01 1Asia Pioneer Pharmaceuticals
02 1Bristol Myers Squibb
03 1CSPC Pharmaceutical Group
04 2Fresenius SE & Co. KGaA
05 1Inner Mongolia Changsheng Pharmaceutical
06 1JIANGXI DONGFENG PHARMACEUTICAL LLC
07 1Pfizer Inc
08 1Reyoung pharmaceutical
09 1Royal DSM
10 2Sandoz B2B
11 1Blank
01 4China
02 2Germany
03 1Netherlands
04 2Switzerland
05 3U.S.A
06 1Blank
01 3Active
02 4Inactive
03 6Blank
01 3Valid
02 10Blank
01 1229MF10121
02 12Blank
01 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13751
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 1992-017 - Rev 08
Issue Date : 2023-09-27
Type : Chemical
Substance Number : 114
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-12
Pay. Date : 2018-01-02
DMF Number : 32299
Submission : 2017-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32300
Submission : 2017-12-22
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 6138
Submission : 1985-12-09
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 : 13768
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13578
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13537
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-163 - Rev 00
Issue Date : 2021-08-10
Type : Chemical
Substance Number : 113
Status : Valid
Certificate Number : R1-CEP 2001-272 - Rev 05
Issue Date : 2018-11-13
Type : Chemical
Substance Number : 113
Status : Valid
Registration Number : 229MF10121
Registrant's Address : Carretera Saltillo-Mty km 12.5, Ramos Arizpe, Coahuila 25900, Mexico
Initial Date of Registration : 2017-07-11
Latest Date of Registration : --
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