News

SEKISUI CHEMICAL CO., LTD. announces the successful registration of Ceglu^TM, a chemically synthesized polymer that enables the culture of iPS cells and can be solubilized to coat the surfaces of various materials, with the U.S. Food and Drug Administration (FDA) Drug Master File (DMF)*¹.

With this DMF registration, pharmaceutical companies and biotechnology ventures using Ceglu^TM will be able to reference the registered master file in their own Investigational New Drug (IND) applications and Biologics License Applications (BLA). This is expected to deliver the following benefits:

• Reduced regulatory documentation burden
• Enhanced reliability of quality and safety-related information
• Smoother and faster development and regulatory approval processes

*¹ Drug Master File (DMF) system
A Drug Master File (DMF) is a system under which manufacturers voluntarily submit confidential information related to quality—such as raw materials, excipients, and manufacturing processes—to the U.S. Food and Drug Administration (FDA).
When companies developing and manufacturing regenerative medicine products submit applications to the FDA, they are required to provide detailed information on drug substances (APIs). By registering such information in a DMF, our company can help simplify the procedures required for regulatory submissions.