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