Adherence to FDA requisite current Good Manufacturing Practices (cGMP) assures consistent identity, characteristics, purity, and most importantly behavior of a component of drug products by requiring that manufacturers of medications adequately control manufacturing operations through proper monitoring and design.

Registration with the U.S. Food & Drug Administration (FDA) submits a facility to routine inspection by an expert evaluator and timely investigation of any reported issues with manufactured products.

Using the criteria and testing protocols specified by the USP-NF monograph as its foundation, trū Chitosan provides a documented and signed comprehensive Certificate of Analysis that confirms the identity, key characteristics, and impurity levels for each individual lot of trū Chitosan.

Shrimp exoskeleton tissue is an approved source for USP conforming chitosan. trū Chitosan is produced exclusively from exoskeleton tissue harvested from shrimp grown with in our own captive, controlled indoor shrimp production facilities enabling chain of custody from a shrimp cohort producing the exoskeleton raw material to finished chitosan and every step in between fully documented by an industry exclusive and comprehensive Certificate of Origin.

From growing the shrimp to harvesting the exoskeleton to extraction, refinement, and analysis, trū Chitosan is the only producer of medical-application chitosan within the United States.