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