Good news express

Great news! Recently, YSK Bio received confirmation from the U.S. Food and Drug Administration (FDA) that its independently developed and manufactured CHO cell culture medium (Aplo CHOL2) has successfully completed FDA Type II DMF registration, with registration number: 042875.

The DMF (Drug Master File) documentation includes details such as the culture medium formulation, raw materials, manufacturing process, and processing procedures.   It can be used for Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biologics License Applications (BLA), significantly shortening the drug review and approval time.

The significance of DMF registration

The value and core function of DMF registration lie in building a bridge for active pharmaceutical ingredient (API) manufacturers to demonstrate the compliance and stability of their products to regulatory authorities, while also providing drug regulatory agencies with a systematic and scientific basis for verifying the quality of pharmaceutical excipients. Successfully obtaining DMF registration not only validates a company's end-to-end management capabilities from raw material selection to final quality control, but also signifies that its industrialization level and quality assurance system have passed rigorous international drug regulatory assessments, officially placing it among the leading companies in the international biopharmaceutical core supply chain.

How to reference the DMF file for YSK Bio culture media?

If you are using CHO cell culture medium (Aplo CHOL2) for research projects related to antibody drugs/protein drugs or gene therapy, and you need to submit an Investigational New Drug (IND) application, New Drug Application (NDA), Abbreviated New Drug Application (ANDA), another DMF, or export application to the FDA, please contact your sales representative or submit an authorization request on our website. We will provide you with an authorization letter, granting the FDA permission to directly review the relevant DMF technical content during the drug application review process, thereby accelerating the FDA review process.