KDMF (Korea Drug Master File) Approved Products & Companies

Dongsung Pharmaceutical Co., Ltd.

  • Product:

    Willow pea 70% ethanol dry extract (6~12→1)

  • Initial Registration:

    2006-01-31

  • Registration Number:

    67-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Dongsung Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-02-23

  • Country:

    germany

  • Status:

    Withdrawal

  • Manufacturer:

    BIONORICA AG

  • Withdrawal Date:

    2024-02-23

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    Kerschensteinerstraße 11-15 92318 Neumarkt

Doosung F&P Co., Ltd.

  • Product:

    Alverine citrate

  • Initial Registration:

    2025-02-28

  • Registration Number:

    20201207-211-J-574(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Doosung F&P Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Procos SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Via Matteotti 249-28062, Cameri (Novara) Italy

DR Bio Korea Co., Ltd.

  • Product:

    piperacillin sodium

  • Initial Registration:

    2022-02-22

  • Registration Number:

    20180702-95-E-133-06(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    DR Bio Korea Co., Ltd.

  • Last Modified:

  • Country:

  • Status:

    Active

  • Manufacturer:

    Shandong Anxin Pharmaceutical Co., Ltd @[Manufacturer of Starting Material 'Piperacillin'] Shandong Anshun Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.849 Dongjia Town, Licheng District, Jinan City, Shangdong Province PR China@Circular Economy Demonstration Park, Laoling County, Dezhou City, Shandong Province, PRChina

Easy Biopharm Co., Ltd.

  • Product:

    Inabogliflozin

  • Initial Registration:

    2023-03-10

  • Registration Number:

    Su171-4-ND(1)

  • MFDS Classification:

    new substance

  • Applicant:

    Easy Biopharm Co., Ltd.

  • Last Modified:

    2024-03-29

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shanghai SynTheAll Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    No. 9 Yuegong Rd., Jinshan Subbranch(West), Chemistry Industry Zone, Shanghai, 201507, China

Eco Pharma Co., Ltd.

  • Product:

    Acetaminophen

  • Initial Registration:

    2015-08-11

  • Registration Number:

    20050831-32-C-129-08(19)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Eco Pharma Co., Ltd.

  • Last Modified:

    2024-10-25

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Anqiu Lu''an Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    No. 35, Weixu North Road, Anqiu City Shandong Province, China.

Eden Pharma Co., Ltd.

  • Product:

    Acetaminophen

  • Initial Registration:

    2020-01-21

  • Registration Number:

    20200121-32-C-386-24

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Eden Pharma Co., Ltd.

  • Last Modified:

    2023-04-07

  • Country:

  • Status:

    Active

  • Manufacturer:

    Eden Pharma Co., Ltd.@Lianyungang Kangle Pharmaceutical Co.,Ltd,

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    1149@No.2, Nongdari-ro, Munbaek-myeon, Jincheon-gun, Chungcheongbuk-do, South Korea, Huanan Road, Ganyu Economic Development Zone, China.

Eisai Korea Co., Ltd.

  • Product:

    Eperisone hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-46-C-152-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Eisai Korea Co., Ltd.

  • Last Modified:

    2014-02-12

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Eisai Co., Ltd., Kashima Plant

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    22 Sunayama, Kamisu-shi, Ibaraki-ken, Japan

Eltech Pharmachem Co., Ltd.

  • Product:

    Isotretinoin

  • Initial Registration:

    2018-07-12

  • Registration Number:

    20180712-209-J-72

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Eltech Pharmachem Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shanghai New Hualian Pharmaceutical Co.,Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    No.217, Minle Road, Development Zone, Haiwan Town, Fengxian District, Shanghai, China

Encomac Co., Ltd.

  • Product:

    Ondansetron hydrochloride hydrate

  • Initial Registration:

    2021-06-01

  • Registration Number:

    20210601-47-B-460-21

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Encomac Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Natco Pharma Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Chemical Division Mekaguda Village, Nandigama Mandal Ranga reddy District Telangana, India

Engchem Life Sciences Co., Ltd.

  • Product:

    Levofloxacin

  • Initial Registration:

    2008-10-31

  • Registration Number:

    20081031-102-F-21-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Engchem Life Sciences Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Engchem Life Sciences Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    59 Biovalley-ro, Jecheon-si, Chungbuk

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