Deadline Fast Approaching for Pharmaceutical Supply Chain Organizations to Comply with Anti-Counterfeit Drug Legislation

In an effort to combat the growing multimillion dollar counterfeit drugs industry, new legislation will be enacted on January 1, 2015 that forces organizations across the pharmaceutical supply chain to implement comprehensive identification and tracking processes for prescription drugs. To ensure compliance with the new Drug Supply Chain Security Act (DSCSA, and Title II of the Drug Quality Security Act), Axway (Paris:AXW), a market leader in governing the flow of data, has introduced Axway Cloud Global Traceability and Compliance Service, a solution that enables organizations to meet the requirements of the DQSA traceability law.

Axway Cloud Global Traceability and Compliance Service is a DSCSA-ready serialization solution that manages regulatory requirements, centrally, while also reducing the cost and complexity of compliance with traceability laws. Deploying the solution via a private cloud enables organizations to gain fast, economical access to Axway’s enterprise-class technology; eliminate overhead required to expand current infrastructure; and leverage economies of scale inherent in cloud computing while maintaining the highest levels of security, reliability and scalability.

Counterfeit drugs account for up to one million deaths globally each year, and in 2013 alone, more than 10 million potentially dangerous medicines were seized by law enforcement agencies around the world. To address this growing concern and to improve the safety and integrity of the global supply chain, the DSCSA will require appropriate organizations to identify and trace prescription drugs as they are distributed in the United States and make the product transaction information available on a batch level. Consequently, organizations need to implement comprehensive traceability strategies, processes and solutions in order to comply with the new law. In addition, a second deadline of November 2017 will require organizations to serialize and make transaction information available on a package level.

"Counterfeit drugs are a tremendous global problem. As a company whose primary goal is producing medications that save lives cost-effectively, we are heavily invested in maintaining the safety of the pharmaceutical supply chain,” said Chirag Patel, Co-CEO and Chairman, Amneal Pharmaceuticals. "With Axway Cloud Global Traceability and Compliance Service, we not only have the peace of mind that we’re going to be compliant with the progressive regulations that are being put in place, but also that we’ll be able to do so while saving time, money and resources.”

Designed to support a range of market regulations and requirements, Axway Cloud Global Traceability and Compliance Service is a GS1 standards-based solution and is the industry’s only solution that is both EPCIS standard certified and 21 CFR Part 11 compliant. Axway Cloud Global Traceability and Compliance also enables additional information sharing in the supply chain by supporting ASN 856, which electronically communicates shipment contents to appropriate trading partners.

"We work with 80 percent of healthcare distributors and more than 250 pharmaceutical manufacturers to govern their flow of data and ensure compliance with complex supply chain regulations,” said Atif Chaughtai, director of healthcare solutions, Axway. "By providing industry leaders such as Amneal Pharmaceuticals with Axway Cloud Global Traceability and Compliance Service, we’re giving organizations a simple and cost-effective way to comply with the January 1^st 2015 DQSA deadline and 2017 serialization deadline.”

For more information about Axway Cloud Global Traceability and Compliance Service visit: http://www.axway.com/sites/default/files/repository/Axway_Datasheet_Cloud-Global-Traceability-and-Compliance-Service_EN.pdf

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About Axway

Axway (NYSE Euronext: AXW.PA), a market leader in governing the flow of data, is a global software company with more than 11,000 public- and private-sector customers in 100 countries. For more than a decade, Axway has empowered leading organizations around the world with proven solutions that help manage business-critical interactions through the exchange of data flowing across the enterprise, among B2B communities, cloud and mobile devices. Our award-winning solutions span business-to-business integration, managed file transfer, operational intelligence, API and identity management, and email security– offered on premise and in the Cloud with professional and managed services. Axway is registered in France with headquarters in the United States and offices in 19 countries. www.axway.com

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