01 4BrightGene Pharmaceutical Co. , Ltd.
02 2KOLON LIFE SCIENCE, INC.
01 4Argatroban
02 1Argatroban (AG-B1)
03 1Argatroban (C)
01 4China
02 2South Korea
Registration Number : 305MF10140
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2023-12-22
Latest Date of Registration : 2023-12-22
Registration Number : 302MF10033
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2020-03-02
Latest Date of Registration : 2021-08-20
Registration Number : 304MF10018
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2022-01-26
Latest Date of Registration : 2022-01-26
Registration Number : 230MF10028
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2018-02-15
Latest Date of Registration : 2021-03-05
Registration Number : 218MF10153
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2006-01-31
Latest Date of Registration : 2019-09-17
Registration Number : 303MF10076
Registrant's Address : 110, MAGOKDONG-RO, GANGSEO-GU, SEOUL, KOREA
Initial Date of Registration : 2021-05-10
Latest Date of Registration : 2021-05-10
A Argatroban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban, including repackagers and relabelers. The FDA regulates Argatroban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Argatroban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Argatroban supplier is an individual or a company that provides Argatroban active pharmaceutical ingredient (API) or Argatroban finished formulations upon request. The Argatroban suppliers may include Argatroban API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Argatroban Drug Master File in Japan (Argatroban JDMF) empowers Argatroban API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Argatroban JDMF during the approval evaluation for pharmaceutical products. At the time of Argatroban JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Argatroban suppliers with JDMF on PharmaCompass.
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