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