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