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