CordenPharma accelerates sterile injectable CDMO manufacturing expansion with €80 million multi-year investment in new facility and additional aseptic fill & finish lines

CordenPharma continues its ambitious long-term injectable CAPEX program at its FDA & EMA-approved Caponago (Milan), Italy site, reinforcing its position as a global leader in sterile injectable manufacturing. The expansion involves two key components to augment manufacturing capacity for sterile injectable drug products.

Firstly, the company has committed a multi-year €80 million investment into the future of injectable drug products, marking a significant milestone of that total with a €13 million acquisition of a new 11,000 m² commercial building and 26,000 m² of land, adjacent to its existing late-stage aseptic fill & finish manufacturing area. This expansion was finalized on 28 July 2026, increasing the site footprint by greater than 50%.

The new facility offers a blank canvas ideal for innovators seeking fit-for-purpose aseptic fill & finish CDMO outsourcing of their peptide, LNP, small molecule, biologic, and oligonucleotide-based injectable therapeutics, tailored to their specific production setups and requirements. The expanded capacity is a versatile foundation for the integration of additional manufacturing lines supporting a wide range of injectable formats including Pre-Filled Syringes (PFS), liquid or lyophilized vials, cartridges, and auto-injectors. Customers will also benefit from a single-site offering injectable solutions integrated with LNP manufacturing capabilities on the same campus at CordenPharma Caponago.

The space can accommodate a minimum of four aseptic fill & finish lines, four visual inspection lines, and four additional packaging lines, with options for customer-owned lines, large-scale lyophilization, and auto-injector assembly.

Secondly, over the past two years, CordenPharma has embarked on a series of strategic expansions at an existing operational area within its Caponago site that immediately contributes to the increased injectable capacity by adding two new aseptic fill & finish isolator lines. These include:

• A clinical and small-scale commercial combo line from Bausch & Ströbel for Pre-Filled Syringes (PFS), vials, and cartridges.
• A high-speed PFS & cartridge line from Syntegon, capable of producing >500,000 units per day.
• Expansion of the automatic secondary packaging area for PFS, vials, and ampoules.
• A doubling of analytical capacity to support growing project pipelines.

Completion of the new isolator lines is targeted for mid-2027 and 2028 respectively, ensuring CordenPharma remains at the forefront of sterility assurance and long-term compliance during sterile injectable manufacturing.

The investment in these new and expanded facilities underscores a proactive approach to addressing the global healthcare industry's increasing need for specialized injectable manufacturing. With these combined investment milestones bolstering a landmark scale-up in production with a projected total capacity up to 500 million injectable units per year, CordenPharma is poised to support innovators across their injectable drug lifecycle from early-phase projects to large-scale commercial production.

This capacity surge helps meet the rising global demand for sterile injectable outsourcing across therapeutic areas such as oncology, obesity, diabetes and Inflammatory diseases with complex modalities such as peptide-based GLP-1 therapeutics, oligonucleotides, LNPs, biosimilars and other biologics.

The company's customers will also gain valuable access to integrated solutions from drug substance to drug products, leveraging CordenPharma's global facility network and expertise in manufacturing peptides (including oral peptide drug products), oligonucleotides, non-viral carriers such as LNPs, and small molecules, including both highly potent and non-potent APIs.

Dr. Michael Quirmbach, President & 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 the manufacture of drug products using complex modalities and enhances our end-to-end supply capabilities to meet rising global demand for injectable outsourcing, ultimately enabling partners to bring vital drug products in key therapeutic areas to patients more efficiently."