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