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