|
 |
|
|
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 |
|
|
|
|
|
