Product:

Amlodipine mesylate

Initial Registration:

2011-08-19

Registration Number:

20101029-130-H-16-04(2)

MFDS Classification:

etc

Applicant:

New One Science Co., Ltd.

Last Modified:

2021-02-26

Country:

India

Status:

Active

Manufacturer:

Cipla Limited

Withdrawal Date:

Final Annual Reporting Year:

2012

Manufacturing Facility:

Virgonagar Post, Old Madras Road, Bangalore 560 049, INDIA

Product:

Clazocentan disodium

Initial Registration:

2023-12-07

Registration Number:

Su5734-1-ND

MFDS Classification:

new substance

Applicant:

Nexera Pharma Korea Co., Ltd.

Last Modified:

2024-05-31

Country:

Swiss

Status:

Active

Manufacturer:

Carbogen Amcis AG

Withdrawal Date:

Final Annual Reporting Year:

Manufacturing Facility:

Gebaude 171, 173 and 177, Hauptstrasse 171 Bubendorf, 4416, Switzerland

Product:

Dexibuprofen

Initial Registration:

2013-04-18

Registration Number:

20120406-145-I-37-02(15)

MFDS Classification:

Appendix 1

Applicant:

Nexpharm Korea Co., Ltd.

Last Modified:

Country:

china

Status:

Active

Manufacturer:

Hubei Biocause Heilen Pharmaceutical Co., Ltd

Withdrawal Date:

Final Annual Reporting Year:

Manufacturing Facility:

122 Yangwan Road, Jingmen City, Hubei Province, 448000, PR China

Product:

Metformin hydrochloride colloidal silicon dioxide

Initial Registration:

2024-11-18

Registration Number:

20170831-37-C-369-26(2)

MFDS Classification:

Appendix 1

Applicant:

Next Bio Co., Ltd.

Last Modified:

Country:

India

Status:

Active

Manufacturer:

Harman Finochem LTD.

Withdrawal Date:

Final Annual Reporting Year:

Manufacturing Facility:

Plot No. E-9, E-7, E-8 MIDC Chikalthana, Aurangabad Aurangabad 431006 Maharashtra State, India

Product:

trimebutine maleate

Initial Registration:

2020-11-05

Registration Number:

20180130-13-B-404-13(22)

MFDS Classification:

Appendix 1

Applicant:

Nexus Co., Ltd.

Last Modified:

2023-10-17

Country:

china

Status:

Withdrawal

Manufacturer:

Zhejiang East-Asia Pharmaceutical Co., Ltd. Ltd.

Withdrawal Date:

2023-10-17

Final Annual Reporting Year:

Manufacturing Facility:

Coastal Industrial City, Pubagang town, Sanmen county, Zhejiang, PRChina

Product:

Leuprorelin acetate

Initial Registration:

2022-06-10

Registration Number:

20220610-210-J-1313

MFDS Classification:

Appendix 1

Applicant:

NIBEC Co., Ltd.

Last Modified:

Country:

korea

Status:

Active

Manufacturer:

NIBEC Co., Ltd.

Withdrawal Date:

Final Annual Reporting Year:

Manufacturing Facility:

116 Bamdi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do

Product:

Heparin sodium

Initial Registration:

2013-08-23

Registration Number:

20100211-124-G-17-01(10)

MFDS Classification:

Appendix 1

Applicant:

NM Pharmaceutical Co., Ltd.

Last Modified:

Country:

china

Status:

Active

Manufacturer:

Yantai Dongcheng Biochemicals Co., Ltd.

Withdrawal Date:

Final Annual Reporting Year:

2024

Manufacturing Facility:

No. 7, Changbaishan Road, Yantai Development Zone, Shandong Province, PR China.

Product:

Memantine hydrochloride

Initial Registration:

2022-07-26

Registration Number:

20210518-209-J-917(1)

MFDS Classification:

Appendix 1

Applicant:

Northeast Farm Korea Co., Ltd.

Last Modified:

Country:

India

Status:

Active

Manufacturer:

Unichem Laboratories Ltd.

Withdrawal Date:

Final Annual Reporting Year:

Manufacturing Facility:

Plot No. 197, Sector-1, Pithampur, Dist. Dhar (M.P.), India

Product:

Remifentanil hydrochloride

Initial Registration:

2014-09-02

Registration Number:

Number 5-1-ND(2)

MFDS Classification:

new substance

Applicant:

Nosa Chemical 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

Product:

Terbinafine hydrochloride

Initial Registration:

2005-08-31

Registration Number:

20050831-49-A-98-08

MFDS Classification:

Appendix 1

Applicant:

Novartis Korea

Last Modified:

2020-03-17

Country:

Status:

Active

Manufacturer:

[Partial Contract Manufacturing (Client)] Novartis Pharma AG@[Partial Contract Manufacturing (Manufacturer)] Novartis Ringaskiddy Ltd@[Partial Contract Manufacturing (Manufacturer)] Novartis Pharma Stein AG

Withdrawal Date:

Final Annual Reporting Year:

2022

Manufacturing Facility:

[Partially Contract Manufacturing (Client)] Lichtstrasse 35, 4056 Basel, Switzerland @ [Partially Contract Manufacturing (Manufacturer)] Ringaskiddy Co. Cork Ireland @ [Partially Contract Manufacturing (Manufacturer)] Schaffhauserstrasse 4332 Stein Switzerland