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