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 Drug Master File in Korea (Fusidic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fusidic Acid. The MFDS reviews the Fusidic Acid KDMF as part of the drug registration process and uses the information provided in the Fusidic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fusidic Acid 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fusidic Acid suppliers with KDMF on PharmaCompass.