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