KDMF (Korea Drug Master File) Approved Products & Companies

Korea Hutech Pharmaceutical Co., Ltd.

  • Product:

    biphenyl dimethyl dicarboxylate

  • Initial Registration:

    2013-05-22

  • Registration Number:

    20070328-17-C-217-06(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea Hutech Pharmaceutical Co., Ltd.

  • Last Modified:

    2013-10-04

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Beijing Union Pharmaceutical Factory

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    North Xingye Road, Huangcun Town, Da Xing County, Beijing 102600, China

Korea Kowa Co., Ltd.

  • Product:

    Riphasdil hydrochloride hydrate

  • Initial Registration:

    2018-11-26

  • Registration Number:

    Su286-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Korea Kowa Co., Ltd.

  • Last Modified:

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Chitose Hamari Chemicals, Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    1007-81, Izumisawa, Chitose, Hokkaido, 066-0051 Japan

Korea Kyowa Kirin Co., Ltd.

  • Product:

    Cinacalcet hydrochloride

  • Initial Registration:

    2008-09-30

  • Registration Number:

    2474-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Korea Kyowa Kirin Co., Ltd.

  • Last Modified:

    2025-06-18

  • Country:

    japan

  • Status:

    Withdrawal

  • Manufacturer:

    Okayama Plant, Oita Works, Sumitomo Chemical Company, Limited

  • Withdrawal Date:

    2025-06-18

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    6-4-1 Kojimatanokuchi, Kurashiki, Okayama, Japan

Korea Melsmon Co., Ltd.

  • Product:

    Ziziphus jujuba extract

  • Initial Registration:

    2007-04-20

  • Registration Number:

    20070420-01-HP-3-09

  • MFDS Classification:

    human placenta origin

  • Applicant:

    Korea Melsmon Co., Ltd.

  • Last Modified:

    2024-11-11

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Melsmon Pharmaceuticals Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    2-35-6 Higashiryoke, Kawaguchi-shi, Saitama Prefecture

Korea Menarini Co., Ltd.

  • Product:

    Calcium zofenopril

  • Initial Registration:

    2004-05-03

  • Registration Number:

    269-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Korea Menarini Co., Ltd.

  • Last Modified:

    2026-03-06

  • Country:

    Italy

  • Status:

    Withdrawal

  • Manufacturer:

    Lusochimica SpA

  • Withdrawal Date:

    2026-03-06

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    La Vettola Pisa (PI) - via Livornese 897

Korea MF3 Co., Ltd.

  • Product:

    Ziziphus jujuba extract

  • Initial Registration:

    2009-12-31

  • Registration Number:

    20091231-01-HP-21-16

  • MFDS Classification:

    human placenta origin

  • Applicant:

    Korea MF3 Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Albert David Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    5/11, D. Gupta Lane, Kolkata-700 050, India

Korea Otsuka Pharmaceutical Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-4-B-15-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea Otsuka Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-06-20

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Korea Otsuka Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    27, Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

Korea Pabis Pharmaceutical Co., Ltd.

  • Product:

    Potassium bismuth citrate

  • Initial Registration:

    2018-01-30

  • Registration Number:

    20170516-209-J-12(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea Pabis Pharmaceutical Co., Ltd.

  • Last Modified:

    2020-11-04

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    5N Plus Lubeck GmbH

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Kaninchenborn 24-28 D-23560 Lubeck Germany

Korea Pharma Co., Ltd.

  • Product:

    Quetiapine fumarate

  • Initial Registration:

    2013-06-04

  • Registration Number:

    20130322-172-I-251-11(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea Pharma Co., Ltd.

  • Last Modified:

    2024-02-19

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Aurobindo Pharma Ltd.

  • Withdrawal Date:

    2024-02-19

  • Final Annual Reporting Year:

    2017

  • Manufacturing Facility:

    Unit-XI, Survey Nos.61-66, IDA, Pydibhimavaram, Ranasthali Mandal, Srikakulam Dist., Andhra Pradesh

Korea Pharmaceutical Co., Ltd.

  • Product:

    Clopidogrel hydrogen sulfate

  • Initial Registration:

    2011-05-16

  • Registration Number:

    20110225-129-H-88-15(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Korea Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-05-13

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Dr. Reddy's Laboratories Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit