2025.01.10
Shanghai Kryogene Technology Co., Ltd. is pleased to announce that its Drug Master File (DMF) for Cell Freezing Media-CGT has been successfully acknowledged by the U.S. Food and Drug Administration (FDA). The DMF, assigned number 040563, was submitted on September 27, 2024, and covers our innovative cell freezing media designed for cell and gene therapy applications.
This milestone marks a significant step forward for Kryogene as it validates the quality and regulatory compliance of our product. The successful filing enables our cell freezing media to be referenced in various drug applications, including New Drug Applications (NDAs) and Investigational New Drug Applications (INDs), upon submission of a Letter of Authorization (LOA).
We are committed to maintaining the highest standards of quality and compliance, and this DMF filing is a testament to our dedication to providing reliable and effective solutions for the cell and gene therapy industry. We look forward to further expanding our presence in the global market and supporting the development of cutting-edge therapies.
