ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Axplora
03 1Minakem (formerly Delmar Chemicals)
04 1Boehringer Ingelheim GmbH
05 1Global Calcium
06 1MSN Laboratories
07 1Mehta API
08 1Taro Pharmaceutical Industries
09 2Blank
01 2ESMOLOL HCL
02 1ESMOLOL HCL USP
03 1ESMOLOL HCl
04 4ESMOLOL HYDROCHLORIDE
05 1ESMOLOL HYDROCHLORIDE USP
06 1ESMOLOL HYDROCHLORIDE USP [ROUTE CODE-"EH"]
01 1Canada
02 2Germany
03 3India
04 2U.S.A
05 2Blank
01 7Active
02 3Inactive
01 4Complete
02 6Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-17
DMF Number : 16053
Submission : 2002-06-27
Status : Active
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-28
Pay. Date : 2020-02-24
DMF Number : 6868
Submission : 1987-01-20
Status : Active
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-21
Pay. Date : 2020-05-15
DMF Number : 4475
Submission : 1982-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15743
Submission : 2001-11-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36877
Submission : 2023-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39475
Submission : 2024-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-16
Pay. Date : 2020-09-30
DMF Number : 26024
Submission : 2012-05-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16863
Submission : 2003-09-24
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5224
Submission : 1984-01-18
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5126
Submission : 1983-11-03
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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