deficiency Letter
57. / Getz Pharma Research Pvt Ltd / 11547, 17705 / Deficiency Letter
58. / Harman Finochem Ltd / 10300, 15992 / Deficiency Letter
59. / Nektar Therapeutics India Pvt Ltd / 8594, 13041 / Deficiency Letter
60. / Novartis Healthcare Pvt Ltd / 8644, 13075 / Deficiency Letter
61. / Sentiss Pharma Pvt Ltd / 8873, 13879 / Deficiency Letter
62. / Sentiss Pharma Pvt Ltd / 11958, 18570 / Deficiency Letter
63. / Sequent Research Ltd / 10901, 16723 / Deficiency Letter
64. / USV Ltd / 9010, 13845, 9015, 13853 / Deficiency Letter
65. / Watson Pharma Pvt Ltd / 9472, 14520 / Deficiency Letter
66. / Sentiss Pharma Pvt Ltd
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Param Pharma / 11493 / Approval Letter
2. / Macleods Pharmaceuticals Limited / 11506 / Approval Letter
3. / Macleods Pharmaceuticals Limited / 11505 / Approval Letter
4. / Torrent Pharmaceuticals Ltd. / 11460 / Approval Letter
5. / Dr. Reddys Laboratories Limited / 11586 / Approval Letter
6. / Sun Pharma Laboratories Ltd. / 11566 / Approval Letter
7. / Scott Edil Pharmacia Ltd. / 11432 / Approval Letter
8. / Pulse Pharma / 11494 / Approval Letter
9. / Torrent Pharamceuticals Ltd. / 11459 / Approval Letter
10. / Sevantilal & Sons / 11630 / Approval Letter
11. / Dilipkumar and Company / 10848 / Approval Letter
12. / Famy Care Limited / 11476 / Approval Letter
13. / VHB Medi Sciences Ltd. / 11794 / Approval Letter
14. / VHB Medi Sciences Ltd. / 11793 / Approval Letter
15. / Ketan Pharma, / 11734 / Approval Letter
16. / Ruskin Chemipharm / 11810 / Approval Letter
17. / Haresh Oveta / 11830 / Approval Letter
18. / Hetero Drugs Limited / 11912 / Approval Letter
19. / Hetero Labs Limited / 11911 / Approval Letter
20. / Cipla Ltd. / 60392 / Approval Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Hipra (I) Pvt Ltd / Clarification letter
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
1. / M/s. Emcure Pharmaceuticals Ltd. / - / Clarification Letter
NEW DRUG
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Athena Drug / 5057 / - / Deficiency Letter
2. / M/s Intas / 3508 / 5969 / Deficiency Letter
3. / M/s Piramal Lifescience / 37031 / 51164- / Deficiency Letter
4. / M/s Novartis India Ltd., / 11848 / 18132 / Deficiency Letter
5. / Themis Medicare Ltd., / 270 / 896 / Deficiency Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Alkem Laboratories Ltd. / 10463 / Query Letter
2. / M/s. Cadila Pharmaceutical Ltd. / 8351 / Query Letter
3. / M/s. Accredited Consultants Pvt. Ltd. / 56171 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Golden Harvest Industries / 9090 / Query Letter
2. / M/s. Avantor Performance Material Pvt. Ltd. / 5209 / Query Letter
3. / M/s. Morepen Laboratories Ltd. / 8416 / Query Letter