KDMF (Korea Drug Master File) Approved Products & Companies

Dongbang FTL Co., Ltd.

  • Product:

    Loxoprofen sodium hydrate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-8-C-70-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dongbang FTL Co., Ltd.

  • Last Modified:

    2025-03-17

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Dongbang FTL

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

Dongduk Pharmaceutical Co., Ltd.

  • Product:

    Zahager X

  • Initial Registration:

    2007-01-26

  • Registration Number:

    20070126-01-HP-10-08

  • MFDS Classification:

    human placenta origin

  • Applicant:

    Dongduk Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Dongduk Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    85-1, Pyeongsan-ri, Munbaek-myeon, Jincheon-gun, Chungcheongbuk-do

Donggoo Biopharmaceutical Co., Ltd.

  • Product:

    Clobetasolpropionate

  • Initial Registration:

    2011-05-16

  • Registration Number:

    20080530-93-E-56-03(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Donggoo Biopharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    Spain

  • Status:

    Active

  • Manufacturer:

    Curia Spain SAU

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Parque Tecnologico de Boecillo, Parcela 105, 47151- Boecillo (Valladolid)

Donghu Pharma Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2024-08-19

  • Registration Number:

    20070504-4-B-240-14(47)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Donghu Pharma Co., Ltd.

  • Last Modified:

    2026-01-30

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

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

Donghwa Pharmaceutical Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-4-B-21-09

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Donghwa Pharmaceutical Co., Ltd.

  • Last Modified:

    2012-03-30

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Donghwa Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    167, Chungjusandan 1-ro, Chungju-si, Chungcheongbuk-do

Dongil Pharmtech Co., Ltd.

  • Product:

    Chondroitin sodium sulfate

  • Initial Registration:

    2013-02-27

  • Registration Number:

    20130122-173-I-229-01(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dongil Pharmtech Co., Ltd.

  • Last Modified:

    2023-09-26

  • Country:

    china

  • Status:

    Withdrawal

  • Manufacturer:

    Yantai Dongcheng Biochemicals Co., Ltd.

  • Withdrawal Date:

    2023-09-26

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.7, Changbaishan Road, Yantai Development Zone, Shandong, China

Dongin Pharmaceutical Co., Ltd.

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2021-07-11

  • Registration Number:

    20210711-96-E-170-53

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dongin Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Fidia Farmaceutici SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Via Ponte Della Fabbrica, 3/A 35031 Abano Terme Padova

Dongkook Life Science Co., Ltd.

  • Product:

    Iopamidol

  • Initial Registration:

    2013-01-04

  • Registration Number:

    20130104-164-I-278-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dongkook Life Science Co., Ltd.

  • Last Modified:

    2023-08-01

  • Country:

  • Status:

    Active

  • Manufacturer:

    Dongkook Life Science Co., Ltd. @ Zhejiang Starry Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    54-1, Taejanggongdan-gil, Wonju-si, Gangwon-do @ No.1 Starry Road of Xian ju Modern Industrial Centralization Zone, Xian ju, Zhejiang

Dongkook Pharmaceutical Co., Ltd.

  • Product:

    Teicoplanin

  • Initial Registration:

    2006-05-03

  • Registration Number:

    20060503-63-A-207-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dongkook Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-05-02

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Dongkook Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    1103 Jingwang-ro, Gwanghyewon-myeon, Jincheon-gun, Chungcheongbuk-do

Dongkwang Pharmaceutical Co., Ltd.

  • Product:

    Roxithromycin

  • Initial Registration:

    2011-06-15

  • Registration Number:

    20050831-9-A-6-05(7)

  • MFDS Classification:

    etc

  • Applicant:

    Dongkwang Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-04-06

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Alembic Pharmaceuticals Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    Vill Panelav, PO Tajpura, Nr. Baska, Tal. Halol, 389 350 Dist. Panchmahal, Gujarat State

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