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