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