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