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