01 1AK BIOPHARM
02 1CI NATURMEGA SA
03 1Chemport Inc
04 2Croda Europe Limited
05 1Huatai Biopharm
06 1K.D. Pharma Bexbach GmbH
07 1KinOmega Biopharm Inc.
08 1Sinomega Biotech Engineering
01 3China
02 1Germany
03 1South Korea
04 1U.S.A
05 3United Kingdom
01 3Active
02 1Inactive
03 5Blank
01 2Valid
02 7Blank
01 1303MF10016
02 1303MF10027
03 7Blank
01 9Blank
01 16148-2-ND
02 8Blank
01 9Blank
01 9Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-03
Pay. Date : 2013-12-19
DMF Number : 22100
Submission : 2008-11-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24996
Submission : 2011-05-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-18
Pay. Date : 2014-07-28
DMF Number : 28170
Submission : 2014-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26880
Submission : 2013-03-21
Status : Inactive
Type : II
Registrant Name : Aekyung Biopharm Co., Ltd.
Registration Date : 2020-12-04
Registration Number : 6148-2-ND
Manufacturer Name : Aekyung Biopharm Co., Ltd.
Manufacturer Address : 81 Sanggae-ro, Nam-gu, Ulsan Metropolitan City (80, 80A)
Certificate Number : R1-CEP 2016-130 - Rev 00
Issue Date : 2021-08-06
Type : Chemical
Substance Number : 1250
Status : Valid
Certificate Number : CEP 2007-366 - Rev 03
Issue Date : 2023-10-06
Type : Chemical
Substance Number : 1352
Status : Valid
Registration Number : 303MF10027
Registrant's Address : Industrial Park, Xiaohan Town, Deyang, Sichuan, P. R. China
Initial Date of Registration : 2021-02-10
Latest Date of Registration :
Registration Number : 303MF10016
Registrant's Address : No. 161, South Yinghuashan Road, Shifang, Deyang City, Sichuan, China
Initial Date of Registration : 2021-01-26
Latest Date of Registration :
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