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