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