Hovione, a fully-integrated global CDMO, today announced the completion of an initial multi-million-dollar investment cycle to expand its manufacturing campus in East Windsor, New Jersey. Upon completion, this world-class campus will cover more than 200,000 square feet, integrating the latest technologies within sustainably designed facilities. The initiative advances Hovione’s long-term strategy to grow its U.S. operations and enhance its integrated drug substance, drug product intermediate, and drug product capabilities.

The initial expansion phase includes a 31,000-square-foot building that will house two size-3 spray dryers (PSD-3) designed for production of amorphous solid dispersions (ASDs) for the company´s customers that have an interest in having a supply node in North America. This investment more than doubles Hovione’s spray drying capacity in the United States, expanding capabilities for ASD development and commercial manufacturing. A global leader in ASD by spray drying for pharmaceutical applications, Hovione applies this critical technology to improve drug solubility and bioavailability across a wide range of compounds. Construction is already underway at the Hovione New Jersey Campus, with GMP operations planned to start in the second quarter of 2026.

“Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States,” said Jean-Luc Herbeaux, Ph.D., CEO of Hovione. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the U.S., we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.”

Dr. Herbeaux continued, “This investment addresses growing customer demand for U.S.-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.”

As part of this expansion, Hovione has also acquired additional adjacent land to enable future growth and ensure the East Windsor site continues to meet evolving customer needs. The 125,000-square-foot greenfield will support large-scale production, including continuous and batch tableting capacity, and introduce the next generation of pharmaceutical technologies and digital innovation with enhanced quality control and R&D capabilities.

David Basile, Vice President of Technical Operations – Americas at Hovione said, “This expansion in New Jersey marks a significant step in extending our capabilities in the U.S., which go far beyond machine time or equipment capacity. We are integrating our teams, specialized assets, proprietary technologies, and digital systems to deliver distinctive end-to-end ASD and continuous tableting platforms to our customers. Through our new strategic engagement model, customers can gain privileged access to innovation and assets that accelerate their programs and create long-term value.”

Hovione’s expansion in East Windsor forms part of a broader international growth plan that also includes capacity investments in Ireland and Portugal. Together, these initiatives will create a network of autonomous campuses spanning the development and commercialization of APIs, drug product intermediates, and drug products, all under harmonized quality systems.

Drug developers seeking to expand U.S. manufacturing capacity, gain strategic access to critical assets, or achieve an expedited pathway to filing and commercialization, are invited to contact Hovione at www.hovione.com/contact-us to discuss potential collaborations.

Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO), it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services – from API and formulation development to manufacturing, capsule filling, and devices. Hovione’s culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. For more information, please visit www.Hovione.com.