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The company will offer a standard serialization solution across 14 locations in Europe and more than 70 product lines.
Recipharm has introduced a novel pricing model aimed at improving the affordability of serialization, the company said in a May 25, 2016 press announcement. The company has devised a pricing structure that removes any upfront investment costs for pharmaceutical companies looking to access the contract development and manufacturing organization’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 offered by Recipharm will be compliant with the pending United States and European Union regulations.
This 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. â¨Companies must adapt their packs, implement their tamper evidence capability, and establish the systems, processes, and data to comply with the EU Falsified Medicines Directive Safety Features Commission Delegated Regulation 2016/161 and the US Drug Supply Chain Security Act (DSCSA), something that is expected to require significant financial investment.
Recipharm said that it plans to invest €40 million over the next three years for serialization processes. 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. â¨â¨Recipharm serves more than 250 customers and expects 85% of its production to require serialization.