In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nitroglycerin in Dextrose 5% Drug Master File in Korea (Nitroglycerin in Dextrose 5% KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nitroglycerin in Dextrose 5%. The MFDS reviews the Nitroglycerin in Dextrose 5% KDMF as part of the drug registration process and uses the information provided in the Nitroglycerin in Dextrose 5% KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nitroglycerin in Dextrose 5% 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 Nitroglycerin in Dextrose 5% API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nitroglycerin in Dextrose 5% suppliers with KDMF on PharmaCompass.