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