01 1Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
02 1Anmol Chemicals
03 1Ashland
04 1Ashland Industries Europe GmbH
05 3BASF
06 1Balaji Amines
07 1CNSG Anhui Hong Sifang
08 3China National Salt Anhui Hongsifang
09 2GC Chemie Pharmie Ltd
10 1Huangshan Bonsun Pharmaceuticals
11 3Huzhou Sunflower Pharmaceutical
12 1INTERNATIONAL SPECIALTY PRODUCTS
13 1JH Nanhang
14 1JIAOZUO ZHONGWEI CHEMICAL CO., LTD
15 1Jubilee Biotech
16 1Shanghai Yuking Water Soluble Material Tech
17 1Star-Tech Specialty Products Co Ltd
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01 19Active
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01 9Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
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01 178
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GDUFA
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DMF Number : 29049
Submission : 2015-02-02
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-372 - Rev 00
Issue Date : 2021-02-05
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 28407
Submission : 2014-06-12
Status : Active
Type : IV
Certificate Number : R1-CEP 2012-196 - Rev 01
Issue Date : 2019-11-22
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 28892
Submission : 2014-12-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-314 - Rev 01
Issue Date : 2023-05-09
Type : Chemical
Substance Number : 685
Status : Valid
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DMF Number : 27417
Submission : 2013-08-14
Status : Active
Type : IV
Certificate Number : CEP 2009-020 - Rev 01
Issue Date : 2024-03-26
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
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DMF Number : 32698
Submission : 2018-11-22
Status : Active
Type : IV
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DMF Number : 33415
Submission : 2018-12-10
Status : Active
Type : IV
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DMF Number : 33592
Submission : 2019-02-21
Status : Active
Type : IV
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DMF Number : 22604
Submission : 2009-01-19
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-079 - Rev 01
Issue Date : 2017-02-09
Type : Chemical
Substance Number : 685
Status : Valid
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DMF Number : 32695
Submission : 2018-03-27
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-078 - Rev 01
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
Status : Withdrawn by Holder
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DMF Number : 11070
Submission : 1994-08-30
Status : Inactive
Type : IV
Certificate Number : R1-CEP 2007-077 - Rev 02
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
Status : Valid
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