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