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