Corporate & Background
 Custom Manufacturing
 Business & Products
 Facilities & Strengths
 Ethics & Values
 Regulatory Submissions
 Investors & Financials
 Careers
 Locations & Contact
 Media Center
 Enquiry
 Home
      News & Events
Drug Master Files Submitted to the US FDA

S.No

Name of the Compound

Date of Submission

DMF Number

01

Dextromethorphan HBr

February 4, 1997

12,356

02

Naproxen

November 27, 1998

13,866

03

Naproxen Sodium

November 27, 1998

13,867

04

Diltiazem HCl

January 26, 2001

15,267

05

Nabumetone

April 2, 2001

15,364

06

Levetiracetam

October 5, 2003

16,894

07

Phenylephrine HCl

October 19, 2003

16,918

08

Carbidopa

November 20, 2004

17,846

09

Levodopa

December 3, 2004

17,874

10

Proguanil HCl

February 6, 2005

18,065

11

Iopamidol

February 6, 2005

18,066

12

Bupropion HCl

April 24, 2005

18,306

13

Niacin

July 5, 2005

18,481

14

Verapamil HCl

July 17, 2005

18,523

15

Fosphenytoin Sodium

September 25, 2005

18,806

16

Zolpidem Tartrate

September 25, 2005

18,808

17

Risedronate Sodium

September 25, 2005

18,807

18

Tamsulosin HCl

November 25, 2005

18,971

19

Gabapentin

December 4, 2005

19,000

20

Desloratadine

May 17, 2006

19,441

21

Sibutramine HCl

September 4, 2006

19,729

22

Quetiapine Fumarate

October 25, 2007

20,983

23

Topiramate

November 25, 2007

21,068

24

Vigabatrin

April 29, 2008

21,579


CoS Submissions to EDQM

S.No

Name of the Compound

Certificate Issued on

CEP Number

01

Naproxen

September 3, 2008

R1-CEP 1999-042-Rev 04

02

Dextromethorphan HBr

July 18, 2007

R1-CEP 1999-103-Rev 01

03

Nabumetone

Nov 6, 2008

R1-CEP 1999-055-Rev 01

04

Diltiazem HCl

June 12, 2008

R1-CEP 1999-156-Rev 00

05

Carbidopa

October 02, 2006

RO-CEP 2005-057-Rev 00

06

Levodopa

June 29, 2007

R0-CEP 2005-161-Rev 00

07

Phenylephrine HCl

April 20, 2007

R0-CEP 2005-291-Rev 01

08

Iopamidol

April 11, 2007

R0-CEP 2006-038-Rev 00

09

Zolpidem Tartrate

October 17, 2008

R0-CEP 2006-105-Rev 00

10

Naproxen Sodium

October 10, 2008

R0-CEP 2007-110-Rev 00


European Drug Master Files

S.No

Name of the Compound

Submitted to

Submitted on

DMF number

01

Naproxen Sodium

AEMPS, Spain [Updated copy submitted]

April 21, 2008

NS/893/02

02

Zolpidem Tartrate

Medicines Evaluation Board, The Netherlands

April 25, 06

1378

03

Zolpidem Tartrate

TGA, Australia

April 25, 06

2006/26062

04

Gabapentin

Agence Francaise De Securite Sanitaire Des Produits De sante

July 02, 06

Yet to be received

05

Naproxen Sodium

The Italian Medicines Agency (AIFA)

June 18, 2005

Yet to be received

06

Naproxen Sodium

Directorate General for Medicinal products, Belgium

July 22, 2005

1064

07

Carbidopa

Cyprus health authorities

August 17, 2006

2006-DMF-510

08

Sibutramine HCl

Spain

December 24, 2006

SE-1883-06

09

Sibutramine HCl

Romania

December 24, 2006

03

10

Sibutramine HCl

Portugal

December 24, 2006

16/2007

11

Sibutramine HCl

Netherlands

December 24, 2006

1493

12

Gabapentin

Finland

July 10, 2007

001

13

Sibutramine HCl

Ireland

October 04, 2007

13420002

14

Zolpidem Tartrate

Iceland

December 12, 2007

DMF-IS-597

15

Zolpidem Tartrate

Poland

December 19, 2007

Yet to be received

16

Zolpidem Tartrate

Czech Republic

December 19, 2007

SUKLS 91/2008

17

Zolpidem Tartrate

Italy

December 19, 2007

Yet to be received

18

Zolpidem Tartrate

United Kingdom

December 19, 2007

MFD-15298-2-08037-0001

19

Zolpidem Tartrate

Belgium

December 19, 2007

Yet to be received

20

Zolpidem Tartrate

Luxembourg

December 19, 2007

Yet to be received

21

Zolpidem Tartrate

Spain

December 19, 2007

Yet to be received

22

Quetiapine Fumarate

Hungary

January 18, 2008

3728/80/08

23

Quetiapine Fumarate

MHRA,UK

January 29, 2008

MFD-15298-2-05649-0001

24

Naproxen Sodium

Poland

January 19, 2008

Yet to be received

25

Levetiracetam

TGA, Australia

March 05, 2008

2008/2460

26

Gabapentin

Cyprus

March 13, 2008

Yet to be received

27

Dextromethorphan Base

Swismedic, Switzerland

April 15, 2008

Yet to be received


Drug Master Files Submitted to HEALTH CANADA

S.No

Name of the Compound

Date of Submission

DMF Number

01

Levetiracetam

December 20, 2004

2005-091

02

Proguanil HCl

January 19, 2005

2005-036

03

Dextromethorphan HBr

July 19, 2005

2005-146

04

Tamsulosin HCl

August 29, 2006

2006-141

05

Naproxen

August 30, 2007

2007-202

06

Carbidopa

September 26, 2007

2007-198

07

Naproxen Sodium

February 13, 2008

2008-032


KDMFs Submitted to the Korea FDA

S.No

Product Name

DMF submitted on

DMF number

01

Nabumetone

July 28, 2004

1764

02

Phenylephrine HCl

January 19, 2007

20070022981




SDA - China submissions

S.No

Name of the Compound

IDL Issued Date

Drug License Number

01

Diltiazem hydrochloride

December 31, 2003

H20030689

02

Dextromethorphan HBr

November 18, 2005

H20050543



DMFs Submitted to the Japan PMDA (Pharmaceutical and Medical Devices Agency)

S.No

Name of the Compound

Date of Submission

DMF Number

01

Dextromethorphan HBr

December 29, 2006

217MF10567

02

Zolpidem Tartrate

January 18, 2007

219MF10009

top
top
Copyright © 2006, Divis Laboratories Ltd. All Rights Reserved      Website Designed by Sumudra