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