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