01 1Apicore LLC
02 1Biesterfeld Spezialchemie GmbH
03 1Fujimoto Chemicals
04 1GMT Fine Chemicals SA
05 1Heraeus Holding
06 1Jiwan Pharmaceutical Technology Co., Ltd
07 1Kekule Pharma
08 2Kyowa Hakko Bio
09 1Mac-Chem Products (India) Pvt.Ltd
10 1Pfizer Inc
11 1Pliva Hrvatska
12 1Suzhou Lixin Pharmaceutical
13 1VUAB Pharma
14 1Vannsh Life Sciences
15 1Viatris
16 1Blank
01 2China
02 1Croatia
03 1Czech Republic
04 2Germany
05 4India
06 3Japan
07 1Switzerland
08 2U.S.A
09 1Blank
01 4Active
02 6Inactive
03 7Blank
01 3Valid
02 2Withdrawn by Holder
03 12Blank
01 17Blank
01 1WC-0110n
02 1WC-0275
03 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25624
Submission : 2011-12-27
Status : Active
Type : II
Certificate Number : R1-CEP 2012-066 - Rev 00
Issue Date : 2018-02-07
Type : Chemical
Substance Number : 1691
Status : Withdrawn by Holder
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-15
Pay. Date : 2013-10-04
DMF Number : 12862
Submission : 1998-02-13
Status : Active
Type : II
Certificate Number : CEP 2008-036 - Rev 03
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 1691
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30107
Submission : 2016-01-18
Status : Active
Type : II
Certificate Number : R0-CEP 2016-082 - Rev 01
Issue Date : 2019-12-18
Type : Chemical
Substance Number : 1691
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8914
Submission : 1991-01-03
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 : 4756
Submission : 1982-12-10
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 : 4914
Submission : 1983-02-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3457
Submission : 1979-02-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6819
Submission : 1987-01-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16326
Submission : 2002-12-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16411
Submission : 2003-01-31
Status : Inactive
Type : II
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