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