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