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