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