KDMF (Korea Drug Master File) Approved Products & Companies

Daehan Pharmaceutical Co., Ltd.

  • Product:

    Metronidazole

  • Initial Registration:

    2011-12-02

  • Registration Number:

    20090626-104-F-43-02(6)

  • MFDS Classification:

    etc

  • Applicant:

    Daehan Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Wuhan Wuyao Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    No.5, Gutian Rd., Hankou. Wuhan. Hubel

Daehwa Pharmaceutical Co., Ltd.

  • Product:

    Roxithromycin

  • Initial Registration:

    2011-09-16

  • Registration Number:

    20050831-9-A-2-02(10)

  • MFDS Classification:

    etc

  • Applicant:

    Daehwa Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Zhenyuan Pharmaceutical Co., Ltd. Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    Paojiang Industrial Zone(YueDong road) Shaoxing 312000 Zhejiang province PR China(No.1015, West Shengli Road. Shaoxing, 312000 Zhejiang province PR China)

Daejeong Pharma Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2025-07-15

  • Registration Number:

    20160725-4-B-387-21(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Daejeong Pharma Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zenji Pharmaceuticals (Suzhou) Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.122, Xuqing Road, Xuguan Town, Suzhou, Jiangsu China

Daepyeong Co., Ltd.

  • Product:

    Pelargonium sidoides

  • Initial Registration:

    2011-10-14

  • Registration Number:

    2361-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Daepyeong Co., Ltd.

  • Last Modified:

    2013-07-25

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Daepyeong Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    417 Odong-ri, Hamchang-eup, Sangju-si, Gyeongbuk

Daeshin Muyak Co., Ltd.

  • Product:

    Glyclazide

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-1-C-6-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Daeshin Muyak Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Synteco SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2014

  • Manufacturing Facility:

    Via Parco del Ticino, 10-27028 San Martino Siccomario (Pavia)-Italy

Daesung Pharmaceutical

  • Product:

    Levamipid

  • Initial Registration:

    2011-08-04

  • Registration Number:

    20110805-4-B-320-16

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Daesung Pharmaceutical

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    No.199 East Huayuan Road, Mudu Town, Suzhou city, China

Daewon Pharmaceutical Co., Ltd.

  • Product:

    Margindol

  • Initial Registration:

    2010-04-14

  • Registration Number:

    20100414-129-G-56-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Daewon Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-01-29

  • Country:

    brazil

  • Status:

    Withdrawal

  • Manufacturer:

    Libbs Farmaceutica Ltda.

  • Withdrawal Date:

    2024-01-29

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    Avenida Dona Cesaria Camargo de Oliveira, 633. Bairro Jardim Vista Alegre. ZC 06807-320, Embu-SP-Brazil

Daewoong Bio Co., Ltd.

  • Product:

    Clopidogrel sulfate

  • Initial Registration:

    2011-12-02

  • Registration Number:

    20111202-129-H-159-28

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Daewoong Bio Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Vitalife Laboratories

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    Village Pathreri, Bilaspur Tauru Road Dist-Gurgaon Haryana-12200, India

Daewoong Pharmaceutical Co., Ltd.

  • Product:

    tyropramide hydrochloride

  • Initial Registration:

    2004-08-31

  • Registration Number:

    20050831-50-C-164-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Daewoong Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-02-09

  • Country:

    Italy

  • Status:

    Withdrawal

  • Manufacturer:

    COSMA SpA

  • Withdrawal Date:

    2026-02-09

  • Final Annual Reporting Year:

    2017

  • Manufacturing Facility:

    COSMA SpA Via Colleoni 15/17 24040- Ciserano (Bergamo) Italy

Daiichi Sankyo Korea Co., Ltd.

  • Product:

    Olmesartan medoxomil

  • Initial Registration:

    2004-08-18

  • Registration Number:

    43-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Daiichi Sankyo Korea Co., Ltd.

  • Last Modified:

    2024-04-22

  • Country:

  • Status:

    Withdrawal

  • Manufacturer:

    Daiichi Sankyo Chemical Pharma Co., Ltd. @[Manufacturer of intermediate 'Olmesartan'] EUROAPI Hungary Ltd.

  • Withdrawal Date:

    2024-04-22

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    477, Takada, Odawara, Kanagawa, Japan.@[Manufacturer of intermediate 'Olmesartan'] Tó utca 1-5., Budapest, 1045, Hungary

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