Drug Master Files

Comprehensive DMF Submissions:

Ananda Scientific has filed Drug Master Files (DMFs) with the FDA to support the use of our investigational drugs in FDA-approved clinical trials. These DMF’s describe the manufacturing and quality control processes we follow to ensure top-tier quality and uniformity of our investigational drug products.

We periodically update our DMF’s to align them with the refinements we make to our products though continuous improvement efforts, and to address feedback we get from the FDA. In addition, these DMF’s reflect the efforts we have made to develop validated test methods for all our products and demonstrate our strong commitment to compliance with all FDA regulations.

Our DMF’s have been referenced in multiple FDA approved clinical trials.