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