ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 2ChemWerth Inc
02 1Medichem S.A
03 1ALP Pharm
04 1CARBOGEN AMCIS AG
05 1Curia
06 2Viatris
01 4NEPAFENAC
02 1NEPAFENAC (STERILE)
03 1NEPAFENAC DRUG SUBSTANCE
04 1NEPAFENAC, NON-STERILE BULK DRUG SUBSTANCE
05 1NEPAFENAC, STERILE BULK DRUG SUBSTANCE
01 1China
02 1Spain
03 1Switzerland
04 5U.S.A
01 8Active
01 1Complete
02 7Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25528
Submission : 2014-12-17
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-22
Pay. Date : 2014-07-11
DMF Number : 28432
Submission : 2014-07-22
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28205
Submission : 2015-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23032
Submission : 2009-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17812
Submission : 2004-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22636
Submission : 2009-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30594
Submission : 2016-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30593
Submission : 2016-06-21
Status : Active
Type : II
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