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