Serialization Solutions Pharma Regulations Drive Growth

Editor: Manja Wühr

Within the space of ten years, Antares Vision has undergone a remarkable transformation. The regulatory framework which governs the pharmaceutical markets has driven enormous growth, and that is unlikely to change in the near term. However, the resourceful Italians are already thinking about what comes next.

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Antares Vision headquarters in Travagliato/Italy
Antares Vision headquarters in Travagliato/Italy
(Source: Antares Vision)

One out of every ten pharmacies in Germany was the victim of pharmaceutical counterfeiting in 2016 according to a survey among 231 pharmacies conducted by the Institut für Handelsforschung. These figures impressively demonstrate the importance of serialization solutions which make each pharmaceutical package unique. In addition to the marking and verification hardware, software solutions are also needed.

To ensure the quality, integrity, safety, traceability and authenticity of all types of pharmaceutical products, Antares Vision has been developing control systems and track & trace solutions since 2007. What started off ten years ago with 18 employees in the small picturesque Italian city of Travagliato in Lombardy has developed into an international full-line supplier with eight subsidiaries and 50 distribution partners. With 1,092 installed serialization and aggregation modules and roughly 20,000 installed inspection systems, the growth of the Italian company has been remarkable.

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Serialization in the Pharma Market — and then what?

Regulatory serialization requirements were one of the major factors behind the rapid growth of the company. Beginning with Turkey and followed by countries such as South Korea, Argentina and China, application of unique serial numbers has become mandatory. Many other countries introduced similar legislation, for example Russia, the US, Brazil, India, Egypt, Saudi Arabia and the EU. Antares Vision will continue to find lucrative sales markets in the worldwide pharmaceutical industry. It is hardly surprising that the Italian company will introduce a software solution for data exchange interoperability at all four ISA95 stack levels within this autumn.

However the company's business vision does not stop at the boundaries of the pharmaceutical industry. Between now and 2020, CEO Emidio Zorzella intends to expand serialization into other markets, e.g. industries such as medical equipment, food & beverage and cosmetics. But why should these industries introduce the same paradigm change as the pharmaceutical industry? Dirk Hendrik Kneusels, Head of Antares Vision's German subsidiary, cites five key reasons:

  • Regulatory compliance: Some countries have introduced laws which apply to specific food categories, for example baby food in China. Strict rules have been also defined for tobacco in the European Directive 2014/40/EU requiring among other things an interoperable track & trace system.
  • Brand Protection: Product counterfeiting causes financial losses running in the billions at German companies and erodes confidence in the brand. In addition, serialization and aggregation facilitate selective recalls and reduce associated costs.
  • Consumer Protection: There is a current trend to protect specific food products, for example to reduce allergy risks by making provision of information about the ingredients mandatory.
  • Margin Protection: The cosmetic industry is already applying serial numbers to high-value products to protect their retail chain.
  • Extraction of Information: Serialization provides access to a wealth of data.

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