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LETTERS FOR ISSUE ON 12.07.2016
BIOLOGICAL DIVISION
S. NO NAME OF COMPANY DY. NO STATUS
1 M/S SANOFI INDIA LTD
39573 APPROVAL LETTER
2 M/S LUPIN LTD 14350 APPROVAL LETTER
3 M/S NOVARTIS HEALTHCARE PVT, LTD
13993 APPROVAL LETTER
4 M/S DR. REDDY’S LABORATORIES LTD
7539 APPROVAL LETTER
5 M/S LG LIFE SCIENCES INDIA PVT, LTD
17530 AMENDMENT LETTER
6 M/S GSK ASIA PVT, LTD
36862, 12532, 12929
AMENDMENT LETTER
7 M/S CADILA HEALTHCARE LTD
18637, 20504
APPROVAL & INVITATION LETTER
8 M/S HETERO DRUGS LTD
18077, APPROVAL LETTER
9 M/S RELIANCE LIFE SCIENCES PVT, LTD
13901 APPROVAL LETTER
10 M/S NOVO NORDISK PVT, LTD `
INVITATION LETTER
11 M/S SANZYME LTD INVITATION LETTER
12 M/S ROCHE PRODUCTS INDIA PVT, LTD
INVITATION LETTER
13 M/S RELIANCE LIFE SCIENCES PVT, LTD
INVITATION LETTER
14 M/S GENNOVA BIOPHARMACEUTICAL LTD
INVITATION LETTER
15 M/S JOHNON & JOHNSON
INVITATION LETTER
INTERNATIONAL CELL
S. NO FIRM NAME TYPE
1. M/S. CADILLA HEALTHCARE, GUJARAT WC
2. M/S. CADILLA PHARMACEUTICALS, GUJARAT WC
3. M/S. SUN PHARMA, TAMIL NADU WC
4. M/S. RICHTER THEMIS MEDICARE PVT LTD., WC
5. M/S. MEHTA API PVT. LTD., MAHARASHTRA WC
6. M/S. EMBIO LTD., MAHARASHTRA WC
7. M/S. SHARON BIOMEDICINE LTD., MAHARSHTRA WC
8. M/S. RA CHEM PHAMACEUTICALS, KRISHNA DIST WC
9. M/S. INOGENT LABORATORIES, HYDERABAD WC
10. M/S. ZYDUS TAKEDA HEALTHCARE PVT. LTD., MUMBAI WC
11. M/S. LAKE CHEMICALS, LAKSHMINARAYAN COMPLEX,
BANGALORE
WC
12. M/S. UNIQUE CHEMICALS, GUJARAT WC
13. M/S. AMI LIFE SCIENCES PVT. LTD., VADODARA,
GUJARAT
WC
14. M/S. BELOOR BAYIR CHEMICALS, BANGALORE WC
15. M/S. HETERO DRUGS LTD., VISHAKHAPATAM WC
16. M/S. MACLEODS PHARMACEUTICALS LTD., GUJARAT WC
17. M/S. SWATI SPENTOSE PVT. LTD. GUJARAT WC
18. M/S. SUN PHARMACEUTICALS INDUSTRIES LTD. WC
19. M/S. MYLAN LABORATORIES LTD., UNIT-VII,
TELANGANA
WC
20. M/S. SANOFI INDIA LIMITED, GUJARAT WC
21. M/S. MELODY HEALTHCARE PVT LTD., MAHARASHTRA WC
22. M/S. ATUL LTD., GUJARAT WC
23. M/S. ANEK PRAYOG, RAIGAD WC
24. M/S. GRANULES INDIA LTD., UNIT-II, AP. WC
25. M/S. KORES (INDIA) LTD., RAIGAD, MAHARASHTRA LETTER
26. M/S. BIOCON LTD., BOMASANDRA, BANGALORE LETTER
27. M/S. BIOCON LTD., SITE-I, ELECTRONIC CITY,
BANGALORE
LETTER
28. M/S. CADILA HEALTHCARE LIMITED, ANKLESHWAR,
GUJARAT
LETTER
29. M/S. PROVENTUS LIFE SCIENCES, CHENNAI LETTER
30. M/S. SYMBIOTECH PHARMALAB, MP LETTER
31. M/S. SHRI KRISHNA PHARMACEUTICALS LIMITED,
UNIT-1, A.P
LETTER
32. M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA,
GUJARAT
LETTER
GLOBAL CLINICAL TRIAL
SR.
NO.
COMPANY
NAME
REFERENCE
NO.
STATUS
1 M/S. SANOFI 18100 CLARIFICATION
LETTER
2 M/S. ROCHE 19198 TL APPROVAL
LETTER
3 M/S. CADILA 19416 SITE APPROVAL
LETTER
4 M/S. NOVARTIS 18322 EXPORT NOC
APPROVAL LETTER
NEW DRUG
S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER
1. M/S. ROCHE PRODUCTS (INDIA) PVT LTD
- MEETING NOTICE LETTER 19.07.2016 (ONCOLOGY)
2. M/S. BOEHRINGER INGELHEIM INDIA PVT LTD.
- MEETING NOTICE LETTER 19.07.2016 (ONCOLOGY)
3. M/S. AJANTA PHARMA - MEETING NOTICE LETTER 25.07.2016 (PULMONARY)
4. M/S. BOEHRINGER INGELHEIM INDIA PVT LTD.
- MEETING NOTICE LETTER 25.07.2016 (PULMONARY)
5. M/S. ELI-LILLY - MEETING NOTICE LETTER 28.07.2016 (REPRODUCTIVE & UROLOGY)
6. M/S. NOVARTIS PHARMACUTICALS
- MEETING NOTICE LETTER 29.07.2016 (ANTIMICROBIAL)
7. M/S. MICRO LABS - MEETING NOTICE LETTER 29.07.2016 (ANTIMICROBIAL)
COSMETICS DIVISION
S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER
1. M/S. ITC LIMITED, KOLKATA 19474 APPROVAL LETTER
2. M/S. N K HEALTHCARE PVT. LTD, NEW DELHI 17588 APPROVAL LETTER
3. M/S. FASHION IDENTITY PVT. LTD, MUMBAI 18217 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
19581 APPROVAL LETTER
2. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.,
NAVI MUMBAI-400709
20261 APPROVAL LETTER
3. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.,
NAVI MUMBAI-400709
20259 APPROVAL LETTER
4. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.,
NAVI MUMBAI-400709
19578 APPROVAL LETTER
5. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.,
NAVI MUMBAI-400709
17820 APPROVAL LETTER
6. M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD.,
NAVI MUMBAI-400709
20245 APPROVAL LETTER
7. M/S. ACTIMUS BIOSCIENCES PVT. LTD.,
VISAKHAPATNAM-530003
19363 APPROVAL LETTER
8. M/S. ACTIMUS BIOSCIENCES PVT. LTD.,
VISAKHAPATNAM-530003
15520 APPROVAL LETTER
9. M/S. ACTIMUS BIOSCIENCES PVT. LTD.,
VISAKHAPATNAM-530003
20148 APPROVAL LETTER
10. M/S. ACTIMUS BIOSCIENCES PVT. LTD.,
VISAKHAPATNAM-530003
15415 APPROVAL LETTER
11. M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA-
390003
20065 APPROVAL LETTER
12. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA
LTD., HYDERABAD-500090
10932 APPROVAL LETTER
13. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA
LTD., HYDERABAD-500090
18975 APPROVAL LETTER
14. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA
LTD., HYDERABAD-500090
18966 APPROVAL LETTER
15. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA
LTD., HYDERABAD-500090
20226 APPROVAL LETTER
16. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA
LTD., HYDERABAD-500090
20228 APPROVAL LETTER
17. M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA
LTD., HYDERABAD-500090
14917 APPROVAL LETTER
18. M/S. APOTEX RESEARCH PVT. LTD., BANGALORE-
560099
13145 APPROVAL LETTER
19. M/S. AZIDUS LABORATORIES LTD., CHENNAI-600048 20388 CLARIFICATION LETTER
20. M/S. AZIDUS LABORATORIES LTD., CHENNAI-600048 18388 APPROVAL LETTER
21. M/S. CADILA PHARMACEUTICAL LTD., DHOLKA-387810,
AHMEDABAD
12844 APPROVAL LETTER
22. M/S. CIPLA LIMITED, MUMBAI-400013 18980 AMENDMENT LETTER
23. M/S. CIPLA LIMITED, MUMBAI-400013 20364 APPROVAL LETTER
24. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-
380054
18935 APPROVAL LETTER
25. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-
380054
19527 APPROVAL LETTER
26. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-
380054
19853 APPROVAL LETTER
27. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-
380054
15862 APPROVAL LETTER
28. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-
380054
14858 APPROVAL LETTER
29. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-
380054
15561 APPROVAL LETTER
30. M/S. DR. REDDY’S LABORATORIES LTD., HYDERABAD-
500034
18470 APPROVAL LETTER
31. M/S. DR. REDDY’S LABORATORIES LTD., HYDERABAD-
500034
11023 APPROVAL LETTER
32. M/S. EMCURE PHARMACEUTICALS LIMITED, PUNE-
411026
19881 APPROVAL LETTER
33. M/S. EMCURE PHARMACEUTICALS LIMITED, PUNE-
411026
19878 APPROVAL LETTER
34. M/S. GLENMARK PHARMACEUTICALS LTD., NAVI
MUMBAI-400705
19339 APPROVAL LETTER
35. M/S. HETERO LABS LTD., HYDERABAD-500018 13013 APPROVAL LETTER
36. M/S. HETERO LABS LTD., HYDERABAD-500018 19152 APPROVAL LETTER
37. M/S. HETERO LABS LTD., HYDERABAD-500018 18485 APPROVAL LETTER
38. M/S. INVENTIA HEALTHCARE PVT. LTD., DIST. THANE- 19335 APPROVAL LETTER
421506
39. M/S. INVENTIA HEALTHCARE PVT. LTD., DIST. THANE-
421506
19336 APPROVAL LETTER
40. M/S. JUBILANT GENERICS LTD., NOIDA-201301, UP 17549 APPROVAL LETTER
41. M/S. LAMBDA THERAPEUTIC RESEARCH LTD.,
AHMEDABAD-382481
17752 APPROVAL LETTER
42. M/S. LAMBDA THERAPEUTIC RESEARCH LTD.,
AHMEDABAD-382481
14082 APPROVAL LETTER
43. M/S. LAMBDA THERAPEUTIC RESEARCH LTD.,
AHMEDABAD-382481
20319 APPROVAL LETTER
44. M/S. LAMBDA THERAPEUTIC RESEARCH LTD.,
AHMEDABAD-382481
17201 APPROVAL LETTER
45. M/S. LAMBDA THERAPEUTIC RESEARCH LTD.,
AHMEDABAD-382481
17199 APPROVAL LETTER
46. M/S. LAMBDA THERAPEUTIC RESEARCH LTD.,
AHMEDABAD-382481
19345 APPROVAL LETTER
47. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., NAVI
MUMBAI-400 614
19344 APPROVAL LETTER
48. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 17718 APPROVAL LETTER
49. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 13100 APPROVAL LETTER
50. M/S. LOTUS LABS PVT. LTD., BANGALORE-560034 19914 APPROVAL LETTER
51. M/S. LOTUS LABS PVT. LTD., BANGALORE-560064 19014 APPROVAL LETTER
52. M/S. LOTUS LABS PVT. LTD., BANGALORE-560064 19915 APPROVAL LETTER
53. M/S. LOTUS LABS PVT. LTD., CHENNAI- 600 004 18711 APPROVAL LETTER
54. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 20602 CLARIFICATION LETTER
55. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 20603 CLARIFICATION LETTER
56. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 12856 APPROVAL LETTER
57. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 19887 APPROVAL LETTER
58. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 19737 APPROVAL LETTER
59. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 19075 APPROVAL LETTER
60. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 18602 APPROVAL LETTER
61. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 17124 APPROVAL LETTER
62. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 17125 APPROVAL LETTER
63. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 10432 APPROVAL LETTER
64. M/S. LUPIN LIMITED (RESEARCH PARK), PUNE-412115 19077 APPROVAL LETTER
65. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI
(EAST), MUMBAI-400059
13633 APPROVAL LETTER
66. M/S. MANIPAL ACUNOVA LIMITED, MANGALORE-
575001
12190 APPROVAL LETTER
67. M/S. MANIPAL ACUNOVA LIMITED, MANIPAL -576104 19723 APPROVAL LETTER
68. M/S. MANIPAL ACUNOVA LTD., MANGALORE-575001 20149 APPROVAL LETTER
69. M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD.,
CHENNAI-600059
20791 AMENDMENT LETTER
70. M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD.,
CHENNAI-600059
19833 CLARIFICATION LETTER
71. M/S. RA CHEM PHARMA LTD., BALANAGAR,
HYDERABAD-500037
19548 APPROVAL LETTER
72. M/S. STRIDES SHASUN LIMITED, BANGALORE-560076 16653 APPROVAL LETTER
73. M/S. SUN PHARMA ADVANCED RESEARCH COMPANY
LTD., VADODARA-390 020
20264 TEST LICENCE
74. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
HARYANA
17344 APPROVAL LETTER
75. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
HARYANA
17550 APPROVAL LETTER
76. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
HARYANA
19836 APPROVAL LETTER
77. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
HARYANA
18471 APPROVAL LETTER
78. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
HARYANA
20023 APPROVAL LETTER
79. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
VADODARA-390 020
19009 APPROVAL LETTER
80. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
VADODARA-390 020
19149 APPROVAL LETTER
81. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
VADODARA-390020
20104 CLARIFICATION LETTER
82. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD.,
VADODARA-390020
18610 CLARIFICATION LETTER
83. M/S. VEEDA CLINICAL RESEARCH PVT. LTD.,
AHMEDABAD-380015
17819 APPROVAL LETTER
84. M/S. VEEDA CLINICAL RESEARCH PVT. LTD.,
AHMEDABAD-380015
18377 APPROVAL LETTER
85. M/S. VERGO PHARMA RESEARCH PVT. LTD. (DIV-
VERGO CLINICALS), GOA-403110
19654 APPROVAL LETTER
86. M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI-
400614
20331 APPROVAL LETTER
87. M/S. WOCKHARDT LIMITED, AURANGABAD-431006 16901 APPROVAL LETTER
SUBSEQUENT NEW DRUG
S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF LETTER
1. M/S TROIKAA PHARMACEUTICAL LTD.,
- 34667 LETTER
MISC.
S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER
1. MYLAN LABORATORIES LTD. NIL LETTER
MEDICAL DEVICE
S.NO. COMPANY NAME DIARY NO STATUS
1. M/S. ST. JUDE MEDICAL INDIA PVT. LTD. 15604 QUERY LETTER
2. M/S. JSS MEDICAL RESEARCH INDIA LIMITED 2358 LETTER
3. M/S. SAHAJANAND MEDICAL TECHNOLOGIES PVT. LTD. FTS. NO.-
33328
LETTER
4. THE DEPUTY DRUGS CONTROLLER, GHAZIABA (CLAA)
THE STATE DRUGS CONTROLLER & LICENSING AUTHORITY,
PANCHKULA ( CLAA)
M/S. R.N.S. SURGICAL PVT. LTD., BAHADURGARH
FTS. NO.-
34464
QUERY LETTER
5. THE DRUGS LICENSING & CONTROLLING AUTHORITY,
LUCKNOW (CLAA)
THE DEPUTY DRUGS CONTROLLER, GHAZIABAD (CLAA)
(M/S. NARANG MEDICAL LTD., GHAZIABAD)
FTS. NO. -
34649
APPROVAL LETTER
6. M/S. CADILA HEALTHCARE LIMITED
(ONLINE APPROVAL)
807 APPROVAL (IL)
7. M/S. DR. REDDYS LABORATORIES LTD.
(ONLINE APPROVAL)
929 APPROVAL (IL)
8. M/S. DR. REDDYS LABORATORIES LTD.
(ONLINE APPROVAL)
1186 APPROVAL (IL)
9. M/S. GLAND PHARMA LIMITED
(ONLINE APPROVAL)
1160 APPROVAL (IL)
10. M/S. G.C. CEHMIE PHARMIE LTD.
(ONLINE APPROVAL)
1306 APPROVAL (IL)
11. M/S. INDICAL MEDSURG PVT. LTD.
(ONLINE APPROVAL)
2727 APPROVAL (IL)
12. M/S. GLAND PHARMA LIMITED
(ONLINE APPROVAL)
2022 APPROVAL (IL)
13. M/S. EDWARDS LIFESCIENCES INDIA PVT. LTD.
(ONLINE APPROVAL)
3048 APPROVAL (E-IL)
14. M/S. ARIHANT ENTERPRISES
(ONLINE APPROVAL)
2519 APPROVAL (IL)
15. M/S. INTAS PHARMACEUTICAL LTD.
(ONLINE APPROVAL)
2155 APPROVAL (IL)
16. M/S. MORULAA HEALTHTECH PVT. LTD.
(ONLINE APPROVAL)
690 APPROVAL (IL)
17. M/S. OSSTEM IMPLANT INDIA PVT. LTD.
(ONLINE APPROVAL)
1917 APPROVAL (IL)
18. M/S. SUN PHARMACEUTICAL INDUSTRIES LIMITED
(ONLINE APPROVAL)
3108 APPROVAL (IL)
19. M/S. WIN SURGICAL
(ONLINE APPROVAL)
2480 APPROVAL (IL)
20. M/S. VYGON INDIA PVT. LTD. 17842 CLARIFICATION LETTER
21. M/S. CARL ZEISS INDIA (BANGALORE) PVT. LTD. 12797 APPROVAL (R-RC)
22. M/S. KLB INSTRUMENTS CO. PVT. LTD. 15090 APPROVAL (E-RC)
DIAGNOSTICS DIVISION
S.NO. COMPANY NAME DIARY NO STATUS
1. M/S. BECKMAN COULTER INDIA PVT. LTD.
(ONLINE APPROVAL)
2138 APPROVAL (IL)
2. M/S. KINEDEX BIOMEDICALS PVT. LTD.
(ONLINE APPROVAL)
1902 APPROVAL (IL)
3. M/S. VANUGUARD DIAGNOSTICS PVT. LTD.,
(ONLINE APPROVAL)
2413 APPROVAL (IL)
4. M/S. ASPEN LABORATORIES PVT. LTD.
(ONLINE APPROVAL)
1748 APPROVAL (IL)
5. M/S. SD BIOSENSOR HEALTHCARE PVT. LTD.
(ONLINE APPROVAL)
1033 APPROVAL (IL)
6. M/S. BIO-RAD LABORATORIES (INDIA) PVT. LTD.
(ONLINE APPROVAL)
1923 APPROVAL (IL)
7. M/S. ACCUREX BIOMEDICAL PVT. LTD.,
(ONLINE APPROVAL)
1405 APPROVAL (IL)
8. M/S. ASTRAA BIOMEDICALS
(ONLINE APPROVAL)
2729 APPROVAL (IL)
9. M/S. BECKTON DICKINSON INDIA PVT. LTD.
(ONLINE APPROVAL)
1362 APPROVAL (IL)
10. M/S. VIJYOTI MANAGEMENT & COMMUNICATIONS
LEARNING INSTITUTE PVT. LTD.
(ONLINE APPROVAL)
1721 APPROVAL (IL)
11. M/S. POCT SERVICES PVT. LTD.
(ONLINE APPROVAL)
1709 APPROVAL (IL)
12. M/S. BECKTON DICKINSON INDIA PVT. LTD.
(ONLINE APPROVAL)
2906 APPROVAL (IL)
13. M/S. BECKTON DICKINSON INDIA PVT. LTD.
(ONLINE APPROVAL)
2942 APPROVAL (IL)
14. M/S. BIOSYSTEMS DIAGNOSTICS PVT. LTD.
(ONLINE APPROVAL)
2941 APPROVAL (IL)
15. M/S. DIASORIN TRIVITRON HEALTHCARE PVT. LTD.
(ONLINE APPROVAL)
2891 APPROVAL (IL)
16. M/S. IMMUCOR INDIA PVT. LTD.
(ONLINE APPROVAL)
2741 APPROVAL (IL)
17. M/S. MATRIX LABS
(ONLINE APPROVAL)
1778 APPROVAL (IL)