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