ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Cilag AG
03 1Divis Laboratories
04 1Fuan Pharmaceutical
05 1GLAND PHARMA LIMITED
06 1Recordati
07 1Shanghai Ziyuan Pharmaceutical
08 1Sun Pharmaceutical Industries Limited
09 1Trifarma
01 2FOSPHENYTOIN SODIUM
02 1FOSPHENYTOIN SODIUM API
03 1FOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT)
04 5FOSPHENYTOIN SODIUM USP
01 2China
02 3India
03 2Italy
04 1Switzerland
05 1U.S.A
01 5Active
02 4Inactive
01 4Complete
02 5Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-03
Pay. Date : 2023-03-30
DMF Number : 37565
Submission : 2023-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 18954
Submission : 2005-11-14
Status : Inactive
Type : II
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DMF Review : N/A
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DMF Number : 18806
Submission : 2005-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-09
Pay. Date : 2020-03-05
DMF Number : 32816
Submission : 2018-08-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-09
Pay. Date : 2019-04-24
DMF Number : 33756
Submission : 2019-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 16899
Submission : 2003-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-23
DMF Number : 17333
Submission : 2004-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19455
Submission : 2006-05-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 20970
Submission : 2007-10-24
Status : Inactive
Type : II
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