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