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