01 1Chemische Fabrik Berg
02 1Moehs Iberica
03 1Herbrand PharmaChemicals GmbH
04 1Macleods Pharmaceuticals Limited
05 1Nantong Chem-land
06 1Nantong Jinghua Pharmaceutical
07 1Roche Diagnostics GmbH
08 1Sumitomo Chemical
09 1Suzhou Hengyi Pharmaceutical
10 1Suzhou Ryway Biotech
11 1Wanbang Biopharmaceuticals
12 1Blank
01 5China
02 3Germany
03 1India
04 1Japan
05 1Spain
06 1Blank
01 3Active
02 2Inactive
03 7Blank
01 1Valid
02 11Blank
01 1217MF10086
02 11Blank
01 1WC-0079
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16578
Submission : 2003-05-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-06
Pay. Date : 2015-05-12
DMF Number : 29101
Submission : 2015-04-28
Status : Active
Type : II
Certificate Number : CEP 2015-125 - Rev 01
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 525
Status : Valid
Date of Issue : 2019-11-28
Valid Till : 2022-07-02
Written Confirmation Number : WC-0079
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4928
Submission : 1983-03-22
Status : Active
Type : II
NDC Package Code : 20012-0001
Start Marketing Date : 2011-12-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 8278
Submission : 1989-10-03
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 : 8377
Submission : 1990-01-15
Status : Inactive
Type : II
NDC Package Code : 59348-0013
Start Marketing Date : 2019-01-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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