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