Breaking News

We are pleased to announce that YSK Bio has received an official confirmation letter from the U.S. Food and Drug Administration (FDA). The affinity chromatography resin — Affinity Resins (Protein A Captarose HL) — independently developed and manufactured by YSK Bio, has been formally registered under the FDA Type II Drug Master File (DMF), with the assigned reference number: 043630.

The DMF submission encompasses comprehensive documentation including the formulation, raw materials, manufacturing processes, and processing procedures of the chromatography resin. This filing can be referenced in support of Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biologics License Applications (BLA), significantly streamlining the drug review and approval timeline.

The Significance of DMF Filing

The core value of a DMF filing lies in its role as a bridge between active pharmaceutical ingredient (API) manufacturers and regulatory review authorities, enabling companies to demonstrate product compliance and consistency in a structured and verifiable manner. It also provides drug regulatory agencies with a scientifically grounded framework for systematically evaluating the quality of pharmaceutical excipients and raw materials.

Achieving a successful DMF filing not only validates a company's end-to-end quality management capabilities — from raw material selection through to final quality control — but also signifies that its industrialization standards and quality assurance systems have undergone rigorous evaluation by international pharmaceutical regulatory bodies. This milestone formally positions YSK Bio among the leading participants in the global biopharmaceutical core supply chain.

YSK Bio's Current DMF-Listed Products

How to Reference YSK Bio's DMF Files

If you are utilizing any of the three products listed above in the research and development of antibody drugs, protein-based therapeutics, or gene therapy-related programs, and require supporting DMF documentation for submission to the FDA — including Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), cross-referenced DMF filings, or export applications — please contact your dedicated sales representative or reach out via our official WeChat account to submit an authorization request.

Upon approval, YSK Bio will provide a Letter of Authorization (LOA), granting the FDA the right to directly access and review the technical content contained within the referenced DMF during the evaluation of your drug application, thereby facilitating an expedited FDA review process.