KDMF (Korea Drug Master File) Approved Products & Companies

Novo Nordisk Pharmaceuticals Inc.

  • Product:

    Repaglinide

  • Initial Registration:

    2021-10-28

  • Registration Number:

    20211028-209-J-1132

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Novo Nordisk Pharmaceuticals Inc.

  • Last Modified:

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    Boehringer Ingelheim Pharma GmbH & Co KG

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany

Nuripharmtech

  • Product:

    Thioctic acid

  • Initial Registration:

    2016-12-07

  • Registration Number:

    20131108-166-I-202-04(7)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Nuripharmtech

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangsu Tohope Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    188, Wuyishan Road, Southeast Economic Development Zone, Changshu City, Jiangsu Province, China

Nutrainno Co., Ltd.

  • Product:

    Phloroglucinol hydrate

  • Initial Registration:

    2025-10-16

  • Registration Number:

    20220901-209-J-1187(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Nutrainno Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shouguang Fukang Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    North-East of Dongwaihuan Road, Dongcheng Industrial Area, Shouguang City, Shandong Province, PRof China.

O'Korea Pharmaceutical Co., Ltd.

  • Product:

    Iohexol

  • Initial Registration:

    2019-01-11

  • Registration Number:

    20180814-210-J-252(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    O'Korea Pharmaceutical Co., Ltd.

  • Last Modified:

    2020-11-04

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Taizhou Hisyn Pharmacetical Co.,Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Chemical and Medical Raw Materials Base Linhai Park, Zhejiang Province China

Opella Healthcare Korea Co., Ltd.

  • Product:

    Ambroxol hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-45-B-117-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Opella Healthcare Korea Co., Ltd.

  • Last Modified:

    2021-10-18

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Bidachem SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    SS 11(Padana Superiore), 8 24040 Fornovo San Giovanni

Optus Pharmaceutical Co., Ltd.

  • Product:

    chondroitin sulfate sodium

  • Initial Registration:

    2014-05-23

  • Registration Number:

    20131119-173-I-277-03(5)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Optus Pharmaceutical Co., Ltd.

  • Last Modified:

    2024-01-02

  • Country:

    Spain

  • Status:

    Withdrawal

  • Manufacturer:

    Bioiberica, SA

  • Withdrawal Date:

    2024-01-02

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Ctra. Nacional II, Km 680.6, 08389, Palafolls, Barcelona, Spain.

Organon Korea Co., Ltd.

  • Product:

    Ezetimib

  • Initial Registration:

    2003-10-19

  • Registration Number:

    906-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Organon Korea Co., Ltd.

  • Last Modified:

    2023-09-14

  • Country:

    Singapore

  • Status:

    Active

  • Manufacturer:

    MSD International GmbH (Singapore Branch)

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    50 Tuas West Drive Singapore 638408

Otran Korea Co., Ltd.

  • Product:

    Caspofungin acetate

  • Initial Registration:

    2019-05-13

  • Registration Number:

    20190111-210-J-111(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Otran Korea Co., Ltd.

  • Last Modified:

    2025-03-24

  • Country:

  • Status:

    Active

  • Manufacturer:

    BrightGene Pharmaceutical Co. Ltd.@BrightGene Fine Chemical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China@No.22 Binjiang South Road, Taixing Economic Development Zone, Taizhou City, Jiangsu, China

Otran Pharm Korea Co., Ltd.

  • Product:

    Entecavir

  • Initial Registration:

    2017-09-12

  • Registration Number:

    Su21-4-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Otran Pharm Korea Co., Ltd.

  • Last Modified:

    2021-04-16

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    BrightGene Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China

Palmtrion Co., Ltd.

  • Product:

    Sefdinir

  • Initial Registration:

    2025-08-19

  • Registration Number:

    20250123-209-J-1664(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Palmtrion Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Apeloa Tospo Pharmaceutical Co., Ltd.., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No. 519 Jiangnan Road, Hengdian Industrial Zone, Dongyang City, Jinhua, Zhejiang Province, China 322118

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