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