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