Recipharm, a contract development and manufacturing organization, has launched a pricing model to improve the affordability of serialization. The company has devised a pricing structure that will see the removal of any upfront investment costs for pharmaceutical companies looking to access the company’s serialization capabilities.

Recipharm will offer a standard solution across 14 locations in Europe and more than 70 production lines, with a fixed service fee per pack for all customers. Each serialized product will be compliant with the pending US and EU regulations, with any customization of the pack offered separately.

The announcement comes as the pharmaceutical industry faces the task of meeting new legal requirements for the serialization of licensed drug products from November 2017 in the US and early 2019 in Europe. Companies must adapt their packs, implement their tamper evidence capability and establish the systems, processes and data to comply with the European Union Falsified Medicines Directive ‘Safety Features' Commission Delegated Regulation 2016/161 and the US Drug Supply Chain Security Act.

Recipharm recently announced plans to invest EUR 40 million ($45 million) over the next three years for serilzation capabiliites. As soon as the service is operational, the company will provide serialization free-of-charge until the legal requirements come into effect to ensure drug developers are prepared ahead of the deadlines.

The company’s serialization project is being led by Staffan Widengren, Director Corporate Projects at Recipharm. He said: “We have spoken to our clients and conducted extensive research to help us fully understand the main challenges associated with the looming requirement for serialization. Many companies are behind in their preparations, not fully aware of the scale and complexity of the task ahead and concerned about the required financial investment. As a result of this consultation exercise, we have created a pricing model designed to spread the cost of serialization across each customer's on-going supply agreement as opposed to them needing to make a major upfront investment. From 2023, we will extend this further, ensuring that serialization is included as standard as part of our product manufacturing costs.”

Source: Recipharm