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