KDMF (Korea Drug Master File) Approved Products & Companies

Darim Biotech Co., Ltd.

  • Product:

    Glimepiride

  • Initial Registration:

    2011-08-19

  • Registration Number:

    20070928-78-D-23-07(1)

  • MFDS Classification:

    etc

  • Applicant:

    Darim Biotech Co., Ltd.

  • Last Modified:

    2023-07-31

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Zydus Lifesciences Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    291, GIDC, Industrial Estate, Ankleshwar - 393 002, Gujarat, India

Dasan Pharmaceutical Co., Ltd.

  • Product:

    Acetaminophen

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-32-C-121-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dasan Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-01-22

  • Country:

  • Status:

    Active

  • Manufacturer:

    [Acetaminophen Coated Granules] Dasan Pharmaceutical Co., Ltd. @ [Manufacturer of Acetaminophen Starting Material] Lianyungang Kangle Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    [Acetaminophen Coated Granules] 342@No. 2, Deogamsan-ro, Dogomyeon, Asan-si, Chungcheongnam-do, South Korea, Huanan Road, Ganyu Economic Development Zone, Lianyungang, Jiangsu, China

DBS Pharm Co., Ltd.

  • Product:

    biphenyl dimethyl dicarboxylate

  • Initial Registration:

    2013-04-05

  • Registration Number:

    20070328-17-C-217-06(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    DBS Pharm Co., Ltd.

  • Last Modified:

  • 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

Deoksan Pharmaceutical Industry Co., Ltd.

  • Product:

    sodium bicarbonate

  • Initial Registration:

    2025-09-01

  • Registration Number:

    20240731-211-J-1672(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Deoksan Pharmaceutical Industry Co., Ltd.

  • Last Modified:

  • Country:

    Singapore

  • Status:

    Active

  • Manufacturer:

    Novabay Pte Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    20 Tembusu Avenue, Jurong Island 627536, Singapore

Digifarm Co., Ltd.

  • Product:

    Acetaminophen

  • Initial Registration:

    2010-01-15

  • Registration Number:

    20100115-32-C-256-17

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Digifarm Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Hebei Jiheng (Group) Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    No. 368 Jianshe Street, Hengshui City, Hebei Province

DKSH Korea Co., Ltd.

  • Product:

    Verteporfin

  • Initial Registration:

    2003-04-18

  • Registration Number:

    163-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    DKSH Korea Co., Ltd.

  • Last Modified:

    2020-08-26

  • Country:

    Canada

  • Status:

    Active

  • Manufacturer:

    Evonik Degussa Canada Inc.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    8045 Argyll Road, Edmonton, Alberta, T6C 4N9, Canada.

DM Co., Ltd.

  • Product:

    Cefuroxim axetyl

  • Initial Registration:

    2024-01-03

  • Registration Number:

    20050915-22-A-166-06(10)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    DM Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Apitoria Pharma Private Limited Unit-I

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Unit-I, Sy.No. 379, 385, 386, 388 - 396, Borpatla Village, Hatnoora Mandal, Sangareddy District, Telangana, 502 296 INDIA

Docheo Co., Ltd.

  • Product:

    Glimepiride

  • Initial Registration:

    2012-11-02

  • Registration Number:

    20080128-78-D-14-11(5)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Docheo Co., Ltd.

  • Last Modified:

    2020-06-04

  • Country:

    India

  • Status:

    Business Closure

  • Manufacturer:

    Glenmark Life Sciences Limited

  • Withdrawal Date:

    2024-04-09

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    Plot No. 3109/C.,GIDC ANKLESHWAR Dist. Bharuch, India

Dong-A Pharmaceutical Co., Ltd.

  • Product:

    Heparin sodium

  • Initial Registration:

    2013-10-31

  • Registration Number:

    20100211-124-G-17-01(12)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dong-A Pharmaceutical Co., Ltd.

  • Last Modified:

    2015-11-06

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Yantai Dongcheng Biochemicals Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    No. 7 Changbaishan Road, Yantai Development Zone, Shandong, China

Dong-A ST Co., Ltd.

+26

  • Product:

    Acetyl-carnitine hydrochloride

  • Initial Registration:

    2005-11-25

  • Registration Number:

    20051125-43-B-216-06

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Dong-A ST Co., Ltd.

  • Last Modified:

    2020-07-29

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Biosint SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Via del Murillo, 16/Via Roio 2 - 04013 SERMONETA(LT) ITALY

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