Recipharm To Invest $45 Million for Serialization Capabilities
Recipharm, a contract development and manufacturing organization based in Jordbro, Sweden, plans to invest EUR 40 million ($44.6 million) over the next three years to provide solutions for the serialization processes. The investment is in line with the European Union’s (EU) Falsified Medicines Directive Safety Features Delegated Regulation, which requires that serialization of licensed drug products will be a legal requirement for companies in the EU from early 2019.
Recipharm already provides serialized products in several markets,including Turkey, Korea, and China. A newly established, dedicated global steering committee within the company will now also work closely with clients in Europe to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialization.
Recipharm serves more than 250 customers and expects 85% of its production to require serialization. In addition to the European requirements, the company said it also will be ready to meet serialization requirements beginning in November 2017 in line with the US Drug Supply Chain Security Act.
Recipharm is preparing a range of educational papers aimed at training staff internally across its global network and supporting customers with the challenges of serialization, verification and complying with new regulatory requirements.