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