|
 |
|
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
|
|
25
|
Ketoenamine
|
October 5, 2008
|
22,065
|
|
26
|
Capecitabine
|
October 27, 2008
|
22,157
|
|
27
|
Dextromethorphan Base
|
January 28, 2009
|
22,469
|
|
28
|
Venlafaxine HCl
|
January 28, 2009
|
22,470
|
|
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 |
January 19, 2009 |
R1-CEP 1999-156-Rev 01 |
|
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 |
PL/DC-4003-0103/08 |
|
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 |
1418 |
|
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 |
PL/DC-4003-0103/08 |
|
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 |
D1448 |
|
28
|
Gabapentin |
MHRA,UK |
June 06, 2008 |
MFD-15298-1-07380-0001 |
|
29
|
Gabapentin |
Australia |
September 19, 2008 |
2008/8808 |
|
30
|
Rizatriptan Benzoate |
Netherlands |
September 15, 2008 |
77106 |
|
31
|
Rizatriptan Benzoate |
Norway |
September 15, 2008 |
08/13333 |
|
32
|
Rizatriptan Benzoate |
Sweden |
September 15, 2008 |
Dnr 116: 2008/73790 |
|
33
|
Rizatriptan Benzoate |
Spain |
September 23, 2008 |
Yet to be received |
|
34
|
Rizatriptan Benzoate |
Italy |
September 27, 2008 |
Yet to be received |
|
35
|
Rizatriptan Benzoate |
Finland |
August 27, 2008 |
001/2008-08-27 |
|
36
|
Rizatriptan Benzoate |
Luxembourg |
September 27, 2008 |
Yet to be received |
|
37
|
Rizatriptan Benzoate |
Germany |
September 27, 2008 |
Yet to be received |
|
38
|
Rizatriptan Benzoate |
MHRA, UK |
September 29, 2008 |
MFD-15298-2-07163-0001 |
|
39
|
Rizatriptan Benzoate |
Denmark |
September 29, 2008 |
2215 – 1434 |
|
40
|
Levetiracetam |
Croatia |
December 19, 2008 |
381-08-37097-1
530-09/08-09/04
|
|
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 |
|
03
|
Dextromethorphan Base |
August 28, 2008 |
220MF10194 |
|
Drug Master Files Submitted to the HPB CANADA
|
S.No
|
Name
of the Compound
|
Date of Submission
|
DMF Number
|
|
01
|
Rizatriptan Benzoate |
September 27, 2008 |
2008-212 |
|
02
|
Ketoenamine |
October 1, 2008 |
2008-216 |
|
|
|
|
|
|
|
