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