What is the regulatory status of MACS GMP Products?

MACS GMP Products are manufactured and tested under a quality management system (ISO 13485) and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. For regulatory status in the USA, please contact your local representative.

Learn more about MACS GMP quality.

Premium gradeMACS GMP Grade
Quality management system-Produced under ISO13485
Product-specific documentationLot-specific CoA

Lot-specific CoA


Product information file

Design control-+
Sterilitysterile-filteredAseptically filled and tested for sterility (Ph. Eur.)
Biological activityLot-specific, standardized with international standard, determined after lyophilization
FormulationWithout carrier protein, animal component-free