On-Product Traceability for

Pharmaceuticals and Nutraceuticals

Anti-Counterfeiting for
Pharmaceuticals and Nutraceuticals

Authenticate the Product, not just the Packaging

Touching nearly every therapeutic class, counterfeit medications total $200 billion annually. The World Health Organization estimates that up to 50% of online medicines could be fake. Additionally, counterfeit nutraceuticals pose a serious threat to consumers as more than 50% of FDA Class I recalls between 2004 and 2012 were for dietary supplements. Product identification and traceability stop at the unit-of-sale level, leaving a gap between product and package that exposes vulnerabilities in the supply chain and creates a significant risk of counterfeiting, tampering, and diversion.

The miniDART™ Solution

The miniDART delivers on-dose traceability with safe, covert DNA tags leveraging GS1 identifiers (FDA-GRAS). Manufacturers generate machine-readable tags that are mixed with coating or ingredients during regular pharmaceutical and nutraceutical production. In turn, downstream supply chain partners can verify the authenticity, origin, and safety of a dose or its ingredients within 25 minutes more accurately and reliably than with package-based serialization alone.

Use Cases and Benefits

Add covert, secure on-product authentication to high-end nutraceutical and active pharmaceutical ingredients (APIs), excipients, or finished doses, by providing a physical link between the product and existing digital supply chain systems. Utilize the miniDART and protect products against counterfeiting, tampering and diversion.

  • Protect revenue and reduce costs by utilizing on-product security to reduce the likelihood, costs, and response time associated with a recall due to counterfeiting or tampering and protects brand reputation
  • Eliminate price arbitrage as safeTracers™ leverage GS1 identifiers, providing an immutable, covert, physical link between the product and digital supply chain systems, including package-based serialization and blockchain solutions
  • Strengthen saleable returns by authenticating the actual product, not just the packaging, with results verified by an off-the-shelf qPCR reader within 25 minutes
  • Improve health and safety as on-dose traceability helps ensure more secure, authenticated products for the patients and consumers who depend on them, and gives wholesalers, pharmacists, health care providers, and retailers greater confidence in the safety and quality of their products
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