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