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