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