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