TraceLink, the world’s largest track and trace network, announced that IBI Lorenzini has selected TraceLink’s solutions to ensure compliance with global serialization regulations.
IBI Lorenzini, IBIGEN group, is an Italian-based, family-run pharmaceutical company and contract manufacturing organization (CMO) that was founded over 100 years ago. IBI’s pharmaceutical products are distributed in 20 countries across all five continents, including Europe, Australia and New Zealand, and the U.S., which accounts for 80% of its exports. In 1961, IBI obtained FDA approval for the production of sterile penicillin for the U.S. market.
In preparation for EU Falsified Medicines Directive (FMD), IBI has started the integration process with its CMO partners, discussing data exchange processes and redesigning artwork to include tamper evidence. The company aims to be ready for FMD serialization by the end of 2018, ahead of the February 2019 deadline.
For its U.S. Drug Supply Chain Security Act (DSCSA) requirements, IBI has completed all serialization packaging line upgrades and partner connections in the U.S.
TraceLink has developed a streamlined program for its more than 190 customers with EU FMD requirements to rapidly complete conformance testing and successfully receive European Medicines Verification Organization (EMVO) approval to submit data to the EU Hub. With TraceLink’s conformance test kit, 42 companies have been able to complete their conformance testing. Of these, 21 companies have received EMVO approval.