Drug Master Files

Drug Master File

Plastics Color offers a catalog of colors, additives and concentrates packaged with FDA-approved Drug Master Files (DMFs).

DMFs provide the Food and Drug Administration (FDA) confidential, detailed information about facilities, processes or articles used to manufacture, process, package or store drugs intended for human use.

The most important benefit of a DMF is that it streamlines the FDA approval process for colors, additives and concentrates intended for medical and pharmaceutical applications and helps brand owners get their product into the marketplace faster.

Plastics Color owns the DMF formulations. As such, brand owners (OEM’s) are able to change molder as they prefer.

DMFs = Faster to Market

DMFs contain valuable information about the chemistry, manufacturing and specifications of components. Manufacturers of compounds, colorants, and additive masterbatches are not required by law to supply a DMF. But:

  1. A DMF is imperative for medical and pharmaceutical customers, especially when two or more firms work in partnership to manufacture a product.
  2. By supplying a DMF, Plastics Color helps to minimize a time-consuming step for its customers, thereby expediting the development process for their product.
  3. Without a DMF, medical and pharmaceutical companies would have to communicate the same information to the FDA separately – a more time-consuming process.
  4. Plastics Color’s DMF colors and additives are made for products that come into contact with drugs and other medical substances as well as medical devices.
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