Drug Master Files

Drug Master Files
Drug Master Files (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 compliance process for colors, additives and concentrates intended for medical and pharmaceutical applications and helps brand owners get their product into the marketplace faster.
Chroma Color offers a catalog of colors, additives and concentrates packaged with FDA-listed DMFs.
Our Corporate Quality Systems and Regulatory Affairs Manager is available to help with any questions relating to the DMF process.

Purity and safety are paramount for all plastic products intended for human use. Colors, facilities and production processes have to be reviewed and deemed compliant by the Food and Drug Administration (FDA) before any production can begin – a process that can be time consuming and affect your business timeline.
Important facts about 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.
  • DMFs streamline the FDA compliance process for colors, additives and concentrates intended for medical and pharmaceutical applications and helps brand owners get their product into the marketplace faster.
  • Chroma Color owns the DMF formulations, which means brand owners can change molders as they prefer.
  • A DMF is imperative for medical and pharmaceutical customers, especially when two or more firms work together to manufacture a product.

Save Time And Money With Chroma Color
Manufacturers of compounds, colorants, and additive masterbatches are not required by law to supply a DMF. But by providing this service, Chroma Color helps minimize a time-consuming step and expedite the product development process for our customers. Our specialists can guide you through the process and help you get your product to market faster.
Contact a Chroma Color representative today to find out more.