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