Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1ChemWerth Inc
03 1ALP Pharm
04 1Alcami
05 1Indoco Remedies Limited
06 1Lonza Group
07 1Micro Labs Limited
08 1SENJU PHARMACEUTICAL CO LTD
09 1Viatris
10 1Yonsung Fine Chemicals
01 4BROMFENAC SODIUM
02 1BROMFENAC SODIUM (FP-098)
03 1BROMFENAC SODIUM (SESQUIHYDRATE)
04 1BROMFENAC SODIUM HYDRATE
05 3BROMFENAC SODIUM SESQUIHYDRATE
01 1China
02 1Czech Republic
03 2India
04 1Japan
05 1South Korea
06 1Switzerland
07 3U.S.A
01 8Active
02 2Inactive
01 6Complete
02 4Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38922
Submission : 2023-10-18
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-17
Pay. Date : 2013-07-09
DMF Number : 24521
Submission : 2011-05-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22915
Submission : 2009-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-01
Pay. Date : 2013-04-16
DMF Number : 23031
Submission : 2009-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-09
Pay. Date : 2013-08-28
DMF Number : 25245
Submission : 2011-08-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10590
Submission : 1993-11-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-04
Pay. Date : 2013-12-23
DMF Number : 27800
Submission : 2013-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16414
Submission : 2003-02-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-23
Pay. Date : 2013-09-20
DMF Number : 25315
Submission : 2011-11-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-27
Pay. Date : 2014-01-17
DMF Number : 23653
Submission : 2010-03-15
Status : Active
Type : II
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