letters for issue on 14.03 - central drugs … for issue on 14.03.2016 import s.no. name of...
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LETTERS FOR ISSUE ON 14.03.2016 IMPORT
S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER
1. TABLETS (INDIA) LIMITED 5973 APPROVAL LETTER
2. TABLETS (INDIA) LIMITED 5974 APPROVAL LETTER
3. CLARIS OTSUKA PRIVATE LIMITED 7373 APPROVAL LETTER
4. VITAL HEALTHCARE PVT. LTD. 7213 APPROVAL LETTER
5. KUSUM HEATLHCARE PVT. LTD. 7457 APPROVAL LETTER
6. SAMARTH LIFE SCIENCES PVT. LTD. (UNIT-II)
7415 APPROVAL LETTER
7. PFIZER PRODUCTS INDIA PVT. LTD. 6801 APPROVAL LETTER
8. ASTRAZENECA PHARMA INDIA LIMITED
5697 APPROVAL LETTER
9. ADD-BIOTEC 7803 APPROVAL LETTER
10. TROIKAA PHARMACEUTICALS LTD., 7063 APPROVAL LETTER
11. TROIKAA PHARMACEUTICALS LTD., 7064 APPROVAL LETTER
12. GUTHY RENKER MARKETING PVT. LTD
7971 CLARIFICATION LETTER
REGISTRATION
S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER
1. NEXT GEN PHARMA INDIA PVT. LTD.
3503 AMENDED LETTER
2. UCB INDIA PVT. LTD 3176 AMENDED LETTER
3. JOHNSON & JOHNSON PVT. LTD. 25426 LETTER
FDC DIVISION
S.NO. NAME OF COMPANY DIARY NO DOCUMENT
1. M/S. GLAXOSMITHKLINE ASIA PVT. LTD., 50009 LETTER
2. M/S. TORRENT PHARMACEUTICALS LTD., 1740 LETTER
3. M/S. FAMY CARE LTD., 39411 LETTER
4. M/S. FAMY CARE LTD., 39410 LETTER
5. M/S. INDIA MEDTRONIC PVT. LTD., 408 LETTER
6. M/S. INDIA MEDTRONIC PVT. LTD., 407 LETTER
7. M/S. LABINDUSS LTD., 62305 LETTER
8. M/S. MERIDIAN ENTERPRISES PVT. LTD., 66867 LETTER
9. M/S. AKUMS DRUGS &
PHARMACEUTICALS LTD.,
50299 LETTER
10. M/S. INTAS PHARMACEUTICALS LTD., 51444 LETTER
11. M/S. TAKEDA PHARMACEUTICALS INDIA 50733 LETTER
12. M/S. SARDIA PHARMACEUTICALS INDIA 531 LETTER
13. M/S. NATCO PHARMA NIL SEC LETTER
14. M/S. PFIZER LTD., 37764 LETTER
15. M/S. RPG LIFE SCIENCES 37345 LETTER
16. M/S. VERIZON GENESIS NIL LETTER
BIOLOGICAL DIVISION
S. NO.
COMPANY NAME/ FILE NO DY. NO STATUS
1 M/S DR. REDDY’S LABORATORIES LTD
5229, 4397 APPROVAL LETTER
2 M/S ROCHE PRODUCTS INDIA PVT, LTD
7375 APPROVAL LETTER
3 M/S PFIZER LTD 7852, 2114 CLARIFICATION LETTER
4 M/S BHARAT BIOTECH INTERNATIONAL LTD
2160, 15130 APPROVAL & CLARIFICATION LETTER
5 M/S HLL LIFECARE LTD 40005 CLARIFICATION LETTER
6 M/S SANOFI SYNTHELABO INDIA PVT, LTD
4201 CLARIFICATION LETTER
7 M/S SANDOR MEDICAIDS PVT, LTD
5443 CLARIFICATION LETTER
8 M/S ALCON LABORATORIES INDIA PVT, LTD
7116 CLARIFICATION LETTER
9 M/S WOCKHARDT LTD 4114 CLARIFICATION LETTER
10 M/S M.J. BIOPHARM PVT,LTD
706 CLARIFICATION LETTER
11 M/S SYNGENE 7441 APPROVAL LETTER
INTERNATIONAL LTD
12 M/S CLIANTHA RESEARCH LTD
7811 APPROVAL LETTER
13 M/S ACCUTEST RESEARCH LABORATORIES I PVT, LTD
7840, 7839 APPROVAL LETTER
14 M/S MERCK SPECIALITIES PVT, LTD
28717 APPROVAL LETTER
15 M/S CHIRON BEHRING VACCINE PVT, LTD
50850 APPROVAL LETTER
GLOBAL CLINICAL TRIAL
SR.
NO.
COMPANY NAME REFERENCE STATUS
1 M/S. NOVO NORDISK - SEC MEETING LETTER
2 M/S. JSS 1259 CHANGE IN CRO, TL &
EXPORT NOC
APPROVAL LETTERS
MEDICAL DEVICE
S.NO. COMPANY NAME DIARY NO STATUS
1. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 2307 APPROVAL (E-IL)
2. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 33063 LETTER
3. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. 33062 QUERY LETTER
4. THE DRUGS CONTROLLER, BANGALORE (CLAA)
THE DEPUTY DRUGS CONTROLLER,
BANGALORE (CLAA)
M/S. BLUE NEEM MEDICAL DEVICES PVT. LTD.
FTS. NO.-
13526
APPROVAL LETTER
5. THE JOINT COMMISSIONER (K.D.), THANE
(CLAA)
THE DEPUTY DRUGS CONTROLLER, MUMBAI
(CLAA)
M/S. RCH ORTHOPAEDICS, THANE
FTS. NO.-
10962
QUERY LETTER
SUBSEQUENT NEW DRUG
S. NO. NAME OF THE FIRM REFERENCE NO.
FTS NO. TYPE OF LETTER
1. M/S MARTIN AND HARRIS LABORATORIES LTD.
- - LETTER
COSMETIC DIVISION
S. NO. COMPANY NAME
DIARY NO. STATUS
1. M/S. EKATRA HOSPITALITY VENTURES PVT. LTD,
NEW DELHI
52044 APPROVAL
LETTER
2. M/S. LOTUS HERBALS PVT. LTD, UTTAR
PRADESH
52116, 140,
5823
APPROVAL
LETTER
3. M/S. FASHION IDENTITY PVT. LTD, MUMBAI 574 APPROVAL
LETTER
4. M/S. PARAMOUNT COSMETICS (INDIA)
LIMITED, BANGALORE
591 APPROVAL
LETTER
5. M/S. SISO IMPORTERS & TRADERS PVT. LTD,
KERALA
1000 APPROVAL
LETTER
6. M/S. SIT PVT. LTD, (SISO IMPORTERS &
TRADERS PVT. LTD, KERALA
1001 APPROVAL
LETTER
7. M/S. VALEO NUTRA PVT. LTD, MUMBAI 2762 APPROVAL
LETTER
8. M/S. ALPINE TRADERS LINKS, NEW DELHI 2966 APPROVAL
LETTER
9. M/S. SHARAYA INTERNATIONAL, NEW DELHI 3232 APPROVAL
LETTER
10. M/S. PERFECT WAY TRADING, MUMBAI 4127 DEFICIENCY
LETTER
11. M/S. BAJORIA FOODS PVT LTD, MUMBAI 5980 APPROVAL
LETTER
12. M/S. BAUSCH AND LOMB (INDIA) PVT. LTD,
GURGAON
6097 APPROVAL
LETTER
13. M/S. HENKEL ADHESIVES TECHNOLOGIES INDIA
PVT LTD, CHENNAI
6319 APPROVAL
LETTER
14. M/S. JONHSON & JOHNSON, MUMBAI 6972 APPROVAL
LETTER
GLOBAL CLINICAL TRIAL
SR.
NO.
COMPANY NAME REFERENCE STATUS
1 M/S. MAYA CLINICALS 4392/4783/4784/1357 NEW SITE / PA
APPROVAL LETTERS
2 M/S. CADILA 34672/238/50492 CHANGE IN PI/NEW SITE
APPROVAL LETTERS
3 M/S. NOVO NORDISK 6694 TL APPROVAL LETTER
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-400709
5825 APPROVAL
LETTER
2. M/S. ACCUTEST RESEARCH
LABORATORIES (I) PVT. LTD., NAVI
MUMBAI-400709
5824 APPROVAL
LETTER
3. M/S. ACCUTEST RESEARCH
LABORATORIES (I) PVT. LTD., NAVI
7448 APPROVAL
LETTER
MUMBAI-400709
4. M/S. ACCUTEST RESEARCH
LABORATORIES (I) PVT. LTD., NAVI
MUMBAI-400709
7484 APPROVAL
LETTER
5. M/S. ACCUTEST RESEARCH
LABORATORIES (I) PVT. LTD., NAVI
MUMBAI-400709
6219 TEST LICENCE
6. M/S. ACCUTEST RESEARCH
LABORATORIES (I) PVT. LTD., NAVI
MUMBAI-400709
7223 TEST LICENCE
7. M/S. ACCUTEST RESEARCH
LABORATORIES (I) PVT. LTD., NAVI
MUMBAI-400709
5107 AMENDMENT
LETTER
8. M/S. ACTIMUS BIOSCIENCES PVT.
LTD., VISAKHAPATNAM-530003,
ANDHRA PRADESH
5636 CLARIFICATION
LETTER
9. M/S. AJANTA PHARMA LIMITED,
MUMBAI-400067
6322 CLARIFICATION
LETTER
10. M/S. ALEMBIC PHARMACEUTICALS
LTD., VADODARA-390003
5721 APPROVAL
LETTER
11. M/S. ALEMBIC PHARMACEUTICALS
LTD., VADODARA-390003
6233 APPROVAL
LETTER
12. M/S. ALEMBIC PHARMACEUTICALS
LTD., VADODARA-390003
6406 APPROVAL
LETTER
13. M/S. ALKEM LABORATORIES LTD.,
TALOJA-410 208, TAL: PANVEL,
DIST: RAIGAD
5953 AMENDMENT
LETTER
14. M/S. ALKEM LABORATORIES LTD.,
TALOJA-410208, TAL: PANVEL, DIST:
RAIGAD
5954 APPROVAL
LETTER
15. M/S. ALKEM LABORATORIES LTD.,
TALOJA-410208, TAL: PANVEL, DIST:
RAIGAD
6471 APPROVAL
LETTER
16. M/S. ANACIPHER CLINICAL
RESEARCH ORGANISATION (A
DIVISION OF INDOCO REMEDIES
LTD.), HYDERABAD-500013
6124 APPROVAL
LETTER
17. M/S. ANACIPHER CLINICAL
RESEARCH ORGANISATION (A
DIVISION OF INDOCO REMEDIES
LTD.), HYDERABAD-500013
1747 APPROVAL
LETTER
18. M/S. APL RESEARCH CENTRE,
AUROBINDO PHARMA LTD.,
HYDERABAD-500090
6185 APPROVAL
LETTER
19. M/S. APL RESEARCH CENTRE,
AUROBINDO PHARMA LTD.,
HYDERABAD-500090
6968 APPROVAL
LETTER
20. M/S. APL RESEARCH CENTRE,
AUROBINDO PHARMA LTD.,
HYDERABAD-500090
6452 TEST LICENCE
21. M/S. AXIS CLINICALS LTD.,
HYDERABAD-500049
6570 CLARIFICATION
LETTER
22. M/S. AXIS CLINICALS LTD.,
HYDERABAD-500049
6571 CLARIFICATION
LETTER
23. M/S. AZIDUS LABORATORIES LTD.,
CHENNAI-600048
5546 CLARIFICATION
LETTER
24. M/S. CADILA HEALTHCARE LTD.,
AHMEDABAD-380015
6131 CLARIFICATION
LETTER
25. M/S. CIPLA LIMITED, MUMBAI-
400013
5828 APPROVAL
LETTER
26. M/S. CIPLA LIMITED, MUMBAI-
400013
990 APPROVAL
LETTER
27. M/S. CIPLA LIMITED, MUMBAI-
400013
6049 AMENDMENT
LETTER
28. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380 054
25845 TEST LICENCE
29. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380 054
25844 TEST LICENCE
30. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
134 ADDITIONAL
STUDY CENTER
31. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
5959 ADDITIONAL
STUDY CENTER
32. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6136 APPROVAL
LETTER
33. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6024 APPROVAL
LETTER
34. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6025 APPROVAL
LETTER
35. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
39259 APPROVAL
LETTER
36. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6135 APPROVAL
LETTER
37. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
51387 APPROVAL
LETTER
38. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6134 APPROVAL
LETTER
39. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6334 APPROVAL
LETTER
40. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6332 APPROVAL
LETTER
41. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6333 APPROVAL
LETTER
42. M/S. CLIANTHA RESEARCH LIMITED,
AHMEDABAD-380054
6338 APPROVAL
LETTER
43. M/S. DR. REDDY’S LABORATORIES
LTD., HYDERABAD-500034
6442 CLARIFICATION
LETTER
44. M/S. DR. REDDY’S LABORATORIES
LTD., HYDERABAD-500034
5819 APPROVAL
LETTER
45. M/S. DR. REDDY’S LABORATORIES
LTD., HYDERABAD-500034
6501 APPROVAL
LETTER
46. M/S. HETERO LABS LTD.,
HYDERABAD-500018
6460 APPROVAL
LETTER
47. M/S. HETERO LABS LTD.,
HYDERABAD-500018
6459 APPROVAL
LETTER
48. M/S. HETERO LABS LTD.,
HYDERABAD-500018
6793 APPROVAL
LETTER
49. M/S. JUBILANT GENERICS LTD.,
NOIDA-201301, UP
6226 APPROVAL
LETTER
50. M/S. JUBILANT GENERICS LTD.,
NOIDA-201301, UP
6232 APPROVAL
LETTER
51. M/S. KUSUM HEALTHCARE PVT.
LTD., NEW DELHI-110020
5904 TEST LICENCE
52. M/S. LAMBDA THERAPEUTIC
RESEARCH LTD., AHMEDABAD-
380061
687 APPROVAL
LETTER
53. M/S. LAMBDA THERAPEUTIC
RESEARCH LTD., NAVI MUMBAI-
400614
6307 APPROVAL
LETTER
54. M/S. LOTUS LABS PVT. LTD.,
BANGALORE-560034
5793 APPROVAL
LETTER
55. M/S. LOTUS LABS PVT. LTD.,
BANGALORE-560052
6107 APPROVAL
LETTER
56. M/S. LOTUS LABS PVT. LTD.,
BANGALORE-560064
6105 CLARIFICATION
LETTER
57. M/S. LOTUS LABS PVT. LTD.,
BANGALORE-560064
6106 APPROVAL
LETTER
58. M/S. LOTUS LABS PVT. LTD.,
CHENNAI-600004
5077 APPROVAL
LETTER
59. M/S. LOTUS LABS PVT. LTD.,
CHENNAI-600004
6548 APPROVAL
LETTER
60. M/S. LUPIN LIMITED (RESEARCH
PARK), PUNE-412115
6213 APPROVAL
LETTER
61. M/S. MACLEODS
PHARMACEUTICALS LTD., ANDHERI
(EAST), MUMBAI-400059
5950 APPROVAL
LETTER
62. M/S. MANIPAL ACUNOVA LIMITED,
MANGALORE-575001
5909 CLARIFICATION
LETTER
63. M/S. MANIPAL ACUNOVA LIMITED,
MANIPAL -576104
6448 APPROVAL
LETTER
64. M/S. MANIPAL ACUNOVA LTD.,
MANGALORE-575001
6449 APPROVAL
LETTER
65. M/S. MANIPAL ACUNOVA LTD.,
MANGALORE-575001
6595 APPROVAL
LETTER
66. M/S. MICRO THERAPEUTIC
RESEARCH LABS PVT. LTD.,
CHENNAI-600059
38787 REJECTION
LETTER
67. M/S. MICRO THERAPEUTIC
RESEARCH LABS PVT. LTD.,
CHENNAI-600059
6054 APPROVAL
LETTER
68. M/S. NORWICH CLINICAL SERVICES
PVT. LTD., BANGALORE-560034
5792 AMENDMENT
LETTER
69. M/S. PANEXCELL CLINICAL LAB PVT.
LTD., NAVI MUMBAI-400701
6024 APPROVAL
LETTER
70. M/S. PANEXCELL CLINICAL LAB PVT.
LTD., NAVI MUMBAI-400701
6880 APPROVAL
LETTER
71. M/S. PAR BIOSCIENCES PRIVATE
LIMITED, CHENNAI-600100
5731 CLARIFICATION
LETTER
72. M/S. PAR BIOSCIENCES PRIVATE
LIMITED, CHENNAI-600100
5730 CLARIFICATION
LETTER
73. M/S. PAR BIOSCIENCES PRIVATE
LIMITED, CHENNAI-600100
5049 APPROVAL
LETTER
74. M/S. PAR BIOSCIENCES PRIVATE
LIMITED, CHENNAI-600100
5853 APPROVAL
LETTER
75. M/S. QPS BIOSERVE INDIA PVT.
LTD., HYDERABAD – 500037
6480 APPROVAL
LETTER
76. M/S. RA CHEM PHARMA LTD.,
BALANAGAR, HYDERABAD-500037
5381 CLARIFICATION
LETTER
77. M/S. RAPTIM RESEARCH LTD., NAVI
MUMBAI-400701
5577 APPROVAL
LETTER
78. M/S. RAPTIM RESEARCH LTD., NAVI
MUMBAI-400701
5920 APPROVAL
LETTER
79. M/S. RELIANCE LIFE SCIENCES PVT.
LTD., NAVI MUMBAI-400 701
4300 TEST LICENCE
80. M/S. SANCILLIO
PHARMACEUTICALS PVT. LTD.,
THANE (WEST)-400607
5054 CLARIFICATION
LETTER
81. M/S. SIDMAK LABORATORIES
(INDIA) PVT. LTD., ABRAMA,
VALSAD-396001
6440 APPROVAL
LETTER
82. M/S. STRIDES SHASUN LTD.,
BANGALORE-560076
7016 AMENDMENT
LETTER
83. M/S. SUN PHARMACEUTICAL
INDUSTRIES LTD., HARYANA
6209 APPROVAL
LETTER
84. M/S. SUN PHARMACEUTICAL
INDUSTRIES LTD., VADODARA-390
020
5899 AMENDMENT
LETTER
85. M/S. SUN PHARMACEUTICAL
INDUSTRIES LTD., VADODARA-
390020
6210 CLARIFICATION
LETTER
86. M/S. SUN PHARMACEUTICAL
INDUSTRIES LTD., VADODARA-
390020
3305 CLARIFICATION
LETTER
87. M/S. SUN PHARMACEUTICAL
INDUSTRIES LTD., VADODARA-
390020
37037 APPROVAL
LETTER
88. M/S. SUN PHARMACEUTICAL
INDUSTRIES LTD., VADODARA-
390020
6272 APPROVAL
LETTER
89. M/S. SUN PHARMACEUTICAL
INDUSTRIES LTD., VADODARA-
390020
6271 APPROVAL
LETTER
90. M/S. SYNAPSE LABS PVT. LTD.,
KHARADI, PUNE-411 014
6584 APPROVAL
LETTER
91. M/S. SYNAPSE LABS PVT. LTD.,
KHARADI, PUNE-411014
6583 APPROVAL
LETTER
92. M/S. SYNGENE INTERNATIONAL
LTD., BANGALORE-560100
6035 APPROVAL
LETTER
93. M/S. VEEDA CLINICAL RESEARCH
PVT. LTD., AHMEDABAD-380 015
1386 APPROVAL
LETTER
94. M/S. VEEDA CLINICAL RESEARCH
PVT. LTD., AHMEDABAD-380 015
5985 TEST LICENCE
95. M/S. VEEDA CLINICAL RESEARCH 5987 CLARIFICATION
PVT. LTD., AHMEDABAD-380015 LETTER
96. M/S. VEEDA CLINICAL RESEARCH
PVT. LTD., AHMEDABAD-380015
5268 APPROVAL
LETTER
97. M/S. VEEDA CLINICAL RESEARCH
PVT. LTD., AHMEDABAD-380015
5986 APPROVAL
LETTER
98. M/S. VEEDA CLINICAL RESEARCH
PVT. LTD., AHMEDABAD-380015
5984 APPROVAL
LETTER
99. M/S. VEEDA CLINICAL RESEARCH
PVT. LTD., AHMEDABAD-380015
6541 APPROVAL
LETTER
100. M/S. VEEDA CLINICAL RESEARCH
PVT. LTD., AHMEDABAD-380015
6294 APPROVAL
LETTER
101. M/S. VERGO CLINICALS, GOA-
403110
6412 CLARIFICATION
LETTER
102. M/S. VIMTA LABS LTD.,
HYDERABAD-500051
5557 APPROVAL
LETTER
103. M/S. WATSON PHARMA PVT. LTD.,
NAVI MUMBAI-400614
50486 ADDITIONAL
STUDY CENTER
104. M/S. WATSON PHARMA PVT. LTD.,
NAVI MUMBAI-400614
6116 CLARIFICATION
LETTER
105. M/S. WATSON PHARMA PVT. LTD.,
NAVI MUMBAI-400614
6103 APPROVAL
LETTER
106. M/S. WATSON PHARMA PVT. LTD.,
NAVI MUMBAI-400614
6104 APPROVAL
LETTER