All fifteen facilities operated by the Swedish CDMO are fully prepared for drug serialisation under EU and US regulations
Recipharm, the Stockholm-based CDMO, has announced that all fifteen of its facilities are now fully prepared for drug serialisation under the new EU Falsified Medicines Directive (EU FMD). The company said it has already delivered serialised batches within Europe ahead of the 9 February deadline.
The facilities are located across Europe in France, Italy, Sweden, Spain, Germany, the UK and Portugal, as well as in India. In addition, all of the facilities are connected to customers to allow them to report serial numbers.
During the period 2016-2018, the Recipharm invested EUR 35 million (US$39 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 FMD and the US Drug Supply Chain Security Act (DSCSA).
Staffan Widengren, Director Corporate Projects, commented: "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."
Widengren continued: "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; the company released its first batch of serialised products to the European market in October 2018.
The company said that almost all of its customers are fully onboard and that it is in the process of ensuring all projects will be fully compliant.