01 1Alembic Pharmaceuticals Limited
02 1Anhui Sinotech Industrial
03 1Averix Bio
04 4Corbion
05 1Eagle Chemical
06 1Extrovis AG
07 3Global Calcium
08 2Harman Finochem
09 1Maithri Drugs
10 1Raks Pharma
11 1Shandong Xinhong Pharmaceutical Co Ltd
12 1Shanpar
13 1Sichuan Renan Pharmaceutical
14 1Sudeep Pharma
15 1Supreem Pharmaceuticals Mysore Pvt Ltd
16 2Tomita Pharmaceutical
17 1Vasa Pharmachem
18 1Zhejiang Ruibang Laboratories
19 1Zydus Lifesciences
01 4China
02 14India
03 2Japan
04 4Netherlands
05 1Switzerland
06 1U.S.A
01 7Active
02 2Inactive
03 17Blank
01 1Expired
02 4Valid
03 2Withdrawn by EDQM Failure to CEP procedure
04 3Withdrawn by Holder
05 16Blank
01 1217MF10521
02 1305MF10100
03 1306MF10018
04 23Blank
01 1WC-0044
02 1WC-0044A6
03 1WC-0104
04 23Blank
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 35940
Submission : 2021-05-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-13
Pay. Date : 2021-05-26
DMF Number : 34748
Submission : 2021-06-01
Status : Active
Type : II
Certificate Number : R1-CEP 2012-068 - Rev 01
Issue Date : 2023-02-20
Type : Chemical
Substance Number : 979
Status : Valid
Registration Number : 305MF10100
Registrant's Address : No. 578, Binhai Ten Road, Economic and Technological Development Zone, Wenzhou, Zhejiang Province, China
Initial Date of Registration : 2023-08-22
Latest Date of Registration : --
GDUFA
DMF Review : N/A
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DMF Number : 31690
Submission : 2017-05-23
Status : Active
Type : II
Registration Number : 217MF10521
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2005-09-07
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-25
Pay. Date : 2022-03-24
DMF Number : 36938
Submission : 2022-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 38969
Submission : 2023-10-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-24
Pay. Date : 2023-10-03
DMF Number : 37213
Submission : 2023-07-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-10
Pay. Date : 2022-03-07
DMF Number : 29432
Submission : 2015-05-28
Status : Active
Type : II
Certificate Number : R1-CEP 2016-091 - Rev 00
Issue Date : 2022-10-25
Type : Chemical
Substance Number : 979
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-07
Written Confirmation Number : WC-0104
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GDUFA
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DMF Number : 8438
Submission : 1990-02-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 2012-094 - Rev 01
Issue Date : 2018-09-27
Type : Chemical
Substance Number : 979
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 24708
Submission : 2010-12-20
Status : Inactive
Type : II
Registration Number : 306MF10018
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2024-01-30
Latest Date of Registration : --
Certificate Number : R1-CEP 2012-095 - Rev 01
Issue Date : 2018-11-23
Type : Chemical
Substance Number : 172
Status : Valid
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