KDMF (Korea Drug Master File) Approved Products & Companies

Ferring Korea Co., Ltd.

  • Product:

    Terlipresin acetate

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-59-A-113-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Ferring Korea Co., Ltd.

  • Last Modified:

    2024-10-04

  • Country:

    Sweden

  • Status:

    Active

  • Manufacturer:

    PolyPeptide Laboratories (Sweden) AB

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Hogerudsgatan 21 SE-216 13 Limhamn

Fine Pharm Co., Ltd.

  • Product:

    Nizatidine

  • Initial Registration:

    2013-01-17

  • Registration Number:

    20121220-144-I-186-02(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Fine Pharm Co., Ltd.

  • Last Modified:

    2024-09-03

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Dr. Reddy's Laboratories Limited

  • Withdrawal Date:

    2024-09-03

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India

Fresenius Kabi Korea Co., Ltd.

  • Product:

    refined fish oil

  • Initial Registration:

    2006-03-02

  • Registration Number:

    Su-31-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Fresenius Kabi Korea Co., Ltd.

  • Last Modified:

  • Country:

    Sweden

  • Status:

    Active

  • Manufacturer:

    Fresenius Kabi AB

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    Rapsgatan 7 SE-751 74 Uppsala SWEDEN

Fresenius Medical Care Korea Co., Ltd.

  • Product:

    Sucrose ferric oxyhydroxide

  • Initial Registration:

    2018-03-19

  • Registration Number:

    Su539-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Fresenius Medical Care Korea Co., Ltd.

  • Last Modified:

    2024-07-30

  • Country:

    Swiss

  • Status:

    Active

  • Manufacturer:

    Vifor(International) AG

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Rechenstrasse 37, 9014 St. Gallen, Switzerland

G-Max Pharmachem Co., Ltd.

  • Product:

    Losartan potassium

  • Initial Registration:

    2010-08-31

  • Registration Number:

    20100831-122-G-74-24

  • MFDS Classification:

    Appendix 1

  • Applicant:

    G-Max Pharmachem Co., Ltd.

  • Last Modified:

    2022-09-26

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    M/s, Vasudha Pharma Chem Ltd. Unit Ⅱ

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    Plot No.79, Jawaharlal Nehru Pharma City, Thanam Village, Parwada(M), Visakhapatnam-531 019,. Andhara Pradesh

Galderma Korea Co., Ltd.

  • Product:

    Clobetasolpropionate

  • Initial Registration:

    2012-11-22

  • Registration Number:

    20121123-93-E-100-06

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Galderma Korea Co., Ltd.

  • Last Modified:

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    Farmabios SpA

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2014

  • Manufacturing Facility:

    via Pavia 1 27027 GROPELLO CAIROLI (PV) (microchem SRL, Via Turati 2 IT-29017 Fiorenzuola D'Arda (PC), Italy)

Gapi Bio Co., Ltd.

  • Product:

    Eperisone hydrochloride

  • Initial Registration:

    2014-09-19

  • Registration Number:

    20140919-46-C-333-11

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Gapi Bio Co., Ltd.

  • Last Modified:

    2024-10-25

  • Country:

    taiwan

  • Status:

    Active

  • Manufacturer:

    Syn-Tech Chem.&Pharm.Co.,Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    No.168 Kai Yuan Rd., Hsin-Ying, Tainan City, 73055, Taiwan

Gayaroparm Co., Ltd.

  • Product:

    Cefaclor hydrate

  • Initial Registration:

    2014-02-07

  • Registration Number:

    20130508-20-A-279-18(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Gayaroparm Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    China Union Chempharma (Suzhou) Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.9, East Jiaotong Road, Lili Town, Wujiang, Suzhou, PRChina.

GE Healthcare AS Korea Branch

  • Product:

    Perfluorobutane

  • Initial Registration:

    2012-03-30

  • Registration Number:

    3231-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    GE Healthcare AS Korea Branch

  • Last Modified:

    2012-08-31

  • Country:

    uk

  • Status:

    Active

  • Manufacturer:

    F2 Chemicals Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2020

  • Manufacturing Facility:

    Lea Lane, Lea Town, Preston, lancashire PR4 ORZ, UK

Genupharma Co., Ltd.

  • Product:

    Clarithromycin

  • Initial Registration:

    2017-04-17

  • Registration Number:

    20050831-62-A-119-02(9)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Genupharma Co., Ltd.

  • Last Modified:

    2025-05-02

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Synthimed Labs Private Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    Village Bhagwanpur, Barwala Road, Derabassi-140507, District SAS Nagar (Mohali), Punjab, India

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