Recipharm, a leading contract development and manufacturing organisation (CDMO) has successfully received European Medicines Verification Organisation (EMVO) approval to submit serialisation data to the European Hub.
The connection, which was facilitated by the company strategic partner TraceLink, is a key milestone in Recipharm’s preparations for the Falsified Medicines Directive (FMD).
While clients of Recipharm’s CDMO business must establish their own connections to the EU Hub for their products, the connection allows the marketing authorisation holders within the Recipharm Group to continue to supply medicines to patients post the EU FMD implementation date.
Recipharm’s three-year serialisation programme began in January 2016 and involves a €40 million investment.
In an announcement on 6th August, the EMVO stated that only 106 of the EU’s 2000-plus pharmaceutical companies have completed the on-boarding process with their National Medicines Verification Organisations (NMVOs) and developed their connection to the EU Hub.
TraceLink acted as Recipharm’s gateway provider to the EU Hub. The firm has developed a streamlined programme for its customers to rapidly complete conformance testing and successfully receive EMVO approval to submit data to the EU Hub. Today, 56% of the companies connected to the hub are TraceLink customers.
Recipharm has already delivered over 2 million serialised packs to markets such as China, South Korea, Saudi Arabia and Turkey where serialisation regulations are currently in place as well as serialising over 500,000 packs for the US.
Headquartered in Stockholm (Sweden), Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing around 5,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharma product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US.