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Addressing Serialization and Aggregation Head-On

CordenPharma Latina moves ahead of the curve when it comes to track and trace, serialization and aggregation as a full-service partner in the contract development and manufacturing of Active Pharmaceutical Ingredients (APIs), drug products and associated packaging services to the global pharmaceutical industry.

Let’s say your company is a contract development and manufacturing organization (CDMO) headquartered in Europe. You might think your firm could take some time to develop its serialization and aggregation efforts, right? Wrong!

For Latina, Italy-based CordenPharma Latina, the company is ahead of the curve when it comes to track and trace, serialization and aggregation as a full-service partner in the contract development and manufacturing of Active Pharmaceutical Ingredients (APIs), drug products and associated packaging services to the global pharmaceutical industry.

Key to the company’s success in addressing serialization and aggregation is its relationship with supplier partner Adept Packaging, a packaging engineering and consulting company (see sidebar below).

CordenPharma Latina’s assertive position is understandable given that it is part of a network of CordenPharma manufacturing facilities across Europe and the U.S. The company is organized under five technology platforms:

• Highly potent and oncology, antibiotics and peptides

• Oligonucleotides

• Lipids and carbohydrates

• Injectables

• Small molecules

CordenPharma’s three major drug manufacturing departments—oncological, cephalosporin and penicillin—produce tablets and vials packed into primary packaging formats such as blisters, cartons and bottles. All manufacturing and packaging is performed within the CordenPharma Latina facility.

In this question-and-answer session, CordenPharma’s Mario Scigliano, Serialization and Drug Product Maintenance Manager, addresses serialization, DSCSA compliance and related issues.

Healthcare Packaging (HCP): Pharmaceutical manufacturers see serialization compliance involving a considerable investment in capital and time. How does your company justify these investments economically?

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