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