KDMF (Korea Drug Master File) Approved Products & Companies
Big Farms Co., Ltd.
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Product:
Tauroridin
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Initial Registration:
2019-08-13
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Registration Number:
20190813-210-J-356
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MFDS Classification:
Appendix 1
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Applicant:
Big Farms Co., Ltd.
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Last Modified:
2022-04-20
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Country:
India
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Status:
Active
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Manufacturer:
Abhilasha Pharma Pvt. Ltd
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Withdrawal Date:
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Final Annual Reporting Year:
2024
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Manufacturing Facility:
Plot No. 1408/1409, GIDC, City : Ankleshwar-393 002, Dist : Bharuch, Gujarat State, India
Big Think Co., Ltd.
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Product:
Neratinib maleate
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Initial Registration:
2021-10-19
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Registration Number:
Su954-1-ND
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MFDS Classification:
new substance
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Applicant:
Big Think Co., Ltd.
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Last Modified:
2024-03-06
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Country:
-
Status:
Active
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Manufacturer:
ESTEVE QUIMICA, SA@Esteve Quimica, SA
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Withdrawal Date:
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Final Annual Reporting Year:
2025
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Manufacturing Facility:
C/Ter, 94. Polígon Industrial, 17460 Celrà (Girona), Spain@Ctra. del Vendrell a St. Jaume dels Domenys, km. 5, 43711 Banyeres del Penedès (Tarragona), Spain
Bigsol Bio Co., Ltd.
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Product:
L-arginine hydrochloride
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Initial Registration:
2025-08-25
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Registration Number:
20250825-210-J-1993
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MFDS Classification:
Appendix 1
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Applicant:
Bigsol Bio Co., Ltd.
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Last Modified:
2026-02-12
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Country:
china
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Status:
Active
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Manufacturer:
Shanghai Ajinomoto Amino Acid Co., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2026
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Manufacturing Facility:
No. 718 East Rongle Road, Songjiang District, Shanghai 201613, China
Binex Co., Ltd.
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Product:
sodium hyaluronate
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Initial Registration:
2011-08-05
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Registration Number:
20071204-96-E-46-05(4)
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MFDS Classification:
etc
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Applicant:
Binex Co., Ltd.
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Last Modified:
-
Country:
japan
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Status:
Active
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Manufacturer:
Kakegawa plant shiseido co.ltd
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Withdrawal Date:
-
Final Annual Reporting Year:
2021
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Manufacturing Facility:
1120, nagaya, kakegawa-shi, shizuoka 436-0047
Bioscience Co., Ltd.
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Product:
anhydrous sodium sulfate
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Initial Registration:
2025-11-21
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Registration Number:
20251121-211-J-2066
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MFDS Classification:
Appendix 1
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Applicant:
Bioscience Co., Ltd.
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Last Modified:
-
Country:
Czech Republic
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Status:
Active
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Manufacturer:
Macco Organiques, sro
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
Zahradní 1938/46c, 792 01 Bruntál, Czech Republic
BioWells Pharm Co., Ltd.
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Product:
Acetaminophen
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Initial Registration:
2019-06-20
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Registration Number:
20161124-32-C-355-21(1)
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MFDS Classification:
Appendix 1
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Applicant:
BioWells Pharm Co., Ltd.
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Last Modified:
2024-07-12
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Country:
china
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Status:
Active
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Manufacturer:
Shenzhou Jiheng Pharmaceutical Co., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
West of Guoxin Road, Xijingming Village, Donganzhuang, Township, Shenzhou County, Hengshui City, Hebei Province, China
Boehringer Ingelheim Korea
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Product:
Dabigatran etexilate mesylate
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Initial Registration:
2010-10-11
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Registration Number:
Su426-2-ND
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MFDS Classification:
new substance
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Applicant:
Boehringer Ingelheim Korea
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Last Modified:
2025-02-21
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Country:
Italy
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Status:
Active
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Manufacturer:
Bidachem SpA
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
Strada Statale 11 (Padana Superiore), N.8 24040 Fornovo San Giovanni (BG) ITALY
Borak Co., Ltd.
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Product:
Paclitaxel
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Initial Registration:
2012-04-13
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Registration Number:
20120413-68-A-264-12
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MFDS Classification:
Appendix 1
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Applicant:
Borak Co., Ltd.
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Last Modified:
-
Country:
korea
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Status:
Active
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Manufacturer:
Borak Co., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2015
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Manufacturing Facility:
720-37, Chorok-ro, Yanggam-myeon, Hwaseong-si, Gyeonggi-do
Boryeong Co., Ltd.
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Product:
erlotinib hydrochloride
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Initial Registration:
2005-07-28
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Registration Number:
Su184-2-ND
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MFDS Classification:
new substance
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Applicant:
Boryeong Co., Ltd.
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Last Modified:
2025-03-04
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Country:
Swiss
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Status:
Active
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Manufacturer:
F. Hoffmann-La Roche Ltd
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
Grenzacherstrasse 124 CH-4070 Basel Switzerland
BR Pharm Co., Ltd.
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Product:
Sodium polydeoxyribonucleotide
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Initial Registration:
2019-01-10
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Registration Number:
20190110-199-I-578-05
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MFDS Classification:
Appendix 1
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Applicant:
BR Pharm Co., Ltd.
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Last Modified:
2024-05-09
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Country:
korea
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Status:
Active
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Manufacturer:
BR Pharm Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
13 Sinpyeong-ro, Jijeong-myeon, Wonju-si, Gangwon-do
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