01 1Cambrex Charles City, Inc
02 1Gilead Alberta ULC
01 2Korea Ezai Co., Ltd.
01 2Filgotinib maleate
01 2U.S.A
Registrant Name : Korea Ezai Co., Ltd.
Registration Date : 2022-04-01
Registration Number : 205-26-ND
Manufacturer Name : Cambrex Charles City, Inc
Manufacturer Address : 1205 11th Street - Charles City, IA 50616, USA
Registrant Name : Korea Ezai Co., Ltd.
Registration Date : 2022-04-01
Registration Number : 205-27-ND
Manufacturer Name : Gilead Alberta ULC
Manufacturer Address : 1021 Hayter Road, Edmonton, Alberta, T6S 1A1, Canada
A Filgotinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Filgotinib, including repackagers and relabelers. The FDA regulates Filgotinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Filgotinib 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 Filgotinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Filgotinib supplier is an individual or a company that provides Filgotinib active pharmaceutical ingredient (API) or Filgotinib finished formulations upon request. The Filgotinib suppliers may include Filgotinib API manufacturers, exporters, distributors and traders.
click here to find a list of Filgotinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Filgotinib Drug Master File in Korea (Filgotinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Filgotinib. The MFDS reviews the Filgotinib KDMF as part of the drug registration process and uses the information provided in the Filgotinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Filgotinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Filgotinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Filgotinib suppliers with KDMF on PharmaCompass.
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