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