Spanish contract development and manufacturing organisation (CDMO) Idifarma has announced its plans to meet forthcoming EU serialisation regulations with a €200,000 investment
The investment will see the installation of the Antares Vision Print&Check EVO-TE carton serialisation station at its EU-GMP approved plant in Pamplona, Spain and comes ahead of the EU Falsified Medicines Directive’s (EU FMD) February 2019 deadline for the serialisation of licensed drug products.
The industry-wide EU FMD regulation is a legal requirement for all pharmaceutical companies intended to improve traceability of drugs, help in the fight against counterfeit products entering the supply chain and ultimately improve patient safety.
Luis Oquiñena, General Manager and co-founder of Idifarma, said: “Recognising our role in combatting counterfeit medicines and supporting our customers with new regulatory requirements, we have taken a proactive approach and have been preparing for the arrival of this legislation for a long time now.”
“We have worked closely with the manufacturers of this machine and track and trace software vendors to specify our requirements according to our clients’ needs across the world.”
“This machine offers us the flexibility to upgrade for future regulatory or client requirements and will enable us to help protect our clients’ products and the public against counterfeit pharmaceuticals.”
The company anticipates that the equipment will be operational six months ahead of the EU FMD deadline.
Oquiñena said: “Our investment will offer real support to our clients as they too prepare to meet the regulations. We will be able to serialise commercial batches manufactured by Idifarma for clients, but we will also be able to offer standalone serialisation services as an outsourcing partner.”
“As the deadline draws closer we fully expect to see demand for these specialised outsourced services to increase.”
The investment in serialisation follows the expansion of its capsule filling capabilities in 2017 and strengthens Idifarma’s position as a specialised contract partner for the development and manufacturing of oral solid dosage forms, including high potency compounds and niche pharmaceuticals requiring small batches.