Letters for Issue on 03.06.2014

LETTERS FOR ISSUE ON 03.06.2014

TEST LICENCES

S. No. / Name of the Company / Diary No. / Type of Letter
1.  / Agila Specialties Pvt. Ltd / 18720,28237 / Approval Letter
2.  / Alkem Laboratories Ltd / 18725,28062 / Approval Letter
3.  / Alkem Laboratories Ltd / 18726,28067 / Approval Letter
4.  / Alkem Laboratories Ltd / 18727,28073 / Approval Letter
5.  / Alphamed Formulations Pvt. Ltd / 18619, 27869 / Approval Letter
6.  / Alphamed Formulations Pvt. Ltd / 18620, 27868 / Approval Letter
7.  / Alphamed Formulations Pvt. Ltd / 18621, 27871 / Approval Letter
8.  / Alphamed Formulations Pvt. Ltd / 18622, 27872 / Approval Letter
9.  / Alphamed Formulations Pvt. Ltd / 18623, 27874 / Approval Letter
10. / Alphamed Formulations Pvt. Ltd / 18624, 27878 / Approval Letter
11. / Alphamed Formulations Pvt. Ltd / 18625, 27879 / Approval Letter
12. / Alphamed Formulations Pvt. Ltd / 18626, 27880 / Approval Letter
13. / Alphamed Formulations Pvt. Ltd / 18627, 27882 / Approval Letter
14. / Alphamed Formulations Pvt. Ltd / 18628, 27884 / Approval Letter
15. / Alphamed Formulations Pvt. Ltd / 18629, 27887 / Approval Letter
16. / Alphamed Formulations Pvt. Ltd / 18630, 27890 / Approval Letter
17. / APL Research Centre / 18698, 27949 / Approval Letter
18. / APL Research Centre / 18699,27946 / Approval Letter
19. / APL Research Centre / 18700,27942 / Approval Letter
20. / APL Research Centre / 18701,27939 / Approval Letter
21. / APL Research Centre / 18702,27929 / Approval Letter
22. / APL Research Centre / 18703,27933 / Approval Letter
23. / APL Research Centre / 18821, 28246 / Approval Letter
24. / Bharat Serums and Vaccines Ltd / 18554, 27972 / Approval Letter
25. / Cadila Healthcare Limited / 18760,28078 / Approval Letter
26. / Cipla Ltd / 18829, 28068 / Approval Letter
27. / Cipla Ltd / 18830, 28065 / Approval Letter
28. / Cipla Ltd / 18831, 28061 / Approval Letter
29. / Cipla Ltd / 18832, 28174 / Approval Letter
30. / Cipla Ltd / 18833, 28206 / Approval Letter
31. / Cipla Ltd / 18834, 28180 / Approval Letter
32. / Cipla Ltd / 18835, 28201 / Approval Letter
33. / EugiaPharmaSpecialities Ltd / 18704,27964 / Approval Letter
34. / EugiaPharmaSpecialities Ltd / 18705,27966 / Approval Letter
35. / EugiaPharmaSpecialities Ltd / 18706,27968 / Approval Letter
36. / Flamingo Pharmaceuticals Ltd / 18810, 28081 / Approval Letter
37. / Fresenius Kabi Oncology Ltd / 18570, 27835 / Approval Letter
38. / Getz Pharma Research Pvt. Ltd / 18721,28244 / Approval Letter
39. / Getz Pharma Research Pvt. Ltd / 18722,28245 / Approval Letter
40. / Getz Pharma Research Pvt. Ltd / 18723,28058 / Approval Letter
41. / Glenmark Pharmaceuticals Ltd / 18841, 28217 / Approval Letter
42. / Glenmark Pharmaceuticals Ltd / 18842, 28228 / Approval Letter
43. / Glenmark Pharmaceuticals Ltd / 18843, 28232 / Approval Letter
44. / Glenmark Pharmaceuticals Ltd / 18844, 28234 / Approval Letter
45. / Glenmark Pharmaceuticals Ltd / 18845, 28236 / Approval Letter
46. / Inventia Healthcare Pvt. Ltd / 18808, 28093 / Approval Letter
47. / Ipca Laboratories Limited / 18792,28139 / Approval Letter
48. / Ipca Laboratories Limited / 18793,28131 / Approval Letter
49. / Ipca Laboratories Limited / 18794,28126 / Approval Letter
50. / Ipca Laboratories Limited / 18795,28122 / Approval Letter
51. / Ipca Laboratories Limited / 18796, 28116 / Approval Letter
52. / Ipca Laboratories Limited / 18797, 28144 / Approval Letter
53. / Ipca Laboratories Limited / 18798, 28153 / Approval Letter
54. / Ipca Laboratories Limited / 18799, 28156 / Approval Letter
55. / Ipca Laboratories Limited / 18800, 28168 / Approval Letter
56. / Johnson and Johnson Ltd / 18836, 28212 / Approval Letter
57. / Jubilant Life Sciences Ltd / 18847, 28241 / Approval Letter
58. / Jubilant Life Sciences Ltd / 18848, 28243 / Approval Letter
59. / Lupin Ltd / 18672, 27917 / Approval Letter
60. / Lupin Ltd / 18673, 27911 / Approval Letter
61. / Lupin Ltd / 18681, 27906 / Approval Letter
62. / Lupin Ltd / 18682, 27899 / Approval Letter
63. / Mylan Laboratories Ltd / 18571, 27844 / Approval Letter
64. / Sentiss Pharma Pvt. Ltd / 18558, 27980 / Approval Letter
65. / Teva API India Ltd / 18678, 27958 / Approval Letter
66. / Vimta Labs Ltd / 18741,28087 / Approval Letter
67. / Vimta Labs Ltd / 18761,28094 / Approval Letter
68. / Vimta Labs Ltd / 18762,28101 / Approval Letter
69. / Vimta Labs Ltd / 18763,28107 / Approval Letter
70. / Watson Pharma Pvt. Ltd / 18581, 27848 / Approval Letter
71. / Watson Pharma Pvt. Ltd / 18582, 27853 / Approval Letter
72. / Zoetis Pharmaceutical Research Pvt Ltd / 18804, 28112 / Approval Letter
73. / Zoetis Pharmaceutical Research Pvt Ltd / 18805, 28103 / Approval Letter

EXPORT NOC

S. No / Firm Name / Type of Letter
1. / M/s. Chandra Bhagat Pharma Pvt. Ltd., / Approval Letter

WRITTEN CONFIRMATION

S. No / Firm Name / Type of Letter
1. / M/s. Alembic Pharmaceuticals Pvt. Ltd., / QueryLetter

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 / 17107 / Approval Letter
2.  / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 17440 / Approval Letter
3.  / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 17442 / Approval Letter
4.  / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 17565 / Approval Letter
5.  / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 17291 / Approval Letter
6.  / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 17820 / Clarification Letter
7.  / M/s. Biocon Ltd, Bangalore-560099 / 7554 / Approval Letter
8.  / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 17686 / Approval Letter
9.  / M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 17324 / Approval Letter
10. / M/s. Glenmark Generics Ltd., Navi Mumbai-400705 / 17224 / Approval Letter
11. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 17135 / Approval Letter
12. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 17148 / Approval Letter
13. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 17149 / Approval Letter
14. / M/s. Lotus Labs Pvt. Ltd., Chennai-600 004 / 17151 / Approval Letter
15. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 Tamil Nadu / 17593 / Approval Letter
16. / M/s. Ranbaxy Laboratories Ltd., New Delhi-110 019 / 22033 / Approval Letter
17. / M/s. Semler Research Center Pvt. Ltd., Bangalore-560078 / 17522 / Approval Letter
18. / M/s. Watson Pharma Pvt Ltd., Navi Mumbai-400614 / 17121 / Approval Letter

ONLY TEST LICENCE FOR BE

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
1.  / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 17273 / Test Licence
2.  / M/s. Cadila Healthcare Ltd.,, Ahmedabad-380015 / 17189 / Test Licence
3.  / M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 17286 / Test Licence
4.  / M/s. GVK Biosciences Pvt. Ltd., Ahmedabad-380 051 / 20241 / Test Licence
5.  / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 17667 / Test Licence
6.  / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 064 / 17130 / Test Licence

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. Serdia / - / Clarification letter
2. / M/s. Ergomed / - / Clarification Letter
3. / M/s. Eli Lilly / 1801 / Clarification Letter
4. / M/s. Parexel / 50147 / TL Approval Letter

LVP DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s. Pentagon Labs. Ltd., M.P. / 25043 / Query
02 / M/s. Aishwarya Lifesciences, H.P. / 28626 / Query
03 / M/s. Althea Pharma Pvt. Ltd., Daman / 30025 / Query
04 / M/s. Abheris Healthcare, Gujarat / 29704 / Query
05 / M/s. Aishwarya Healthcare, H.P. / 11320 / Query
06 / M/s. Baxter (I) Pvt. Ltd., Maharashtra / 17628 / Query
07 / M/s. Venus Remedies, Haryana / 26153 / Query
08 / M/s. Innvol Medical India Ltd., Tamil Nadu / 20681 / Query

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
1.  / The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller, Ahmedabad (CLAA)
(M/s. Meril Healthcare Pvt. Ltd) / FTS-20646 / Approval Letter

REGISTRATION

S.No. / Name of Applicant / Diary No. / Type of Letter
1.  / Zambon India Pvt. Ltd. / 13515 / Clarification Letter
2.  / DSM Nutritional Products India Pvt. Ltd. / 41913 / Clarification Letter
3.  / Allied Pharma Solutions / 9878 / Clarification Letter
4.  / Unichemie International / 17304 / Clarification Letter
5.  / Shah Tc Overseas Pvt. Ltd. / 9887 / Clarification Letter
6.  / Raj Nakra Associates Life Science Pvt. Ld. / 1762 / Clarification Letter
7.  / Esschem Pvt. Ltd. / 14804 / Clarification Letter
8.  / GlaxoSmithKline Pharmaceuticals Limited / 16244 / Clarification Letter
9.  / Shah Tc Overseas Pvt. Ltd. / 9886 / Clarification Letter
10. / Shah Tc Overseas Pvt. Ltd. / 16945 / Clarification Letter
11. / Wyeth Limited / 1180 / Clarification Letter
12. / Trichem / 128 / Clarification Letter
13. / Claris Lifescience Limited / 3964 / Clarification Letter
14. / DPB Antibiotics (P) Limited / 11492 / Clarification Letter
15. / Astrazeneca Pharma India Ltd. / 5419 / Clarification Letter
16. / Chemet / 63854 / Clarification Letter
17. / Bayer Pharmaceuticals Pvt. Ltd. / 11979 / Clarification Letter
18. / Unipharma / 2854 / Clarification Letter
19. / Zoetis India Limited / 10903 / Clarification Letter
20. / Bayer Pharmaceuticals Pvt. Ltd. / 11278 / Clarification Letter
21. / Reckitt Benckiser India Limited / 10281 / Clarification Letter
22. / Baxter (India) Pvt. Ltd. / 9996 / Clarification Letter
23. / IMCD Group B.V. / 16041 / Amendment Letter
24. / Abbott India Limited / 17707 / Amendment Letter
25. / Novartis India Limited / 16701 / Amendment Letter
26. / Wipro GE Healthcare Pvt. Ltd. / 10672 / Amendment Letter
27. / Biocon Ltd. / 10844 / Amendment Letter
28. / Fresenius Kabi India Pvt. Ltd. / 13703 / Approval Letter
29. / Baxter (India) Pvt. Ltd. / 9031 / Approval Letter
30. / Jubilant Draximage Ltd. / 20859 / Approval Letter
31. / Bohra Sales & Services Ltd. / 8600 / Approval Letter
32. / Merck ltd. / 8543 / Approval Letter
33. / Biocon Ltd. / 17139 / Approval Letter
34. / Anantco Enterprises Pvt. Ltd. / 2363 / Approval Letter
35. / Esschem (Pvt) Ltd. / 6169 / Approval Letter
36. / Olympia / 11106 / Approval Letter
37. / Eli Lilly Asia Inc. / 15319 / Approval Letter
38. / Divine SBR International Pvt. Limited / 10063 / Approval Letter

EXTENSION OF SHELF-LIFE FOR EXPORT

S.No. / Name of Applicant / Diary No. / Type of Letter
1.  / Tuton Pharmaceuticals / 18193 / Approval Letter
2.  / Tuton Pharmaceuticals / 20667 / Approval Letter
3.  / Tuton Pharmaceuticals / 21738 / Approval Letter
4.  / Tuton Pharmaceuticals / 21739 / Approval Letter
5.  / Kopran Limited / 14429 / Clarification Letter

IMPORT LICENCES

1.  / Abil Chempharma Pvt. Ltd. / 17021 / Approval Letter
2.  / Haresh Chemicals / 18046 / Approval Letter
3.  / Haresh Chemicals / 18045 / Approval Letter
4.  / Haresh Chemicals / 18044 / Approval Letter
5.  / Haresh Chemicals / 18047 / Approval Letter
6.  / Sagar Rubber Products Pvt. Ltd. / 17918 / Approval Letter
7.  / Sagar Rubber Products Pvt. Ltd. / 17917 / Approval Letter
8.  / Haresh Oveta / 18048 / Approval Letter
9.  / Haresh Oveta / 18049 / Approval Letter
10. / Scott Edil Pharmacia Ltd. / 17914 / Approval Letter
11. / Scott Edil Pharmacia Ltd. / 17915 / Approval Letter
12. / Scott Edil Pharmacia Ltd. / 17916 / Approval Letter
13. / Pharose Remedies Limited / 18153 / Approval Letter
14. / Kantilal Manilal & Co. Pvt. Ltd., / 17907 / Approval Letter
15. / Kantilal Manilal & Co. Pvt. Ltd., / 17906 / Approval Letter
16. / Kantilal Manilal & Co. Pvt. Ltd., / 17908 / Approval Letter
17. / Kantilal Manilal & Co. Pvt. Ltd., / 17909 / Approval Letter
18. / Kantilal Manilal & Co. Pvt. Ltd., / 18292 / Approval Letter
19. / Kantilal Manilal & Co. Pvt. Ltd., / 18293 / Approval Letter
20. / Umedica Laboratories Pvt. Ltd. / 18206 / Approval Letter
21. / Abil Chempharma Pvt. Ltd. / 18283 / Approval Letter
22. / Shell Lifesciences Pvt. Ltd., / 18210 / Approval Letter
23. / Rainbow Pharma Agencies / 18277 / Approval Letter
24. / Rainbow Pharma Agencies / 18278 / Approval Letter
25. / Mahima Life Sciences Pvt Ltd. / 18279 / Approval Letter
26. / Samarth Lifesciences Pvt.Ltd.(Unit-II) / 18306 / Approval Letter
27. / Ketan Pharma, / 18291 / Approval Letter
28. / Fulford (India) Ltd. / 18285 / Approval Letter
29. / Nakoda Pharma / 17790 / Approval Letter
30. / Inspira Bio Pharm Pvt. Ltd. / 20028 / Approval Letter
31. / IMCD Group B.V / 16041 / Approval Letter
32. / Abbott India Limited / 18232 / Approval Letter
33. / C.J. Shah & Co. / 18441 / Approval Letter
34. / Sun Rise Enterprises / 18391 / Approval Letter
35. / Sun Rise Enterprises / 18393 / Approval Letter
36. / Sun Rise Enterprises / 18390 / Approval Letter
37. / Sun Rise Enterprises / 18392 / Approval Letter
38. / Pradipkumar Pharma Pvt. Ltd. / 18387 / Approval Letter
39. / Pradipkumar & Co. / 18388 / Approval Letter
40. / Abil Chempharma Pvt. Ltd. / 18460 / Approval Letter
41. / Syntho Pharmaceutical Pvt. Ltd. / 18389 / Approval Letter
42. / Mundra Enterprises / 18385 / Approval Letter
43. / Gangwal Chemicals Pvt. Ltd. / 18477 / Approval Letter
44. / Gangwal Chemicals Pvt. Ltd. / 18478 / Approval Letter
45. / J.B. Khokhani & Co. / 18480 / Approval Letter
46. / J.B. Khokhani & Co. / 18479 / Approval Letter
47. / Elder Pharmaceuticals Ltd. / 18482 / Approval Letter
48. / Baader Schulz Laboratories / 18481 / Approval Letter
49. / Ruskin Chemipharm / 18459 / Approval Letter
50. / C.J. Shah & Co. / 18596 / Approval Letter
51. / J.B. Khokhani & Co. / 18548 / Approval Letter
52. / Dolphin International, / 18549 / Approval Letter
53. / Pratistha Pharma, / 18555 / Approval Letter
54. / Pure Pharma Ltd. / 18814 / Approval Letter
55. / Panacea Biotec Limited / 18786 / Approval Letter
56. / United Biotech Pvt. Ltd. / 18816 / Approval Letter
57. / Ace Pharma / 18809 / Approval Letter
58. / Dilipkumar and Company / 18773 / Approval Letter
59. / Central Drug House / 18803 / Approval Letter
60. / Anuh Pharma Ltd.(C/o. M/s. Great Pacific Exports Pvt. Ltd.) / 18802 / Approval Letter
61. / Ace Pharma / 18802 / Approval Letter
62. / Maxcure Nutravedics Limited / 18828 / Approval Letter
63. / Maxcure Nutravedics Limited / 18827 / Approval Letter
64. / C.J. Shah & Co. / 19018 / Approval Letter
65. / Abil Chempharma Pvt. Ltd. / 19087 / Approval Letter
66. / Mehta Pharmaceutical Industries, / 18999 / Approval Letter
67. / Harshada Corporation, / 18892 / Approval Letter
68. / Harshada Corporation, / 18891 / Approval Letter
69. / Sun Pharma Laboratories Ltd. / 18889 / Approval Letter
70. / Sun Pharma Laboratories Ltd. / 18888 / Approval Letter
71. / Sagar Rubber Products Pvt. Ltd. / 18880 / Approval Letter
72. / Ind-Swift Laboratories Limited / 18884 / Approval Letter
73. / Micro Labs Ltd. / 18885 / Approval Letter
74. / Micro Labs Ltd. / 18886 / Approval Letter
75. / General Import Company (India) Pvt. Ltd. / 19016 / Approval Letter
76. / Sagar Rubber Products Pvt. Ltd. / 18881 / Approval Letter
77. / Gorang International / 19094 / Approval Letter
78. / Pradipkumar & Co. / 19092 / Approval Letter
79. / Pradipkumar Pharma Pvt. Ltd. / 19091 / Approval Letter
80. / General Import Company (India) Pvt. Ltd. / 19017 / Approval Letter
81. / Imex Overseas / 19088 / Approval Letter
82. / Ind-Swift Laboratories Limited / 18961 / Approval Letter
83. / Innova Captab / 18962 / Approval Letter
84. / Gorang International / 19093 / Approval Letter
85. / Aquatic Remedies Pvt. Ltd. / 18963 / Approval Letter
86. / Wipro GE Healthcare Pvt. Ltd. / 19607 / Amendment Letter
87. / Yeluri Formulations Pvt. Ltd. / 21108 / Amendment Letter

VACCINE DIVISION

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