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