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