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