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