Clariant Corporation

The FDA is getting more and more stringent with the use of colorants in medical device components. Clariant understands the regulatory rigor and has supported our submissions by giving us information directly, and by dealing with the FDA directly thru their masterfile. The responsiveness of Clariant to our needs has enabled us to keep their colorant in our product - a statement that is not universal as we had to drop at least one other colorant supplier.

Strengths: Regulatory support for plastic colorants

Needs to improve: none

Clariant produces Medical Grade Polymer Colorants. They also maintain a "Master File" with the FDA. This is crucial as it streamlines approval of products regulated by the FDA. Without a master fils, a company must provide you, the user, with the required FDA data. This is often a confidentiality issue. Having a Master File eliminates this problem.

Strengths: Medical Grade Polymer Colorants

Needs to improve: None

R&D uses this vendor for their raw plastics for tubing modeling and development of catheters and guidewires for neurology. The catheters and guidewires are very flexible to navigate vessels in the body.

Strengths: Plastics for tubing with a quality selection of colorants

Needs to improve: more expensive than other plastic raw material vendors

Great vendor for medical grade polymer colorants. Will work with you to make sure the required safety data is available for Regulatory submissions. Responsive and Helpful. Custom colors are available.

Strengths: Polymer Colorants

Needs to improve: None

Good quality colorant with repeatable color and sufficient documentation. As the FDA demands tighter controls on colorants, Clariant keeps exceeding the requirement.

Strengths: Medical Grade Colorant

Needs to improve: None

excellent customer service; team is responsive and doesn't think they are the CIA or FBI with their "corporate secrets"

Strengths: colorant

Needs to improve: none

We purchase the colorant for our extrusions from Clariant with ease. Their deliveries are always on time.

Strengths: Colorant

Needs to improve: None