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