ISO 13485 certified manufacturing sites ISO 10993 and USP Class VI compliant solutions

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.

Gamma 650 Parque Industrial Santa María Ramos Arizpe, Coahuila 25900 México has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 14001:2015 The Environment Management System is applicable to: COMPOUNDING OF THERMOPLASTIC PRODUCTS This certificate may be found on the ABS QE Website (www.abs-qe.com).

Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard Solutions compliant with USP Class VI and ISO-10993 regulations

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopoeia, and ICH Q3D protocols for differentiation and patient adherence support Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce product carbon footprint

They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need   Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring

Global ISO Certificate Library

ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP and evaluations reduce risk of non-compliance during regulatory submission​

All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.

Our PCF calculator is third-party certified by TÜV Rheinland and aligns with the ISO 14067:2018 Standard for quantifying and reporting the carbon footprint of a product.