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Healthcare/ DMF

– 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.

– 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.

– Chroma Color offers a catalog of colors, additives and concentrates packaged with FDA-listed DMFs. 

Click to download our Healthcare Product Information PDF

Our Corporate Quality Systems and Regulatory Affairs Manager is available to help with any questions relating to the DMF process – Call: Jennifer Presnell 800.247.7428 or email [email protected]

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Chroma Color Corporation Medical & Healthcare Capabilities

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.

ISO/IEC 17025

Chroma Color’s lab in Asheboro, NC is accredited by the American Association for Laboratory Accreditation (A2LA) to meet the requirements set forth in ISO/IEC 17025. Our state-of-the-art testing and production equipment is complimented by the unparalleled quality and experience of our staff. The labs work in close union with the Chroma Color Solutions Center to develop new polymer solutions for an ever-expanding range of applications.

Watch this video on ISO/IEC 17025,  and Quality & Compliance Policy

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Chroma Colors ISO/IEC 17025 Quality & Compliance Policy

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