Recipharm has launched a showcase line for serialization, offering pharmaceutical companies the chance to view and trial its solution to the new European and U.S. regulations.

The contract development and manufacturing organization’s (CDMO) showcase line is located at its Fontaine, France, facility and is now operational, ready to demonstrate the company’s new standard solution for serialization. The showcase line will perform activities including the downloading of serial numbers from its Level 4 solution, serialization of the package and the application of tamper evidence labels. It will also demonstrate manual aggregation including labeling of boxes and pallets and post-serialization work, including the reworking and uploading of data to Level 4.

Recipharm’s new line is the latest step in a €40 million project to implement a state-of-the-art solution for its customers’ serialization requirements across its 75 production lines in Europe.

The company says the project, which is being carried out over the next three years, will ensure that all pharmaceutical companies using its contract manufacturing services comply with the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation, which makes the serialization of licensed drug products in Europe a legal requirement from 2019.

As part of the serialization roll-out, the CDMO has developed a pricing model that spreads the cost of the process across each customer’s ongoing supply agreement, removing the need to make any upfront investment.

From early 2017, Recipharm will offer the service free of charge until it becomes a legal requirement, allowing customers to overcome any challenges, determine their individual requirements and request any customization before the deadline passes.

The CDMO’s company-wide serialization project is being led by Staffan Widengren, director corporate projects at Recipharm. He said, “Having already provided serialized products in markets including Turkey, Korea and China we understand the complexity of implementing serialization processes across existing production lines, so we made the decision very early on to be proactive and get ready for the changes as soon as we could.

“Companies that delay their preparations face a high risk of disruption to their production when the changes come into effect in 2019. By introducing this showcase line so far in advance we’ll be able to overcome any hurdles prior to the deadline and make the transition to serialized products as seamless as possible for our customers.