OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
PTSM: Pharmaceutical Technology Sourcing and Management
Recipharm launched a showcase line to demonstrate the company’s new serialization solutions.
On Oct. 3, 2016, Recipharm launched a showcase line for serialization, offering pharmaceutical companies the chance to view and trial its solution to the new European and United States regulations. The company’s showcase line is housed at Recipharm in Fontaine, France.
The showcase line will perform activities including downloading serial numbers, serializing packages, and applying tamper-evident labels. The line will also demonstrate manual aggregation including labeling of boxes and pallets, and post serialization work, including the reworking and uploading of data. Recipharm’s new line is the latest step in a €40-million (approximately $44.17-million) project to implement a solution for its customers’ serialization requirements across its 75 production lines in Europe.
The three-year project will ensure that all pharmaceutical companies using Recipharm’s contract manufacturing services comply with the EU Falsified Medicines Directive 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 company says it has developed a pricing model which 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.