KDMF (Korea Drug Master File) Approved Products & Companies
SM Wooil Co., Ltd.
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Product:
Milk Thistle Dry Extract
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Initial Registration:
2017-12-26
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Registration Number:
20171226-18-K-20-03
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MFDS Classification:
Appendix 1-2
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Applicant:
SM Wooil Co., Ltd.
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Last Modified:
2026-01-02
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Country:
china
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Status:
Active
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Manufacturer:
Shaanxi Jiahe Pharmaceutical Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
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Manufacturing Facility:
NO.7 Binhe Road, Yangling Agricultural Hi-tech Industries Demonstration Zone, Shaanxi, CHINA 712100
Space Industry Co., Ltd.
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Product:
potassium chloride
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Initial Registration:
2024-07-25
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Registration Number:
20220520-209-J-1266(2)
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MFDS Classification:
Appendix 1
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Applicant:
Space Industry Co., Ltd.
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Last Modified:
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Country:
Czech Republic
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Status:
Active
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Manufacturer:
Macco Organiques, sro
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
Zahradní 1938/46c, 792 01 Bruntál, Czech Republic
SPC Co., Ltd.
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Product:
Cefotiam hydrochloride
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Initial Registration:
2014-09-12
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Registration Number:
20140912-117-G-124-07
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MFDS Classification:
Appendix 1
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Applicant:
SPC Co., Ltd.
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Last Modified:
2025-07-28
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Country:
-
Status:
Active
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Manufacturer:
SPC Co., Ltd. @[Product Manufacturer ①] Youngjin Pharmaceutical Co., Ltd. @[Product Manufacturer ②] Engchem Life Sciences Co., Ltd. @SHANDONG LUOXIN PHARMACEUTICAL GROUP HENGXIN PHARMACEUTICAL CO., LTD
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Withdrawal Date:
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Final Annual Reporting Year:
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Manufacturing Facility:
386, Pyeongtaekhangman-gil, Poseung-eup, Pyeongtaek-si, Gyeonggi-do @ [Product Manufacturer ①] 817, Yongam-ri, Bongdong-eup, Wanju-gun, Jeonbuk Special Self-Governing Province @ [Product Manufacturer ②] 59, Biovalley-ro, Jecheon-si, Chungbuk @ West side of Yanbin Road, Economic Development Zone, Feixian, Linyi, Shandong Province, China
SPC Korea Co., Ltd.
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Product:
Aclidinium bromide
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Initial Registration:
2014-06-30
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Registration Number:
Su4000-3-ND
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MFDS Classification:
new substance
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Applicant:
SPC Korea Co., Ltd.
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Last Modified:
2025-06-02
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Country:
-
Status:
Active
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Manufacturer:
Ranke Quimica, SA@[Partial process manufacturer] Ranke Quimica, SA (Planta Sant Celoni)@[Micro-pulverization process manufacturer] Catalent Micron Technologies Limited@[Micro-pulverization process manufacturer] Ranke Quimica, SA
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Withdrawal Date:
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Final Annual Reporting Year:
2022
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Manufacturing Facility:
Carretera de Martorell 41-61, Sant Andreu de la Barca 08740 Barcelona, Spain@Ctra. C-35, Km 58.85, Sant Celoni 08470 Barcelona, Spain@Crossways Boulevard, Crossways, Dartford, Kent, DA2 6QY, United Kingdom@[Pulverization process manufacturer] Carretera de Martorell 41-61, Sant Andreu de la Barca 08740 Barcelona, Spain
SQ Pharmaceutical Co., Ltd.
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Product:
Tadarafil
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Initial Registration:
2020-01-09
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Registration Number:
20190808-203-I-589-15(1)
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MFDS Classification:
Appendix 1
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Applicant:
SQ Pharmaceutical Co., Ltd.
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Last Modified:
2022-02-16
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Country:
India
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Status:
Active
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Manufacturer:
Mylan Laboratories Limited (Unit-9)
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
Plot No.5, Road No.12 Tadi Village JN Pharma City, Parwada Mandal, Visakhapatnam District, Andhra Pradesh, India.
SS Pharm Co., Ltd.
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Product:
Ibuproxam
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Initial Registration:
2005-08-31
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Registration Number:
20050831-55-C-182-02
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MFDS Classification:
Appendix 1
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Applicant:
SS Pharm Co., Ltd.
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Last Modified:
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Country:
korea
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Status:
Active
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Manufacturer:
SS Pharm Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2014
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Manufacturing Facility:
779-8, Wonsi-dong, Danwon-gu, Ansan-si, Gyeonggi-do
ST Pharm Co., Ltd.
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Product:
Udenafil
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Initial Registration:
2005-11-29
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Registration Number:
15-1-ND
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MFDS Classification:
new substance
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Applicant:
ST Pharm Co., Ltd.
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Last Modified:
2025-08-25
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Country:
korea
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Status:
Active
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Manufacturer:
ST Pharm Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2025
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Manufacturing Facility:
171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Sunfine Global Co., Ltd.
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Product:
sodium hyaluronate
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Initial Registration:
2016-08-29
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Registration Number:
20151016-96-E-123-38(3)
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MFDS Classification:
Appendix 1
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Applicant:
Sunfine Global Co., Ltd.
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Last Modified:
-
Country:
china
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Status:
Active
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Manufacturer:
Bloomage Freda Biopharm Co.,Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
No.678 Tianchen St., High-Tech Development Zone, Jinan City, Shangdong Province, China
Sungil BioX Co., Ltd.
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Product:
Pelargonium sidoides
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Initial Registration:
2011-09-16
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Registration Number:
Su5097-1-ND
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MFDS Classification:
new substance
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Applicant:
Sungil BioX Co., Ltd.
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Last Modified:
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Country:
korea
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Status:
Active
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Manufacturer:
Sungil BioX Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2025
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Manufacturing Facility:
775 Madaro, Mado-myeon, Hwaseong-si, Gyeonggi-do
Sungjin Exim Co., Ltd.
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Product:
Nabumeton
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Initial Registration:
2005-08-31
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Registration Number:
20050831-2-C-63-06
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MFDS Classification:
Appendix 1
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Applicant:
Sungjin Exim Co., Ltd.
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Last Modified:
2023-11-17
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Country:
India
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Status:
Withdrawal
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Manufacturer:
Ipca Laboratories Limited
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Withdrawal Date:
2023-11-17
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Final Annual Reporting Year:
2020
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Manufacturing Facility:
PO Sejavta Dist. Ratlam(MP)PIN. 457 002, India
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