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Drug Master Files Submitted to the US FDA

S.No

Name of the Compound

Date of Submission

DMF Number

01

Dextromethorphan HBr

04-Feb-1997

12,356

02

Naproxen

27-Nov-1998

13,866

03

Naproxen Sodium

27-Nov-1998

13,867

04

Diltiazem HCl

26-Jan-2001

15,267

05

Nabumetone

02-Apr-2001

15,364

06

Levetiracetam

05-Oct-2003

16,894

07

Phenylephrine HCl

19-Oct-2003

16,918

08

Loratadine

07-Nov-2004

17,810

09

Carbidopa

20-Nov-2004

17,846

10

Levodopa

03-Dec-2004

17,874

11

Proguanil HCl

06-Feb-2005

18,065

12

Iopamidol

06-Feb-2005

18,066

13

Bupropion HCl

24-Apr-2005

18,306

14

Niacin

05-Jul-2005

18,481

15

Verapamil HCl

17-Jul-2005

18,523

16

Fosphenytoin Sodium

25-Sep-2005

18,806

17

Zolpidem Tartrate

25-Sep-2005

18,808

18

Risedronate Sodium

25, Sep-2005

18,807

19

Tamsulosin HCl

25-Nov-2005

18,971

20

Gabapentin

04-Dec-2005

19,000

21

Desloratadine

17-May-2006

19,441

22

Sibutramine HCl

04-Sep-2006

19,729

23

Quetiapine Fumarate

25-Oct-2007

20,983

24

Vigabatrin

29-Apr-2008

21,579

25

Ketoenamine

05-Oct-2008

22,065

26

Capecitabine

27-Oct-2008

22,157

27

Dextromethorphan Base

28-Jan-2009

22,469

28

Venlafaxine HCl

28-Jan-2009

22,470

29

Sumatriptan and Sumatriptan Succinate

10-Mar-2010

23,624

30

Valsartan

08-Apr-2011

24,797


CoS Submissions to EDQM

S.No

Name of the Compound

Certificate Issued on

CEP Number

01

Naproxen

03-Sep-2008

R1-CEP 1999-042-Rev 04

02

Dextromethorphan HBr

18-Jul-2007

R1-CEP 1999-103-Rev 01

03

Nabumetone

06-Nov-2008

R1-CEP 1999-055-Rev 01

04

Diltiazem HCl

19-Jan-2009

R1-CEP 1999-156-Rev 02

05

Carbidopa

02-Oct-2006

RO-CEP 2005-057-Rev 01

06

Levodopa

29-Jun-2007

R0-CEP 2005-161-Rev 01

07

Phenylephrine HCl

20-Apr-2007

R0-CEP 2005-291-Rev 01

08

Iopamidol

11-Apr-2007

R0-CEP 2006-038-Rev 01

09

Zolpidem Tartrate

17-Oct-2008

R0-CEP 2006-105-Rev 00

10

Naproxen Sodium

10-Oct-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]

21-Apr-2008

NS/893/02

02

Zolpidem Tartrate

MEB, The Netherlands

25-Apr-2006

1378

03

Zolpidem Tartrate

TGA, Australia

25-Apr-2006

2006/26062

04

Gabapentin

AFSSAPS, France

31-Mar-2010

Yet to be received

05

Naproxen Sodium

AIFA, Italy

18-Jun-2005

Yet to be received

06

Naproxen Sodium

Directorate General for Medicinal products, Belgium

22-Jul-2005

1064

07

Carbidopa

MInistry of Health, Cyprus

17-Aug-2006

2006-DMF-510

08

Sibutramine HCl

AEMPS, Spain

24-Dec-2006

SE-1883-06

09

Sibutramine HCl

Romania

24-Dec-2006

03

10

Sibutramine HCl

INFARMED, Portugal

24-Dec-2006

16/2007

11

Sibutramine HCl

MEB, The Netherlands

24-Dec-2006

1493

12

Gabapentin

Finland

10-Jul-2007

001

13

Sibutramine HCl

IMB, Ireland

04-Oct-2007

13420002

14

Zolpidem Tartrate

Iceland

12-Dec-2007

DMF-IS-597

15

Zolpidem Tartrate

Poland

19-Dec-2007

PL/DC-4003-0103/08

16

Zolpidem Tartrate

Czech Republic

19-Dec-2007

SUKLS 91/2008

17

Zolpidem Tartrate

AIFA, Italy

19-Dec-2007

Yet to be received

18

Zolpidem Tartrate

United Kingdom

19-Dec-2007

MFD-15298-2-08037-0001

19

Zolpidem Tartrate

Belgium

19-Dec-2007

1418

20

Zolpidem Tartrate

Luxembourg

19-Dec-2007

Yet to be received

21

Zolpidem Tartrate

ZEMPS, Spain

19-Dec-2007

Yet to be received

22

Quetiapine Fumarate

OGYI, Hungary

18-Jan-2008

3728/80/08

23

Quetiapine Fumarate

MHRA,UK

29-Jan-2008

MFD-15298-2-05649-0001

24

Naproxen Sodium

Poland

19-Jan-2008

PL/DC-4003-0103/08

25

Levetiracetam

TGA, Australia

05-Mar-2008

2008/2460

26

Gabapentin

Ministry of Health, Cyprus

13-Oct-2008

Yet to be received

27

Dextromethorphan Base

Swismedic, Switzerland

15-Apr-2008

D1448

28

Gabapentin

MHRA,UK

06-Jun-2008

MFD-15298-1-07380-0001

29

Gabapentin

Australia

19-Sep-2008

2008/8808

30

Rizatriptan Benzoate

Netherlands

15-Sep-2008

77106

31

Rizatriptan Benzoate

Norway

15-Sep-2008

08/13333

32

Rizatriptan Benzoate

Sweden

15-Sep-2008

Dnr 116: 2008/73790

33

Rizatriptan Benzoate

Spain

04-Nov-2008

RB/2245/08

34

Rizatriptan Benzoate

Italy

27-Sep-2008

Yet to be received

35

Rizatriptan Benzoate

Finland

27-Aug-2008

001/2008-08-27

36

Rizatriptan Benzoate

Luxembourg

27-Sep-2008

Yet to be received

37

Rizatriptan Benzoate

Germany

10-Sep-2008

2122

38

Rizatriptan Benzoate

MHRA, UK

29-Sep-2008

MFD-15298-2-07163-0001

39

Rizatriptan Benzoate

Denmark

29-Sep-2008

2215 ? 1434

40

Levetiracetam

Croatia

19-Dec-2008

381-08-37097-1
530-09/08-09/04

41

Dextromethorphan Base

INFARMED,Portugal [Updated copy submitted]

8-May-2009

Yet to be received

42

Dextromethorphan Base

Spain

8-May-2009

Yet to be received

43

Proguanil.HCl

MHRA,UK

17-Jul-2009

MFD-15298-2-08310-0001

44

Proguanil.HCl

Germany

22- Jul-2009

2346

45

Proguanil.HCl

France

24-Sep-2009

2009-128

46

Proguanil.HCl

Netherlands

10- Jul-2009

Yet to be received

47

Proguanil.HCl

Denmark

5-Aug-2009

2215-1605

48

Quetiapine Fumarate

Australia

24- Jul-2009

Yet to be received

49

Dextromethorphan Base

Spain

08-Sep-2009

DB/2528/09

50

Dextromethorphan Base

Germany

12-Nov-2009

2430

51

Dextromethorphan Base

UK

08-Dec-2009

MFD-15298-1-03241-0001

52

Triprolidine.HCl

Belgium

27-Jan- 2010

1606

53

Triprolidine HCl

Cyprus

02-Mar-2010

2010-DMF-944

54

Levetiracetam

France

02-Nov-2009

2009-213

55

Dextromethorphan Base

TGA

03-Dec-2009

2009/011929

56

Gabapentin

Greece

08-Mar-2010

2365

57

Gabapentin

Austria

16-Mar-2010

10057

58

Gabapentin

Germany

16-Mar-2010

2505

59

Gabapentin

Czech Republic

25-Mar-2010

27824/10

60

Gabapentin

Denmark

16-Apr-2010

2215-1712

61

Gabapentin

Sweden

18-Mar-2010

Dnr 116:2010/507516

62

Gabapentin

Italy

02-Apr-2010

Yet to be received

63

Gabapentin

Poland

25-Feb-2010

Yet to be received

64

Gabapentin

Portugal

09-Jun-2010

Yet to be received

65

Gabapentin

Spain

03-Jun-2010

Yet to be received

66

Gabapentin

MHRA

12-July-2010

Yet to be received

67

Gabapentin

Belgium

06-July-2010

105470

68

Dextromethorphan Base

France

07-July-2010

Yet to be received

69

Dextromethorphan Base

Belgium

07-July-2010

Yet to be received

70

Dextromethorphan Base

Hungary

12-July-2010

Yet to be received

71

Dextromethorphan Base

Czech republic

07-July-2010

Yet to be received

72

Dextromethorphan Base

Poland

12-July-2010

Yet to be received


Drug Master Files Submitted to HEALTH CANADA

S.No

Name of the Compound

Date of Submission

DMF Number

01

Levetiracetam

20-Dec-2004

2005-091

02

Proguanil HCl

19-Jan-2005

2005-036

03

Dextromethorphan HBr

19-Jul-2005

2005-146

04

Tamsulosin HCl

29-Aug-2006

2006-141

05

Naproxen

30-Aug-2007

2007-202

06

Carbidopa

26-Sep-2007

2007-198

07

Naproxen Sodium

13-Feb-2008

2008-032

08

Rizatriptan Benzoate

27-Sep-2008

2008-212

09

Ketoenamine

01-Oct-2008

2008-216

10

Levodopa

07-Mar-2009

2009-062

11

Desloratadine

31-Jul-2009

2009-168

12

Triprolidine hydrochloride

12-Jun-2010

Yet to be received

13

Sumatriptan

15-Oct-2010

2010-220

14

Sumatriptan Succinate

15-Oct-2010

2010-219

15

Diltiazem Hydrochloride

06-Jan-2011

2010-279


KDMFs Submitted to the Korea FDA

S.No

Product Name

DMF submitted on

DMF number

01

Nabumetone

28-Jul-2004

1764

02

Phenylephrine HCl

19-Jan-2007

20070022981




SDA - China submissions

S.No

Name of the Compound

IDL Issued Date

Drug License Number

01

Diltiazem hydrochloride

31-Dec-2003

H20030689

02

Dextromethorphan HBr

18-Nov-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

29-Dec-2006

217MF10567

02

Zolpidem Tartrate

18-Jan-2007

219MF10009

03

Dextromethorphan Base

28-Aug-2008

220MF10194

04

Gabapentin

16-Nov-2009

221MF10243

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