KDMF (Korea Drug Master File) Approved Products & Companies

Allico Pharmaceutical Co., Ltd.

  • Product:

    Valsartan

  • Initial Registration:

    2011-08-12

  • Registration Number:

    20101011-135-H-9-03(3)

  • MFDS Classification:

    etc

  • Applicant:

    Allico Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-02-26

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Cipla Limited

  • Withdrawal Date:

    2024-02-26

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    D-7, D-27 MIDC Industrial Area, Kurkumbh, Taluka Daund, District : Pune , Maharashtra State, India

Alpha Pharma Co., Ltd.

  • Product:

    scopolamine

  • Initial Registration:

    2022-05-06

  • Registration Number:

    20220506-211-J-1287

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Alpha Pharma Co., Ltd.

  • Last Modified:

    2024-11-11

  • Country:

    australia

  • Status:

    Active

  • Manufacturer:

    Phytex Australia Pty Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    6 Norman Street Peakhurst NSW 2210 Australia

Alvogen Korea Co., Ltd.

  • Product:

    Phentermine hydrochloride

  • Initial Registration:

    2007-08-31

  • Registration Number:

    20070831-98-E-33-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Alvogen Korea Co., Ltd.

  • Last Modified:

    2015-09-15

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Sun Pharmaceutical Industries Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    A7/A-8 MIDC industrial area, ahmednagar-414 111, maharashtra

Amgen Korea Co., Ltd.

  • Product:

    Carfilzomib

  • Initial Registration:

    2016-08-18

  • Registration Number:

    Su36-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Amgen Korea Co., Ltd.

  • Last Modified:

    2023-06-21

  • Country:

    USA

  • Status:

    Withdrawal

  • Manufacturer:

    Sterling Wisconsin, LLC

  • Withdrawal Date:

    2023-06-21

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    W130 N10497 Washington Drive Germantown, WI 53022-4448, USA

Anguk Pharmaceutical Co., Ltd.

  • Product:

    S-Atenolol

  • Initial Registration:

    2011-04-14

  • Registration Number:

    20110414-125-H-59-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Anguk Pharmaceutical Co., Ltd.

  • Last Modified:

    2022-03-10

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Emcure Pharmaceuticals Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Plot No. D-24 & D-24/1, MIDC, Kurkumbh, Tal.: Daund, Pune-413 802, Maharashtra, India

Astellas Pharma Korea Co., Ltd.

  • Product:

    Solifenacin succinate

  • Initial Registration:

    2007-07-24

  • Registration Number:

    Su118-3-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Astellas Pharma Korea Co., Ltd.

  • Last Modified:

    2023-09-01

  • Country:

    Ireland

  • Status:

    Active

  • Manufacturer:

    Astellas Ireland

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Damastown Road, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

AstraZeneca Korea

  • Product:

    Gefitiniv

  • Initial Registration:

    2003-05-27

  • Registration Number:

    661-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    AstraZeneca Korea

  • Last Modified:

    2008-02-25

  • Country:

    uk

  • Status:

    Active

  • Manufacturer:

    AstraZeneca UK Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Silk Road Business Park, Macclesfield, Cheshire SK 10 2NA, UK

B. Braun Korea Co., Ltd.

  • Product:

    Omega-3 triglycerides

  • Initial Registration:

    2009-08-21

  • Registration Number:

    Su511-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    B. Braun Korea Co., Ltd.

  • Last Modified:

    2025-02-07

  • Country:

    uk

  • Status:

    Withdrawal

  • Manufacturer:

    Croda Europe LTD

  • Withdrawal Date:

    2025-02-07

  • Final Annual Reporting Year:

    2014

  • Manufacturing Facility:

    Barnfield Road, Leek Staffordshire ST13 5QJ, UK (Cowick Hall, Snaith, Goole, East Yorkshire, DN14 9AA, UK)

B1 Medison Korea Co., Ltd.

  • Product:

    Janubrutinib

  • Initial Registration:

    2022-09-16

  • Registration Number:

    Number 969-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    B1 Medison Korea Co., Ltd.

  • Last Modified:

    2023-09-25

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Changzhou SynTheAll Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    589 North Yulong Road, Xinbei District Changzhou, Jiangsu, 213127, China

Baeksu Pharmaceutical Co., Ltd.

  • Product:

    Remifentanil hydrochloride

  • Initial Registration:

    2014-09-02

  • Registration Number:

    Number 5-1-ND(1)

  • MFDS Classification:

    new substance

  • Applicant:

    Baeksu Pharmaceutical Co., Ltd.

  • Last Modified:

    2020-04-09

  • Country:

    uk

  • Status:

    Active

  • Manufacturer:

    Macfarlan Smith Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom

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