SigNature DNA Offers Authenticity and Traceability for Pharmaceutical Global Supply Chains
February 25, 2016 11:42 AM EST
STONY BROOK, NY -- (Marketwired) -- 02/25/16 -- Applied DNA Sciences, Inc. (NASDAQ: APDN) (NASDAQ: APDNW) (Twitter: @APDN), a provider of DNA-based supply chain, anti-counterfeiting and anti-theft technology, product genotyping and product authentication solutions, has introduced its SigNature® DNA marker into new pharmaceutical-grade and packaging inks suitable for tablet and packaging marking, in partnership with Nissha Printing Company ("Nissha") and Kishu Giken Kogyo Co.,Ltd. ("KGK"). From February 24-26, 2016, SigNature DNA ink and printing solutions will be presented at Medical Japan Expo in Osaka.
Powered by unique botanical-based SigNature DNA, these inks allow for seamless marking at the point-of-manufacture, ensuring that original raw materials or ingredients used to produce pharmaceuticals are fully protected and traceable to point-of-sale. APDN has completed trials with Nissha and KGK partners, proving that unique SigNature DNA marks can be authenticated on the pharmaceutical tablet and packaging materials. The technology satisfies the principles established by FDA Guidelines for inclusion in pharmaceutics and is equally applicable to food and cosmetic products.
APDN can also DNA-mark other elements of a finished product including bulk Active Pharmaceutical Ingredient (API), cellulosic excipients (bulk fillers) that are used in almost all drug tablets and the commercial binders and enteric coatings that hold prescription and Over-the-Counter (OTC) drug tablets together. This unique, multi-factor identification enables verification of its authenticity at any point in the supply chain.
Countries around the world have accelerated their adoption of drug quality regulations in the effort to ensure product integrity and protect patient safety. Regulations covering more than 75% of the global medicine supply by 2018 include packaging standards from Japan's Ministry of Health, Labor and Welfare and directives from the U.S. FDA's Title II of the Drug Supply Chain Security Act. Companies acting now can benefit from SigNature DNA solutions that forensically backstop pharmaceutical traceability.
"The scalability of SigNature DNA for pharmaceuticals solves many supply chain challenges as recently highlighted in Scientific American*. Many of our clients that are using SigNature DNA know that forensic tagging and authentication will protect them from the risk of legal liability and product recall while maintaining profitability and market differentiation," stated Dr. James A. Hayward, President and CEO, APDN.
* For more information please see article "Authentic Drugs Tagged with Plant DNA Could Help Snare Fake Meds" published in Scientific American on January 12, 2016.
