01 1CKD Bio Corporation
02 1Fujian South Pharmaceutical
03 1Hunan Warrant Chiral Pharmaceutical
04 2Kyongbo Pharmaceutical Co., Ltd
05 4Suzhou no. 4 Pharmaceutical Factory
06 2Yamasa Corporation
07 1Yangtze River Pharmaceutical Group
08 1Zhejiang Ausun Pharmaceutical
09 1Zhejiang Hisoar Pharmaceutical
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01 9China
02 2Japan
03 3South Korea
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01 1Active
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01 1220MF10109
02 1304MF10089
03 1307MF10049
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01 11673-30-ND
02 11673-51-ND
03 12253-3-ND
04 1357-3-ND
05 14272-2-ND
06 14272-2-ND(1)
07 1Su133-17-ND
08 1Su289-11-ND
09 1Su289-11-ND(1)
10 1Su289-11-ND(A)
11 1Su289-11-ND(B)
12 1Su289-23-ND
13 1Su513-11-ND
14 1Su812-27-ND
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40009
Submission : 2024-05-29
Status : Active
Type : II
Registration Number : 220MF10109
Registrant's Address : 2-10-1 Shinseicho, Choshi City, Chiba Prefecture
Initial Date of Registration : 2008-04-11
Latest Date of Registration :
Registrant Name : Huons Co., Ltd.
Registration Date : 2015-06-02
Registration Number : 4272-2-ND(1)
Manufacturer Name : YAMASA CORPORATION
Manufacturer Address : 10-1, Araoi-cho 2-chome, Choshi, Chiba-ken 288-0056, Japan
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Redox Bio Co., Ltd.
Registration Date : 2025-08-29
Registration Number : 357-3-ND
Manufacturer Name : Ridox Bio Co., Ltd. @Hunan Warrant Chiral Pharmaceutical Co., Ltd.
Manufacturer Address : 83, 3rd Jakyakgongdan-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, No. 139, Tongguan Avenue, Tongguan Circular Economy Industrial Park, Wangcheng District, Changsha City,, Hunan Province, China
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Registration Number : 304MF10089
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2022-06-22
Latest Date of Registration :
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2022-07-18
Registration Number : 1673-51-ND
Manufacturer Name : Kyungbo Pharmaceutical Co., Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2025-07-28
Registration Number : Su513-11-ND
Manufacturer Name : Zhejiang Warrant Pharmaceutical Co., Ltd.
Manufacturer Address : Binhai Industry Zone, Keqiao District, Shaoxing City, Zhejiang province
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Registration Number : 307MF10049
Registrant's Address : No. 100 Waisha Branch Rd. , Jiaojiang, Taizhou, Zhejiang, China
Initial Date of Registration : 2025-04-02
Latest Date of Registration :
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-01-06
Registration Number : Su289-23-ND
Manufacturer Name : Zhejiang Hisoar Pharmaceutical Co.,Ltd.
Manufacturer Address : No. 100 Waisha Branch Road. Jiaojiang, Taizhou, 318000. Zhejiang China
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2025-05-26
Registration Number : Su289-11-ND(B)
Manufacturer Name : Suzhou No.4 Pharmaceutical Factory Co., Ltd
Manufacturer Address : No. 2, Haixin Road, Haiyu Town, Changshu City, Jiangsu Province, China
Registrant Name : Mpeak Korea Co., Ltd.
Registration Date : 2025-03-26
Registration Number : Su812-27-ND
Manufacturer Name : Fujian South Pharmaceutical Co., Ltd.
Manufacturer Address : No. 28, Economic Development Zone D, Mingxi County, Sanming City, Fujian PR China
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