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