6th October

conversesoilBiotechnology

Dec 3, 2012 (4 years and 10 months ago)

276 views

LETTERS FOR ISSUE ON 06.10.2010

1.
FDC DIVISION

S.NO.

NAME OF COMPANY

DIARY NO

DOCUMENT

1.


Aurobindo Pharma

33877

Approval Letter

2.


Macleods Pharmaceuticals

36391

Approval Letter

3.


Macleods Pharmaceuticals

34558

2 Approval Letter

4.


Ajanta Pharma

39341

2 Ap
proval Letter

5.


Dr. Reddy’s Laboratories

40170

Approval Letter

6.


Hetero Labs

39463

Approval Letter

7.


Alkem Laboratories

40638

Approval letter

8.


Ontop Pharmaceutical

26093

Approval Letter

9.


Torrent Pharmaceuticals

46840

Expert Letter

10.


SAI Mirra

36659

Defic
iency Letter

11.


Macleods Pharmaceuticals

36391

Deficiency Letter

12.


Gena Pharmaceuticals

16072

Deficiency Letter

13.


GKM New Pharma

43702

Deficiency Letter

14.


Biocon Ltd.,

40463

Deficiency Letter

15.


BDR Pharmaceuticals

39225

Deficiency Letter

16.


Venus Remedies

6
184

Deficiency Letter

17.


Synokem Pharmaceuticals

25626

Deficiency Letter

18.


Vapi Care

37535

Deficiency Letter

19.


Tablets (I) Ltd.,

38173

Deficiency Letter

20.


Novartis (I) Ltd.,

37716

Deficiency Letter


2.
S
UBSEQUENT NEW DRUGS

S. NO.

NAME IF THE APPLICANT

REFE
RENCE
NO.

FTS NO.

TYPE OF LETTER

1

MSN Laboratories Ltd.,

33553

-

Approval

2

MSN Laboratories Ltd.,

22408

-

Approval

3

Lupin Ltd.,

34298

7720

Approval

4

Ind
-
Swift Ltd.,

33424

6192

Approval

5

Lambda Therapeutic Research
Ltd.,

37794

12273

Approval

6

Th
emis Medicare Ltd.,

35925

-

Deficiency

7

Cosmas Pharmacls

36490

9899

Approval

8

Troikaa Pharmaceuticals Ltd.,

31752

3956

Approval

9

Lyka Labs Ltd.,

31695

3925

Deficiency

10

Optimus Drugs Pvt. Ltd.,

7083

-

Approval


3.
EXPORT NOC


S. No

D. No

Firm N
ame

Type of Letter

1

45881

24186

M/s. Helios Pharmaceuticals

Approval Letter

2

39030

14207

M/s. InterMed

Deficiency Letter

3

44831

22782

M/s. Parabolic Dreugs Ltd.

Approval Letter

4

45926

24207

M/s. Cipla Limited

Approval Letter

5

43816

21255

M/s. Lab
orate Pharmaceuticals

Approval Letter

6

43324

M/s. Cipla Limited

Deficiency Letter


4.

Biological Division
-
Fo
rm
-
41/10/28
-
D/29/Blood Products




S. NO.

NAME OF THE COMPANY

REF. NO.

TYPE OF LETTER

1

M/s Lupin Ltd

33881

Deficiency letter

2

M/s Intervet Ind
ia Pvt. Ltd.

31084

Deficiency letter

3

M/s Wockhardt

39313

Deficiency letter

4

M/s Taksal Pharma

42599

Deficiency letter

5

M/s Johnson & Johnson

42426

Deficiency letter

6

Shantha biotechnics

40038

Deficiency letter


5.

MEDICAL DEVICES




6.
DIAGNOSTIC KITS

S. NO.

NAME OF COMPANY

DIARY NO.

DOCUMENT


1.


Browndove Healthcare

41948

Deficiency Letter

2.


Miti Electronics

14211

Deficiency Letter

3.


Oncocare Scientific

44953

Deficiency Letter

4.


Chemtron Analytical

17853

Deficiency Letter

5.


Sahajanand Medical

34808

Deficiency

Letter

6.


Hester Diagnostics

35854

Deficiency Letter

7.


St. Jude Medical

40442

Approval Letter

S. NO.

NAME OF COMPANY

DIARY NO.

DOCUMENT


1.


Shivani Scientific

42141

Deficiency Letter

2.


Reckon Diagnostics

41703

Deficiency Letter

3.


Weldo
n Biotech

44486

Deficiency letter

4.


RFCL

44132

Deficiency Letter

5.


RFCL

42490

Deficiency Letter

6.


RFCL

42491

Deficiency Letter

7.


RFCL

42674

Deficiency Letter





8.


Trivitron Healthcare

44767

Deficiency Letter

9.


Modi
-
Mundipharma

41323

Deficiency Letter

10.


Mo
di
-
Mundipharma

40768

Deficiency Letter

11.


Global Medikit

41511

Deficiency Letter

12.


Novo healthcare

44052

Deficiency Letter

13.


Novo healthcare

44053

Deficiency Letter

14.


Alere Medical

43341

Deficiency Letter

15.


Alere Medical

43340

Deficiency Letter

16.


Alere Medi
cal

43338

Deficiency Letter

17.


Alere Medical

43343

Deficiency Letter

18.


Alere Medical

43339

Deficiency Letter

19.


Quest Diagnostics

43690

Deficiency Letter

20.


Yashraj Biotechnology

40353

Deficiency Letter

21.


Phadia

43838

Deficiency letter

22.


Phadia

43837

Defici
ency letter


23.


UR Diagnostics


45029


Deficiency Letter

24.

Immunoshop

39837

Deficiency Letter

25.

ACU
-
Check

15327

Deficiency Letter

26.

Mind Biomeds

42761

Deficiency Letter

27.

LG Lifesciences

38296

Approval Letter

7.
Form 29(NOC)


S.No

Name
of the Firm

Diary No

Documents

1

M/s Torrent Pharmaceutical Ltd.

39349

Amendment

2

M/s Torrent Pharmaceutical Ltd.

40337

Amendment

3

M/s Torrent Pharmaceutical Ltd.

43921

Amendment

4

M/s Torrent Pharmaceutical Ltd.

43920

Amendment

5

M/s APL Research C
entre

41302

Approval

6

M/s APL Research Centre

41304

Approval

7

M/s APL Research Centre

41310

Approval

8

M/s APL Research Centre

41307

Approval

9

M/s APL Research Centre

41305

Approval

10

M/s APL Research Centre

41303

Approval

11

M/s APL Research Cen
tre

41309

Approval

12

M/s APL Research Centre

41311

Approval

13

M/s APL Research Centre

41308

Approval

14

M/s APL Research Centre

41306

Approval



8.
VACCINE DIVISION

S. No.

COMPANY NAME

DY. NO.

STATUS

01

M/s Nektar Therapeutics (India) Pvt
Ltd

3831
30

Deficiency Letter

02

M/s Intas Biopharmaceuticals Ltd

37953

Letter

03

M/s Roche Scientific Company Pvt
Ltd

36004

Deficiency Letter

04

M/s Novartis Health Care Pvt. Ltd

35009

Deficiency Letter

05.

M/s Johnson & Johnson Ltd

41925

Deficiency Letter

06
.

M/s Sanofi
-

pasteur India Pvt. Ltd

48796

Deficiency Letter

07.

M/s Glaxo Smith Kline
Pharmaceuticals Ltd

32142

Letter

08.

M/s Wockhardt Ltd

39998

Approval Letter

09.

M/s Wockhardt Ltd

16475

Deficiency Letter

10.

M/s Bharat Seums and Vaccines Ltd

286
19

Deficiency Letter