KDMF (Korea Drug Master File) Approved Products & Companies

Medipoem Co., Ltd.

  • Product:

    esomeprazole magnesium dihydrate

  • Initial Registration:

    2016-06-14

  • Registration Number:

    20150402-127-H-277-18(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Medipoem Co., Ltd.

  • Last Modified:

    2023-11-03

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Nosch Labs Pvt. Ltd(Unit-II)

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Sy.No.14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, Medak District, Telangana, India

Medisquare Co., Ltd.

  • Product:

    Ziziphus jujuba extract

  • Initial Registration:

    2007-04-20

  • Registration Number:

    20070420-01-HP-3-09

  • MFDS Classification:

    human placenta origin

  • Applicant:

    Medisquare Co., Ltd.

  • Last Modified:

    2024-11-11

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Melsmon Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    35-6, 2-chome, Higashiryoke, Kawaguchi-shi, Saitama, Japan, 332-0003

Meditip Co., Ltd.

  • Product:

    Ketorolact tromethamine salt

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-61-C-186-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Meditip Co., Ltd.

  • Last Modified:

    2023-12-07

  • Country:

    Ireland

  • Status:

    Withdrawal

  • Manufacturer:

    Roche Ireland, Ltd.

  • Withdrawal Date:

    2023-12-07

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    Clarecastle County Clare Republic of Ireland

Meditox Co., Ltd.

  • Product:

    cholic acid

  • Initial Registration:

    2025-09-19

  • Registration Number:

    Su2454-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Meditox Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    ICE SPA

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Via Novi 78, 15060 Basaluzzo (AL), Italy

Merck Corp.

  • Product:

    Metformin hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-37-C-29-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Merck Corp.

  • Last Modified:

    2025-10-29

  • Country:

    france

  • Status:

    Active

  • Manufacturer:

    Merck Sante sas (Production Center of Calais)

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    5 rue Clement Ader, 62100 CALAIS, France (37 rue Saint Romain, 69379 Lyon Cedex 08, France)

Merz Asia Pacific PTE Ltd

  • Product:

    Heparin sodium

  • Initial Registration:

    2017-12-08

  • Registration Number:

    20100331-124-G-29-02(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Merz Asia Pacific PTE Ltd

  • Last Modified:

    2026-02-26

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Changzhou Qianhong Bio Pharma Co., Ltd

  • Withdrawal Date:

    2026-02-26

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    No. 192 Huanghe West Road, Xinbei District, Changzhou, Jiangsu

MFC Corporation

  • Product:

    Trimebutin

  • Initial Registration:

    2016-01-05

  • Registration Number:

    20160105-13-B-383-11

  • MFDS Classification:

    Appendix 1

  • Applicant:

    MFC Corporation

  • Last Modified:

    2022-03-10

  • Country:

  • Status:

    Active

  • Manufacturer:

    MFC Co., Ltd. @ [Product Manufacturer Name] Suqian Ruixing Chemical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    35@No.3, Jingsi Road, Cheongwonsandan 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do, South Korea, Ecological Chemical Park, Suqian City, Jiangsu Province, China

Mothers Pharmaceutical Co., Ltd.

  • Product:

    Acecclofenac

  • Initial Registration:

    2024-07-17

  • Registration Number:

    20120905-31-C-301-18(18)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Mothers Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-07-30

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co.,Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province,PR China

MPK Korea Co., Ltd.

  • Product:

    Solifenacin succinate

  • Initial Registration:

    2013-01-23

  • Registration Number:

    Su4692-7-ND

  • MFDS Classification:

    new substance

  • Applicant:

    MPK Korea Co., Ltd.

  • Last Modified:

    2024-04-29

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Alivus Life Sciences Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Plot No. 3109-C, GIDC Industrial Estate, Ankleshwar - 393 002, Dist. Bharuch, Gurajat State, India

MSD Korea Co., Ltd.

  • Product:

    Temozolomide

  • Initial Registration:

    2005-03-16

  • Registration Number:

    406-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    MSD Korea Co., Ltd.

  • Last Modified:

    2024-09-11

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    Ampac Fine Chemicals

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Highway 50 & Hazel Avenue, Rancho Cordova, CA, USA

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