FDA Drug Master Files for Packaging Materials: What They Cover

A Drug Master File is a submission to the FDA that holds confidential information about a material or component. Packaging suppliers use it to support customer filings without disclosing proprietary detail.

What it typically holds

• Material composition and manufacturing information
• Quality control and testing approach
• Supporting data for the material's intended use

How customers use it

• Reference the file in their own submission
• An authorisation letter allows the agency to review the file
• The file supports, but does not replace, the customer's own data

Next steps

See Certifications or request a quote.