KDMF (Korea Drug Master File) Approved Products & Companies

Chemipharm Co., Ltd.

  • Product:

    Atorvastatin calcium

  • Initial Registration:

    2015-08-24

  • Registration Number:

    20150824-132-H-281-31

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Chemipharm Co., Ltd.

  • Last Modified:

    2023-09-14

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Morepen Laboratories Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    (Morepen Village) Vill. Malkumajra, Baddi-Nalagarh Road, Baddi. District-Solan (Himachal Pradesh), India

Chemotros Co., Ltd.

  • Product:

    Tenofovir disoproxil

  • Initial Registration:

    2017-07-17

  • Registration Number:

    1670-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Chemotros Co., Ltd.

  • Last Modified:

    2018-04-27

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Chemotros Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    B14-17, Banwol Industrial Complex, 7 Neungan-ro, Danwon-gu, Ansan-si, Gyeonggi-do

Chemport Co., Ltd.

  • Product:

    refined fish oil

  • Initial Registration:

    2015-12-08

  • Registration Number:

    3-1-ND

  • MFDS Classification:

    Appendix 1-2

  • Applicant:

    Chemport Co., Ltd.

  • Last Modified:

    2025-10-22

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Chemport Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    (58275) 30-51 Dongsunonggongdanji-gil, Naju-si, Jeollanam-do

Cheongsol Biotech Co., Ltd.

  • Product:

    Omeprazole

  • Initial Registration:

    2007-10-25

  • Registration Number:

    20071025-52-B-266-12

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Cheongsol Biotech Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    M/S. Lee Pharma Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    sy No.199, plot No.3&4, door No.5-9-265/1&2, rajiv gandi nagar, prasanthinagar in di.exts.,kukatpally, hyderabad-500 072

Chodang Pharmaceutical Co., Ltd.

  • Product:

    Nabumeton

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-2-C-57-01

  • MFDS Classification:

  • Applicant:

    Chodang Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    ZHEJIANG SHENZHOU Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    No.14 Chuancheng Nan road 317300 Xianju, Zhejiang

Chong Kun Dang Bio Co., Ltd.

  • Product:

    Cyclosporine

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-18-C-96-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Chong Kun Dang Bio Co., Ltd.

  • Last Modified:

    2026-03-10

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Chong Kun Dang Bio Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do

Chong Kun Dang Co., Ltd.

  • Product:

    disodium valsalagide

  • Initial Registration:

    2005-06-10

  • Registration Number:

    12-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Chong Kun Dang Co., Ltd.

  • Last Modified:

    2025-12-19

  • Country:

    Belgium

  • Status:

    Withdrawal

  • Manufacturer:

    SA Ajinomoto Omnichem NV

  • Withdrawal Date:

    2025-12-19

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    SA Ajinomoto Omnichem NV Cooppallaan 91 B-9230 Wettern, Belgium

Clasia Co., Ltd.

  • Product:

    Olopatadine hydrochloride

  • Initial Registration:

    2018-11-16

  • Registration Number:

    20181116-209-J-150

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Clasia Co., Ltd.

  • Last Modified:

    2022-03-10

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Indoco Remedies Limited(KILO LAB)

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    R-92/93, 1st floor, TTC, MIDC, Thane Belapur Road, Rabale, Navi Mumbai, Thane 400701. Maharashtra State India

Clinigen Korea Ltd.

  • Product:

    Galantamine hydrobromide

  • Initial Registration:

    2021-06-10

  • Registration Number:

    20210610-209-J-538

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Clinigen Korea Ltd.

  • Last Modified:

    2025-06-02

  • Country:

    Belgium

  • Status:

    Active

  • Manufacturer:

    Janssen Pharmaceutica NV

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    Jassen Pharmaceuticalaan 3, Geel, 2440, Belgium

CMG Pharmaceutical CO., Ltd.

+4

  • Product:

    Levamipid

  • Initial Registration:

    2012-08-27

  • Registration Number:

    20070504-4-B-240-14(17)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    CMG Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-09-26

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No. 699, Changle Avenue, Jiangxi Fengxin Industrial Park, Fengxin County, 330700, Yichun City, Jiangxi Province, China

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