US DMF Filing Process Explained: Ultimate Guide to API Regulatory Compliance and FDA Submissions Compliance-Ready Guide for API Regulatory Affairs Professionals Introduction to the US DMF Filing Process and Its Importance Drug Master Files (DMFs) are confidential submissions made to the US Food and Drug Administration (FDA) that provide detailed information about the facilities, processes, and materials used in the manufacturing, packaging, and testing of active pharmaceutical ingredients (APIs) or excipients. A DMF supports regulatory submissions such as New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), without disclosing proprietary information to applicants. By 2025,…