Kono Mab ChromA has been filed with FDA DMF, helping Chinese pharmaceutical companies to apply for a step closer to the United States!

Recently, Kono Biotech has received a confirmation letter from the US Food and Drug Administration (FDA). Kono Mab ChromA affinity chromatography medium has obtained DMF filing from FDA, filing number: MF038691. This marks a step closer to helping Chinese pharmaceutical companies declare in the United States.

DMF (Drug Master File) is a dossier submitted to FDA for review. The information includes: detailed information on production facilities, process flow, quality control, raw materials and packaging materials used in manufacturing, processing, packaging, storage and wholesale of human drugs. Investigational New Drug Application (IND), New Drug Application (NDA), New Drug/Generic Drug Application (ANDA) used to support biological drugs.

After completion of filing registration, if Mab ChromA is used in the project in the future, the customer of Kono can directly quote the corresponding DMF filing number to replace the specific information about raw materials and excipients in the application materials when submitting the new drug registration application to FDA, which not only shortens the review and evaluation time of the product, speeds up the application process, but also reduces the risk of technology leakage of the enterprise.