KDMF (Korea Drug Master File) Approved Products & Companies

Enterpharm Co., Ltd.

  • Product:

    Medicinal charcoal

  • Initial Registration:

    2020-10-19

  • Registration Number:

    20201019-210-J-752

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Enterpharm Co., Ltd.

  • Last Modified:

    2022-04-22

  • Country:

    Netherlands

  • Status:

    Business Closure

  • Manufacturer:

    Norit Nederland BV

  • Withdrawal Date:

    2023-05-30

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Mr. Ovingkanaal Oz. 3, Klazienaveen, 7891EV, Netherlands

EQ Bio Co., Ltd.

  • Product:

    Dapagliflozin propanediol hydrate

  • Initial Registration:

    2022-05-23

  • Registration Number:

    Number 674-1-ND(4)

  • MFDS Classification:

    new substance

  • Applicant:

    EQ Bio Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    MSN Laboratories Private Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pincode-502 329 Telangana, India

Erison Pharmaceutical Co., Ltd.

  • Product:

    nifedipine

  • Initial Registration:

    2014-12-08

  • Registration Number:

    20141208-134-H-266-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Erison Pharmaceutical Co., Ltd.

  • Last Modified:

    2023-02-17

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Limited)

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    Plot No. 5, Phase IV, GIDC Industrial area, City: Panoli-394 116, Dist. Bharuch, Gujarat, India.

Essel Bio Co., Ltd.

  • Product:

    Cefpodoxime proxetil

  • Initial Registration:

    2013-12-27

  • Registration Number:

    20120907-25-A-270-06(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Essel Bio Co., Ltd.

  • Last Modified:

    2023-10-05

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Parabolic Drugs Ltd

  • Withdrawal Date:

    2023-10-05

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Village Sundhran, Post office : Mubarakpur, Tehsil : Derabassi, District : Mohali, Punjab, India.

Ester Corporation Co., Ltd.

  • Product:

    Ivy leaf 30% ethanol dry extract (5~7.5->1)

  • Initial Registration:

    2019-04-12

  • Registration Number:

    20190412-5-K-46-05

  • MFDS Classification:

    Appendix 1-2

  • Applicant:

    Ester Corporation Co., Ltd.

  • Last Modified:

  • Country:

    germany

  • Status:

    Active

  • Manufacturer:

    Anklam Extrakt GmbH

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Johann-Friedrich-Bottger Strasse 4 & 10 D-17389 Anklam Germany

Everest Medicine Korea Ltd.

  • Product:

    Ethrasimod∙L-arginine

  • Initial Registration:

    2026-05-20

  • Registration Number:

    Su6214-1-ND

  • MFDS Classification:

  • Applicant:

    Everest Medicine Korea Ltd.

  • Last Modified:

  • Country:

    USA

  • Status:

    Active

  • Manufacturer:

    AMPAC Fine Chemicals, LLC

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Highway 50 and Hazel AvenueRancho Cordova, CA 95670USA

Farm & Biz Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2012-01-06

  • Registration Number:

    20070504-4-B-240-14(12)

  • MFDS Classification:

  • Applicant:

    Farm & Biz Co., Ltd.

  • Last Modified:

    2025-06-10

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co.,Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Jiangxi Fengxin Industrial Park, Fengxin 330700, Jiangxi Province, China

FarmChem Service Co., Ltd.

  • Product:

    Fimasartan potassium trihydrate

  • Initial Registration:

    2023-02-22

  • Registration Number:

    Number 423-1-ND(1)

  • MFDS Classification:

    new substance

  • Applicant:

    FarmChem Service Co., Ltd.

  • Last Modified:

    2024-10-18

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Ami Lifesciences Private Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India

Farmist Co., Ltd.

  • Product:

    Dexibuprofen

  • Initial Registration:

    2013-02-08

  • Registration Number:

    20130208-145-I-184-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Farmist Co., Ltd.

  • Last Modified:

    2026-05-15

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Solara Active Pharma Sciences Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    RSNo.33&34 Mathur Road, Periyakalapet, Puducherry, 605 014, India

Felix Co., Ltd.

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2020-10-26

  • Registration Number:

    20071228-96-E-38-09(15)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Felix Co., Ltd.

  • Last Modified:

    2025-05-22

  • Country:

    Czech Republic

  • Status:

    Active

  • Manufacturer:

    Contipro as

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Czech, dolni dobrouc 401 561 02 dolni dobrouc

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