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