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