KDMF (Korea Drug Master File) Approved Products & Companies

Servier Korea Co., Ltd.

  • Product:

    Glyclazide

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-1-C-1-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Servier Korea Co., Ltd.

  • Last Modified:

    2023-04-03

  • Country:

    france

  • Status:

    Active

  • Manufacturer:

    ORIL INDUSTRIE

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    Plaine de Baclair, BOLBEC, 76210, France

SG Biochem Co., Ltd.

  • Product:

    gabapentin

  • Initial Registration:

    2012-12-14

  • Registration Number:

    20121214-142-I-193-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    SG Biochem Co., Ltd.

  • Last Modified:

    2023-07-27

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Chiral Medicine Chemicals Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Nanyang Economy Development Zone, Xiaoshan, Hangzhou, Zhejiang Province, China

Shinil Pharmaceutical Co., Ltd.

  • Product:

    Omeprazole

  • Initial Registration:

    2007-03-02

  • Registration Number:

    20070302-52-B-248-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Shinil Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-12-11

  • Country:

    Spain

  • Status:

    Withdrawal

  • Manufacturer:

    LICONSA

  • Withdrawal Date:

    2025-12-11

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Avda.Miralcampo 7, Pol, Ind, Miralcampo, 19200 B Azuqueca de Henares (Guadalajara)Spain

Shinpoong Pharmaceutical Co., Ltd.

  • Product:

    tyropramide hydrochloride

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-50-C-167-05

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Shinpoong Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Shinpoong Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2015

  • Manufacturing Facility:

    7, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do (5th Floor, Dongyoung Cultural Center, 772, Yeoksam-dong, Gangnam-gu, Seoul)

Shinshin Pharmaceutical Co., Ltd.

  • Product:

    xylometazoline hydrochloride

  • Initial Registration:

    2015-05-22

  • Registration Number:

    20140121-189-I-379-03(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Shinshin Pharmaceutical Co., Ltd.

  • Last Modified:

    2026-01-23

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    CTX Life Sciences Pvt. Ltd.

  • Withdrawal Date:

    2026-01-23

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    Block No. 251/P, 252/P, 253 to 255, 256/P, 258/P, 276/P, 277, 278/P, 279 to 282, 283/P, 284/P, GIDC, City : Sachin, Dist : Surat, Gujarat State, India

Shinyoung Biotech Co., Ltd.

  • Product:

    Naproxen

  • Initial Registration:

    2019-04-11

  • Registration Number:

    20130708-143-I-374-07(14)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Shinyoung Biotech Co., Ltd.

  • Last Modified:

    2025-08-26

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Divi's Laboratories Limited

  • Withdrawal Date:

    2025-08-26

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Unit-1: Lingojigudem Village, Choutuppal Mandal, Nalgonda District. Telangana, India

Sinpo Pharm Co., Ltd.

  • Product:

    Glimepiride

  • Initial Registration:

    2011-03-15

  • Registration Number:

    20110315-78-D-89-15

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sinpo Pharm Co., Ltd.

  • Last Modified:

    2013-03-15

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    USV LIMITED

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    B-1/8,MIDC,Lote,Parshuram,Industrial,Area,Taluka,Khed,District,Ratnagiri,Maharashtra,India,415-722

SK Biotech Co., Ltd.

  • Product:

    Choline alfoscerate

  • Initial Registration:

    2018-03-08

  • Registration Number:

    20180308-168-I-547-21

  • MFDS Classification:

    Appendix 1

  • Applicant:

    SK Biotech Co., Ltd.

  • Last Modified:

    2023-05-30

  • Country:

    korea

  • Status:

    Withdrawal

  • Manufacturer:

    SK Biotech Co., Ltd.

  • Withdrawal Date:

    2023-05-30

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    80 Myeonghaksandan-ro, Yeondong-myeon, Sejong Special Self-Governing City

SK Chemicals Co., Ltd.

  • Product:

    Napamostat mesylate

  • Initial Registration:

    2004-04-16

  • Registration Number:

    189-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    SK Chemicals Co., Ltd.

  • Last Modified:

    2022-11-04

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    SHIZUOKA COFFEIN Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2013

  • Manufacturing Facility:

    129, Suido-cho, Aoi-ku, Shizuoka-shi, Shizuoka, Japan

SM International Co., Ltd.

  • Product:

    Caspofungin acetate

  • Initial Registration:

    2020-01-09

  • Registration Number:

    20190111-210-J-111(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    SM International Co., Ltd.

  • Last Modified:

    2025-08-05

  • 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

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