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