KDMF (Korea Drug Master File) Approved Products & Companies

  • Product:

    Tauroridin

  • Initial Registration:

    2019-08-13

  • Registration Number:

    20190813-210-J-356

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Big Farms Co., Ltd.

  • Last Modified:

    2022-04-20

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Abhilasha Pharma Pvt. Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Plot No. 1408/1409, GIDC, City : Ankleshwar-393 002, Dist : Bharuch, Gujarat State, India

  • Product:

    Neratinib maleate

  • Initial Registration:

    2021-10-19

  • Registration Number:

    Su954-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Big Think Co., Ltd.

  • Last Modified:

    2024-03-06

  • Country:

  • Status:

    Active

  • Manufacturer:

    ESTEVE QUIMICA, SA@Esteve Quimica, SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    C/Ter, 94. Polígon Industrial, 17460 Celrà (Girona), Spain@Ctra. del Vendrell a St. Jaume dels Domenys, km. 5, 43711 Banyeres del Penedès (Tarragona), Spain

  • Product:

    L-arginine hydrochloride

  • Initial Registration:

    2025-08-25

  • Registration Number:

    20250825-210-J-1993

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Bigsol Bio Co., Ltd.

  • Last Modified:

    2026-02-12

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shanghai Ajinomoto Amino Acid Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    No. 718 East Rongle Road, Songjiang District, Shanghai 201613, China

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2011-08-05

  • Registration Number:

    20071204-96-E-46-05(4)

  • MFDS Classification:

    etc

  • Applicant:

    Binex Co., Ltd.

  • Last Modified:

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Kakegawa plant shiseido co.ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    1120, nagaya, kakegawa-shi, shizuoka 436-0047

  • Product:

    anhydrous sodium sulfate

  • Initial Registration:

    2025-11-21

  • Registration Number:

    20251121-211-J-2066

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Bioscience Co., Ltd.

  • Last Modified:

  • Country:

    Czech Republic

  • Status:

    Active

  • Manufacturer:

    Macco Organiques, sro

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Zahradní 1938/46c, 792 01 Bruntál, Czech Republic

  • Product:

    Acetaminophen

  • Initial Registration:

    2019-06-20

  • Registration Number:

    20161124-32-C-355-21(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    BioWells Pharm Co., Ltd.

  • Last Modified:

    2024-07-12

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shenzhou Jiheng Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    West of Guoxin Road, Xijingming Village, Donganzhuang, Township, Shenzhou County, Hengshui City, Hebei Province, China

  • Product:

    Dabigatran etexilate mesylate

  • Initial Registration:

    2010-10-11

  • Registration Number:

    Su426-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Boehringer Ingelheim Korea

  • Last Modified:

    2025-02-21

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Bidachem SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Strada Statale 11 (Padana Superiore), N.8 24040 Fornovo San Giovanni (BG) ITALY

  • Product:

    Paclitaxel

  • Initial Registration:

    2012-04-13

  • Registration Number:

    20120413-68-A-264-12

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Borak Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Borak Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    720-37, Chorok-ro, Yanggam-myeon, Hwaseong-si, Gyeonggi-do

  • Product:

    erlotinib hydrochloride

  • Initial Registration:

    2005-07-28

  • Registration Number:

    Su184-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Boryeong Co., Ltd.

  • Last Modified:

    2025-03-04

  • Country:

    Swiss

  • Status:

    Active

  • Manufacturer:

    F. Hoffmann-La Roche Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Grenzacherstrasse 124 CH-4070 Basel Switzerland

  • Product:

    Sodium polydeoxyribonucleotide

  • Initial Registration:

    2019-01-10

  • Registration Number:

    20190110-199-I-578-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    BR Pharm Co., Ltd.

  • Last Modified:

    2024-05-09

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    BR Pharm Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    13 Sinpyeong-ro, Jijeong-myeon, Wonju-si, Gangwon-do

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