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