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DMFs can provide medical and pharmaceutical packaging benefits

Although not required by law or FDA regulation, Drug Master Files provide information about facilities, manufacturing, processing, packaging, and storage of drugs to support New Drug Applications.

Plastics scientists work to meet medical packaging standards and FDA requirements.'
Plastics scientists work to meet medical packaging standards and FDA requirements."

The U.S. FDA’s “Drug Master Files: Guidelines” defines DMF as “a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

“The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these. A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.”

The agency describes DMF procedures here.

In the following article, Plastics Color Corp., a provider of color concentrates, functional additives, and custom polymer masterbatches for the plastics industry, describes the medical and pharmaceutical benefits of DMFs.

Manufacturers that use custom polymer solutions, compounds, colorants, and plastic additive masterbatches in the medical or pharmaceutical markets may benefit greatly by using a DMF. DMFs are important because they contain information on the chemistry, manufacturing, and specifications of several packaging components used for certain medical products.

Maintaining a DMF is critically imperative in both medical and pharmaceutical markets. Some drugs can react with certain polymers within plastic packaging or plastics applications in a way that produces a negative effect on the drug. Understanding the regulatory requirements and end use is essential to successfully formulating a concentrate or additive package that meets all requirements. Since this formulation process is so important, once a polymer concentrate or additive package is approved, communicating that information with those submitting to the FDA is crucial through the aid of a DMF.

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