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