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