KDMF (Korea Drug Master File) Approved Products & Companies

Bracco Imaging Korea Ltd.

  • Product:

    Sulfahexafluoride

  • Initial Registration:

    2005-06-14

  • Registration Number:

    Su267-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Bracco Imaging Korea Ltd.

  • Last Modified:

    2024-01-11

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    Airgas Therapeutics, LLC

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2017

  • Manufacturing Facility:

    6141 Easton Road-Building 3, Plumsteadville, PA 18949-0310

Bring Bio Co., Ltd.

  • Product:

    Mica fungin sodium

  • Initial Registration:

    2025-01-24

  • Registration Number:

    Su6207-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Bring Bio Co., Ltd.

  • Last Modified:

    2025-03-12

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    MSN Life Sciences Private Limited, Unit-II;

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Unit-II, Sy.No. *Parts of 454, 455,457,458 & 459, Chandampet (Village), Shankarampet-R (Mandal), Medak District, Telangana Pincode: 502 255 India.

BT Pharm Co., Ltd.

  • Product:

    Doxophylline

  • Initial Registration:

    2020-12-24

  • Registration Number:

    20201224-209-J-777

  • MFDS Classification:

    Appendix 1

  • Applicant:

    BT Pharm Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Bajaj Healthcare Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Block No. 588, Savli Karachia Road, At & Post – Gothada, Tal-Savli, Dist – Vadodara – 391 776, India

Bukwang Pharmaceutical Co., Ltd.

  • Product:

    Vinorelbin tartrate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-57-A-111-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Bukwang Pharmaceutical Co., Ltd.

  • Last Modified:

    2013-03-13

  • Country:

    france

  • Status:

    Active

  • Manufacturer:

    Pierre Fabre Medicament

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Zone Industrielle des Clergous, 16 rue Jean Rostand - 81600 Gaillac, France

Bukyeong SM Co., Ltd.

  • Product:

    Perflutren

  • Initial Registration:

    2006-12-28

  • Registration Number:

    Su372-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Bukyeong SM Co., Ltd.

  • Last Modified:

    2025-03-10

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    FluoroMed LP

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    2350 DOUBLE Creek Drive Round Rock, TX 78664

Cell Biotech Co., Ltd.

  • Product:

    Lactobacillus acidophilus

  • Initial Registration:

    2012-08-24

  • Registration Number:

    20120824-146-I-197-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Cell Biotech Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Cell Biotech Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    50, Aegibong-ro 409beon-gil, Wolgot-myeon, Gimpo-si, Gyeonggi-do

Celltrion Pharmaceutical Co., Ltd.

  • Product:

    Pioglitazone hydrochloride

  • Initial Registration:

    2012-12-06

  • Registration Number:

    20121206-196-I-82-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Celltrion Pharmaceutical Co., Ltd.

  • Last Modified:

    2023-04-13

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Juzen Chemical Corporation

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    1-10, Kiba-machi, Toyama-city, Toyama930-0806

CG Inbites Co., Ltd.

  • Product:

    Polmacoxiv

  • Initial Registration:

    2015-02-05

  • Registration Number:

    6-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    CG Inbites Co., Ltd.

  • Last Modified:

    2015-12-22

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Kyungbo Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    174 Silok-ro, Asan-si, Chungcheongnam-do

CH Chemical Co., Ltd.

  • Product:

    Levofloxacin

  • Initial Registration:

    2012-05-18

  • Registration Number:

    20100414-102-F-50-10(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    CH Chemical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang East-asia Pharmaceutical Co.Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2013

  • Manufacturing Facility:

    Economic Development zone of Sanmen country, Zhejiang,PR

Chanidam Co., Ltd.

  • Product:

    Cefaclor hydrate

  • Initial Registration:

    2009-11-25

  • Registration Number:

    20091125-20-A-229-14

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Chanidam Co., Ltd.

  • Last Modified:

    2026-02-03

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Dongbang Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    No. 21, Donghai 5th Avenue, Taizhou Bay Economic and Technological Development Zone, Linhai, Taizhou City, Zhejiang province, China, 317016

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