ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Rochem International Inc
03 1Symbiotec Pharmalab
04 1BrightGene Bio-Medical Technology Co.,Ltd
05 1Chongqing DaXin Pharmaceutical
06 1Corteva Agriscience
07 1Hubei Honch Pharmaceutical
08 1Qilu Pharmaceutical
09 1Tecoland Corporation
10 1Blank
01 4China
02 1India
03 4U.S.A
04 1Blank
01 5Active
02 5Blank
01 10Blank
01 10Blank
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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 : 36707
Submission : 2022-06-01
Status : Active
Type : II
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36324
Submission : 2022-05-16
Status : Active
Type : II
VMF Number : 6490
Submission : 2022-11-09
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 : Reviewed
Rev. Date : 2024-09-11
Pay. Date : 2024-08-15
DMF Number : 40075
Submission : 2024-07-30
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-15
Pay. Date : 2021-09-16
DMF Number : 36293
Submission : 2021-09-27
Status : Active
Type : II
NDC Package Code : 62227-020
Start Marketing Date : 2021-04-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17795
Submission : 2004-09-29
Status : Active
Type : II
NDC Package Code : 73064-0305
Start Marketing Date : 2007-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
VMF Number : 5791
Submission : 2004-01-02
Status : Active
Type : II
NDC Package Code : 62158-0009
Start Marketing Date : 2021-09-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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