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