Product:

Acetaminophen

Initial Registration:

2009-06-26

Registration Number:

20090626-32-C-261-14

MFDS Classification:

Appendix 1

Applicant:

Kenview Korea Sales Co., Ltd.

Last Modified:

2022-12-13

Country:

USA

Status:

Active

Manufacturer:

SpecGx LLC

Withdrawal Date:

Final Annual Reporting Year:

2024

Manufacturing Facility:

8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

Product:

Paricalcitol

Initial Registration:

2018-04-27

Registration Number:

20151218-198-I-467-04(1)

MFDS Classification:

Appendix 1

Applicant:

Kisan Pharmaceutical Co., Ltd.

Last Modified:

Country:

taiwan

Status:

Active

Manufacturer:

Formosa Laboratories, Inc. Louchu Plant

Withdrawal Date:

Final Annual Reporting Year:

2023

Manufacturing Facility:

36, Hoping Street, Louchu, Taoyuan 33842, Taiwan

Product:

felodipine

Initial Registration:

2011-06-30

Registration Number:

20050831-69-B-181-03(2)

MFDS Classification:

etc

Applicant:

KMS Pharmaceutical Co., Ltd.

Last Modified:

Country:

India

Status:

Active

Manufacturer:

Cipla Limited

Withdrawal Date:

Final Annual Reporting Year:

2012

Manufacturing Facility:

Virgonagar, Old Madras Road, Bangalore 560 049, India (Mumbai Central Mumbai 400 008 India)

Product:

Loxoprofen sodium hydrate

Initial Registration:

2014-03-10

Registration Number:

20140310-8-C-320-12

MFDS Classification:

Appendix 1

Applicant:

Kolon Life Science Co., Ltd.

Last Modified:

2025-10-29

Country:

korea

Status:

Active

Manufacturer:

Kolon Life Science Co., Ltd.

Withdrawal Date:

Final Annual Reporting Year:

2025

Manufacturing Facility:

54, Gibeopdosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do

Product:

Roxithromycin

Initial Registration:

2005-08-31

Registration Number:

20050831-9-A-1-01

MFDS Classification:

Applicant:

Kolon Pharmaceutical Co., Ltd.

Last Modified:

2024-02-02

Country:

Spain

Status:

Withdrawal

Manufacturer:

Sandoz Industrial Products SA

Withdrawal Date:

2024-02-02

Final Annual Reporting Year:

2012

Manufacturing Facility:

Ctra.Granollers a Cardedeu C-250, Km4 E-08520 Les Franques Barcelona, Spain(POBox 97 E-08400 Granollers Barcelona, Spain)

Product:

Acecclofenac

Initial Registration:

2011-12-15

Registration Number:

20111216-31-C-290-16

MFDS Classification:

Applicant:

Korea Biochem Pharmaceutical Co., Ltd.

Last Modified:

2021-01-21

Country:

Status:

Active

Manufacturer:

Korea Biochem Pharmaceutical Co., Ltd. @[(Article 4) Manufacturer of the product] Henan Dongtai Pharmaceutical Co., Ltd. @Magma Industries Ltd

Withdrawal Date:

Final Annual Reporting Year:

2021

Manufacturing Facility:

204, Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City @ East Changhong Road, Tangyin County, Anyang City, China @ C-24 to 27, Begrajpur Industrial Area Muzaffamagar (UP) India

Product:

Heparin sodium

Initial Registration:

2013-02-26

Registration Number:

20100331-124-G-29-02(4)

MFDS Classification:

Appendix 1

Applicant:

Korea BMI Co., Ltd.

Last Modified:

2026-05-13

Country:

china

Status:

Withdrawal

Manufacturer:

Changzhou Qianhong Bio-pharma Co., Ltd

Withdrawal Date:

2026-05-13

Final Annual Reporting Year:

2022

Manufacturing Facility:

No. 192 Huanghe West Road, Xinbei District, Changzhou, Jiangsu, China

Product:

Entecavir

Initial Registration:

2006-03-02

Registration Number:

Su335-1-ND

MFDS Classification:

new substance

Applicant:

Korea BMS Pharmaceutical Co., Ltd.

Last Modified:

2023-04-11

Country:

Ireland

Status:

Active

Manufacturer:

SK Biotek Ireland Limited

Withdrawal Date:

Final Annual Reporting Year:

2024

Manufacturing Facility:

Watery Lane, Swords, Co.Dublin, Ireland

Product:

biphenyl dimethyl dicarboxylate

Initial Registration:

2006-08-29

Registration Number:

20070328-17-C-217-06

MFDS Classification:

Appendix 1

Applicant:

Korea Chorus Co., Ltd.

Last Modified:

Country:

china

Status:

Active

Manufacturer:

Beijing Union Pharmaceutical Factory

Withdrawal Date:

Final Annual Reporting Year:

2017

Manufacturing Facility:

North Xingye Road, Huangcun Town, Da Xing County, Beijing 102600, China

Product:

Acetylcysteine

Initial Registration:

2015-01-20

Registration Number:

20110805-139-H-102-03(16)

MFDS Classification:

Appendix 1

Applicant:

Korea Chorus Pharmaceutical Co., Ltd.

Last Modified:

Country:

china

Status:

Active

Manufacturer:

Wuhan Grand Hoyo Co., Ltd.

Withdrawal Date:

Final Annual Reporting Year:

Manufacturing Facility:

No.1 Industrial Park, Gedian Economy Development Zone, Hubei, China