Why Drug Master Files Are Important and How to Create One

Drug Master Files, or DMFs, are submissions to the Food and Drug Administration that provide confidential, detailed information about facilities, processes and other specifics used to manufacture, process, pack or store drugs intended for human use.

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Benefits of DMFs for the Medical and Pharmaceutical Industries

Plastics are widely used for medical and pharmaceutical applications. Having an up-to-date DMR is an indication of both credibility and reliability. Plastics Color Corporation offers a catalog of colors, additives and concentrates packaged with FDA-accepted DMFs.

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Value of a Drug Master File

It’s important for companies in the plastics industry supply chain to be in compliance with the various regulatory standards and procedures. Since plastics are ubiquitous and touch nearly every corner of our day-to-day lives, health and safety are critical issues for Plastics Color to ensure that the colorants and functional additives that go into our customers’ plastics products meet strict standards.

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Medical and Pharmaceutical Packaging Benefits With Drug Master Files

DMFs are important because they contain information on the chemistry, manufacturing, and specifications of several packaging components used for certain medical products. The primary benefits of a DMF for plastic use include legal protection for all entities involved, confidentiality of specific formulations, documented accuracy of chemistries, and communication of different parties involved.

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