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