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