01 3Apicore 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
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04 2Germany
05 6India
06 3Japan
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08 2U.S.A
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01 4Active
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01 3Valid
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01 1WC-0110
02 1WC-0110A3
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04 1WC-0275
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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Status : Withdrawn by Holder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
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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
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DMF Number : 8914
Submission : 1991-01-03
Status : Active
Type : II
GDUFA
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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Status : Withdrawn by Holder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
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DMF Number : 3457
Submission : 1979-02-27
Status : Inactive
Type : II
GDUFA
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DMF Number : 6819
Submission : 1987-01-06
Status : Inactive
Type : II
GDUFA
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DMF Number : 4914
Submission : 1983-02-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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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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GDUFA
DMF Review : N/A
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DMF Number : 4756
Submission : 1982-12-10
Status : Inactive
Type : II
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