A Drug Master File (DMF) is a confidential, detailed submission to the U.S. Food and Drug Administration (FDA) that provides information about the facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of human drugs. While not legally required, DMFs are critical for companies that want to supply Active Pharmaceutical Ingredients (APIs), excipients, or packaging components to drug manufacturers seeking FDA approval.

By submitting a DMF, suppliers protect proprietary information while enabling drug product manufacturers to reference the DMF in their Investigational New Drug (IND), Abbreviated New Drug Application (ANDA), or New Drug Application (NDA) submissions. This streamlines the approval process without requiring full disclosure of sensitive manufacturing details to third parties.

Types of DMFs include:

• Type II – For APIs, drug substances, and intermediates.
• Type III – For packaging materials in direct contact with drug products.
• Type IV – For excipients, colorants, flavors, or other additives.
• Type V – For FDA-accepted reference information not covered under other types.

Maintaining an active DMF requires regular updates to reflect changes in manufacturing processes, facilities, quality systems, or raw material sourcing. Failure to update a DMF can result in FDA delays, deficiencies, or rejection of related product applications.

At XPRO America, we assist companies with:

• DMF preparation and formatting as per FDA’s electronic submission requirements.
• Confidentiality protection while allowing client companies to cross-reference the DMF.
• Gap analysis and compliance review to ensure completeness and accuracy.
• Electronic submission through the FDA ESG (Electronic Submissions Gateway).
• Ongoing maintenance and updates to keep DMFs current and aligned with FDA standards.

Our experts ensure that your DMF submission is comprehensive, compliant, and properly structured for seamless FDA review. With our guidance, suppliers can expand their market reach, enhance partnerships with drug product manufacturers, and ensure regulatory acceptance.

XPRO America provides FDA DMF preparation, filing, and maintenance services for APIs, excipients, and packaging components under Type II, III, IV, and V DMFs.