KDMF (Korea Drug Master File) Approved Products & Companies

Pamire Co., Ltd.

  • Product:

    bromide cymetropium

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-16-C-95-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pamire Co., Ltd.

  • Last Modified:

    2009-05-21

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Alkaloids Private Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2021

  • Manufacturing Facility:

    25/3, Gundlapochampally, Medchal-Malkajgiri District, Telangana State 500 100, India

Pampia Co., Ltd.

  • Product:

    Acetaminophen

  • Initial Registration:

    2018-04-23

  • Registration Number:

    20141022-32-C-325-19(8)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pampia Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Anhui BBCA LiKang Pharmaceutical CO.,LTD

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    High&New Technology Industries Development Zone, Bengbu City, Anhui Province, China

Penmix Co., Ltd.

  • Product:

    Potassium clavulanate

  • Initial Registration:

    2010-11-30

  • Registration Number:

    20101130-113-F-56-15

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Penmix Co., Ltd.

  • Last Modified:

    2025-10-01

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhuhai United Laboratories Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

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

Pfizer Korea

  • Product:

    Paclitaxel

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-68-A-132-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pfizer Korea

  • Last Modified:

    2023-10-10

  • Country:

    USA

  • Status:

    Withdrawal

  • Manufacturer:

    Corden Pharma Boulder, Inc.

  • Withdrawal Date:

    2023-10-10

  • Final Annual Reporting Year:

    2023

  • Manufacturing Facility:

    4876 Sterling Drive, Boulder, Colorado (CO) 80301, USA

Pharma One Co., Ltd.

  • Product:

    Quetiapine fumarate

  • Initial Registration:

    2021-04-21

  • Registration Number:

    20200519-172-I-592-22(1)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharma One Co., Ltd.

  • Last Modified:

    2025-03-04

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Hetero Labs Limited (Unit-IX)

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Plot No. 2, Hetero Infrastructure SEZ Ltd., N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District Andhra Pradesh India

Pharma Solution Co., Ltd.

  • Product:

    pregabalin

  • Initial Registration:

    2018-02-08

  • Registration Number:

    Number 6580-16-ND(A)

  • MFDS Classification:

    new substance

  • Applicant:

    Pharma Solution Co., Ltd.

  • Last Modified:

    2026-04-03

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    CTX Lifesciences Pvt. Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2026

  • Manufacturing Facility:

    Block No.-251/B, 252/B, 253, 254, 255, 256, 258/B, 276, 277, 278/P, 279, 280, 281, 282, 283/P, 284/P, Sachin GIDC, Near Gabheni Chokdi, City-Sachin, Dist.-Surat, Gujarat - 394 230, INDIA.

Pharmacostec Co., Ltd.

  • Product:

    Cilostazol

  • Initial Registration:

    2008-01-28

  • Registration Number:

    20080128-28-C-236-13

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharmacostec Co., Ltd.

  • Last Modified:

    2016-04-05

  • Country:

    korea

  • Status:

    Active

  • Manufacturer:

    Pharmacostec Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    47, Jeyakdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

Pharmaking Co., Ltd.

  • Product:

    Levodropizine

  • Initial Registration:

    2015-05-22

  • Registration Number:

    20131029-137-H-241-10(2)

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharmaking Co., Ltd.

  • Last Modified:

    2023-10-19

  • Country:

    Ireland

  • Status:

    Withdrawal

  • Manufacturer:

    Clarochem Ireland Ltd.

  • Withdrawal Date:

    2023-10-19

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    Damastown, Mulhuddart, Dublin 15, Ireland

Pharmaline Co., Ltd.

  • Product:

    Nabumeton

  • Initial Registration:

    2005-08-31

  • Registration Number:

    20050831-2-C-58-02

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharmaline Co., Ltd.

  • Last Modified:

    2024-09-03

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Divi's Laboratories Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2025

  • Manufacturing Facility:

    Unit-1, Linggojigudem village Choutuppal Mandal Yadadri Bhuvanagiri District Telangana - 508252, India

Pharmapia Co., Ltd.

  • Product:

    sodium risedronate

  • Initial Registration:

    2010-01-29

  • Registration Number:

    20100129-121-G-22-04

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Pharmapia Co., Ltd.

  • Last Modified:

  • Country:

    India

  • Status:

    Active

  • Manufacturer:

    Fleming Laboratories Limited

  • Withdrawal Date:

  • Final Annual Reporting Year:

    2014

  • Manufacturing Facility:

    Plot No.152&160, Phase-V, IDA Jeedimetla, Hyderabad, AP, India

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