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