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