KDMF (Korea Drug Master File) Approved Products & Companies
Ibsen Korea Co., Ltd.
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Product:
Hexaminolevulinate hydrochloride
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Initial Registration:
2008-05-07
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Registration Number:
3231-1-ND
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MFDS Classification:
new substance
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Applicant:
Ibsen Korea Co., Ltd.
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Last Modified:
2012-11-02
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Country:
Spain
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Status:
Active
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Manufacturer:
Union Quimica Farmaceutica SA
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Withdrawal Date:
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Final Annual Reporting Year:
2012
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Manufacturing Facility:
Poligon Industrial Moli de les Planes, Font de Bocs S/N 08470, Sant Celoni, Barcelona
iCure Co., Ltd.
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Product:
Ribastigmin
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Initial Registration:
2017-04-17
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Registration Number:
20130830-184-I-343-07(5)
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MFDS Classification:
Appendix 1
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Applicant:
iCure Co., Ltd.
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Last Modified:
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Country:
India
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Status:
Active
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Manufacturer:
Shodhana Laboratories Limited
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
Plot No. 26, 25 & 24, Phase - 1, IDA, Jeedimetla Hyderabad-500 055, Telangana, INDIA
Ikemi Korea Co., Ltd.
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Product:
Metformin hydrochloride
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Initial Registration:
2024-06-27
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Registration Number:
20140319-37-C-314-22(2)
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MFDS Classification:
Appendix 1
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Applicant:
Ikemi Korea 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:
Shandong Keyuan Pharmaceutical Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
Keyuan Street, Shandong Shanghe Economic Development Zone, Junan City, Shandong, China
Iksoo Pharmaceutical Co., Ltd.
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Product:
Roxithromycin
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Initial Registration:
2005-08-31
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Registration Number:
20050831-9-A-2-02
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MFDS Classification:
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Applicant:
Iksoo Pharmaceutical Co., Ltd.
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Last Modified:
2025-12-09
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Country:
china
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Status:
Active
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Manufacturer:
Zhejiang Zhenyuan Pharmaceutical Co., Ltd. Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2026
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Manufacturing Facility:
No. 61 North Yuedong Road, Shaoxing City, Zhejiang Province, PR China
Ildong Pharmaceutical Co., Ltd.
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Product:
Hydrochloric acid cefcaphen coating
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Initial Registration:
2003-12-30
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Registration Number:
34-1-ND
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MFDS Classification:
new substance
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Applicant:
Ildong Pharmaceutical Co., Ltd.
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Last Modified:
2016-09-08
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Country:
japan
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Status:
Active
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Manufacturer:
Shionogi Pharma Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2025
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Manufacturing Facility:
7 Moriyama Nishine Kanegasaki Town Isawa County Iwate, Japan
Ilhwa Co., Ltd.
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Product:
Adefovierdiboxil
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Initial Registration:
2010-12-30
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Registration Number:
Number 2698-1-ND
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MFDS Classification:
new substance
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Applicant:
Ilhwa Co., Ltd.
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Last Modified:
2024-07-25
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Country:
china
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Status:
Withdrawal
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Manufacturer:
Tianjin Institute of Pharmaceutical Research Pharmaceutical Co., Ltd.
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Withdrawal Date:
2024-07-25
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Final Annual Reporting Year:
2012
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Manufacturing Facility:
NO. 96 Yuquan Road, Nankai District, Tianjin;Huanghuadian Town,,Wuqing District,Tianjin, China
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Product:
escarboxymethylcysteine
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Initial Registration:
2007-09-28
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Registration Number:
20070928-83-D-66-02
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MFDS Classification:
Appendix 1
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Applicant:
Ilshin Chemical Co., Ltd.
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Last Modified:
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Country:
korea
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Status:
Business Closure
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Manufacturer:
Ilshin Chemical Co., Ltd.
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Withdrawal Date:
2023-06-01
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Final Annual Reporting Year:
2014
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Manufacturing Facility:
1074 Yangsan-daero, Yangsan-si, Gyeongsangnam-do (Bukjeong-dong)
Ilsung IS Co., Ltd.
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Product:
Sulfasalazine
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Initial Registration:
2009-05-21
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Registration Number:
20090521-105-F-24-01
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MFDS Classification:
Appendix 1
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Applicant:
Ilsung IS Co., Ltd.
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Last Modified:
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Country:
Sweden
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Status:
Active
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Manufacturer:
Kemwell AB
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Withdrawal Date:
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Final Annual Reporting Year:
2014
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Manufacturing Facility:
Bjorkgatan 30, SE-751 82 Uppsala, Sweden
Ilsung Pharmaceutical Co., Ltd.
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Product:
Amoxicillin sodium
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Initial Registration:
2012-02-03
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Registration Number:
20101116-30-A-240-15(1)
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MFDS Classification:
Appendix 1
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Applicant:
Ilsung Pharmaceutical Co., Ltd.
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Last Modified:
2023-12-01
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Country:
Austria
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Status:
Withdrawal
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Manufacturer:
Sandoz GmbH
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Withdrawal Date:
2023-12-01
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Final Annual Reporting Year:
2016
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Manufacturing Facility:
Biochemiestrasse 10, A-6250 Kun, Tyrol, Austria
Ilyang Pharmaceutical Co., Ltd.
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Product:
Ilaprazole
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Initial Registration:
2008-05-29
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Registration Number:
1336-1-ND
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MFDS Classification:
new substance
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Applicant:
Ilyang Pharmaceutical Co., Ltd.
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Last Modified:
2021-05-27
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Country:
korea
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Status:
Active
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Manufacturer:
Ilyang Pharmaceutical Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2024
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Manufacturing Facility:
110 Hagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do
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