CordenPharma is expanding its sterile injectable manufacturing operations at its Caponago site in Italy. The company will invest €80 million through a multi-year expansion program. The investment will strengthen CordenPharma’s position in sterile injectables manufacturing. The FDA- and EMA-approved Caponago facility serves pharmaceutical customers worldwide. The expansion includes two major initiatives focused on increasing manufacturing capacity.
These initiatives will greatly increase the site’s sterile injectable manufacturing capabilities. The company expects total capacity to be up to 500 million injectable units a year. First, CordenPharma committed €80 million to its future injectable pharmaceutical business. The investment comprises a €13 million acquisition of a new commercial building. The company has also purchased a further 26,000 m² of land adjacent to the site. The new facility is 11,000 m² and is adjacent to the existing production facility.
On July 28, 2026, CordenPharma completed the expansion. The change increased the overall footprint of the site by more than 50%. The new facility offers a greenfield opportunity for pharmaceutical innovation. The site can be used by customers for specialized CDMO outsourcing services. These services will support sterile fill and finish for injectable therapies. The facility is capable of working with peptides, LNPs, small molecules, biologics and oligonucleotides.
Moreover, the expanded facility can support several injectable formats. These formats include pre-filled syringes, liquid vials, lyophilized vials, cartridges, and autoinjectors. Customers can also access injectable solutions alongside LNP manufacturing capabilities. Both capabilities will operate within the same area as CordenPharma Caponago.
Dr. Michael Quirmbach, President and CEO of CordenPharma Group, commented: “The support of our shareholders, Astorg, underscores our commitment to advancing sterile injectable manufacturing at CordenPharma Caponago. This strategic investment strengthens our leadership in complex pharmaceutical manufacturing and enhances our end-to-end procurement capabilities to meet the growing global demand for injectable outsourcing, ultimately enabling partners to more efficiently deliver vital pharmaceutical products in key therapeutic areas to patients.”
New Aseptic Filling and Finishing Infrastructure
The new space can accommodate at least four aseptic filling and finishing lines. It can also support four visual inspection lines. In addition, the facility can accommodate four additional packaging lines. Customers can also install customer-owned production lines within the available space. The facility also offers options for large-scale freeze-drying operations. Furthermore, customers can use dedicated space for autoinjector assembly.
CordenPharma has also expanded its present operating area in Caponago. The company has made a number of strategic upgrades in the past two years. These upgrades will immediately increase capacity for sterile injectable manufacturing. They are two new closed environment aseptic filling and finishing lines. One line is from Bausch & Ströbel. It provides integrated clinical and commercial manufacturing.
The line allows to handle pre-filled syringes, vials and cartridges. This flexibility allows customers to address diverse needs for manufacturing of injectables. CordenPharma is also installing a high-speed PFS cartridge line from Syntegon. The line churns out more than 500,000 units a day. Also, the company is expanding the automatic secondary packaging area. The area will accommodate vials and ampoules PFS. CordenPharma will double its analytical capacity. This expansion will support the growing pipeline of projects under development.
Capacity Expansion Supports Global Injectable Demand
The new cleanroom lines are expected to be available in mid-2027 and in 2028. The expansion will permit long-term sterility assurance and regulatory compliance. CordenPharma intends to sustain high manufacturing standards during the expansion. The company also wants to help customers at different stages of development.
The joint investments will substantially increase the production capacity. The new plant will have a capacity of 500 million injectable units a year, CordenPharma said. This ability will help pharmaceutical innovators throughout the lifecycle of injectable drugs. The company can support customers from early stage development projects through to commercial manufacturing. At the same time, the global need for sterile injectable outsourcing remains on the rise. Pharma companies are going to need specific manufacturing capabilities for complex therapies.
The expansion will meet demand in a number of key therapeutic areas. Like oncology, obesity, diabetes and inflammatory diseases. It will also facilitate complex modalities and emerging therapies. These include peptide-based GLP-1 therapies, oligonucleotide therapies, LNPs, biosimilars, and other biologics . The expanded operations will therefore give additional manufacturing flexibility. CordenPharma’s capabilities for multiple injectable products and production requirements are available to customers.
End to End Capability for Pharmaceutical Manufacturing
Customers will also benefit from integrated solutions for the drug substance and pharmaceutical products. CordenPharma will utilize its global manufacturing network and technical expertise. The company has manufacturing capabilities in a variety of sophisticated pharmaceutical technologies. Peptides, including oral peptide drug products, and oligonucleotides. Its capabilities include non-viral vectors such as LNPs. CordenPharma makes small molecules and highly potent APIs.
The company’s network also supports non-potent APIs. These capabilities can help customers solve multiple manufacturing needs with a single global partner. The Caponago enlargement is also an improvement of this integrated approach. It brings together sterile injectable manufacturing and other technologies available across CordenPharma’s network.
This means that broader development and manufacturing support can be leveraged by pharmaceutical innovators. This model can assist companies in moving injectable therapies toward commercialization. It is also another example of CordenPharma’s commitment to long-term growth in pharmaceutical manufacturing. As demand for complex therapies rises, the company is expanding its infrastructure.
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News Source: PRNewswire.com
