KDMF (Korea Drug Master File) Approved Products & Companies
Sungwoo Biopharm Co., Ltd.
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Product:
Oseltamivir phosphate
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Initial Registration:
2021-02-05
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Registration Number:
20210205-209-J-833
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MFDS Classification:
Appendix 1
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Applicant:
Sungwoo Biopharm Co., Ltd.
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Last Modified:
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Country:
china
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Status:
Business Closure
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Manufacturer:
Sinopep-Allsino Biopharmaceutical Co., Ltd.
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Withdrawal Date:
2024-09-27
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Final Annual Reporting Year:
-
Manufacturing Facility:
No. 28, Linpu Road, Economic & Technological Development Zone, Lianyungang, Jiangsu Province, 222000, China
Sunil Yanghaeng Co., Ltd.
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Product:
sodium chondroitin sulfate
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Initial Registration:
2022-12-06
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Registration Number:
20221206-173-I-653-06
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MFDS Classification:
Appendix 1
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Applicant:
Sunil Yanghaeng Co., Ltd.
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Last Modified:
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Country:
japan
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Status:
Active
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Manufacturer:
SEIKAGAKU CORPORATION Kurihama Plant Fukusaku
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
3-1, Kurihama 9-chome, Yokosuka-shi, Kanagawa 239-0831,
Synex Co., Ltd.
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Product:
sodium hyaluronate
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Initial Registration:
2008-05-30
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Registration Number:
20080530-96-E-70-19
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MFDS Classification:
Appendix 1
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Applicant:
Synex Co., Ltd.
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Last Modified:
2023-03-08
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Country:
france
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Status:
Active
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Manufacturer:
HTL
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
7 Rue Alfred Kastler ZI De L'Aumaillerie 35133 JAVENE
Taegeuk Pharmaceutical Co., Ltd.
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Product:
Terbinafine hydrochloride
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Initial Registration:
2011-06-15
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Registration Number:
20050905-49-A-94-10(1)
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MFDS Classification:
etc
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Applicant:
Taegeuk Pharmaceutical Co., Ltd.
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Last Modified:
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Country:
china
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Status:
Active
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Manufacturer:
Zhejiang East-Asia Pharmaceutical Chemical Co., Ltd
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Withdrawal Date:
-
Final Annual Reporting Year:
2012
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Manufacturing Facility:
Economy Development Zone of Sanmen County
Taejun Pharmaceutical Co., Ltd.
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Product:
Irsogladin maleate
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Initial Registration:
2006-12-28
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Registration Number:
Su17-1-ND
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MFDS Classification:
new substance
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Applicant:
Taejun Pharmaceutical Co., Ltd.
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Last Modified:
2026-04-03
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Country:
japan
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Status:
Active
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Manufacturer:
HAMARI PFST, Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
1007-81, Izumisawa, Chitose, Hokkaido, Japan
Taewang Mulsan Co., Ltd.
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Product:
rivaroxaban
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Initial Registration:
2015-08-17
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Registration Number:
Number 6410-2-ND(1)
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MFDS Classification:
new substance
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Applicant:
Taewang Mulsan Co., Ltd.
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Last Modified:
2021-01-13
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Country:
India
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Status:
Active
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Manufacturer:
Alembic Pharmaceuticals Limited
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
API Division, Karakhadi., Plot No. 842-843, Tal-Padra, City : Karakhadi-391 450, Dist : Vadodara, Gujarat State, India
Takeda Pharmaceutical Korea
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Product:
Anagrelide hydrochloride
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Initial Registration:
2009-06-17
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Registration Number:
22-4-ND
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MFDS Classification:
new substance
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Applicant:
Takeda Pharmaceutical Korea
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Last Modified:
2024-11-01
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Country:
-
Status:
Active
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Manufacturer:
Sterling Wisconsin, LLC @ [Powdersize Process Manufacturing Plant] Powdersize, LLC
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Withdrawal Date:
-
Final Annual Reporting Year:
2021
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Manufacturing Facility:
W130 N10497 Washington Drive, Germantown, WI 53022, USA@20 Pacific Drive, Quakertown, PA 18951
Tanabe Pharma Korea Co., Ltd.
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Product:
Remifentanil hydrochloride
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Initial Registration:
2014-10-28
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Registration Number:
Su2480-16-ND
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MFDS Classification:
new substance
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Applicant:
Tanabe Pharma Korea Co., Ltd.
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Last Modified:
2021-08-27
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Country:
Belgium
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Status:
Active
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Manufacturer:
Minakem High Potent SA
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Withdrawal Date:
-
Final Annual Reporting Year:
2024
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Manufacturing Facility:
Rue Fonds Jean Paques 8, Mont-Saint-Guibert, 1435 Belgium
Teragen Etex Co., Ltd.
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Product:
sodium ibandronate
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Initial Registration:
2012-04-20
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Registration Number:
Number 4766-1-ND(1)
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MFDS Classification:
new substance
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Applicant:
Teragen Etex Co., Ltd.
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Last Modified:
2024-02-22
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Country:
India
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Status:
Active
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Manufacturer:
Fleming Laboratories Limited
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Withdrawal Date:
-
Final Annual Reporting Year:
2022
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Manufacturing Facility:
Plot No. 152&160, Phase-V, IDA, Jeedimetla(V), Quthbullapur(M) Medchal-Malkajgiri District Telangana State, India
The Core Co., Ltd.
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Product:
Sulbactam sodium
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Initial Registration:
2018-01-16
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Registration Number:
20180116-150-I-535-10
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MFDS Classification:
Appendix 1
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Applicant:
The Core Co., Ltd.
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Last Modified:
2024-09-04
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Country:
-
Status:
Active
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Manufacturer:
Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd @ [Manufacturer of starting material 'Sulbactam'] Jiangxi Fushine Pharmaceutical Co., Ltd
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Withdrawal Date:
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Final Annual Reporting Year:
2019
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Manufacturing Facility:
West Side of Yanbin Road, Economic Development Zone, Feixian, China@[Manufacturer of starting material 'Sulbactam'] No.2 Yuli Industrial Zone, Changjiang District, Jingdezhen City, Jiangxi Province, China.
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