ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Transo-Pharm USA LLC
03 1Almelo
04 1Beijing Fukangren Biopharmaceutical
05 1Beijing Mesochem Technology
06 1DMFs Not Supported
07 1Fresenius Kabi AB Brunna
08 1Fuan Pharmaceutical
09 1Guangzhou Tosun Pharmaceutical
10 1Hanways Chempharm
11 1Orchid Pharma
12 1Qilu Antibiotics Pharmaceutical Co., Ltd.
13 1Vitalpharms
01 7China
02 2India
03 1Sweden
04 2U.S.A
05 1Blank
01 4Active
02 9Blank
01 13Blank
01 13Blank
01 13Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-20
Pay. Date : 2024-02-08
DMF Number : 39510
Submission : 2024-02-09
Status : Active
Type : II
NDC Package Code : 66558-0212
Start Marketing Date : 2023-05-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (.2kg/kg .8kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-06
Pay. Date : 2024-02-23
DMF Number : 39355
Submission : 2024-01-23
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36090
Submission : 2021-07-05
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-25
Pay. Date : 2023-08-22
DMF Number : 38569
Submission : 2023-07-31
Status : Active
Type : II
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