KDMF (Korea Drug Master File) Approved Products & Companies

QL Pharma Co., Ltd.

  • Product:

    Sevelamer carbonate

  • Initial Registration:

    2024-05-28

  • Registration Number:

    20240528-209-J-1649

  • MFDS Classification:

    Appendix 1

  • Applicant:

    QL Pharma Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Shandong Xinhua Pharmaceutical Co.,Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Hutian Chemical Industrial Zone, Zibo, Shandong, PR 255075 China

Redox Bio Co., Ltd.

  • Product:

    Loxoprofen sodium hydrate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-8-C-76-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Redox Bio Co., Ltd.

  • Last Modified:

    2021-03-10

  • Country:

  • Status:

    Active

  • Manufacturer:

    Redox Bio Co., Ltd. @ [Loxoprofen Manufacturer] Dijia Pharmaceutical Group Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    83, Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @ [Loxoprofen Manufacturer] No.268 Tianrun Road, Wendeng Economic Development Zone, Weihai China

Renew Medical Co., Ltd.

  • Product:

    Simvastatin

  • Initial Registration:

    2021-07-07

  • Registration Number:

    20120217-29-B-327-26(12)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Renew Medical Co., Ltd.

  • Last Modified:

  • Country:

  • Status:

    Active

  • Manufacturer:

    Zhejiang Jiangbei Pharm Co.ltd @ Manufacturer of starting material 'Lovastatin' ① Chongqing Daxin @ Manufacturer of starting material 'Lovastatin' ② Sterling Biotech Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Dongdai village Zhang an Street, Jiaojiang, Taizhou, Zhejiang @Manufacturer of starting material 'Lovastatin' ① No.21 Founder Road, Shuitu Town, Beibei District, Chongqing 400700 PR China @[Manufacturer of starting material Lovastatin ②] Jambusar State Highway, Village Masar-391 421, Ta.Padra, Vadodara, Gujarat, India

Repure Healthcare Co., Ltd.

  • Product:

    Deferifron

  • Initial Registration:

    2007-03-28

  • Registration Number:

    Su613-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Repure Healthcare Co., Ltd.

  • Last Modified:

    2024-01-02

  • Country:

    Canada

  • Status:

    Withdrawal

  • Manufacturer:

    Apotex pharmachem Inc

  • Withdrawal Date:

    2024-01-02

  • Final Annual Reporting Year:

    2014

  • Manufacturing Facility:

    11, 34, 50 Spalding Drive Brantford, Ontario N3T 6B8, Canada

RH Biopharm Co., Ltd.

  • Product:

    Losartan potassium

  • Initial Registration:

    2010-10-11

  • Registration Number:

    20100226-122-G-72-17(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    RH Biopharm Co., Ltd.

  • Last Modified:

    2023-01-31

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Huahai Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Duqiao, Linhai 317016, Zhejiang, China

Rihu Healthcare Co., Ltd.

  • Product:

    Valsartan

  • Initial Registration:

    2010-12-30

  • Registration Number:

    20101230-135-H-50-09

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Rihu Healthcare Co., Ltd.

  • Last Modified:

    2025-08-05

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Huahai Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Chuannan, Duqiao, Linhai, Zhejiang

Roche Korea

  • Product:

    Baloxavir Marboxil

  • Initial Registration:

    2019-11-22

  • Registration Number:

    Su188-4-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Roche Korea

  • Last Modified:

    2023-12-12

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    Shionogi Pharma Co., Ltd. (Tokushima Plant)

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    224-20, Hiraishiebisuno, Kawauchi-cho, Tokushima Tokushima 771-0132, Japan

Rocket Korea Co., Ltd.

  • Product:

    Icodextrin

  • Initial Registration:

    2024-08-28

  • Registration Number:

    20240828-211-J-1682

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Rocket Korea Co., Ltd.

  • Last Modified:

  • Country:

    france

  • Status:

    Active

  • Manufacturer:

    ROQUETTE FRERES

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    1 Rue de la Haute Loge, 62136 LESTREM, France

RP Bio Co., Ltd.

  • Product:

    Dexibuprofen

  • Initial Registration:

    2012-10-05

  • Registration Number:

    20120330-145-I-36-01(10)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    RP Bio Co., Ltd.

  • Last Modified:

    2023-05-26

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Hubei Biocause Heilen Pharmaceutical CO., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2013

  • Manufacturing Facility:

    122 Yangwan Road, Jingmen City, Hubei Province, 448000, PR China

Saehan Pharmaceutical Co., Ltd.

  • Product:

    Medroxyprogesterone acetate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-58-B-142-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Saehan Pharmaceutical Co., Ltd.

  • Last Modified:

    2016-06-21

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Farmabios SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    Farmabios SpA via Pavia 1 27027 GROPELLO CAIROLI-Pavia ITALY

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