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