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