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