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