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