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