How an Italian Pharmaceutical Manufacturer and CMO Complies 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.

“IBI Lorenzini is a unique business, operating as both a pharmaceutical company and a CMO in a number of markets, which adds an additional layer of complexity when implementing a serialization solution. After careful analysis of serialization solutions and a strong recommendation from our pharmaceutical brand customers, we selected TraceLink’s Life Sciences Cloud platform to deliver the flexibility and scalability we needed to connect with both our partners and customers as quickly and efficiently as possible, while providing a simple connection into the EU Hub,” said Luca Pezzano, Operations Director at IBI Lorenzini.

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. 

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.

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 and seven companies are awaiting review from the EMVO.