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