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