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Press Release / Oct 27, 2025

Hovione Completes Initial $100M Investment Cycle to Expand U.S. Operations at New Jersey Manufacturing Site

Investment More Than Doubles Capacity for Spray Drying, a Critical Solubility Enhancement Technology That Could Benefit the Development of 70% of Drugs*

new jersey site exterior view of main entrance

EAST WINDSOR, N.J. — October 27, 2025 Hovione, a fully-integrated global CDMO, today announced the completion of an initial multi-million-dollar investment cycle to expand its manufacturing site in East Windsor, New Jersey. Upon completion, this world-class site 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 site, 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 sites 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 here to discuss potential collaborations.

 

*Poor Solubility – Where Do We Stand 25 Years after the ‘Rule of Five’?

 

 

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Hovione is bringing momentum to the intranasal field after announcing that its lead single-use nasal dry powder device, developed in collaboration with Industrial Design Consultancy Ltd (IDC), is now available for commercial partnerships. The milestone marks the transition from prototype to a fully integrated intranasal drug delivery platform that spans Hovione’s end-to-end partnership capabilities–from API synthesis through advanced formulation and particle engineering to drug product manufacturing, including device supply and advanced analytical tools for nasal performance characterization. The platform’s single-use device is designed to be manufacturable at scale and to leverage existing advanced particle engineering and drug product manufacturing capabilities, a practical advantage that can shorten timelines to clinic and commercialization while reducing development risk and cost. The device’s patented mechanism supports targeted nasal deposition, including access to the upper olfactory region. This enables rapid systemic absorption and potential nose-to-brain delivery pathways that are increasingly important for CNS and emergency-use indications. Beyond the single-use format, Hovione and IDC are advancing a multi-dose variant to broaden applicability across dosing regimens and therapeutic areas. The collaboration is backed by an intellectual property portfolio and initial patent grants, positioning the platform as a turnkey option for pharma partners seeking a single integrated supplier for both drug substance and device. This development arrives as intranasal delivery gains traction for systemic, CNS and rapid-onset therapies. This is precisely the focus of the upcoming 4th Nasal Formulation & Delivery Summit, for which Hovione is a key sponsor. The annual summit unites formulation, delivery and product development leaders to tackle drug-device compatibility, translational preclinical models, and strategies for scalable, regulatory-ready intranasal programs. Hovione’s recent progress will be highly relevant to attendees looking to de-risk nose-to-brain and systemic intranasal programs. Read the full article at News-Medical.net    

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