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