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