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