KDMF (Korea Drug Master File) Approved Products & Companies
HS Bio Co., Ltd.
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Product:
Choline alfoscerate
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Initial Registration:
2018-06-05
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Registration Number:
20180605-168-I-558-23
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MFDS Classification:
Appendix 1
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Applicant:
HS Bio Co., Ltd.
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Last Modified:
2020-07-13
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Country:
korea
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Status:
Active
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Manufacturer:
HS Bio Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2023
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Manufacturing Facility:
HS Bio Co., Ltd., 57, Sincheoksandan 4-ro, Deoksan-eup, Jincheon-gun, Chungcheongbuk-do
Humedics Co., Ltd.
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Product:
sodium hyaluronate
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Initial Registration:
2008-03-31
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Registration Number:
20080331-96-E-66-13
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MFDS Classification:
Appendix 1
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Applicant:
Humedics Co., Ltd.
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Last Modified:
2026-02-11
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Country:
-
Status:
Active
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Manufacturer:
Humedix Co., Ltd. @ Bloomage Biotechnology Corp., LTD
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Withdrawal Date:
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Final Annual Reporting Year:
2023
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Manufacturing Facility:
17, Biovalley 2-ro, Jecheon-si, Chungbuk @ No. 678 Tianchen St., High-Tech Development Zone, Jian City, Shandong Province, PR of China
Huons Co., Ltd.
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Product:
Ketorolact tromethamine salt
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Initial Registration:
2007-12-04
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Registration Number:
20071204-61-C-230-06
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MFDS Classification:
Appendix 1
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Applicant:
Huons Co., Ltd.
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Last Modified:
2023-02-15
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Country:
Spain
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Status:
Active
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Manufacturer:
Quimica sintetica sa
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Withdrawal Date:
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Final Annual Reporting Year:
2016
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Manufacturing Facility:
C/dulcinea, s/n 28805 alcala de henares madrid
Huons Life Science Co., Ltd.
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Product:
Ofloxacin
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Initial Registration:
2025-01-24
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Registration Number:
20180816-89-E-100-07(17)
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MFDS Classification:
Appendix 1
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Applicant:
Huons Life Science 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 Co., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
Coastal Industrial City, Pubagang Town, Sanmen County, Zhejiang (317100), China
Huseong Bio Co., Ltd.
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Product:
Empagliflozin (amorphous)
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Initial Registration:
2023-07-11
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Registration Number:
Su21-10-ND(4)
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MFDS Classification:
new substance
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Applicant:
Huseong Bio Co., Ltd.
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Last Modified:
2024-04-08
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Country:
India
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Status:
Active
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Manufacturer:
Honour Lab Limited(Unit-III)
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
Plot No.4, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal, Anakapalli District, Andhra Pradesh, India
Husid Co., Ltd.
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Product:
S-amlodipine besylate
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Initial Registration:
2021-04-02
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Registration Number:
20110615-131-H-85-05(12)
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MFDS Classification:
Appendix 1
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Applicant:
Husid Co., Ltd.
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Last Modified:
-
Country:
India
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Status:
Active
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Manufacturer:
Glochem Industries Private Limited
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Withdrawal Date:
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Final Annual Reporting Year:
2023
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Manufacturing Facility:
Sy. No.174 to 176, IDA, Bollaram, Jinnaram Mandal, Sangareddy District, Telangana State, India
Hwadeok Pharmaceutical Co., Ltd.
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Product:
Famotidine
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Initial Registration:
2005-08-31
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Registration Number:
20050831-67-B-175-02
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MFDS Classification:
Appendix 1
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Applicant:
Hwadeok Pharmaceutical Co., Ltd.
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Last Modified:
2010-04-20
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Country:
India
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Status:
Active
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Manufacturer:
SMS Lifesciences India Limited.
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Withdrawal Date:
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Final Annual Reporting Year:
2018
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Manufacturing Facility:
Unit-IV, Plot No. 66/B-2, Phase-I, IDA, Jeedimetla, Medchal Malkajgiri Distrct, Hyderabad, Telangana, INDIA -50055(507 A,ADITYA ENCLAVE, NILGIRI BLOCK AMEERPET, HYDERABAD 500038, INDIA)
Hwail Pharmaceutical Co., Ltd.
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Product:
Acecclofenac
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Initial Registration:
2005-08-31
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Registration Number:
20050831-31-C-106-04
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MFDS Classification:
Appendix 1
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Applicant:
Hwail Pharmaceutical Co., Ltd.
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Last Modified:
2024-04-05
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Country:
-
Status:
Active
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Manufacturer:
Henan Dongtai Pharmaceutical Co., Ltd. [Manufacturer of Substances under Act 2]
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Withdrawal Date:
-
Final Annual Reporting Year:
2023
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Manufacturing Facility:
57, Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @ [Manufacturer of Raw Material under Act 2] No. 2, East Kangtai Road, Tangyin County, Anyang City, Henan Province, China
Hyundai Bioland Co., Ltd.
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Product:
Artemisia leaf 95% ethanol soft extract (20→1)
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Initial Registration:
2017-12-28
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Registration Number:
20171228-9-K-23-03
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MFDS Classification:
Appendix 1-2
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Applicant:
Hyundai Bioland Co., Ltd.
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Last Modified:
2025-10-02
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Country:
korea
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Status:
Active
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Manufacturer:
Hyundai Bioland Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2026
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Manufacturing Facility:
22, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
Hyundai Pharmaceutical Co., Ltd.
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Product:
Atenolol
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Initial Registration:
2005-08-31
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Registration Number:
20050831-34-B-86-01
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MFDS Classification:
Appendix 1
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Applicant:
Hyundai Pharmaceutical Co., Ltd.
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Last Modified:
2023-09-07
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Country:
Italy
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Status:
Withdrawal
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Manufacturer:
Teva Pharmaceutical Fine Chemicals srl
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Withdrawal Date:
2023-09-07
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Final Annual Reporting Year:
2012
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Manufacturing Facility:
Via E. Fermi 20/26, 20019 Settimo Milanese (MI)
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