ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Alcami
03 1Apothecon Pharmaceuticals
04 1Ascensus Specialties
05 1GLAND PHARMA LIMITED
06 1Global Calcium
07 1Seratec SAS
08 1Viatris
01 6FOMEPIZOLE
02 1FOMEPIZOLE (4-METHYLPYRAZOLE)
03 1FP-059 (FOMEPIZOLE) DRUG SUBSTANCE
01 1France
02 3India
03 4U.S.A
01 8Active
01 3Complete
02 5Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
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DMF Number : 19978
Submission : 2006-12-13
Status : Active
Type : II
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DMF Number : 19151
Submission : 2006-02-03
Status : Active
Type : II
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DMF Number : 19683
Submission : 2006-08-10
Status : Active
Type : II
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DMF Review : Complete
Rev. Date : 2024-09-17
Pay. Date : 2024-07-11
DMF Number : 40058
Submission : 2024-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-15
Pay. Date : 2021-04-29
DMF Number : 35383
Submission : 2020-11-30
Status : Active
Type : II
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DMF Number : 36871
Submission : 2023-07-27
Status : Active
Type : II
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DMF Number : 20305
Submission : 2007-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-18
DMF Number : 19472
Submission : 2006-05-24
Status : Active
Type : II
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