Nutriceutical and Pharmaceutical Authentication

TruTag® microtags can track drug product at the batch level

Markets:  Pharmaceutical and Nutritional

 

Counterfeit medicines are a serious public health problem that puts lives at risk and undermines the credibility of companies, brands, and the health system at large.  With an estimated 10% of all medicines being counterfeit, this represents not only a health concern but extensive financial risk to pharmaceutical and nutritional supplement companies.

Counterfeiting affects both high and lower priced drug products as well as generic and branded categories. As international criminal organizations become more sophisticated, packaging security is continuously defeated and proven inadequate. Additionally, when consumer safety and quality issues arise, the ability to confirm product authenticity and origin is critical to managing potential liability and financial damage to the brand.  TruTag microtags are manufactured of inert silica, also known as silicon dioxide (SiO2), which is “generally recognized as safe” (GRAS) by the FDA.  Silica has been in wide use as an ingredient for many years in a range of food products and pharmaceuticals.

In October 2011, the FDA issued final guidance regarding on-dose authentication solutions like TruTag microtags entitled: “Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting” in which the FDA recommends the use of well-studied materials, such as substances that are GRAS (like pure GRAS silica TruTag microtags). This opens the door for an on-dose solution like TruTag’s and we are certain this will change the authentication methodology for the industry going forward.  Click here for a copy of the FDA guidance.

TruTag solutions are uniquely etched through a highly proprietary process with an optical signature that is manufactured into the tags without the use of additional additives or markers. This allows the high-purity silica tags to be added to coatings and applied to the exterior of edible goods, or added to ingredients such as powders and used as a forensic marker, to be read and verified as part of an investigation or inspection process by authorized security or quality assurance personnel.