KDMF (Korea Drug Master File) Approved Products & Companies

IMCD Korea Co., Ltd.

  • Product:

    Domperidone maleate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-11-B-42-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    IMCD Korea Co., Ltd.

  • Last Modified:

    2024-03-06

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    VASUDHA PHARMA CHEM LTD

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    UnitⅠ, Plot No.37/A, 38, 39 A&B, Phase-Ⅰ IDA, Jeedimetla, Hyderabad-500 055, Telangana, INDIA

Inist Pharm Co., Ltd.

  • Product:

    Irbesartan

  • Initial Registration:

    2014-08-08

  • Registration Number:

    20120106-133-H-175-21(5)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Inist Pharm Co., Ltd.

  • Last Modified:

    2017-04-05

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Tianyu Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang, 318020, China

Inist ST Co., Ltd.

  • Product:

    tyropramide hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-50-C-162-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Inist ST Co., Ltd.

  • Last Modified:

    2025-05-20

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Inist ST Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    152-1, Bondae-ri, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do

Innoten Co., Ltd.

  • Product:

    Ranitidine hydrochloride

  • Initial Registration:

    2016-11-22

  • Registration Number:

    20050831-35-B-99-07(7)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Innoten Co., Ltd.

  • Last Modified:

    2017-12-08

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    SMS Lifesciences India Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2017

  • Manufacturing Facility:

    Unit1, Sy No.180/2, Kazipalli(V), Jinnaram(M), Sangareddy District - 502319 India

Innovent

  • Product:

    Nintedanib esylate hemihydrate

  • Initial Registration:

    2025-01-13

  • Registration Number:

    Su6206-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Innovent

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Sichuan Kelun Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No. 3 of Yangzong 6th Road, Yang'an Industrial Park, Qionglai, Chengdu, Sichuan PR China

Insung Trading Co., Ltd.

  • Product:

    Metformin hydrochloride

  • Initial Registration:

    2012-10-12

  • Registration Number:

    20050831-37-C-34-05(9)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Insung Trading Co., Ltd.

  • Last Modified:

    2025-02-25

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Granules India Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District - 500 055 Telangana State, India

International Pharmaceutical Co., Ltd.

  • Product:

    cephbuferazone sodium

  • Initial Registration:

    2007-07-23

  • Registration Number:

    20070723-82-D-42-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    International Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-07-25

  • Country:

    korea

  • Status:

    Withdrawal

  • Manufacturer:

    International Pharmaceutical Co., Ltd.

  • Withdrawal Date:

    2024-07-25

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    47 Sanseong-ro, Danwon-gu, Ansan-si, Gyeonggi-do

Intro Biopharma Co., Ltd.

  • Product:

    Omega-3 ethyl ester 90

  • Initial Registration:

    2017-12-28

  • Registration Number:

    Su353-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Intro Biopharma Co., Ltd.

  • Last Modified:

  • Country:

    uk

  • Status:

    Active

  • Manufacturer:

    Croda Europe Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Barnfield Road Leek Staffordshire ST13 5QJ

IT Chem Co., Ltd.

  • Product:

    Choline alfoscerate

  • Initial Registration:

    2016-11-24

  • Registration Number:

    20161124-168-I-515-18

  • MFDS Classification:

    Appendix 1

  • Applicant:

    IT Chem Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    IT Chem Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    231 Yangcheongsongdae-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do

J-Tech Biogen

  • Product:

    Acetate terliprecin

  • Initial Registration:

    2005-09-15

  • Registration Number:

    20050915-59-A-112-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    J-Tech Biogen

  • Last Modified:

    2023-10-11

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    NeoMPS, Inc.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    9395 Cabot Drive, San Diego, CA 92121, USA

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