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