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