KDMF (Korea Drug Master File) Approved Products & Companies

  • Product:

    Atenolol

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-34-B-88-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Youngjin Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Recordati Industria Chimica Farmacutica SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    Campoverde-Aprilia (LT) - Via Mediana Cisterna 4, Italy

  • Product:

    Bimatoprost

  • Initial Registration:

    2009-12-24

  • Registration Number:

    767-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    YS Life Science Co., Ltd.

  • Last Modified:

    2025-12-23

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    YS Life Science Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    207 Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do

  • Product:

    Levaprazan

  • Initial Registration:

    2005-07-18

  • Registration Number:

    416-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Yuhan Chemical Co., Ltd.

  • Last Modified:

    2025-08-13

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Yuhan Chemical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Room 402, 5-ba, Sihwa Industrial Complex, 45, Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (Seonggok-dong)

  • Product:

    Evastin

  • Initial Registration:

    2013-05-10

  • Registration Number:

    20130510-156-I-338-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Yuil Pharmtech Co., Ltd.

  • Last Modified:

    2020-10-27

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Yuil Pharmtech Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    3 Mulmi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do

  • Product:

    Dexamethasone cyclosylate

  • Initial Registration:

    2014-08-27

  • Registration Number:

    Su108-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Yuyoung Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-01-20

  • Country:

    japan

  • Status:

    Withdrawal

  • Manufacturer:

    Fukuzyu Pharmaceutical Co., Ltd. Toyama Plant

  • Withdrawal Date:

    2025-01-20

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    48, Hagiwara Toyama, 939-8261, Japan

  • Product:

    sodium risedronate

  • Initial Registration:

    2009-12-24

  • Registration Number:

    20091224-121-G-20-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Yuyu Pharmaceutical Co., Ltd.

  • Last Modified:

    2022-02-28

  • Country:

    Swiss

  • Status:

    Active

  • Manufacturer:

    Lonza Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    Lonzastrasse, CH-3930 Visp, Switzerland

  • Product:

    Metformin hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-37-C-40-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Yuhan Corporation

  • Last Modified:

    2025-11-28

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    USV Private Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    B-1/8, MIDC Lote Parshuram Industrial Area, Taluka Khed, District Ratnagiri, Maharashtra, India 415 722

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