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