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