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