01 1Alembic Pharmaceuticals Limited
02 1Bayer AG
03 1DEAFARMA
04 1Emcure Pharmaceuticals
05 1Erregierre SpA
06 1Lusochimica
07 1Orchid Pharma
08 1Par Pharmaceutical
09 1Permachem Asia, Ltd
10 1Sanmar Speciality Chemicals Limited IN 600 086 Chennai
11 1Unipex
01 1France
02 1Germany
03 4India
04 3Italy
05 1Japan
06 1U.S.A
01 7Active
02 1Inactive
03 3Blank
01 11Blank
01 1217MF10589
02 1217MF10719
03 9Blank
01 1WC-0082
02 10Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-28
Pay. Date : 2013-06-07
DMF Number : 25750
Submission : 2012-03-20
Status : Active
Type : II
NDC Package Code : 14593-864
Start Marketing Date : 2023-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22539
Submission : 2009-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14337
Submission : 1999-07-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-10
DMF Number : 16215
Submission : 2002-10-22
Status : Active
Type : II
Registration Number : 217MF10589
Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY
Initial Date of Registration : 2005-09-14
Latest Date of Registration : --
NDC Package Code : 49706-1607
Start Marketing Date : 2010-01-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10167
Submission : 1993-03-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-23
Pay. Date : 2013-09-26
DMF Number : 25365
Submission : 2011-10-07
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21106
Submission : 2007-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19329
Submission : 2006-04-04
Status : Inactive
Type : II
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