KDMF (Korea Drug Master File) Approved Products & Companies

Bansen Co., Ltd.

  • Product:

    xylometazoline hydrochloride

  • Initial Registration:

    2014-01-21

  • Registration Number:

    20140121-189-I-379-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Bansen Co., Ltd.

  • Last Modified:

    2025-02-19

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    CTX Life Sciences Pvt. Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Block No. 251/P, 252/P, GIDC, City : Sachin, Dist : Surat, India.

Basefarm Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2011-10-21

  • Registration Number:

    20070504-4-B-240-14(7)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Basefarm Co., Ltd.

  • Last Modified:

    2025-09-30

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co.,Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

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

BASF Korea

  • Product:

    Omega-3 ethyl ester 90

  • Initial Registration:

    2012-12-27

  • Registration Number:

    Su6246-1-ND

  • MFDS Classification:

  • Applicant:

    BASF Korea

  • Last Modified:

    2013-08-30

  • Country:

    uk

  • Status:

    Active

  • Manufacturer:

    BASF Pharma (Callanish) Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Breasclete, Callanish, Isle of Lewis, HS2 9ED, Scotland

Bausch Health Korea Co., Ltd.

  • Product:

    Roteprednol etaboate

  • Initial Registration:

    2008-05-07

  • Registration Number:

    4063-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Bausch Health Korea Co., Ltd.

  • Last Modified:

    2024-06-14

  • Country:

    france

  • Status:

    Active

  • Manufacturer:

    Zach system

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Zone Industrielle La Croix Cadeau Avrille, 49240, France

Baxter Korea Co., Ltd.

  • Product:

    Doxorubicin hydrochloride

  • Initial Registration:

    2021-02-17

  • Registration Number:

    20210217-210-J-674

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Baxter Korea Co., Ltd.

  • Last Modified:

    2026-03-16

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Meiji Seika Pharma Co., Ltd. Kitakami Plant

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    3-3, Kitakogyodanchi Kitakami-shi, Iwate-ken 024-0193, Japan

Bayer Korea Co., Ltd.

  • Product:

    Gadobutrol

  • Initial Registration:

    2004-11-05

  • Registration Number:

    309-1-ND

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Bayer Korea Co., Ltd.

  • Last Modified:

    2022-08-03

  • Country:

  • Status:

    Active

  • Manufacturer:

    Bayer AG@Dynamit Nobel GmbH Explosivstoff- und Systemtechnik

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Ernst-Schering-Straße 14 59192 Bergkamen, Germany@Kalkstraße 218 51377 Leverkusen Germany

BC World Healthcare Co., Ltd.

  • Product:

    Meropenem hydrate

  • Initial Registration:

    2020-07-01

  • Registration Number:

    20200302-210-J-504(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    BC World Healthcare Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    ACS Dobfar SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Viale Addetta, 2a/12 – 3/5 20067 Tribiano (Milano), Italy

BC World Pharmaceutical Co., Ltd.

  • Product:

    pregabalin

  • Initial Registration:

    2011-06-15

  • Registration Number:

    Number 4838-3-ND(1)

  • MFDS Classification:

    etc

  • Applicant:

    BC World Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Cipla Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2014

  • Manufacturing Facility:

    D-MIDC Patalganga, 410 220 Dist. Raigad Maharashtra

Beatris Korea Co., Ltd.

  • Product:

    pregabalin

  • Initial Registration:

    2005-06-10

  • Registration Number:

    Su189-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Beatris Korea Co., Ltd.

  • Last Modified:

    2025-07-16

  • Country:

    Ireland

  • Status:

    Withdrawal

  • Manufacturer:

    Pfizer Ireland Pharmaceuticals

  • Withdrawal Date:

    2025-07-16

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Ringaskiddy Drug Substance Plant, POBox 140, Ringaskiddy, Co Cork, Ireland

Berto Korea Limited Liability Company

  • Product:

    Travectedin

  • Initial Registration:

    2009-03-31

  • Registration Number:

    Su217-6-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Berto Korea Limited Liability Company

  • Last Modified:

    2024-05-27

  • Country:

    Spain

  • Status:

    Active

  • Manufacturer:

    Pharma Mar SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    Avda. de los Reyes 1, Pol. Ind. La Mina, 28770-Colmenar Viejo, Madrid

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