How an Italian Pharmaceutical Manufacturer and CMO Complies with Global Serialization Regulations

IBI Lorenzini is unique in that it operates as both a pharmaceutical company and a CMO. The company selected a TraceLink Inc. Life Sciences Cloud platform to ensure compliance with global regulations, including the EU Falsified Medicines Directive.

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.

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