ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 2Bachem AG
03 1GLAND PHARMA LIMITED
04 1Johnson & Johnson Innovative Medicine
05 1Pisgah Labs
06 1Reliable Biopharmaceutical Corporation
07 1Solara Active Pharma Sciences
01 6ETOMIDATE
02 1ETOMIDATE PROCESS B
03 1ETOMIDATE USP NON STERILE BULK DRUG SUBSTANCE
01 2India
02 2Switzerland
03 4U.S.A
01 6Active
02 2Inactive
01 5Complete
02 3Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-13
DMF Number : 20500
Submission : 2007-04-30
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-16
Pay. Date : 2014-10-14
DMF Number : 20234
Submission : 2007-01-29
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-12
Pay. Date : 2023-09-22
DMF Number : 38855
Submission : 2023-09-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-11
Pay. Date : 2020-02-04
DMF Number : 34205
Submission : 2019-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10635
Submission : 1993-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-30
DMF Number : 15983
Submission : 2002-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11229
Submission : 1994-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27580
Submission : 2013-09-20
Status : Active
Type : II
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