LETTERS FOR ISSUE ON 12.01.2015
BE NOC FOR EXPORT
S. NO.
REF. NO.
Type of letter
49343
Approval Letter
2.
M/s. APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad-500 090
M/s. Azidus Laboratories Ltd., Chennai-600 048
49954
3.
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052
49852
Clarification
Letter
Approval Letter
4.
M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052
49839
Approval Letter
5.
M/s. Lupin Limited (Research Park), Pune-412 115
49883
Approval Letter
6.
M/s. Semler Research Center, Bangalore-560078
50479
Approval Letter
7.
M/s. Shasun Pharmaceuticals Limited, Puducherry605014
M/s. Sidmak Laboratories (India) Pvt. Ltd., Abrama,
Valsad-396 001
M/s. Synchron Research Services Pvt. Ltd.,
Ahmedabad-380 059
44343
Test Licence
50038
Approval Letter
50606
Approval Letter
1.
8.
9.
NAME OF THE COMPANY
MEDICAL DEVICE
S.NO.
COMPANY NAME
DIARY NO
STATUS
1.
M/s. Shah Distributors, Karnataka
46650
Letter
2.
M/s. Boston Scientific India Pvt. Ltd., New Delhi
36332
RC & F-10
3.
M/s. Becton Dickinson India Pvt. Ltd., Chennai
41117
RC & F-10
4.
M/s. Myovatec Surgical Systems Pvt. Ltd., New
Delhi
M/s. Carewell Medical Systems, Chandigarh
24088
RC
46394
RC
M/s. Biotronik Medical Devices India Pvt. Ltd.,
New Delhi
M/s. Span Healthcare Pvt. Ltd., Bangalore
48889
E-F-10
32719
Letter
5.
6.
7.
8.
M/s. Bard India Healthcare Pvt. Ltd., Mumbai
38273
Letter
9.
M/s. Boston Scientific India Pvt. Ltd., New Delhi
47779
Letter
10.
47692
Letter
47694
Letter
12.
M/s. Kimberly-Clark Hygiene Products Pvt. Ltd.,
Pune
M/s. Kimberly-Clark Hygiene Products Pvt. Ltd.,
Pune
M/s. India Medtronic Pvt. Ltd., Mumbai
48556
Letter
13.
M/s. MN Solutions, New Delhi
40473
Letter
14.
30302
Letter
36299
Letter
16.
M/s. Regenerative Medical Services Pvt. Ltd.,
Mumbai
M/s. S3V Vascular Techjnologies Pvt. Ltd.,
Mysore
M/s. Virdis BioPharma Pvt. Ltd., Thane
46779
Letter
17.
M/s. Skincare SUrgipharma Pvt. Ltd., Mumbai
30283
Letter
18.
M/s. LG Life Sciences India Pvt. Ltd., Gurgaon
36976
Letter
19.
M/s. MAKRO Pharma, Ranga Reddy District
40998
Letter
20.
M/s. Boston Scientific India pvt. Ltd., New Delhi
43745
Letter
21.
M/s. Bard India Healthcare Pvt. Ltd., Mumbai
22446
Letter
22.
M/s. India Medtronic Pvt. Ltd., Bhiwandi
36118
Letter
23.
M/s. Covidien Healthcare India Pvt. Ltd., Chennai
37041
Letter
24.
FTS no.
67137
FTS no.
67137
Letter
25.
Deputy Drugs Controller (Ghaziabad) / Drugs
Controller (Jaipur) / M/s. Frozen Cell (ALwar)
Deputy Drugs Controller (Panchkula) / Deputy
Drugs Controller (Ghaziabad) / M/s. Ribble
International Ltd., Sonepat
26.
Drugs Controller (Jaipur)
FTS no.
69675
Letter
11.
15.
DIAGNOSTICS DIVISION
Letter
S.NO.
COMPANY NAME
DIARY NO
STATUS
1.
M/s. Roche Diagnostics India Pvt. Ltd., Mumbai
2.
M/s. Abbott Healthcare Pvt. Ltd., Mumbai
42399
F-10
3.
M/s. Agappe Diagnotics Ltd., Ernakulum
40650
F-10
4.
M/s. Alliance Transfusion Pvt. Ltd., Gurgaon
43619
Letter
5.
M/s. Agility Biotech Pvt. Ltd., Delhi
44581
Letter
6.
M/s. Beckman Coulter India Pvt. Ltd., Mumbai
45388
Letter
7.
M/s. Biomerieux India Pvt. Ltd., New Delhi
40536
Letter
8.
M/s. DHR Holding India Pvt. Ltd., Chennai
44726
Letter
9.
M/s. Geniune Biosystem, Chennai
43120
Letter
10.
M/s. Johnsons& Johnsons, Thane
45957
Letter
11.
M/s. Johnson & Johnson, Thane
46974
Letter
12.
M/s. Lilac Medicare Pvt. Ltd., Mumbai
44897
Letter
13.
M/s. Lab India Healthcare Pvt. Ltd., Guragon
47260
Letter
14.
M/s. Saify Traders, Indore
45653
Letter
15.
M/s. Transasia Bio Medicals Limited., Daman
47579
Letter
16.
M/s. Alere Medical Pvt. Ltd., Rewari
44934
Letter
17.
M/s. BioMerieux India Pvt. Ltd., New Delhi
47827
Letter
18.
M/s. Kabs Healthcare Pvt. Ltd., New Delhi
45463
Letter
19.
M/s. BioMereiux India Pvt. Ltd., New Delhi
47637
Letter
20.
M/s. Beacon Diagnostics Pvt. Ltd., Navsari
FTS no.
67411
Letter
Letter
VACCINE DIVISION
S. No.
COMPANY NAME
Dy. No.
STATUS
1
M/s Indian Immunologicals Ltd 47736
Approval letter
2
M/s GlaxoSmithKline
Pharmaceuticals Ltd
33910
Approval letter
3
M/s Zoetis India Ltd
48524
Amendment letter
4
M/s Intervet India Pvt. Ltd
11942
Approval letter
5
M/s Panav Biotech
45469
Approval letter
6
M/s Biocon Limited
46502
Clarification letter
7
M/s Novartis Healthcare
Private Limited
57234
Clarification letter
8
M/s Sanofi India Limited
42795
Clarification letter
9
M/s Roche Products (India) Pvt 46030, 47724,
Ltd
29500, 12904
Approval Acknowledge
& Clarification letter
10
M/s Organon India Pvt Ltd
46085
Clarification letter
11
M/s Novo Nordisk India Pvt Ltd 47581
Clarification letter
12
M/s Sanofi Synthelabo India
Ltd
Clarification letter
13
M/s Novartis India Ltd
14
M/s Alpha Drugs
15
M/s Abbott India ltd
25564
Approval letter
16
M/s Wockhardt Ltd
46508
Approval letter
17
M/s Intas Pharmaceuticals Ltd
17575, 17675,
17601, 18376
Approval letter
18
M/s Serum Institute of India
ltd
49428, 49427
Approval &
Amendment letter
19
M/s Virchow Bioteh Pvt, ltd
62001 (fts no)
Approval letter
20
M/s Venkateswara Hatcheries
PVt, ltd
49790 (fts no)
Approval letter
21
M/s Bharat Serum and vaccine
ltd
42733
Clarification letter
22
M/s Shantha Biotechnices
42538,
Clarification letter
23
M/s Biological E. Ltd
48597, 48792,
48791
Approval letter
44121, 39977
Clarification letter
Approval letter
REGISTRATION
S.NO.
1.
2.
NAME OF APPLICANT
DIARY NO.
Pfizer Products India Pvt. Ltd. 42715
Bayer pharmaceutical pvt. ltd. 33357
TYPE OF LETTER
CLARIFICATION LETTER
CLARIFICATION LETTER
GLOBAL CLINICAL TRIAL
Sr. No.
Name of Firm
Reference No.
-
Type of Letter
1.
M/s. Maya Clinicals
Clarification Letters
2.
M/s. Quintiles
48002
Clarification Letter
3.
M/s. Novartis
-
Clarification Letter
4.
M/s. MSD
-
Clarification Letter
5.
M/s. St. John’s Research
Institute
-
Clarification Letter
NEW DRUG
S.NO. NAME OF APPLICANT
DIARY
NO.
-
TYPE OF LETTER
1.
M/s. Venus Remedies Ltd.
2.
Hetero Labs Limited
-
Query Letter (5)
3.
Dr. Ananth kumar. S.
-
Query Letter
4.
M/s Themis Medicare Ltd.
-
Query Letter
5.
M/s Bharat Serum and Vaccine Ltd-
-
Query Letter
6.
M/s Cadila Healthcare
-
CT-NOC Letter (2)
7.
M/s. Takeda Pharmaceuticals India Pvt
-
Query Letter
8.
M/s Cipla Ltd
-
Query Letter
Query Letter
9.
M/s Sun Pharmaceuticals Industries Ltd.
-
Query Letter
10.
M/s. Zuventus Healthcare Ltd.
-
Query Letter
11.
M/s Intas
-
12.
Dr. Gadipudi Avanthi
-
13.
M/s WestCoast
-
14.
M/s. Ajanta
-
15.
M/s MSN Labs
-
16.
M/s MSN Labs
-
Meeting Notice 16-012015 (Reproductive &
Urology)
Meeting Notice 16-012015 (Reproductive &
Urology)
Meeting Notice 16-012015 (Reproductive &
Urology)
19-01-2015 Meeting
Notice (Ophthalmology)
21-01-2015 meeting
notice (Cardiovascular &
Renal)
23-01-2015 meeting
notice (Rheumatology )
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
M/s. Aizant Drug Research Solutions Pvt. Ltd.,
Hyderabad-500 100
M/s. Aizant Drug Research Solutions Pvt. Ltd.,
Hyderabad-500 100
M/s. APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad-500 090
M/s. APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad-500 090
M/s. APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad-500 090
M/s. APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad-500 090
50108
Test Licence
50111
Test Licence
45991
Test Licence
49993
Approval Letter
49701
Approval Letter
49702
Test Licence
46092
Test Licence
2.
3.
4.
5.
6.
7.
8.
M/s. Azidus Laboratories Ltd., Chennai-600 048
50212
Test Licence
9.
M/s. Azidus Laboratories Ltd., Chennai-600 048
49953
Test Licence
10.
M/s. Cliantha Research Limited, Ahmedabad-380 054
49924
Test Licence
11.
M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020
49993
Approval Letter
12.
M/s. Macleods Pharmaceuticals Ltd., Andheri (East),
Mumbai-400 059
M/s. Manipal Acunova Limited, Bangalore-560 066
50029
Approval Letter
49662
Clarification Letter
46187
Approval Letter
50001
Approval Letter
16.
M/s. QPS Bioserve India Pvt. Ltd., Hyderabad – 500
037
M/s. RA Chem Pharma Ltd., Balanagar, Hyderabad500 037
M/s. Ranbaxy Laboratories Ltd., Gurgaon-122 015
50000
Test Licence
17.
M/s. Semler Research Center, Bangalore-560078
49931
Clarification Letter
18.
M/s. Semler Research Center, Bangalore-560078
51240
Approval Letter
19.
M/s. Synchron Research Services Pvt. Ltd.,
Ahmedabad-380 059
M/s. Therapeutic Drug Monitoring Laboratory,
Mumbai-400 022
M/s. Torrent Pharmaceuticals Ltd. (Research Centre),
Gujarat
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad380 015
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad380 015
346
Test Licence
48402
Approval Letter
49833
Approval Letter
49951
Clarification Letter
49947
Test Licence
13.
14.
15.
20.
21.
22.
23.