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