Great news! YSK recently received a confirmation letter from the U.S. Food and Drug Administration (FDA) stating that its independently developed and manufactured insect cell culture medium, IB907, has officially completed the US FDA Type II Drug Master File (DMF) filing process (DMF No.: 044150).

The DMF filing documentation encompasses details such as the medium's formulation, raw materials, manufacturing processes, and processing steps. It supports applications for Investigational New Drugs (IND), New Drug Applications (NDA), and Biologics License Applications (BLA), thereby significantly shortening the timeline for drug review and approval.

List of YSK Products with DMF Filings

If you are using the four products listed above for research on antibody drugs, protein-based drugs, or gene therapy projects, and need to submit an IND, NDA, ANDA, another DMF, or an export application to the FDA, please contact your sales representative or reach out via our official WeChat account to request authorization. We will provide a Letter of Authorization (LOA) allowing the FDA to directly review the relevant DMF technical content during the drug application review process, thereby accelerating the FDA's review timeline.