KDMF (Korea Drug Master File) Approved Products & Companies

Lifeceuticals

  • Product:

    Teicoplanin

  • Initial Registration:

    2012-10-25

  • Registration Number:

    20121025-63-A-282-08

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Lifeceuticals

  • Last Modified:

    2024-03-22

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Lifeceuticals

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    100 Bio Valley 2-ro, Jecheon-si, Chungcheongbuk-do

Lilly Korea Ltd.

  • Product:

    Atomoxetine hydrochloride

  • Initial Registration:

    2006-03-27

  • Registration Number:

    Su51-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Lilly Korea Ltd.

  • Last Modified:

    2025-02-04

  • Country:

    Ireland

  • Status:

    Withdrawal

  • Manufacturer:

    Eli Lilly Kinsale Limited

  • Withdrawal Date:

    2025-02-04

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    Dunderrow, Kinsale, Co. Cork, Ireland

Luce Pharm Co., Ltd.

  • Product:

    Testosterone undecanoate

  • Initial Registration:

    2023-06-12

  • Registration Number:

    20230612-210-J-1510

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Luce Pharm Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Symbiotec Pharmalab Pvt. Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No. 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma Zone, Pithampur, Dist. Dhar - 454 774, (MP), INDIA

Lundbeck Korea Co., Ltd.

  • Product:

    Rasagiline mesylate

  • Initial Registration:

    2013-08-16

  • Registration Number:

    Su4496-2-ND

  • MFDS Classification:

    new substance

  • Applicant:

    Lundbeck Korea Co., Ltd.

  • Last Modified:

    2025-08-25

  • Country:

    Israel

  • Status:

    Active

  • Manufacturer:

    Asia Chemical Industries Ltd. Teva Tech Site

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2019

  • Manufacturing Facility:

    Neot Hovav Eco-Industrial Park, Emek Sara, Be'er Sheva 8412316, Israel

Lutech Co., Ltd.

  • Product:

    sodium hyaluronate

  • Initial Registration:

    2011-04-14

  • Registration Number:

    20110414-96-E-97-30

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Lutech Co., Ltd.

  • Last Modified:

    2023-05-23

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Lutech Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    53-1, Gongdan-ro 98beon-gil, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do

Maekmulsan Co., Ltd.

  • Product:

    Minocycline hydrochloride

  • Initial Registration:

    2026-05-07

  • Registration Number:

    20220905-211-J-1355(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Maekmulsan Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Changhai Pharmaceuticals Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    188 Mid Zhiyuan Avenue, Binhai New Area, Shaoxing City, Zhejiang Province, 312366, PR China

Masung LS Co., Ltd.

  • Product:

    Topiso Farm

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-64-C-192-03

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Masung LS Co., Ltd.

  • Last Modified:

    2021-02-05

  • Country:

    Hungary

  • Status:

    Active

  • Manufacturer:

    Egis Pharmaceuticals PLC (Egis Pharmaceuticals Private Limited Company)

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    H-1106 Budapest Kereszturi ut 30-38, Hungary

McNulty Pharmaceuticals Co., Ltd.

  • Product:

    gabapentin

  • Initial Registration:

    2016-10-26

  • Registration Number:

    20121214-142-I-193-08(4)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    McNulty Pharmaceuticals Co., Ltd.

  • Last Modified:

    2020-12-30

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Chiral medicine Chemicals Co.,Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Nanyang Economy Development Zone,Xiaoshan,hangzhou

Medica Korea Co., Ltd.

  • Product:

    Fluconazole

  • Initial Registration:

    2011-06-30

  • Registration Number:

    20050831-74-A-153-07(7)

  • MFDS Classification:

    etc

  • Applicant:

    Medica Korea Co., Ltd.

  • Last Modified:

    2025-03-18

  • Country:

    India

  • Status:

    Withdrawal

  • Manufacturer:

    IPCA Laboratories Limited

  • Withdrawal Date:

    2025-03-18

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    PO Sejavta Dist. Ratlam(MP)PIN. 457 002, India(48, KANDIVLI INDUSTRIAL ESTATE, KANDIVIL(WEST) MUMBAI400 067. INDIA)

Medihelpline Co., Ltd.

  • Product:

    Thiotropium bromide

  • Initial Registration:

    2019-08-01

  • Registration Number:

    20190801-211-J-399

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Medihelpline Co., Ltd.

  • Last Modified:

    2020-06-04

  • Country:

  • Status:

    Active

  • Manufacturer:

    Cerbios Pharma SA@[Spray Drying Factory] Micro-Sphere SA

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Via Figino 6, 6917 Barbengo, Switzerland @ [Spray Drying Plant] Via Cantonale 77, 6998 Monteggio, Switzerland

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit