Recipharm, a contract development and manufacturing organization (CDMO), has delivered its first batch of serialized drug products to Saudi Arabia, following the introduction of new regulatory requirements in March 2017.
The €300,000 ($321,075) project, which is in addition to a wider €40 million ($42.8 million) investment into new serialization technology and processes to comply with the European Falsified Medicines Directive (FMD), enables Recipharm to supply serialized products to Saudi Arabia.
Since the Saudi Food and Drug Authority (SFDA) enforced the latest version of the Saudi Drug Code (SDC), which aims to protect against counterfeit pharmaceuticals, Recipharm has serialized, packed, QP released and shipped more than 240,000 units to this market from its facility in Lisbon, Portugal. This includes three different stock keeping units (SKUs) and drug formulations including tablets to treat nausea and discomfort caused by gastroparesis and powder and tincture for skin infections.
The CDMO’s company-wide serialization project is being led by Staffan Widengren, director corporate projects at Recipharm. He said: “Recipharm has been supplying serialized products to markets including Turkey, Korea and China for many years and our investment in the Saudi Arabian market is the latest step in our goal to assist pharmaceutical companies with the complex web of requirements in the U.S., Europe and Asia.”
“We are already supplying serialized products in several markets including Turkey, Korea and China, which was a major advantage when preparing for the new Saudi requirements. That said, the project required a significant outlay, a high degree of technical complexity and the need to involve multiple stakeholders, including quality assurance, IT, packaging, engineering and dedicated serialization teams, as well as our serialization hardware and software partners.”
In June 2016, Recipharm announced Marchesini and SEA Vision as its hardware and software providers for pharmaceutical serialization. The new solution is completely integrated with the customer’s operations at enterprise resource planning (ERP) level and connected directly to its own Level 4 platform to manage serialization and regulatory data.
Recipharm has facilities in more than 20 locations across the globe and plans for a further six in the U.K., Germany, Sweden, Spain and France to supply serialized products to Saudi Arabia according to customer requirements.
Staffan Widengren continued: “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 serialization technologies and processes in recent years.”
“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.”
Recipharm serves 250+ customers and expects 80 percent of its production to require serialization in line with the European FMD. The CDMO will also be ready to meet U.S. serialization requirements from November 2017 set out by the U.S. Drug Supply Chain Security Act (DSCSA).