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