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