ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Cohance Lifesciences
03 1Alcami
04 1Apothecon Pharmaceuticals
05 1Ascensus Specialties
06 1GLAND PHARMA LIMITED
07 1Global Calcium
08 1Seratec SAS
09 1Viatris
10 1Vijayasri Organics Limited
01 1France
02 5India
03 4U.S.A
01 8Active
02 2Blank
01 10Blank
01 10Blank
01 1WC-0150
02 9Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19978
Submission : 2006-12-13
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
NDC Package Code : 17511-101
Start Marketing Date : 2006-08-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36871
Submission : 2023-07-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-15
Pay. Date : 2021-04-29
DMF Number : 35383
Submission : 2020-11-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-09-17
Pay. Date : 2024-07-11
DMF Number : 40058
Submission : 2024-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20305
Submission : 2007-02-26
Status : Active
Type : II
NDC Package Code : 65732-702
Start Marketing Date : 2008-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-08
Pay. Date : 2012-12-18
DMF Number : 19472
Submission : 2006-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19151
Submission : 2006-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19683
Submission : 2006-08-10
Status : Active
Type : II
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