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