Letters for Issue on 22.10.2014

LETTERS FOR ISSUE ON 22.10.2014 BE NOC FOR EXPORT

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

1. M/s. Accutest Research Laboratories (I) 39251 Approval Letter Pvt. Ltd., Navi Mumbai-400 709

3. M/s. Alembic Pharmaceuticals Ltd., 42336 Test Licence Vadodara-390 003

4. M/s. Biocon Limited, Bangalore-560 41708 Amendment 100 Letter

5. M/s. GVK Biosciences Pvt. Ltd., 42459 Clarification Ahmedabad-380 051 Letter

6. M/s. GVK Biosciences Pvt. Ltd., 31918 Rejection Letter Hyderabad-500 038

7. M/s. Jubilant Generics Ltd., Noida-201 42471 Test Licence 301, UP

8. M/s. Lupin Limited (Research Park), 42316 Approval Letter Pune-411 042

9. M/s. Manipal Acunova Ltd., 42104 Approval Letter Mangalore-575 001

10. M/s. QPS Bioserve India Pvt. Ltd., 37811 Test Licence Hyderabad – 500 037

11. M/s. Raptim Research Ltd., Navi 42932 Approval Letter Mumbai-400 701

12. M/s. Synchron Research Services Pvt. 42748 Approval Letter Ltd., Ahmedabad-380 059

13. M/s. Torrent Pharmaceuticals Ltd. 42429 Approval Letter (Research Centre), Gujarat

14. M/s. Veeda Clinical Research Pvt. Ltd., 16283 Approval Letter Ahmedabad-380 015

15. M/s. Watson Pharma Pvt. Ltd., Navi 42240 Approval Letter Mumbai-400614

GLOBAL CLINICAL TRIAL

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

1. M/s. Max Neeman - NDAC Meeting Letter

2. M/s. Novartis 39624 Clarification Letter

3. M/s. Boehringer 37173 Clarification Letter

4. M/s. GSK 16247 TL Approval Letter

FDC DIVISION

S.NO. NAME OF COMPANY DIARY NO DOCUMENT

1. M/s. Sudarshan Pharmaceuticals 43602 Clarificaiton Letter

2. M/s. Acme Formulations 40768 Clarificaiton Letter

3. M/s. Easat West Pharma 49246 Clarificaiton Letter

4. M/s. Vance & health 44376 Clarificaiton Letter Pharamceuticals

5. M/s. SunGlow Pharmaceuticals 42851 Letter

6. M/s. Reckitt Benckiser 35222 Clarificaiton Letter MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS 1. M/s. Johnson & Johnson Ltd. 24997 Approval (R-RC)

2. M/s. Johnson & Johnson Ltd. 24997 Approval (R-IL)

3. M/s. Johnson & Johnson Ltd. 19791 Approval (E-RC)

4. M/s. Johnson & Johnson Ltd. 19791 Approval (E-IL)

5. M/s. Johnson & Johnson Ltd. 33632 Approval (R-E-RC)

6. M/s. Johnson & Johnson Ltd. 33632 Approval (R-E-IL)

7. M/s. Stryker India Pvt. Ltd. 30967 Approval (E-RC)

8. M/s. Terumo Penpol Ltd. 21655 Approval (R-RC)

9. M/s. Terumo Penpol Ltd. 21655 Approval (R-IL)

10 M/s. Covidien Healthcare India Pvt. Ltd. 18115 Approval (R-RC) .

11 M/s. Covidien Healthcare India Pvt. Ltd. 18115 Approval (R-IL) .

12 M/s. Boston Scientific India Pvt. Ltd. 34125 Clarification Letter .

13 M/s. Encarta Pharma Pvt. Ltd. 33750 Clarification Letter . 14 M/s. Innvolution Healthcare Pvt. Ltd. FTS-57963 Clarification Letter .

15 M/s. Covidien Healthcare India Pvt. Ltd. 34694 Letter .

16 M/s. Lotus Surgical Pvt. Ltd. 7071 Query Letter .

17 All state Drugs Controller, Nil Letter . All Heads of port offices/zonal/sub zonal offices

18 Mr. Greh Pal Singh, New Delhi FTS-44896 Letter .

DIAGNOSTIC DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. Immunoshop India Pvt. Ltd. 36380 Approval (IL)

All port offices of CDSCO.

2. M/s. OSB Agencies Pvt. Ltd. 34649 Approval (IL)

3. M/s. Roche Diagnostics India Pvt. Ltd. 35841 Approval (E-IL)

4. M/s. Sysmex India Pvt. Ltd. 32397 Approval (TL)

5. M/s. Avantor Performance Material India 35709 Approval Letter Ltd.

The State Drugs Controller, Delhi

All Zonal offices of CDSCO.

6. M/s. Mindray Medical India Pvt. Ltd. 40487 Approval Letter

All port offices of CDSCO

7. M/s. Mindray Medical India Pvt. Ltd. 40488 Approval Letter

All port offices of CDSCO

SUBSEQUENT NEW DRUG

S. NAME OF THE FIRM REFERENCE FTS NO. TYPE OF LETTER NO. NO. 1. M/s Sun 33652 49759 Deficiency Letter Pharmaceuticals Industries Ltd., 2. M/s Novartis India Ltd., 36135 53226 Deficiency Letter

3. M/s Zim Laboratories 35765 52493 Deficiency Letter Ltd., 4. M/s Alkem Laboratories 32461 47874 Deficiency Letter Ltd., 5. M/s CD Pharma India 40375 59213 Amendment Pvt. Ltd., Letter

GLOBAL CLINICAL TRIAL

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

1. M/s. Novartis 38570/38569/38133/36461 New Sites Approval/Clarification Letter

2. M/s. Sanofi 30868 Clarification Letter

LETTER PERTAINING TO IMPORT

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. Dilipkumar and Company 41567 APPROVAL LETTER 2. Abil Chempharma Pvt. Ltd. 41348 APPROVAL LETTER 3. Gorang International 41405 APPROVAL LETTER 4. Sagar Rubber Products Pvt. 41407 APPROVAL LETTER Ltd. 5. DPB Antibiotics 41607 APPROVAL LETTER 6. Abil Chempharma Pvt. Ltd. 41347 APPROVAL LETTER 7. Sterile-Gene Life 41549 APPROVAL LETTER Sciences(P) Ltd. 8. Cadila Healthcare Ltd. 41593 APPROVAL LETTER 9. Century Pharmaceuticals 41592 APPROVAL LETTER Limited 10. Add-Biotec 41581 APPROVAL LETTER 11. Medi Pharma Drug House 41606 APPROVAL LETTER 12. Indoco Remedies Ltd. 41516 APPROVAL LETTER (Plant-II) 13. Attis Remedies 41852 APPROVAL LETTER 14. Ind-Swift Laboratories 41863 APPROVAL LETTER Limited 15. Alembic Ltd., 41681 APPROVAL LETTER 16. B.M. Chemie 41692 APPROVAL LETTER 17. Dolphin International, 41689 APPROVAL LETTER 18. Pradipkumar Pharma Pvt. 41690 APPROVAL LETTER Ltd. 19. Pradipkumar Pharma Pvt. 41691 APPROVAL LETTER Ltd. 20. Unimed Technologies Ltd. 41694 APPROVAL LETTER 21. SRS Pharmaceuticals Pvt. 40806 APPROVAL LETTER Ltd.(C/o. Gufic Bioscineces Limited) 22. Sun Pharma Laboratories 40839 APPROVAL LETTER Ltd. 23. Sanofi India Ltd. 41565 APPROVAL LETTER 24. Emcure pharmaceuticals 40808 APPROVAL LETTER ltd. 25. B.M.Chemie 20263 APPROVAL LETTER 26. Biotavia Labs Pvt. Ltd. 40801 APPROVAL LETTER 27. Sentiss Pharma Pvt. Ltd. 38364 APPROVAL LETTER 28. Aspire India Inc. 40812 APPROVAL LETTER 29. Dhanuka Laboratories Ltd. 41041 APPROVAL LETTER 30. Novo Nordisk India Pvt. 41325 APPROVAL LETTER Ltd. 31. Medi Pharma Drug House 41605 APPROVAL LETTER 32. Pradipkumar & Co. 41406 APPROVAL LETTER 33. Harish Enterprises, 41865 APPROVAL LETTER 34. Harshada Corporation 41862 APPROVAL LETTER 35. C.J. Shah & Co. (Godown) 41868 APPROVAL LETTER 36. Macleods Pharmaceuticals 41756 APPROVAL LETTER Limited 37. Pratistha Pharma 41864 APPROVAL LETTER 38. Imex Overseas 41842 APPROVAL LETTER 39. Sun Rise Enterprises 41693 APPROVAL LETTER 40. Crystal Pharma 41700 APPROVAL LETTER 41. Centaur Pharmaceuticals 40751 APPROVAL LETTER Pvt. Ltd. 42. Macleods Pharmaceuticals 41753 APPROVAL LETTER Limited 43. Y.Chem Agency nil APPROVAL LETTER 44. Lincoln Pharmaceuticals 39769 APPROVAL LETTER Ltd. 45. Sterile India (Pvt.) Ltd. 40803 APPROVAL LETTER 46. Reckitt Benckiser 33785 APPROVAL LETTER Healthcare India Limited 47. Glenmark Pharmaceuticals 42047 APPROVAL LETTER Ltd. 48. Zydus Hospira Oncology 42063 APPROVAL LETTER Pvt.Ltd. 49. K.Sevantilal & Co. 42066 APPROVAL LETTER 50. Claris Otsuka Ltd. 41874 APPROVAL LETTER 51. Skies Inc 41897 APPROVAL LETTER 52. Skies Inc 41898 APPROVAL LETTER 53. Skies Inc 41899 APPROVAL LETTER 54. Skies Inc 41896 APPROVAL LETTER 55. Skies Inc 41895 APPROVAL LETTER 56. Skies Inc 41900 APPROVAL LETTER 57. Skies Inc 41901 APPROVAL LETTER 58. Zydus Hospira Oncology 42062 APPROVAL LETTER Pvt.Ltd. 59. Associated Biotech 42044 APPROVAL LETTER 60. Aquatic Remedies Pvt. Ltd. 41950 APPROVAL LETTER 61. Sevantilal & Sons 41949 APPROVAL LETTER 62. Finecure Pharmaceuticals 40605 APPROVAL LETTER Ltd. 63. Dhanuka Laboratories Ltd. 41040 APPROVAL LETTER 64. DPB Antibiotics 42290 APPROVAL LETTER 65. Aurobindo Pharma Ltd. 42306 APPROVAL LETTER (Unit-VI) 66. Aquatic Remedies Pvt. Ltd. 42298 APPROVAL LETTER 67. Aquatic Remedies Pvt. Ltd. 42297 APPROVAL LETTER 68. Skies Inc 42116 APPROVAL LETTER 69. Reddhi Enterprises 42130 APPROVAL LETTER 70. Jubilant Generics Ltd. 42285 APPROVAL LETTER (Formerly Jubilant Lifesciences Ltd.) 71. Nandlal Bankatlal Pvt. Ltd. 42291 APPROVAL LETTER 72. Ind-Swift Laboratories 42304 APPROVAL LETTER Limited 73. Combitie Glbal Caplet Pvt. 42136 APPROVAL LETTER Ltd. 74. Unichem Laboratories Ltd., 42314 APPROVAL LETTER 75. K.Sevantilal & Co. 42129 APPROVAL LETTER 76. Ind-Swift Laboratories 42299 APPROVAL LETTER Limited 77. Pratistha Pharma 42300 APPROVAL LETTER 78. Sagar Rubber Products Pvt. 42303 APPROVAL LETTER Ltd. 79. Nandlal Bankatlal Pvt. Ltd. 42301 APPROVAL LETTER 80. New medicon Pharma Lab 42187 APPROVAL LETTER Pvt. Ltd. 81. Glenmark Pharmaceuticals 42287 APPROVAL LETTER Ltd. 82. Glenmark Pharmaceuticals 42286 APPROVAL LETTER Ltd. 83. Micro Labs Ltd. 42269 APPROVAL LETTER 84. Micro Labs Ltd. 42269 APPROVAL LETTER 85. Symbio Generrics India Pvt. nil APPROVAL LETTER Ltd. 86. Jubilant Generics Ltd. 42289 APPROVAL LETTER (Formerly Jubilant Lifesciences Ltd.) 87. Ind-swift Laboratories Ltd. 40807 Amended Letter 88. Nirma Ltd. 41042 Amended Letter 89. Pfizer ltd. 38637 Clarification letter 90. Novartis india ltd. 39246,39415,39414, 5 Clarification 39417,39637, letter 91. Roche Products India Pvt. 38811 Clarification letter Ltd. 92. B.Braun Medical India Pvt. 38575,38574 2 Clarification Ltd. letter 93. Bxter India Pvt. Ltd. 39725 Clarification letter 94. Anantco Enterprises Pvt. 38826 Clarification letter Ltd./Dilipkumar & Co. 95. Provet Pharma Pvt. 42191 Clarification letter Ltd./Skies 96. Chemet /N.J. Pharma 41951 Clarification letter

LETTER PERTAINING TO REGISTRATION

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. SHAH TC OVERSEASE PVT. 31464 APPROVAL LETTER LTD. 2. EASTERN CHEMICALS PVT. 38905 APPROVAL LETTER LTD. 3. SHAH TC OVERSEAS PVT. LTD. 32573 CLARIFICATION LETTER 4. ALLERTAN HEALTHCARE 19976 CLARIFICATION INDIA PVT. LTD. LETTER

TEST LICENCES

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

1. ActavisPharma Development 40990, Approval Letter Centre Pvt. Ltd 60297 2. ActavisPharma Development 41320, Approval Letter Centre Pvt. Ltd 60583

3. ActavisPharma Development 41317, Approval Letter Centre Pvt. Ltd 60631

9. Ajanta Pharma Ltd 41055, Approval Letter 60490

17. APL Research Centre 40964, Approval Letter 60217

21. Apotex Research Pvt. Ltd 40883, Approval Letter 60050

30. Azidus Laboratories Ltd. 33463, Approval Letter 49102

31. Cadila Pharmaceuticals Limited 40810, Approval Letter 60064

32. Centaur Pharmaceuticals Pvt. 41278, Approval Letter Ltd 60694 33. Centaur Pharmaceuticals Pvt. 41279, Approval Letter Ltd 60688

34. Centaur Pharmaceuticals Pvt. 41276, Approval Letter Ltd 60700

35. Centaur Pharmaceuticals Pvt. 41277, Approval Letter Ltd 60697

36. Getz Pharma Research Pvt. Ltd 41082, Approval Letter 60522

44. Gland Pharma Ltd 41235, Approval Letter 60595

45. Gland Pharma Ltd 41236, Approval Letter 60591

46. Glenmark Generics Ltd 41295, Approval Letter 60536

49. Intas Pharmaceuticals Ltd 41234, Approval Letter 60606

50. Intas Pharmaceuticals Ltd 41233, Approval Letter 60538

51. Ipca Laboratories Ltd 41280, Approval Letter 60635

58. Jubilant Generics Ltd 40962, Approval Letter 60190

59. Jubilant Generics Ltd 41314, Approval Letter 60601

60. Leiutis Pharmaceuticals Pvt Ltd 41211, Approval Letter 60560

61. Leiutis Pharmaceuticals Pvt Ltd 41212, Approval Letter 60557

62. Lupin Ltd 41232, Approval Letter 60547

63. Lupin Ltd 41272, Approval Letter 60566 64. Lupin Ltd 41273, Approval Letter 60562

67. Mylan Pharmaceuticals Pvt. Ltd 41217, Approval Letter 60585

70. Piramal Enterprises Ltd 40893,600 Approval Letter 60

71. Piramal Enterprises Ltd 41214, Approval Letter 60650

72. Piramal Enterprises Ltd 41213, Approval Letter 60655

73. Sai Life Sciences Ltd 40912, Approval Letter 60295

84. Sun Pharma Laboratories Ltd 41296, Approval Letter 60525

85. Sun Pharmaceutical Industries 40842, Approval Letter Ltd 60181

91. Torrent Pharmaceuticals Ltd 41301, Approval Letter 60676

94. Torrent Pharmaceuticals Ltd 41304, Approval Letter 60670 95. Torrent Pharmaceuticals Ltd 41305, Approval Letter 60668

98. Watson Pharma Pvt Ltd 41087, Approval Letter 60546

99. Wintac Limited 41071, Approval Letter 60552

COSMETICS DIVISION

S.NO COMPANY NAME DIARY NO STATUS .

1. M/s. United Imports, New Delhi 34865 Approval Letter

2. M/s. Gautam Marketing Kolkata 35690 Approval Letter

3. M/s. Lure Nails & Spa Solutions Pvt. Ltd, 36097 Approval New Delhi Letter

4. M/s. PZ Cussons India Private Limited, 35723 Approval Mumbai Letter

5. M/s. Nivea India Pvt. Ltd, Mumbai 36900 Approval Letter 6. M/s. Amway India Enterprises Pvt. Ltd, 14110 Approval New Delhi Letter

7. M/s. Berina Cosmetics Pvt. Ltd, New 36096 Approval Delhi Letter

8. M/s. Mingfai Quality amenities(India) 36952 Approval Private Limited, New Delhi Letter

9. M/s. Nutra Skyn Care, Mumbai 36571 Approval Letter

10 M/s. Avon Beauty Products India Pvt. Ltd, 32741 Approval . Faridabad Expressway Gurgaon Letter

11 M/s. Sephora Cosmetics Private Limited, 33479 Approval . New Delhi Letter

12 M/s. Reviera overseas, Gandhinagar 34113 Approval . Letter

13 M/s. Kavin International, Tamil Nadu 33946 Approval . Letter

14 M/s. Rohto Pharma (India) Private 35525, 35526 Approval . Limited, New Delhi Letter

BE NOC FOR EXPORT

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

2. M/s. Accutest Research Laboratories (I) 42369 Test Licence Pvt. Ltd., Navi Mumbai-400 709

3. M/s. Accutest Research Laboratories (I) 42616 Test Licence Pvt. Ltd., Navi Mumbai-400 709

4. M/s. APL Research Centre, Aurobindo 37748 Clarification Pharma Ltd., Hyderabad-500 090 Letter

5. M/s. Azidus Laboratories Ltd., Chennai- 42476 Test Licence 600 048

6. M/s. Lambda Therapeutic Research Ltd., 42397 Test Licence Ahmedabad-380 061

7. M/s. Macleods Pharmaceuticals Ltd., 30315 Approval Letter Andheri (East), Mumbai-400 059

8. M/s. RA Chem Pharma Ltd., Balanagar, 41160 Approval Letter Hyderabad-500 037

9. M/s. Raptim Research Ltd., Navi Mumbai- 42410 Test Licence 400 701

10. M/s. Reliance Life Sciences Pvt. Ltd., Navi 43068 Approval Letter Mumbai-400 701

11. M/s. Sun Pharmaceutical Industries Ltd., 40280 Test Licence Vadodara-390 020

12. M/s. Sun Pharmaceutical Industries Ltd., 42480 Test Licence Vadodara-390 020

13. M/s. Veeda Clinical Research Pvt. Ltd., 42387 Approval Letter Ahmedabad-380 015

14. M/s. Watson Pharma Pvt. Ltd., Navi 42466 Approval Letter Mumbai-400614

LVP DIVISION

S. NO. COMPANY NAME FTS NO. /Diary No. STATUS

01 M/s. Global Pharmatech., Tamil 56958 Query Nadu 02 M/s. M/s. Themis Medicare Ltd., 55831 Query C/o. M/s. Akums Drugs, Haridwar

BA/BE DIVISION

S. NO. COMPANY NAME FTS NO. /Diary No. STATUS

01 M/s. Clinse Labs Pvt. Ltd., 42181 Query Hyderabad

02 M/s. Cadila Pharmaceuticals, 38904 Query Gujarat

WRITTEN CONFIRMATION

Sr. No Firm Name Letter

1. M/s. Shasun Pharmaceuticals Ltd., WC Letter

2. M/s. Glenmark Generics Limited. Clarification Letter EXPORT NOC

Sr. No Firm Name Letter

1. M/s. Unichem Labs Ltd., Letter