c-LEcta successfully filed a Drug Master File (Type II) with the US FDA in 2021.
We spoke with Dr. Paula Pescador, our Vice President Regulatory Affairs and prepared a document that covers basic questions concerning the DMF File.
For more detailed information how to use the DMF File please request the US FDA DMF Support for DENARASE® GMP-grade: https://denarasetest.c-lecta.com/downloads