Recipharm, the contract development and manufacturing organisation (CDMO), today announced that all fifteen of its facilities outlined in its investment plan are now fully prepared for drug serialisation and have delivered serialised batches within Europe ahead of the February 9th deadline.
During the period 2016-2018, the CDMO invested EUR 35 million into its operations and launched a three-year programme to provide a compliant serialisation solution for its customers, ahead of the introduction of the EU Falsified Medicines Directive (EU FMD) and the US Drug Supply Chain Security Act (DSCSA).
In addition, all of the facilities are connected to customers to allow them to report serial numbers. The facilities are located across Europe in France, Italy, Sweden, Spain, Germany, the UK and Portugal, as well as in India.
Staffan Widengren, Director Corporate Projects, said: “Recipharm has been very committed to meeting compliance deadlines, establishing a dedicated task force three years ago. A lot of time and effort has gone into our preparations so it’s rewarding to report that we are ready, especially ahead of the enforcement date.”
“Standardising our serialisation capabilities has enabled us to provide a seamless and flexible service to our customers, across multiple markets.”
Recipharm has been at the forefront of the serialisation challenge and successfully released its first batch of serialised products to the European market in October 2018. Almost all of its customers are fully onboarded, Recipharm is now in the process of ensuring all projects will be fully compliant.”