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