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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-27
Pay. Date : 2022-08-04
DMF Number : 25056
Submission : 2011-06-17
Status : Active
Type : II
Certificate Number : R1-CEP 2013-238 - Rev 00
Issue Date : 2020-05-28
Type : Chemical
Substance Number : 1615
Status : Valid
Registration Number : 230MF10079
Registrant's Address : GEDIAN ECONOMIC DEVELOPMENT DISTRICT 436070, E-zhou, Hubei, China
Initial Date of Registration : 2018-07-05
Latest Date of Registration :
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-001
Start Marketing Date : 2012-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140725-94-E-119-10
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.25 Juxian Road, Gedian Economic Development District, E-zhou City, Hubei Province, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-03
Pay. Date : 2022-04-21
DMF Number : 34268
Submission : 2019-10-29
Status : Active
Type : II
Certificate Number : CEP 2019-295 - Rev 02
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 1075
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-004
Start Marketing Date : 2013-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-29
Registration Number : 20210329-209-J-903
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : Gedian Economic Development District, E-zhou City, Hubei Province, China