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