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