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