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