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