NanoEncryption anti-counterfeiting gains FDA approval

By Nick Taylor

- Last updated on GMT

Related tags: Authentication

The US Food and Drug Administration (FDA) has approved
NanoEncryption technology, a method for applying anti-counterfeit
measures to dosage forms.

NanoInk is the company behind the technology, which can apply multi-layered, authentication and tracing brand protection onto individual dosages. The company believes that this complex information applied to individual dosage forms presents too great an obstacle for counterfeiters. James Hussey, NanoInk CEO, said: "FDA approval of our NanoEncryption technology is an important milestone for public health and the continued fight to secure the pharmaceutical supply chain​. "This novel technology is virtually impossible to copy and creates an impenetrable barrier to reverse engineering by counterfeiters​." NanoEncryption technology can apply a "virtually unlimited​" array of information to dosage forms, such as manufacturing information, dosage, expiration date, and the targeted site of distribution. This information is applied at the nanoscale, which creates a covert protection system for individual dosages. Information can be applied directly to tablets, capsules or vials depending on the delivery form of the pharmaceutical. NanoInk regards this as complementary to overt solutions such as colour shifting dyes or packaging based measures like radio-frequency identification (RFID). The information applied to the dosage forms can be authenticated using the tools at NanoInk's authentication centres. This process is said to take 24 to 48 hours and does not destroy the medicine. The process of incorporating the technology into existing manufacturing lines is said to be simple, with most manufacturing facilities already having the technology in their operations. Consequently the efficiency and cost-effectiveness of the production process is not adversely affected. In addition, the technology does not alter the chemical composition of the dosage form, negating the need for drawn out and expensive navigation of regulatory barriers. NanoInk believes it has created a long-term solution to the counterfeiting problem, which can not be circumnavigated using reverse engineering. As such it would represent a sound investment for pharmaceutical manufacturers, with NanoInk believing the technology "can easily pay for itself in less than a year​".

Related topics: Drug Delivery, QA/QC

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