ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Transo-Pharm USA LLC
03 1Chongqing Sintaho Pharmaceutical
04 1Shanghai Minbiotech
05 1Apicore LLC
06 1BrightGene Bio-Medical Technology Co.,Ltd
07 1MSN Laboratories
08 1Natco Pharma
09 1PharmaMar
10 1Shenzhen Haorui
11 1Wisdom Pharmaceutical
12 1Blank
01 5China
02 3India
03 1Spain
04 2U.S.A
05 1Blank
01 7Active
02 5Blank
01 12Blank
01 12Blank
01 12Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33969
Submission : 2019-10-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-28
Pay. Date : 2024-01-16
DMF Number : 39171
Submission : 2024-01-13
Status : Active
Type : II
NDC Package Code : 42973-353
Start Marketing Date : 2023-05-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39228
Submission : 2023-12-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-04-23
Pay. Date : 2024-03-21
DMF Number : 37785
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-05-08
Pay. Date : 2024-04-18
DMF Number : 39672
Submission : 2024-03-28
Status : Active
Type : II
NDC Package Code : 54893-0508
Start Marketing Date : 2024-03-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37624
Submission : 2023-01-18
Status : Active
Type : II
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