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