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