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