20th March

concernedimpartialBiotechnology

Dec 3, 2012 (4 years and 6 months ago)

391 views

LETTERS FOR ISSUE ON
20.03
.201
2

1. BIOLOGICAL DIVISION
-
III


2.
NGO DONATION


S. NO

FIRM NAME

D. NO

TYPE OF LETTER

1

Native Missionary Movement


9660

Letter


3.
NEUTRAL CODE


S. NO

FIRM NAME

D. NO

TYPE OF LETTER

1

Medicamen Biotech Limited

8
538

Approval Letter

2

Cadila Healthcare Limited

8870

Approval Letter

3

Ranbaxy Laboratories Limited

8539

Approval Letter





S. NO.


NAME OF THE COMPANY

REF. NO.

TYPE OF LETTER

1.

M/s Eli Lilly and Company (India)
Pvt. Ltd.

1822

Clarification
Letter

2.

M/s MSD Pharmaceutical Pvt.
Ltd.

3589

Clarification
Letter

3.

M/s
Pfizer Animal Health India
Pvt. Ltd.

34820

Clarification

Letter

4.
BE NOC/TEST LICENCE

S. NO.

NAME OF THE COMPANY

REF. NO.

TYPE OF LETTER

1.


M/s. Accutest Research Laboratories (I) Pvt. Ltd.,
Ahmedabad
-
380 015

776

Approval Letter

2.


M/s. Alembic Pharmaceuticals Ltd., Vadodara
-
390
003

59504

Approval Letter

3.


M/s. Alembic Pharmaceuticals Ltd., Vadodara
-
390
003

479

Approval Letter

4.


M/s. Axis Clinicals Ltd., Hyderabad
-
500 049

1899

Approval Letter

5.


M/s. Axis Clinicals Ltd., Hyderabad
-
500 049

156

Approval Letter

6.


M/s. Axis Clinicals Ltd., Hyderabad
-
500 049

59789

Clarification Letter

7.


M/s. Cipla Ltd., Mumbai
-
400 008

56233

Approval Letter

8.


M/s. Cliantha Research Limited, Ahmedabad
-
380
054

53016

Appr
oval Letter

9.


M/s. Clinigene International Ltd., Bangalore
-
560 100

1608

Approval Letter

10.


M/s. Clinigene International Ltd., Bangalore
-
560 100

58120

Approval Letter

11.


M/s. Clinigene International Ltd., Bangalore
-
560 100

1291

Approval Letter

12.


M/s. Emcure P
harmaceuticals Ltd., Pune
-
411 026

43987

Clarification Letter

13.


M/s. Glenmark Generics Ltd., Mumbai
-
400 026

58409

Approval Letter

14.


M/s. Hetero Labs Ltd., Hyderabad
-
500 018

3703

Approval Letter

15.


M/s. Lotus Labs Pvt. Ltd., Bangalore
-
560 052

55877

Clarificat
ion Letter

16.


M/s. Lotus Labs Pvt. Ltd., Bangalore
-
560 052

58970

Approval Letter



17.


M/s. Manipal Acunova Ltd., Bangalore
-
560 066

856

Approval Letter

18.


M/s. QPS Bioserve India (P) Ltd., Hyderabad
-
500 037

52322

Clarification Letter

19.


M/s. QPS Bioserve India (P
) Ltd., Hyderabad
-
500 037

53871

Approval Letter

20.


M/s. RA Chem Pharma Ltd., Hyderabad
-
500 037

56905

Approval Letter

21.


M/s. RA Chem Pharma Ltd., Hyderabad
-
500 037

42208

Approval Letter

22.


M/s. RA Chem Pharma Ltd., Hyderabad
-
500 037

58808

Approval Letter

23.


M/
s. RA Chem Pharma Ltd., Hyderabad
-
500 037

57071

Approval Letter

24.


M/s. RA Chem Pharma Ltd., Hyderabad
-
500 037

59851

Approval Letter

25.


M/s. RA Chem Pharma Ltd., Hyderabad
-
500 037

57205

Approval Letter

26.


M/s. RA Chem Pharma Ltd., Hyderabad
-
500 037

58809

Appr
oval Letter

27.


M/s. Ranbaxy Laboratories Ltd., Gurgaon
-
122 015

56124

Approval Letter

28.


M/s. Ranbaxy Laboratories Ltd., Gurgaon
-
122 015

59154

Approval Letter

29.


M/s. Sandoz Pvt. Ltd., Navi Mumbai
-
400 709

59517

Approval Letter

30.


M/s. Semler Research Center Pvt
. Ltd., Bangalore
-
560 078

27

Approval Letter

31.


M/s. Semler Research Center Pvt. Ltd., Bangalore
-
560 078

47057

Approval Letter

32.


M/s. Semler Research Center Pvt. Ltd., Bangalore
-
560 078

252

Approval Letter

33.


M/s. Sun Pharmaceutical Industries Ltd., Vadodara
-
390 020

234

Approval Letter

34.


M/s. Veeda clinical Research Pvt. Ltd., Ahmedabad
-
380015

1733

Approval Letter

5.
MEDICAL DEVICE



S.
NO.

NAME OF COMPANY

DIARY NO.

DOCUMENT

1

M/s Fresenius Medical Care India

55110

Clarification Letter

2

M/s Abbott Heal
thcare

54168

Clarification Letter

3

St. Jude Medical India

8732

Approval Letter

4

M/s J. R. Shah Exports Ltd

6117

Approval Letter

5

M/s Allergan Healthcare India

54838

Clarification Letter

6

M/s Becton Dickinson India

4879

Approval Letter

7

M/s UP
Dental Product

6893

Clarification Letter

8

M/s Covident Healthcare India

3252,
51892

Clarification Letter (2)

9

M/s Biomet Orthopaedics India

7475

Approval Letter

10

Ms. Lab Medica Systems

8645

Approval Letter

11

M/s SMR Lens

8646

Approval Letter

12

M/s Teleflex Medical

40107

Clarification Letter

13

M/s Emergo (India) Consulting

52225

Clarification Letter

14

M/s Depuy Medical

7856,
8432

Approval Letter (2)

15

M/s Smith & Nephew Healthcare

3899

Approval Letter

16

M/s Nipro India Corporation

8
348

Clarification Letter

17

M/s Innotech Technologies

8644

Approval Letter

18

M/s S3V Vascular Technologies

14309

Approval Letter

19

M/s Carl Zeiss India (Bangalore)

3424,7471

Approval Letter (2)

20

B. L. Life Sciences Pvt. Ltd

7904

Approval Letter

21

M/
s Romsons Scientific & Surgical
Industries

5325

Approval Letter

22

M/s Romsons Medicons

5323

Approval Letter

23

M/s Johnson and Johnson

54715

Clarification Letter

24

M/s Angiplast Private Limited
(CLAA)

12493

Approval Letter

25

M/s Yogeswar Implan
ts (I) (CLAA)

10521

Approval Letter

26

M/s R A Market Analytics

5437

Approval Letter


6.
DIAGNOSTIC KIT


S.NO.

NAME OF COMPANY

DIARY
NO.

DOCUMENT

1

M/s Ubio Biotechnology
System

12895

Approval Letter

2

M/s Kan Healthcare

48212,
7473,7474

Clarificatio
n Letter
(3)

3

M/s Trivitron Healthcare Pvt.
Ltd

6956

Approval Letter

4

M/s Biosense Medical Devices

7078

Clarification Letter



7.
PSUR


S. NO.

NAME OF THE FIRM

REFERENCE NO.

FTS NO.

TYPE OF LETTER

1.


Micro Lbs. Ltd.,

47937

70274

Lette
r


8.
NEW DRUG

S.
NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


M/s. Plethico Pharmaceuticals

-

Clarification Letter

2.


M/s. Pureera India

-

Clarification Letter

3.


M/s. Allergan

-

Clarification Letter

4.


M/s. Bayer Pharmaceutical

-

Clarification Letter

5.


M/s. Cadila

-

Clarification Letter (2)

6.


M/s. Jagsonpal

-

Clarification Letter

7.


M/s. Pfizer

-

Clarification Letter

8.


Dr. Suneeta Mittal, AIIMS

-

Clarification Letter

9.


Dr. Rhytm Ahuja, MAMC

-

Clarification Letter

10.


Dr. Bhupendra Kumar Jain, GTB
Hospital

-

Clarifi
cation Letter

11.


M/s. Ajanta Pharma

-

Clarification Letter


9.
BULK DRUG

S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


M/s. Alkem Laboratories

-

Approval Letter

2.


M/s. Themis Medicare

-

Clarification Letter


10.
IND

S.NO.

NAME OF APPLICANT

DIARY

NO.

TYPE OF LETTER

1.


M/s. Cadila Healthcare

-

Clarification Letter


11.
IMPORT

S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


Micro Labs Ltd.

6711

Approval Letter

2.


Nandlal Bankatlal Pvt. Ltd.

6308

Approval Letter

3.


Pfizer Limited

6336

Approval Le
tter

4.


Ind
-
Swift Laboratories Limited

6076

Approval Letter

5.


Sevantilal & Sons

6223

Approval Letter

6.


Glenmark Generics Ltd.

6335

Approval Letter

7.


Renesa Exports Private Limited

6324

Approval Letter

8.


Ind
-
Swift Laboratories Limited

6077

Approval Letter

9.


Abil Chempharma Pvt. Ltd.

6075

Approval Letter

10.


Biocon Ltd.

6164

Approval Letter

11.


Prachem Laboratories

6309

Approval Letter

12.


Kantilal Manilal & Co. Pvt. Ltd.

6310

Approval Letter

13.


Windlas Biotech Ltd.

6086

Approval Letter

14.


Windlas Healthcare(P) Ltd.

6085

Approval Letter

15.


Micro Labs Ltd.

6087

Approval Letter

16.


Micro Labs Limited Unit
-
III

6088

Approval Letter

17.


Piramal Healthcare Limited

6257

Approval Letter

18.


Piramal Healthcare Limited

6256

Approval Letter

19.


C.J. Shah & Co.

6392

Approval Letter

20.


Hare
sh oveta

6078

Approval Letter

21.


Medreich Ltd.

6112

Approval Letter

22.


Haresh oveta

6352

Approval Letter

23.


C.J. Shah & Co.

6393

Approval Letter

24.


C.J. Shah & Co.

6394

Approval Letter

25.


C.J. Shah & Co.

6395

Approval Letter

26.


C.J. Shah & Co.

6397

Approval Lett
er

27.


Zest Pharma,

6421

Approval Letter

28.


FDC Limited

6452

Approval Letter

29.


Alcon Laboratories (India) Pvt. Ltd.

6455

Approval Letter

30.


Medi Pharma Drug House

6354

Approval Letter

31.


G.C. Chemie Pharmie Ltd.

6365

Approval Letter

32.


Zuventus Healthcare Ltd.,

6469

Approval Letter

33.


MSC Chemicals

6356

Approval Letter

34.


Troikaa Pharmaceuticals Ltd.

6451

Approval Letter

35.


MSC Chemicals

6355

Approval Letter

36.


Anuh Pharma Ltd.,

6366

Approval Letter

37.


Harshada Corporation

6393

Approval Letter

38.


Wallace Pharmaceutical
s Pvt. Ltd.

6611

Approval Letter

39.


Sun Pharmaceutical Industries Ltd.

6601

Approval Letter

40.


Sun Pharma Sikkim

6600

Approval Letter

41.


Sun Pharmaceutical Industries Ltd.

6558

Approval Letter

42.


Unimed Technologies Ltd.

6559

Approval Letter

43.


Cadila Healthcar
e Ltd.

6661

Approval Letter

44.


Haresh oveta

6584

Approval Letter

45.


Glaxo SmithKline Pharmaceuticals
Ltd.,

6550

Approval Letter

46.


Pfizer Ltd.

6673

Approval Letter

47.


Abil Chempharma Pvt. Ltd.

6688

Approval Letter

48.


Cipla Limited

6857

Approval Letter

49.


Ketan P
harma,

6843

Approval Letter

50.


Umedica Laboratories Pvt. Ltd.

6720

Approval Letter

51.


Sun Pharmaceutical Industries Ltd.

6833

Approval Letter

52.


Micro Labs Ltd.,

6712

Approval Letter

53.


Ketan Pharma,

6802

Approval Letter

54.


Puja Enterprises

6717

Approval Letter

55.


Cipla Limited

6857

Approval Letter

56.


Dilipkumar & Co.

6851

Approval Letter

57.


Umedica Laboratories Pvt. Ltd.

6718

Approval Letter

58.


Umedica Laboratories Pvt. Ltd.

6719

Approval Letter

59.


Dr. Reddy's Laboratories Ltd.

7047

Approval Letter

60.


Unimax Chemical
s Private Limited

7041

Approval Letter

61.


Pradipkumar Pharma Pvt. Ltd.

6923

Approval Letter

62.


R.T. Pharma

6913

Approval Letter

63.


Sevantilal & Sons

6944

Approval Letter

64.


Ranbaxy Laboratories Ltd.

6942

Approval Letter













12.
REGI
STRATION

S.NO.

NAME OF APPLICANT

DIARY NO.

TYPE OF LETTER

1.


Bayer Pharmaceuticals Pvt. Ltd.

193

Approval Letter

2.


Archerchem

2784

Approval Letter

3.


Vita Pharma Agencies

6946

Amended Letter

4.


Symbio Generrics India pvt. Ltd.

56740

Clarification Letter

5.


Al
con Laboratories India Pvt. Ltd.

54782

Clarification Letter

6.


Astrazeneca Pharma India Ltd.

50181

Clarification Letter

7.


Criticare Pharma pvt. Ltd.

3896

Clarification Letter


13.
FDC DIVISION

S.NO.


NAME OF COMPANY


DIARY NO

DOCUMENT

1.


M/s. Alembic Pharm
aceuticals

38015

Letter

2.


M/s. Abbott Healthcare

54520

Letter

3.


M/s. Akums Drugs

1723

Letter

4.


M/s.Akums Drugs

50993

Letter

5.


M/s. Ajanta Pharma

47425

Letter

6.


M/s.Ajanta Pharma

56358

Letter

7.


M/s. Biocon

4400

Letter

8.


M/s. Biocon

48954

Letter

9.


M/s. Brid
ge Pharmaceuticals

55134

Letter

10.


M/s. Emcure Pharmaceuticals

3714

Letter

11.


M/s. Glenmark Pharmaceuticals

4403

Clarification Letter

12.


M/s.Hetero Labs

51371

Letter

13.


M/s.Hetero Labs

58267

Letter

14.


M/s. IPCA Laboratories

1849

Letter

15.


M/s. Inventia Healthcar
e

58318

Clarification Letter

16.


M/s. Kilitch Drugs (I)

28311

Letter

17.


M/s.Kilitch Drugs (I)

48549

Letter

18.


M/s. Novartis India

50325

Clarification Letter

19.


M/s. Shield Healthcare

51905

Letter

20.


M/s. Serdia Pharmaceuticals

5826

Letter

21.


M/s. Torrent Pharmace
uticals

49732

Letter

22.


M/s. Themis Medicare

2105

Letter



14. VACCINE DIVISION

S. No.

COMPANY NAME

Dy.No.

STATUS

01

M/s Cadila health Care Ltd

766, 7366

Clarification letter (2)

02

M/s Roche Product (I) Pvt Ltd

647

Clarification letter

03

M/s Serum I
nstitute ltd

56016, 53367,
745, 2751, 58003

Acknowledges
Letter,(T/L), Approval
Letter,

04

M/s MSD Pharmaceutical Pvt Ltd

55386, 47833

Clarification Letter (2)

05

M/s Parexel Int’l Pvt Ltd

5083

Clarification letter

06

M/s GSK Pharmaceutical Ltd

57588,
2599,
11789, 55250

Clarification Letter,
Approval Letter

07

M/s Prosper Channel Life Sciences (I) Pvt
Ltd

47146

Clarification Letter

08

M/s Sanofi Pasteur (I) Pvt Ltd

4091, 4089

Acknowledges Letter

09

M/s Regional Cancer Centre


Clarification Letter

10

M/s Quintiles Research (I) Ltd

4493, 1446,

Clarification Letter,
Expert Letter, (T/L)

11

M/s Panera Biotec Pvt Ltd


Approval Letter

12

M/s Clonz Biotech Pvt Ltd

4986

Clarification Letter

13

M/s Novartis Healthcare Pvt Ltd

58341

Approval Letter

14

M/s

Bharat Biotch

8944

Expert Letter, (T/L)

15

M/s Lundback India Pvt Ltd

1123

T/L

16

M/s PPD Pharmaceutical

7763, 2288, 2287.

Approval Letter0 (T/L),
Clarification Letter
Amendment Letter

17

M/s USV Ltd

3805

Approval Letter (T/L)

18

M/s Intervet (I) Pvt

Ltd

38553

Approval Letter, (MF)

19

M/s Artemis Medicare Services Pvt Ltd

47471

Approval Letter

20

M/s Merck Specialities Pvt Ltd

58496

Approval Letter

21

M/s J&J Ltd

56510

Approval Letter

22

M/s Reddy’s Laboratories Ltd

54341

Approval Letter (Form
46A
)

23

M/s Novartis Healthcare Pvt Ltd

56307, 6050

Approval Letter (T/L),
Clarification Letter


15.
SUBSEQUENT NEW DRUG


S. NO.

NAME OF THE FIRM

REFERENCE
NO.

FTS NO.

TYPE OF LETTER

1.


Naprod Life Sciences Pvt.
Ltd..,

23541

32419

Approval

2.


Emcure Pharmaceu
ticals
Ltd.,

57958

86106

Clarification

3.


Intas Pharmaceuticals
Ltd.,

39184

-

Approval

4.


Precise Chemipharma
Pvt. Ltd.,

2896

5086

Clarification

5.


Emcure Pharmaceuticals
Ltd.,

59670

88623

Approval

6.


Rubicon Research Pvt.
Ltd.,

54314

80321

Clarification

7.


Jo
hnson & Johnson Ltd.,

45407

66628

2 Clarification

8.


Troikaa Pharmaceuticals
Ltd.,

52476

-

Clarification

9.


Troikaa Pharmaceuticals
36816

-

Clarification

Ltd.,

10.


J.B. Chemicals and
Pharmaceuticals Ltd.,

31507

-

Clarification

11.


Ranbaxy Laboratories
Ltd.,

332
5

-

Clarification

12.


Ranbaxy Laboratories
Ltd.,

25442

-

Clarification

13.


Ranbaxy Laboratories
Ltd.,

43115

-

Clarification

14.


IPCA Laboratories Ltd.,

56957

-

Clarification

15.


IPCA Laboratories Ltd.,

54058

-

Clarification

16.


IPCA Laboratories Ltd.,

58578

-

C
larification

17.


Synokem
Pharmaceuticals Ltd.,

5450

-

Clarification

18.


Torrent Pharmaceuticals
Ltd.,

57045

-

Clarification

19.


Cadila Healthcare Ltd.,

50139

-

Clarification

20.


LG Life sciences (I) Pvt.
Ltd.,

35231

-

Clarification

21.


Alcon Laboratories India

Pvt. Ltd.,

55850

-

Clarification

22.


Inventia Healthcare Ltd.,

32832

-

Clarification

23.


Inventia Healthcare Ltd.,

48523

-

Clarification

24.


Alkem Laboratories Ltd.,

1867

-

Clarification

25.


Ankur Drugs and Pharma
Ltd.,

61590

-

Clarification




16.
LVP







SL. N
o

COMPANY NAME

DIARY

No.

Letter type

1

M/s. IVES Drugs (P) Ltd.

8527

Approval Letter

2

M/s. Althea Pharma Pvt. Ltd.

5697

Approval Letter

3

M/s Nirma Ltd.

5657 & 465

Approval Letter