KDMF (Korea Drug Master File) Approved Products & Companies

Samsung Pharmaceutical Co., Ltd.

  • Product:

    Sulbactam sodium

  • Initial Registration:

    2013-05-15

  • Registration Number:

    20130207-150-I-192-05(3)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samsung Pharmaceutical Co., Ltd.

  • Last Modified:

    2021-10-07

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhuhai United Laboratories Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2016

  • Manufacturing Facility:

    No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China

Samung Industry Co., Ltd.

  • Product:

    Remifentanil hydrochloride

  • Initial Registration:

    2014-09-02

  • Registration Number:

    Number 5-1-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Samung Industry Co., Ltd.

  • Last Modified:

    2020-04-09

  • Country:

    uk

  • Status:

    Active

  • Manufacturer:

    Macfarlan Smith Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2018

  • Manufacturing Facility:

    10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom

Samwon Pharmaceutical Co., Ltd.

  • Product:

    Naproxen

  • Initial Registration:

    2012-12-12

  • Registration Number:

    20121212-143-I-153-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samwon Pharmaceutical Co., Ltd.

  • Last Modified:

    2025-04-22

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Charioteer Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2024

  • Manufacturing Facility:

    Tongyuanxi, Dazhan, Xianju, Zhejiang Province. P.R. China

Samyang Biopharm Co., Ltd.

  • Product:

    Paclitaxel

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-68-A-133-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Samyang Biopharm Co., Ltd.

  • Last Modified:

    2025-12-16

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Samyang Biopharm Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    79 Sinildong-ro, Daedeok-gu, Daejeon

Sandoz Korea Co., Ltd.

  • Product:

    felodipine

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-69-B-183-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sandoz Korea Co., Ltd.

  • Last Modified:

    2023-07-04

  • Country:

    Spain

  • Status:

    Withdrawal

  • Manufacturer:

    Esteve Quimica, SA

  • Withdrawal Date:

    2023-07-04

  • Final Annual Reporting Year:

    2012

  • Manufacturing Facility:

    C.Caracas, 17-19 08030 Barcelona, Spain

Sangjin Trading Co., Ltd.

  • Product:

    Cilostazol

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-28-C-26-07

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sangjin Trading Co., Ltd.

  • Last Modified:

    2025-11-06

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    Glenmark Life Sciences Limited

  • Withdrawal Date:

    2025-11-06

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    Plot No. 3109-GIDC Industrial Estate ANKLESHWAR-393002 Dist. Bharuch, Gujarat, India

Sanil Pharma Co., Ltd.

  • Product:

    Levamipid

  • Initial Registration:

    2011-05-31

  • Registration Number:

    20070504-4-B-240-14(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sanil Pharma Co., Ltd.

  • Last Modified:

    2011-07-26

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Jiangxi Synergy Pharmaceutical Co., Ltd

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    699, Changle Ave, Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, PRChina

Sanil Pharmaceutical Co., Ltd.

  • Product:

    trimebutine maleate

  • Initial Registration:

    2013-09-12

  • Registration Number:

    20050930-13-B-215-04(9)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sanil Pharmaceutical Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Xinhe Yuansheng Medicine Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    No.2 Qinggong road, Gushi county, 465200 Henan province. China

Sanofi-Aventis Korea Co., Ltd.

  • Product:

    Teicoplanin

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-63-A-127-01

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Sanofi-Aventis Korea Co., Ltd.

  • Last Modified:

    2025-10-02

  • Country:

    Italy

  • Status:

    Active

  • Manufacturer:

    EUROAPI ITALY SRL

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Via Angelo Titi 22/26 – 72100 Brindisi, Italy

Santen Korea Co., Ltd.

  • Product:

    Phenylephrine hydrochloride

  • Initial Registration:

    2007-12-28

  • Registration Number:

    20071228-88-D-12-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Santen Korea Co., Ltd.

  • Last Modified:

  • Country:

    japan

  • Status:

    Active

  • Manufacturer:

    SPERA NEXUS, Inc. Shizuoka Plant

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2022

  • Manufacturing Facility:

    1700, Hamagawa Shinden, Kakegawa-shi, Shizuoka 437-1423, Japan

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