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