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