In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Remibrutinib Drug Master File in Korea (Remibrutinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Remibrutinib. The MFDS reviews the Remibrutinib KDMF as part of the drug registration process and uses the information provided in the Remibrutinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Remibrutinib 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 Remibrutinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Remibrutinib suppliers with KDMF on PharmaCompass.