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