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