GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42462
Submission : 2025-12-25
Status : Active
Type : IV

Registrant Name : J2H Biotech Co., Ltd.
Registration Date : 2023-08-07
Registration Number : 20230807-210-J-1532
Manufacturer Name : J2H Biotech Co., Ltd. @ Shantou Jiahe Biologic Technology Co., Ltd
Manufacturer Address : Building B, part of Building D, 349 Sandan-ro, Danwon-gu, Ansan-si, Gyeonggi-do @ No.4 Lane 1, Xigang Road, Shantou, Guangdong, China

Registrant Name : Bigsol Bio Co., Ltd.
Registration Date : 2025-08-25
Registration Number : 20250825-210-J-1993
Manufacturer Name : Shanghai Ajinomoto Amino Acid Co., Ltd.
Manufacturer Address : No. 718 East Rongle Road, Songjiang District, Shanghai 201613, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Pharmaline Co., Ltd.
Registration Date : 2026-02-27
Registration Number : 20260227-211-J-2139
Manufacturer Name : Shijiazhuang Jirong Pharmaceutical Co., Ltd.
Manufacturer Address : No.8 North of Huagong Road, Circular Chemical Industry Zone, Shijiazhuang, Hebei, China

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