KDMF (Korea Drug Master File) Approved Products & Companies

  • Product:

    ibuprofen

  • Initial Registration:

    2020-01-20

  • Registration Number:

    20190423-209-J-340(7)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Jinyoung Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Hubei Granules-Biocause Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.122, Yangwan Road, Jingmen, Hubei Province, China

  • Product:

    Acetaminophen

  • Initial Registration:

    2022-05-03

  • Registration Number:

    20151015-32-C-350-20(26)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    JL Bio Co., Ltd.

  • Last Modified:

    2026-01-20

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Lianyungang Kangle Pharmaceutical Co.,Ltd,

  • Withdrawal Date:

    2026-01-20

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.2, Huanan Road, Ganyu Economic Development Zone, China.

  • Product:

    Iron protein extract

  • Initial Registration:

    2011-08-18

  • Registration Number:

    20091112-130-G-69-01(2)

  • MFDS Classification:

    etc

  • Applicant:

    Joa Pharmaceutical Co., Ltd.

  • Last Modified:

    2012-10-31

  • Country:

    New Zealand

  • Status:

    Active

  • Manufacturer:

    NewZealand Pharmaceuticals Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    68 Weld Street, Palmerston North, New Zealand

  • Product:

    Ketoconazole

  • Initial Registration:

    2019-06-25

  • Registration Number:

    20130522-167-I-135-04(6)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    JSP Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang East-Asia Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Economic Development Zone of Sanmen County, Zhejiang, PRChina

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2020-03-25

  • Registration Number:

    20200325-96-E-154-48

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Jungheon Pharmaceutical Co., Ltd.

  • Last Modified:

    2020-06-10

  • Country:

  • Status:

    Active

  • Manufacturer:

    Maruha Nichiro Corporation, Foods and Fine Chemicals Department@Bloomage Biotechnology Corp., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    8-1, Kiyohara Kogyo Danchi, Utsunomiya-City, Tochigi Pref. Japan @No.678, Tianchen St., High-Tech Development Zone, Jinan, city, Shandong Province China

  • Product:

    Levofloxacin

  • Initial Registration:

    2011-03-31

  • Registration Number:

    20081128-102-F-2-04(1)

  • MFDS Classification:

    etc

  • Applicant:

    JW Life Science Co., Ltd.

  • Last Modified:

    2013-06-20

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Dr. Reddy's Laboratories Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, 502325 INDIA

  • Product:

    pitavastatin calcium

  • Initial Registration:

    2004-09-14

  • Registration Number:

    Su269-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    JW Pharmaceutical Co., Ltd.

  • Last Modified:

    2013-01-31

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Onoda Plant, Nissan Chemical Corporation

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    6903-1, Oaza Onoda, Sanyo Onoda, Yamaguchi 756-0093 Japan

  • Product:

    Clobetasolpropionate

  • Initial Registration:

    2012-01-27

  • Registration Number:

    20071204-93-E-15-01(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    JW Shinyak Co., Ltd.

  • Last Modified:

    2024-04-25

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    ANUH PHARMA LTD

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    PLOT NO. D-5/8, D-5/9, MIDC TURBHE, NAVI MUMBAI - 400703

  • Product:

    gabapentin

  • Initial Registration:

    2015-08-03

  • Registration Number:

    20120831-142-I-75-05(12)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Kangil Chemipharm Co., Ltd.

  • Last Modified:

    2025-08-07

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    No. 699, Changle Avenue, Jiangxi Fengxin Industrial Park, Fengxin County, 330700, Yichun City, Jiangxi Province, China

  • Product:

    Cimetidine

  • Initial Registration:

    2020-06-30

  • Registration Number:

    20200424-27-B-434-09(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    KD Pharma Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Yancheng Kaili Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    The North side of Zhongshan No. 2 Road, Coastal Industrial Park, Binhai Economic Development Area, Yancheng City, Jiangsu Province, China

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