Contract development and manufacturing organisation (CDMO), Recipharm, has delivered its first batch of serialised drug products to Saudi Arabia. This follows the introduction of new regulatory requirements in March this year.
Saudi Arabia flag
The Saudi Food and Drug Authority’s (SFDA) enforcement of the latest version of the Saudi Drug Code (SDC) — to protect against counterfeit pharmaceuticals — has led to Recipharm serialising, packing, QP releasing and shipping more than 240,000 units from its facility in Lisbon, Portugal, to this market. This €300,000 project is in addition to Recipharm’s wider €40 million investment into serialisation technology and processes to comply with the European Falsified Medicines Directive (EU FMD).
“Recipharm has been supplying serialised products to markets including Turkey, Korea and China for many years and our investment into the Saudi Arabian market is the latest step in our goal to assist pharmaceutical companies with the complex web of requirements in the US, Europe and Asia,” noted Steffan Widengren, director corporate projects at Recipharm.
Last year, Recipharm announced its hardware and software providers for pharmaceutical serialisation as Marchesini and SEA Vision, respectively. The new solution is integrated with the customer’s operations at enterprise resource planning level and connected directly to its own Level 4 platform to manage serialisation and regulatory data.
“Global regulatory requirements are advancing to overcome the growing challenge of counterfeit medicines. As a CDMO with customers in most territories, we must be ready and able to meet the varying regulations across the globe and have invested heavily in new serialisation technologies and processes in recent years,” added Widengren. “Those companies that delay their preparations risk disruption to product supply, with potentially significant consequences for patients. In the case of Saudi Arabia, we were ready to meet the compliance deadline and having already launched our pilot line for European requirements, we will also be prepared for this challenge.”