ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Shanghai Minbiotech
03 1TAPI Technology & API Services
04 1Aspen Biopharma Labs
05 1Concord Biotech
06 1Hubei Honch Pharmaceutical
07 1Kyowa Hakko Bio
08 1Sicor Societa Italiana Corticosteroidi Srl
09 1Sumar Biotech
10 1Teva Pharmaceutical Industries
11 1Wuxi Fortune Pharmaceutical Co., Ltd
12 2Zhejiang Hisun Pharmaceutical
13 1Zhejiang Huida Biotech
14 1Blank
01 6China
02 3India
03 2Israel
04 1Italy
05 1Japan
06 1U.S.A
07 1Blank
01 6Active
02 3Inactive
03 6Blank
01 5Valid
02 1Withdrawn by Holder
03 9Blank
01 1304MF10010
02 14Blank
01 1WC-0111
02 14Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33811
Submission : 2019-11-04
Status : Active
Type : II
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-29
Pay. Date : 2012-11-09
DMF Number : 13791
Submission : 1998-09-01
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-21
Pay. Date : 2019-04-24
DMF Number : 33662
Submission : 2019-04-20
Status : Active
Type : II
Certificate Number : R0-CEP 2019-308 - Rev 00
Issue Date : 2021-02-25
Type : Chemical
Substance Number : 1655
Status : Valid
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0016
Start Marketing Date : 2016-05-16
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 : 37462
Submission : 2023-10-10
Status : Active
Type : II
Certificate Number : CEP 2022-400 - Rev 01
Issue Date : 2024-04-26
Type : Chemical
Substance Number : 1655
Status : Valid
NDC Package Code : 62158-0005
Start Marketing Date : 2019-08-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-23
Pay. Date : 2020-09-25
DMF Number : 34866
Submission : 2020-09-14
Status : Active
Type : II
Certificate Number : R1-CEP 2016-034 - Rev 00
Issue Date : 2022-11-09
Type : Chemical
Substance Number : 1655
Status : Valid
NDC Package Code : 65050-0058
Start Marketing Date : 2020-03-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-08
Pay. Date : 2012-11-15
DMF Number : 25659
Submission : 2011-12-30
Status : Active
Type : II
Certificate Number : R1-CEP 2005-021 - Rev 00
Issue Date : 2011-01-25
Type : Chemical
Substance Number : 1655
Status : Withdrawn by Holder
NDC Package Code : 58623-0045
Start Marketing Date : 2019-08-05
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 : 13521
Submission : 1998-09-01
Status : Inactive
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 : 18599
Submission : 1988-07-14
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13783
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2012-013 - Rev 00
Issue Date : 2022-05-10
Type : Chemical
Substance Number : 1655
Status : Valid
NDC Package Code : 58623-0045
Start Marketing Date : 2019-08-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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