Recipharm, a leading contract development and manufacturing organisation (CDMO), has released its first serialised products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.
In 2016 Recipharm committed to invest €40 million in preparing its facilities for the European Falsified Medicines Directive (EU FMD). The release of its first batch of serialised medicine to the European market is a significant milestone in the CDMO’s journey towards compliance with the new regulation. Recipharm’s other facilities across Europe will also be ready to release fully serialized products to Europe by the end of the year, two months ahead of the EU FMD deadline in February 2019.
Recipharm has already delivered over 2.5 million serialized packs to markets where serialisation regulations are in place, including China, South Korea, Saudi Arabia and Turkey, as well as 500,000 packs to the US. The company is implementing the technologies of cloud network provider TraceLink and software and hardware providers SeaVision and Marchesini.
Earlier this year, Recipharm launched its standalone serialization service, which allows pharmaceutical companies to benefit from its serialization capabilities as a standalone service even if their products are not manufactured by the CDMO. This will ensure that companies that have not yet prepared for the upcoming FMD deadline have a way to achieve compliance in time. As part of the service, Recipharm will add 2D codes, human readable text and tamper evidence to prepackaged medicines.