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