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