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