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