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