1st August

echinoidclapBiotechnology

Dec 1, 2012 (4 years and 11 months ago)

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LETTERS FOR ISSUE ON

01/08
/2012


1.FDC DIVISION

S.NO.


NAME OF COMPANY


DIARY NO

DOCUMENT

1.


M/s. Akums Drugs & Pharmaceuticals Ltd.,

16464

Letter

2.


M/s.Raptim Research Ltd.,

26131

Letter


3.


M/s.Lincoln Pharmaceuticals Ltd.,

17062

Letter

4.


M/s. Fresenius

Medical Care India Pvt. Ltd.,

4336

Letter




2.
VACCINE DIVISION

S. No.

COMPANY NAME

Dy.No.

STATUS

01

M/s Biocon Ltd

25712

Approval Letter

02

M/s Sun Pharma

25727

Approval Letter

03

M/s Reddy’s labo

22685

Approval Letter

04

M/s Intas Pharmaceuticlal
s

15297

Approval Letter

05

M/s Reliance Life Sciences


Joint Inspectiona Report

06

M/s Lupin Ltd

24706, 24708

Approval Letter (2)

07

M/s Novartis

5327, 7830, 21196,
21644

Approval Letter (3),
Clarification Letter

08

M/s Allmed International


Approval
Letter

09

M/s Cadila Pharmaceutical

54580, 8969

Approval Letter (CT)

10

M/s Kentron Biotechnology Pvt Ltd

5793

Approval Letter (CT)

11

M/s Diagnosearch Life

19388

Approval Letter

12

M/s PPD

2700

Clarification Letter

13

M/s Indian Immunologicals

21964

Approval Letter

14

M/s Maya Clinical


Letter

15

M/s Wyeth Ltd

18823

Clarification Letter

16

M/s MSD


Expert Letter

17

M/s Green Signal Bio


Letter




3.NEW DRUG

S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


M/s. Sandor Medicaids

-

Clarificatio
n Letter

2.


M/s. Precise Chemipharma

-

Clarification Letter


4.BULK DRUG

S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


M/s. Mylan Laboratories

-

Approval Letter (2)

2.


M/s. Alembic Pharmaceuticals

-

Approval Letter


5.IND

S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


M/s. Piramal Healthcare

-

Approval Letter (2)


6.
VACCINE DIVISION

S. No.

COMPANY NAME

Dy.No.

STATUS

01

M/s Biocon Ltd

25712

Approval Letter

02

M/s Sun Pharma

25727

Approval Letter

03

M/s Reddy’s labo

22685

Approval Letter

04

M/s Intas Pharmaceuticlals

15297

Approval Letter

05

M/s Reliance Life Sciences


Joint Inspectiona Report

06

M/s Lupin Ltd

24706, 24708

Approval Letter (2)

07

M/s Novartis

5327, 7830, 21196,
21644

Approval Letter (3),
Clarification Letter

08

M/s All
med International


Approval Letter

09

M/s Cadila Pharmaceutical

54580, 8969

Approval Letter (CT)

10

M/s Kentron Biotechnology Pvt Ltd

5793

Approval Letter (CT)

11

M/s Diagnosearch Life

19388

Approval Letter

12

M/s PPD

2700

Clarification Letter

13

M/s

Indian Immunologicals

21964

Approval Letter

14

M/s Maya Clinical


Letter

15

M/s Wyeth Ltd

18823

Clarification Letter

16

M/s MSD


Expert Letter

17

M/s Green Signal Bio


Letter


7.REGISTRATION

S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


JOHNSO
N AND JOHNSON LTD

20521

CLARIFICATION LETTER

2.


SHAH TC OVERSEAS PVT LTD

12903

APPROVAL LETTER

3.


AVENTIS PHARMA LTD

14236

CLARIFICATION LETTER




8.LETTER PERTAINING TO RULE 37



S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


SANOFI SYNTHELABO (I) LTD


9043

CLARIFICATION LETTER

2.


MSD PHARMACEUTICALS PVT LTD

23616

CLARIFICATION LETTER




9.GLOBAL CLINICAL TRIAL

S.No

Name of Firm

Reference No.

Type of Letter

1.


M/s Max Neeman

24071

Clarification Letter

2.


M/s. Boehringer

-

Approval Letter

3.


M/s. Siro

184
08

Approval Letter






10 MEDICAL DEVICE


1

M/s Epsilon E
ye Care Pvt. Ltd.

16858, 15989

Clarification Letter
(2)

2

M/s Karl Storz Endoscopy India Pvt. Ltd.

25323

Clarification Letter

3

M/s Karl Storz Endoscopy India Pvt. Ltd.

22697

Approval Letter

4

M/s Johnson & Johnson Ltd.

4847, 20924,
19332

Approval Lette
r (3)

5

M/s Johnson & Johnson Ltd.

23419, 23418,
15434

Approval Letter (3)

6

M/s Johnson & Johnson Ltd.

6491

Clarification Letter

7

M/s Edvego Technologies

26477

Clarification Letter

8

M/s Becton Dickinson India Pvt. Ltd.

22934

Approval Letter

4.


M/s. Pfizer

5575

Approval letter

5.


M/s. PPD

11775

Approval
letter/Clarification Letter

6.


M/s. Boehringer


Letter

7.


M/s. Serdia

20748

Approval letter

8.


M/s. Wyeth

19480

Approval letter

9.


M/s. AstraZeneca

65371

Approval Letter

10.


M/s. Pha
rmanet

20410

Approval letter

11.


M/s. Johnson & Johnson

19862

Approval Letter

12.


M/s. ICON

-

Letter

13.


M/s. Kendle

20210

Approval Letter

14.


M/s. Veeda

49554

Approval letter

15.


M/s. Medicine Company

-

Clarification Letter

9

M/s
Becton Dickinson India Pvt. Ltd.

26322

Approval Letter

10

M/s Hester Diagnostics Pvt. Ltd.

22696

Approval Letter

11

M/s Zimmer India Pvt. Ltd.

24496

Approval Letter

12

M/s Faith Biotech Pvt. Ltd.

21858, 27900

Approval Letter (2)

13

M/s St. Jude Medical

India Pvt. Ltd.

26701

Approval Letter

14

M/s St. Jude Medical India Pvt. Ltd.

26701, 27564

Approval Letter (2)

15

M/s Boston Scientific International B.V.

25914

Clarification Letter

16

M/s Uniapex Biomedics

21789

Approval Letter

17

M/s Kirloskar Tech
nologies Pvt. Ltd.

26527

Approval Letter

18

M/s Amardeep Enterprise

27173

Approval Letter

19

M/s First Medical

27897

Approval Letter

20

M/s Kalyx India Healthcare Pvt. Ltd.

46181

Clarification Letter

21

M/s B.Barun Medical (India) Pvt. Ltd.

27567

Appr
oval Letter

22

M/s DePuy Medical Pvt. Ltd.

23878

Approval Letter

23

M/s DePuy Medical Pvt. Ltd.

27112

Approval Letter

24

M/s Stericat Gutstrings (P) Ltd.

26283

Clarification Letter

25

M/s Boston Scientific India Pvt. Ltd.

26596

Approval Letter

26

M
/s Life Care Device Pvt. Ltd.

16231

Clarification Letter

27

M/s Biomet Orthopaedics India Pvt. Ltd.

27202

Clarification Letter

28

M/s Biomet Orthopaedics India Pvt. Ltd.

22777

Clarification Letter

29

M/s Allergen Healthcare India Pvt. Ltd.

9299

Clarific
ation Letter

30

M/s Heraeus Technologies India Pvt. Ltd.

26073

Clarification Letter

31

M/s Synthes Medical Pvt. Ltd.

21859

Clarification Letter

32

M/s Devparv Surgico (CLAA)

43724

Approval Letter

33

M/s Universal Ortho Systems (CLAA)

41946

Approval L
etter


11.DIAGNOSTIC KITS


1

M/s Trivitron Healthacre Pvt. Ltd.

25412, 24112

Clarification Letter
(2)

2

M/s Trivitron Healthacre Pvt. Ltd.

24112

Approval Letter

3

M/s RFCL Ltd.

24131, 21553

Clarification Letter (2)

4

M/s RFCL Ltd.

27413, 27412

Appro
val Letter (2)

5

M/s Ashish Healthcare

26612

Clarification Letter

6

M/s Apex Diagnostics

27242

Approval Letter

7

M/s Kan Healthcare

25317

Clarification Letter

8

M/s Anand Brothers

24046, 25826

Clarification Letter (2)

9

M/s Anand Brothers

25826

App
roval Letter

10

M/s Arun & Co.

38556, 38554

Clarification Letter (2)

11

M/s Jeev Diagnostics Pvt. Ltd.

24976

Clarification Letter

12

M/s APL Institute of Clinical Research
Pvt. Ltd.

39471

Clarification Letter

13

M/s Morepen Laboratories Ltd.

23691

Cla
rification Letter

14

M/s Beckman Coulter India Pvt. Ltd.

25537

Approval Letter

15

M/s Modi
-
Mudipharma

26831

Approval Letter

16

M/s Oremed Healthcare Inc.

25399

Approval Letter

17

M/s Becton Dickinson India Pvt. Ltd.

25228

Clarification Letter

18

M
/s Roche Diagnostics India Pvt. Ltd.

21933, 21931,
25352, 25354,
25353, 21932,
25334

Approval Letter (7)

19

M/s Iris Healthcare Technologies Pvt.
Ltd.

25116

Approval Letter

20

M/s Siemens Ltd.

25595, 25596

Approval Letter (2)

21

M/s SD Biostandard D
iagnostics Pvt.
23846

Clarification Letter

Ltd.

22

M/s SD Biostandard Diagnostics Pvt.
Ltd.

23847

Approval Letter

23

M/s P.D. Hinduja National Hospital
and Medical Research Centre


Clarification Letter

24

M/s Transasia Bio
-
Medicals Ltd.

25904

Approval

Letter