KDMF (Korea Drug Master File) Approved Products & Companies
Mundipharma Korea Co., Ltd.
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Product:
Naloxone hydrochloride
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Initial Registration:
2013-06-14
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Registration Number:
20130507-176-I-164-01(1)
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MFDS Classification:
Appendix 1
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Applicant:
Mundipharma Korea Co., Ltd.
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Last Modified:
2025-06-26
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Country:
france
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Status:
Active
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Manufacturer:
Sanofi Winthrop Industrie
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Withdrawal Date:
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Final Annual Reporting Year:
2024
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Manufacturing Facility:
Route d'Avignon 30390 Aramon France
Mundipharma Korea Ltd.
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Product:
Tramadol hydrochloride
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Initial Registration:
2012-09-13
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Registration Number:
20120803-161-I-28-02(1)
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MFDS Classification:
Appendix 1
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Applicant:
Mundipharma Korea Ltd.
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Last Modified:
2024-05-09
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Country:
Israel
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Status:
Active
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Manufacturer:
Wavelength Enterprises Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2025
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Manufacturing Facility:
Neot Hovav Eco-Industrial Park, POB 3593, Be'er Sheva 8413502, Israel
Myeongmun Bio Co., Ltd.
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Product:
Amlodipine besylate
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Initial Registration:
2011-03-31
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Registration Number:
20110331-130-H-141-16
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MFDS Classification:
Appendix 1
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Applicant:
Myeongmun Bio Co., Ltd.
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Last Modified:
2018-09-05
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Country:
-
Status:
Active
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Manufacturer:
Myeongmun Bio Co., Ltd. @ [Manufacturer of Starting Material (Amlodipine)] Changzhou Ruiming Pharmaceutical Co. Ltd
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Withdrawal Date:
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Final Annual Reporting Year:
2022
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Manufacturing Facility:
28, Jeyakgongdan 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do (Building 10 and others) @ #1558, Longjiang Bei Road, Chunjiang Town, New-North District, Changzhou, Jiangsu, China
Myeongmun Pharmaceutical Co., Ltd.
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Product:
Acecclofenac
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Initial Registration:
2005-09-30
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Registration Number:
20050930-31-C-114-11
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MFDS Classification:
Appendix 1
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Applicant:
Myeongmun 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 Yongning Pharmaceutical Factory
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Withdrawal Date:
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Final Annual Reporting Year:
2022
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Manufacturing Facility:
No. 4 Meihuajing Lane, Taizhou, Zhejiang, PR China
Myungin Pharmaceutical Co., Ltd.
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Product:
Triplelusal
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Initial Registration:
2005-08-31
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Registration Number:
20050831-66-B-173-05
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MFDS Classification:
Appendix 1
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Applicant:
Myungin Pharmaceutical Co., Ltd.
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Last Modified:
2020-02-12
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Country:
Spain
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Status:
Active
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Manufacturer:
URQUIMA SA
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Withdrawal Date:
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Final Annual Reporting Year:
2023
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Manufacturing Facility:
Arnau de vilanova 22-42 08105 Sant fost de Campsentelles (Barcelona), SPAIN
Naeum Pharmaceutical Co., Ltd.
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Product:
Sulfasalazine
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Initial Registration:
2014-05-09
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Registration Number:
20120601-105-F-65-03(1)
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MFDS Classification:
Appendix 1
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Applicant:
Naeum 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:
Shanghai Zhongxi Sunve Pharmaceutical Co., Ltd
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Withdrawal Date:
-
Final Annual Reporting Year:
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Manufacturing Facility:
50 Yong Deng Road Shanghai, 200331 PR China
Narsha Farm Co., Ltd.
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Product:
Flumazenil
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Initial Registration:
2016-08-31
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Registration Number:
20050831-73-A-142-01(2)
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MFDS Classification:
Appendix 1
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Applicant:
Narsha Farm Co., Ltd.
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Last Modified:
2025-02-14
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Country:
Israel
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Status:
Active
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Manufacturer:
Wavelength Enterprises LTD.
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Withdrawal Date:
-
Final Annual Reporting Year:
2024
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Manufacturing Facility:
Neot Hovav Eco-Industrial Park, POBox 3593, Be'er Sheva 8413502, Israel
NBP Healthcare Co., Ltd.
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Product:
Apixaban
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Initial Registration:
2023-09-20
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Registration Number:
Su55-4-ND(3)
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MFDS Classification:
new substance
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Applicant:
NBP Healthcare 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:
Glenmark Life Sciences Limited
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
Plot No 3109, GIDC Industrial Estate, Ankleshwar City: Ankleshwar-393 002, Dist: Bharuch, Gujarat state, India
Neo Co., Ltd.
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Product:
Atorvastatin calcium hydrate
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Initial Registration:
2023-07-19
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Registration Number:
20200318-132-H-354-44(3)
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MFDS Classification:
Appendix 1
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Applicant:
Neo Co., Ltd.
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Last Modified:
-
Country:
India
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Status:
Active
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Manufacturer:
Hetero Labs Limited (Unit-IX)
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
Plot No.2, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal, Anakapalli District-531 081, Andhra Pradesh, India
Neochem Co., Ltd.
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Product:
atomoxetine hydrochloride
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Initial Registration:
2013-06-18
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Registration Number:
Su5702-1-ND
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MFDS Classification:
new substance
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Applicant:
Neochem 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:
Sun Pharmaceutical Industries Limited.
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
Plot No. 24/2, 25, Phase-IV, GIDC Industrial Estate, Panoli-394 116, District Bharuch, Gujarat, India.
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