Recipharm, a leading contract development and manufacturing organisation (CDMO) has announced the launch of its standalone serialisation service ahead of the introduction of the EU Falsified Medicines Directive (FMD).
The new service is designed to offer pharmaceutical companies access to Recipharm's serialisation capabilities as a standalone service due to increasing concerns that many will not be ready for the February 2019 compliance deadline.
Moving forward Recipharm will be able to add 2D codes, human readable text and tamper evidence to pre-packed medicines using existing equipment across its facilities.
Staffan Widengren, Director of Corporate Projects at Recipharm and Head of the Global Steering Committee for Recipharm’s serialisation programme said: "This new offering is the latest phase in our company-wide serialisation project which was launched in 2016 following a €40 million investment."
"In recent years, Recipharm has become known for taking a lead in the serialisation challenge. As the deadline gets closer we’re seeing more and more companies ask if we can provide an outsourced serialisation service that caters for the new requirements, even if the product itself is not manufactured within Recipharm it made sense to allow customers who were struggling with their existing provider to get access to our solution."
”Implementing these measures independently across packaging lines to ensure compliance is a relatively straightforward process when using offline equipment. Our experience of serialisation means we can ensure compliance quickly and efficiently for our customers."
Recipharm has already delivered over 1.3 million serialised and aggregated packs to markets such as China, South Korea, Saudi Arabia and Turkey, and 0.5 million packs to the US, where serialisation regulations are currently in place.