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
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06 1U.S.A
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02 4Valid
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01 1217MF10521
02 1305MF10100
03 1306MF10018
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02 1WC-0044A6
03 1WC-0104
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GDUFA
DMF Review : N/A
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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
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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
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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
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DMF Number : 38969
Submission : 2023-10-09
Status : Active
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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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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
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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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