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Value of a Drug Master File

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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.

That is why at Plastics Color, we have a number of certifications and accreditations to ensure our customers that they are getting only the best for their products. For example, we offer a Drug Master File (DMF) assistance. DMF in general consists of documentation prepared by drug makers of Active Pharmaceutical Ingredients (API) that is submitted to the FDA on a voluntary basis.

Typically, when two or more firms work in partnership on developing a drug, or just as importantly the plastic packaging for the drug, a DMF is important. It provides the regulatory authority (i.e. the FDA) with confidential, detailed information about the participating manufacturing facility, and the processes and the materials used to manufacture the product. While the DMF does contain detailed information about the participating manufacturers, the documentation allows companies to protect their intellectual property from the participating partners while being compliant with the regulatory requirements for the disclosure of these details.

In Plastics Color’s case, the various functional additives and colorants that go into producing masterbatches for the molding of vials, syringes and other containers that hold drugs provide customers with the assurance that it is FDA compliant. The same holds true for thermoformers of various types of blister packaging for medication.

Plastics Color continually invests in the quality and safety standards that our customers require when working with us. We provide them with the best in polymer materials that contain the unique properties to meet the application’s needs.

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