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