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