Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
01 1Shanghai Minbiotech
02 1TAPI Technology & API Services
03 1Aspen Biopharma Labs
04 1Concord Biotech
05 1Grand Health Industrial Co Ltd
06 1Hubei Honch Pharmaceutical
07 1Nippon Kayaku
08 1Teva Pharmaceutical Industries
09 3Zhejiang Hisun Pharmaceutical
10 2Blank
01 6China
02 2India
03 2Israel
04 1Japan
05 2Blank
01 2Active
02 4Inactive
03 7Blank
01 3Valid
02 1Withdrawn by Holder
03 9Blank
01 13Blank
01 13Blank
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2016-11-07
DMF Number : 13784
Submission : 1998-09-01
Status : Active
Type : II
| Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-13
Pay. Date : 2012-11-15
DMF Number : 26312
Submission : 2012-09-21
Status : Active
Type : II
NDC Package Code : 58623-0033
Start Marketing Date : 2019-08-12
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 : 12814
Submission : 1998-01-06
Status : Inactive
Type : II
Certificate Number : R1-CEP 2012-197 - Rev 00
Issue Date : 2022-05-10
Type : Chemical
Substance Number : 976
Status : Valid
NDC Package Code : 58623-0033
Start Marketing Date : 2019-08-12
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 : 12962
Submission : 1998-04-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-422 - Rev 02
Issue Date : 2012-06-05
Type : Chemical
Substance Number : 976
Status : Withdrawn by Holder
NDC Package Code : 58623-0033
Start Marketing Date : 2019-08-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2002-149 - Rev 05
Issue Date : 2023-12-12
Type : Chemical
Substance Number : 976
Status : Valid
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 : 9805
Submission : 1992-05-07
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 13254
Submission : 1998-10-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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