Letters for Issue on 09.07.2014

LETTERS FOR ISSUE ON 09.07.2014

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 23173 / Approval Letter
2. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 23902 / Approval Letter
3. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 1437 / Approval Letter
4. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 21065 / Approval Letter
5. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 22691 / Approval Letter
6. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 23051 / Approval Letter
7. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 29665 / Approval Letter
8. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 26864 / Approval Letter
9. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 23358 / Approval Letter
10. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 23359 / Approval Letter
11. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 23638 / Approval Letter
12. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 23780 / Approval Letter
13. / M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 56060 / Approval Letter
14. / M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 22697 / Approval Letter
15. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 4667 / Approval Letter
16. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 23557 / Approval Letter
17. / M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 18852 / Approval Letter
18. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 23977 / Approval Letter
19. / M/s. Lupin Bioresearch Center, Pune-411 021 / 25969 / Amendment Letter
20. / M/s. Lupin Bioresearch Center, Pune-411 021 / 12299 / Approval Letter
21. / M/s. Lupin Bioresearch Center, Pune-411 021 / 23248 / Approval Letter
22. / M/s. Lupin Bioresearch Center, Pune-411 021 / 23112 / Approval Letter
23. / M/s. Lupin Bioresearch Center, Pune-411 021 / 22185 / Approval Letter
24. / M/s. Lupin Bioresearch Center, Pune-411 021 / 15801 / Approval Letter
25. / M/s. Lupin Bioresearch Center, Pune-411 021 / 23500 / Approval Letter
26. / M/s. Lupin Bioresearch Center, Pune-411 021 / 15361 / Approval Letter
27. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 23114 / Approval Letter
28. / M/s. MSN Laboratories Ltd., Hyderabad-500 018 / 22508 / Approval Letter
29. / M/s. Piramal Clinical Research, Hyderabad-500 013 / 26292 / Approval Letter
30. / M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad-500 037 / 22379 / Approval Letter
31. / M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 23453 / Approval Letter
32. / M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 23710 / Approval Letter
33. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 22904 / Approval Letter
34. / M/s. Synchron Research Services Pvt. Ltd., Ahmedabad-380 054 / 22901 / Approval Letter
35. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 19257 / Amendment Letter
36. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 23121 / Approval Letter
37. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 22988 / Approval Letter
38. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 23641 / Approval Letter
39. / M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 23642 / Approval Letter
40. / M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 19480 / Approval Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 23394 / Test Licence
2. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 23395 / Test Licence
3. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 100 / 23905 / Test Licence
4. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 22640 / Test Licence
5. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 24038 / Test Licence
6. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 24115 / Test Licence
7. / M/s. Axis Clinical Ltd., Hyderabad-500 049 / 22692 / Test Licence
8. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 23708 / Test Licence
9. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 23555 / Test Licence
10. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 23706 / Test Licence
11. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 23425 / Test Licence
12. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 23424 / Test Licence
13. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 22789 / Test Licence
14. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 23365 / Test Licence
15. / M/s. Famy Care Ltd., Mumbai-400 001 / 23553 / Test Licence
16. / M/s. Glenmark Generics Ltd., Navi Mumbai-400 705 / 7289 / Test Licence
17. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 23031 / Test Licence
18. / M/s. Hetero Labs Ltd., Hyderabad-500 018 / 22897 / Test Licence
19. / M/s. Jubilant Life Sciences Limited, Noida-201 301, UP / 15805 / Test Licence
20. / M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 23899 / Test Licence
21. / M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 23907 / Test Licence
22. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 23392 / Test Licence
23. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 23142 / Test Licence
24. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 23143 / Test Licence
25. / M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 22989 / Test Licence
26. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 23319 / Test Licence
27. / M/s. Manipal Acunova Limited, Manipal -576104 / 23577 / Test Licence
28. / M/s. Manipal Acunova Ltd., Manipal AcuNova KMC CPU, Mangalore-575 001 / 23595 / Test Licence
29. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 23322 / Test Licence
30. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 23320 / Test Licence
31. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 16428 / Test Licence
32. / M/s. VerGo Clinicals, Goa-403 110 / 23259 / Test Licence
33. / M/s. Watson Pharma Pvt Ltd ., Navi Mumbai-400614 / 23144 / Test Licence

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Wyeth Limited / 14392 / Approval letter

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
1. / M/s. Piramal Enterprises Ltd. / - / Letter
2. / M/s. MSN Laboratories Pvt. Ltd. / - / Letter
3. / M/s. Hetero Labs Limited. / - / Letter
4. / M/s. Lupin Limited / - / Letter
5. / M/s. Intas Pharmaceuticals Ltd. / - / Letter

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
1. / M/s. Bard India Healthcare (P) Ltd. / 19456 / Approval (F-RC)
2. / M/s. Bard India Healthcare (P) Ltd. / 13125 / Approval (F-IL)
3. / M/s. Covidien Healthcare India Pvt. Ltd. / 1088 / Approval (F-RC)
4. / M/s. Covidien Healthcare India Pvt. Ltd. / 1088 / Approval (F-IL)
5. / M/s. MN Solutions. / 18758 / Approval (F-RC)
6. / M/s. Pharma Leaf India Pvt. Ltd. / 24923 / Approval (F-RC)
7. / M/s. Bard India Healthcare Pvt. Ltd. / 19877 / Approval (R-RC)
8. / M/s. Boston Scientific India Pvt. Ltd. / 21474 / Approval (E-RC)
9. / M/s. Boston Scientific India Pvt. Ltd. / 21474 / Approval (E-IL)
10. / M/s. Boston Scientific India Pvt. Ltd. / 18779 / Approval (E-RC)
11. / M/s. Boston Scientific India Pvt. Ltd. / 18779 / Approval (E-IL)
12. / M/s. Johnson & Johnson Ltd. / 19797 / Approval (F-IL)
13. / M/s. Vishal Surgical Equipment Co. Pvt. Ltd. / 22531 / Approval (R-IL)
14. / M/s. DuraentBiolgoical Ltd. / 18316 / Clarification Letter
15. / The Director of Drugs Control, Chennai (CLAA)
The Deputy Drugs Controller (I), Chennai (CLAA)
(M/s. Aurolab, Madurai) / FTS-32675 / Approval Letter
16. / The Sate Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Poly Medicure Ltd.) / FTS-34113 / Approval Letter
17. / The Sate Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Poly Medicure Ltd.) / FTS-30018 / Approval Letter
18. / The Drugs Controller & Licensing Authority, Jaipur (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Vitromed Healthcare, Jaipur) / FTS-36335 / Approval Letter
19. / The Sate Drugs Controller, Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
(M/s. Hindustan Syringes & Medical Devices Ltd..) / FTS-37284 / Approval Letter

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
1. / M/s. Roche Diagnostics India Pvt. Ltd. / 22137 / Approval (IL)
2. / M/s. Alere Medical Pvt. Ltd. / 20426 / Approval (E-IL)
3. / M/s. Roche Diagnostics India Pvt. Ltd. / 22138 / Approval (E-IL)
4. / M/s. Roche Diagnostics India Pvt. Ltd. / 22694 / Approval (E-IL)
5. / M/s. Werfen Medical India Pvt. Ltd. / 21930 / Approval (E-IL)
6. / M/s. Roche Diagnostics India Pvt. Ltd. / 21547 / Approval Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
1. / M/s Lark Laboratories / 8001 / 2002 / Deficiency Letter
2. / M/s Dr. Reddy’s Laboratories / - / - / Test Licence

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
1. / Akorn India Pvt Ltd / 25416, 37270 / Approval Letter
2. / Alphamed Formulations Pvt. Ltd / 25272, 37393 / Approval Letter
3. / Alphamed Formulations Pvt. Ltd / 25273, 37392 / Approval Letter
4. / APL Research Centre / 25451, 37885 / Approval Letter
5. / APL Research Centre / 25452, 37799 / Approval Letter
6. / APL Research Centre / 25453, 37822 / Approval Letter
7. / APL Research Centre / 25454, 37819 / Approval Letter
8. / APL Research Centre / 25455, 37815 / Approval Letter
9. / APL Research Centre / 25456, 37814 / Approval Letter
10. / APL Research Centre / 25457, 37840 / Approval Letter
11. / APL Research Centre / 25458, 37837 / Approval Letter
12. / APL Research Centre / 25459, 37834 / Approval Letter
13. / APL Research Centre / 25460, 37830 / Approval Letter
14. / APL Research Centre / 25461, 37828 / Approval Letter
15. / APL Research Centre / 25462, 37826 / Approval Letter
16. / Cadila Healthcare Limited / 25169, 37033 / Approval Letter
17. / Cadila Healthcare Limited / 25170, 37034 / Approval Letter
18. / Cadila Healthcare Limited / 25171, 37038 / Approval Letter
19. / Cipla Ltd / 25339, 37430 / Approval Letter
20. / Claris Lifesciences Ltd / 25149, 37001 / Approval Letter
21. / Claris Lifesciences Ltd / 25150, 37005 / Approval Letter
22. / Claris Lifesciences Ltd / 25151, 36996 / Approval Letter
23. / Claris Lifesciences Ltd / 25152, 36992 / Approval Letter
24. / Claris Lifesciences Ltd / 25153, 37008 / Approval Letter
25. / Claris Lifesciences Ltd / 25154, 37006 / Approval Letter
26. / Claris Lifesciences Ltd / 25212, 37425 / Approval Letter
27. / Emcure Pharmaceuticals Ltd / 25211, 37335 / Approval Letter
28. / Glenmark Generics Ltd / 25401, 37252 / Approval Letter
29. / Glenmark Generics Ltd / 25402, 37206 / Approval Letter
30. / Glenmark Generics Ltd / 25403, 37200 / Approval Letter
31. / Glenmark Generics Ltd / 25404, 37268 / Approval Letter
32. / Glenmark Generics Ltd / 25405, 37264 / Approval Letter
33. / Glenmark Generics Ltd / 25407, 37257 / Approval Letter
34. / Hospira Healthcare India Pvt. Ltd / 25522, 37915 / Approval Letter
35. / Hospira Healthcare India Pvt. Ltd / 25523, 37919 / Approval Letter
36. / Hospira Healthcare India Pvt. Ltd / 25524, 37896 / Approval Letter
37. / Hospira Healthcare India Pvt. Ltd / 25525, 37904 / Approval Letter
38. / Intas Pharmaceuticals Ltd / 25596, 37793 / Approval Letter
39. / Intas Pharmaceuticals Ltd / 25597, 37791 / Approval Letter
40. / Intas Pharmaceuticals Ltd / 25598, 37789 / Approval Letter
41. / Kusum Healthcare Pvt. Ltd / 25595, 37796 / Approval Letter
42. / Lupin Ltd. / 25245, 37419 / Approval Letter
43. / Lupin Ltd. / 25246, 37421 / Approval Letter
44. / Lupin Ltd. / 25247, 37363 / Approval Letter
45. / Lupin Ltd. / 25248, 37394 / Approval Letter
46. / Macleods Pharmaceuticals Ltd / 25362, 37475 / Approval Letter
47. / Macleods Pharmaceuticals Ltd / 25363, 37476 / Approval Letter
48. / Medreich Ltd / 25526, 37891 / Approval Letter
49. / Piramal Enterprises Ltd / 25372, 37472 / Approval Letter
50. / Ranbaxy Laboratories Ltd / 25215, 37374 / Approval Letter
51. / Rubicon Research Pvt Ltd / 25382, 37468 / Approval Letter
52. / Rubicon Research Pvt Ltd / 25383, 37470 / Approval Letter
53. / Rubicon Research Pvt Ltd / 25384, 37286 / Approval Letter
54. / Rubicon Research Pvt Ltd / 25385, 37291 / Approval Letter
55. / Sanofi-Synthelabo (India) Ltd / 25122, 36983 / Approval Letter
56. / Sun Pharmaceutical Industries Ltd / 25604, 37806 / Approval Letter
57. / Sun Pharmaceutical Industries Ltd / 25605, 37803 / Approval Letter
58. / Sun Pharmaceutical Industries Ltd / 25606, 37869 / Approval Letter
59. / Sun Pharmaceutical Industries Ltd / 25607, 37872 / Approval Letter
60. / Synchron Research Services Pvt Ltd / 25366, 37479 / Approval Letter
61. / Tevapharm India Private limited / 25179, 37120 / Approval Letter
62. / Tevapharm India Private limited / 25180, 37118 / Approval Letter
63. / Tevapharm India Private limited / 25181, 37116 / Approval Letter
64. / Vimta Labs Ltd / 25417, 37276 / Approval Letter
65. / Vimta Labs Ltd / 25418, 37280 / Approval Letter
66. / Zoetis Pharmaceutical Research Pvt Ltd / 25229, 37378 / Approval Letter
67. / Zoetis Pharmaceutical Research Pvt Ltd / 25230, 37410 / Approval Letter
68. / Zoetis Pharmaceutical Research Pvt Ltd / 25231, 37413 / Approval Letter

COSMETICS DIVISION