In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1-(b-D-Arabinofuranosyl)cytosine Drug Master File in Korea (1-(b-D-Arabinofuranosyl)cytosine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1-(b-D-Arabinofuranosyl)cytosine. The MFDS reviews the 1-(b-D-Arabinofuranosyl)cytosine KDMF as part of the drug registration process and uses the information provided in the 1-(b-D-Arabinofuranosyl)cytosine KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1-(b-D-Arabinofuranosyl)cytosine 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 1-(b-D-Arabinofuranosyl)cytosine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1-(b-D-Arabinofuranosyl)cytosine suppliers with KDMF on PharmaCompass.