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