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