Letters for Issue On20.06.2014

LETTERS FOR ISSUE ON 20.06.2014 GLOBAL CLINICAL TRIAL

Sr. Name of Firm Reference No. Type of Letter No.

1. M/s. Biogen Idec - NDAC Follow-up letter

2. M/s. Novartis 13384/17840 Change in PI Approval

3. M/s. Chiltern 21481 Amendment in CT NOC Approval

4. M/s. Novotech 20154 Export NOC Approval

5. M/s. Quintiles 51053 PA Approval

6. M/s. Pfizer NDAC Follow-up letter

7. M/s. Maya Clinicals 23216 Clarification letter

8. M/s. ICON 54899 Clarification Letter

BE NOC FOR EXPORT

S. NO. NAME OF THE COMPANY REF. NO. Type of letter

1. M/s. Accutest Research Laboratories (I) 17441 Approval Letter Pvt. Ltd., Navi Mumbai-400 709

2. M/s. Agila Specialties Pvt. Ltd., 19862 Clarification Bangaluru-560 076 Letter

3. M/s. Cliantha Research Limited, 18867 Approval Letter Ahmedabad-380 054

4. M/s. Famy Care Ltd., Mumbai-400 001 20761 Clarification Letter

5. M/s. Glenmark Generics Ltd., Navi 19534 Approval Letter Mumbai-400 705 6. M/s. Glenmark Generics Ltd., Navi 19533 Approval Letter Mumbai-400 705

7. M/s. Inventia Healthcare Pvt. Ltd., Dist. 19527 Approval Letter Thane-421 506

8. M/s. Lambda Therapeutic Research Ltd., 12351 Additional Study Ahmedabad-380 061 Centre

9. M/s. Lotus Labs Pvt. Ltd., Chennai-600 21229 Approval Letter 004

10. M/s. Micro Therapeutic Research Labs 13023 Amendment Pvt. Ltd., Coimbatore-641029 Letter

11. M/s. Quest Life Sciences (P) Ltd., 20862 Approval Letter Chennai-600045

12. M/s. Semler Research Center Pvt. Ltd., 14953 Clarification Bangalore-560078 Letter

13. M/s. Sun Pharmaceutical Industries Ltd., 16636 Clarification Vadodara-390 020 Letter

14. M/s. Sun Pharmaceutical Industries Ltd., 19014 Approval Letter Vadodara-390 020

15. M/s. Sun Pharmaceutical Industries Ltd., 19019 Approval Letter Vadodara-390 020

16. M/s. Synchron Research Services Pvt. 18516 Amendment Ltd., Ahmedabad-380 054 Letter

17. M/s. Unichem Laboratories Ltd., Mumbai- 48911 Approval Letter 400 102

18. M/s. Veeda Clinical Research Pvt. Ltd., 22325 Approval Letter Ahmedabad-380 015

19. M/s. Vimta Labs Ltd., Hyderabad-500051 20234 Approval Letter

20. M/s. Watson Pharma Pvt. Ltd., Navi 19460 Clarification Mumbai-400 614 Letter

21. M/s. Wockhardt Limited, Aurangabad- 60283 Approval Letter 431 006 ONLY TEST LICENCE FOR BE

S. NO. NAME OF THE COMPANY REF. NO. Type of letter

1. M/s. Accutest Research Laboratories (I) Pvt. 19819 Test Licence Ltd., Navi Mumbai-400 709

2. M/s. Cliantha Research Limited, Ahmedabad- 18868 Test Licence 380 054

3. M/s. Cliantha Research Limited, Ahmedabad- 17711 Test Licence 380 054

4. M/s. Emcure Pharmaceuticals Limited, Pune- 20255 Test Licence 411 026

5. M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 23030 Test Licence 038

6. M/s. Kusum Healthcare Pvt. Ltd., New Delhi- 25433 Test Licence 110 020

7. M/s. Lambda Therapeutic Research Ltd., 13699 Test Licence Ahmedabad-380 061

8. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 20640 Test Licence

9. M/s. Om Sai Clinical Research Pvt. Ltd., Sangli- 24884 Test Licence 416 416, Maharsahtra

10. M/s. Vimta Labs Ltd., Hyderabad-500051 19955 Test Licence

11. M/s. Watson Pharma Private Ltd., Navi 18446 Test Licence Mumbai-400 614

12. M/s. Watson Pharma Pvt Ltd ., Navi Mumbai- 19949 Test Licence 400614

GLOBAL CLINICAL TRIAL

Sr. Name of Firm Reference No. Type of Letter No. 1. M/s. Biogen Idec 7521/17358 Clarification Letter

2. M/s. Quintiles 4604 Clarification Letter

MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. Nutri Synapzz Therapeutix Private Limited. 20628 Clarification Letter

2. M/s. White Pharmaceuticals. 20861 Clarification Letter

3. M/s. Mais India Medical Devices Pvt. Ltd. 16022 Query Letter (CLAA)

The State Drugs Controller, Haryana (CLAA)

TEST LICENCES

S. No. Name of the Company Diary No. Type of Letter

1. Actavis Pharma Development 21465, Approval Letter Centre Pvt. Ltd 32013

4. Alembic Pharmaceuticals Ltd 21521, Approval Letter 31933

5. APL Research Centre 21336, Approval Letter 31773

6. Cipla Ltd 21657, Approval Letter 32286

12. Fresenius Kabi Oncology Ltd 16262, Approval Letter 24265, 23360, 34885

13. Getz Pharma Research Pvt. Ltd 21582, Approval Letter 32264

18. Glenmark Pharmaceuticals Ltd 21533, Approval Letter 31959

21. Glenmark Pharmaceuticals Ltd 21536, Approval Letter 31973 22.

23. Intas Pharmaceuticals Ltd 21593, Approval Letter 32273

24. Intas Pharmaceuticals Ltd 21594, Approval Letter 32272

25. Ipca Laboratories Limited 21471, Approval Letter 32040

32. Lupin Ltd 16110, Approval Letter 24119, 24096, 35600

33. Mylan Laboratories Ltd 21572, Approval Letter 32227

34. Novartis Healthcare Pvt Ltd 8644, Approval Letter 13075, 20373, 30575, 22872, 33751

35. Novartis Healthcare Pvt Ltd 13708, Approval Letter 21391, 22873, 33932

39. Pfizer Products India Pct Ltd 9647, Approval Letter 14980, 15209, 22959

40. Pfizer Products India Pct Ltd 9648, Approval Letter 14956, 15210, 22955

41. RA Chem Pharma Ltd 12404, Approval Letter 19243, 20243

42. Ranbaxy Laboratories Ltd 21612, Approval Letter 32289

43. Ranbaxy Laboratories Ltd 12329, Approval Letter 18670, 22317, 33307

44. Reliance Life Sciences Pvt Ltd 16079, Approval Letter 24173, 20334, 36488

45. Roche Products (India) Pvt Ltd 17055, Approval Letter 25172, 19878, 29791, 24620, 36015

46. Sequent Research Ltd 21422, Approval Letter 32059

47. Sequent Research Ltd 21423, Approval Letter 32069

48. Shalina Laboratories Pvt Ltd 21524, Approval Letter 31943

49. Shalina Laboratories Pvt Ltd 21525, Approval Letter 31950

50. Shasun Pharmaceuticals 21573, Approval Letter Limited 32237

51. Shasun Pharmaceuticals 21574, Approval Letter Limited 32249

52. Stabicon Life Sciences Pvt Ltd 21233, Approval Letter 31858

53. Stabicon Life Sciences Pvt Ltd 21234, Approval Letter 31860

54. Sun Pharma Advanced 21591, Approval Letter Research Company Ltd 32274

55. Sun Pharmaceutical Industries 21589, Approval Letter Ltd 32255

56. Unichem Laboratories Ltd 21486, Approval Letter 32034

57. United States Pharmacopeia- 21436, Approval Letter India (P) Ltd 32120 58. United States Pharmacopeia- 21437, Approval Letter India (P) Ltd 32118

59. United States Pharmacopeia- 21438, Approval Letter India (P) Ltd 32117

64. V-ensure Pharma Technologies 21609, Approval Letter Pvt. Ltd 32268

65. Watson Pharma Pvt. Ltd 21470, Approval Letter 32028

66. Wintac Ltd 14436, Approval Letter 21919, 21419, 32063

67. APL Research Centre 18703, Deficiency 27933 Letter

68. Cipla Ltd 20060, Deficiency 30326 Letter

69. Getz Pharma Research Pvt Ltd 21318, Deficiency 31582 Letter

70. Ipca Laboratories Ltd 20623, Deficiency 30732, Letter 20626, 30889, 20627, 30886 71. Jubilant Life Sciences Ltd 20827, Deficiency 31034 Letter

72. Modi Mundipharma Pvt Ltd 21424, Deficiency 32122 Letter

73. RA Chem Pharma Ltd 20242, Deficiency 30102 Letter

74. Sanofi-Synthelabo (India) Ltd 20709, Deficiency 31031, Letter 20710, 31027, 20712, 30966, 20713, 30962, 20714, 30654, 20716, 30657, 20930, 31168, 20942, 31181, 20943, 31308, 20944, 31306

75. Shilpa Medicare Ltd 17182, Deficiency 25478 Letter

76. Stabicon Life Sciences Pvt Ltd 21235, Deficiency 31862, Letter 21238, 31732, 21238-A, 31729,

77. Stabicon Life Sciences Pvt Ltd 21095, Deficiency 31723 Letter

78. Vimta Labs Ltd 20986, Deficiency 31082 Letter