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