Hovione New Jersey

Manufacturing Plant and R&D Center

The site houses a high-caliber team of professionals with broad experience in developing and commercializing products across Drug Substance, Particle Engineering, and Continuous Drug Product processes.

The Hovione New Jersey site commenced operations in 2002 providing process development and small volume API manufacturing. Since then its technologies portfolio has greatly expanded with additional offerings in highly potent compounds, a variety of particle engineering capabilities and drug product continuous tableting services. The site was first inspected by the FDA in 2007 and hence has had an excellent track record with multiple regulatory authorities around the globe.

The Hovione New Jersey site is again expanding its capacity in the U.S. with the addition of a size 2 spray dryer at our existing facility at 40 Lake Drive, ready for commercial launch in late 2024. 

The New Jersey campus has welcomed a new facility located at 89 Twin Rivers Drive. This is an adjacent building which will carry the same FDA registration number and contain two state of the art size 3 pharmaceutical spray dryers. Commercial operation of these new spray dryers is planned for late 2025 and mid 2026 respectively. Our continued growth will leverage the latest technologies to best serve our customers and patients with an integrated offering from Drug Substance to Drug Product at Hovione in New Jersey.

 

new jersey site exterior view of main entrance

Areas of Focused Expertise

The site boasts strong capabilities and physical assets in the following areas:

For details about production equipment – click here

 

Operations

  • Hovione New Jersey plant operates 24 hours a day 5 days a week.
  • Quality Control labs support production 24 hours a day 5 days a week.

 

Certifications

The site was rewarded with VPP Star Award by the Occupational Safety and Health Administration (OSHA) in 2007 and has successfully maintained this status since.

Hovione New Jersey is certified for the Customs-Trade Partnership Against Terrorism (C-TPAT) by the U.S. Customs and Border Protection (CBP).

 

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News

Developing drugs with poor water solubility remains a major challenge for pharmaceutical manufacturers, because solubility impacts bioavailability and effective drug delivery. The vast majority of small molecule drug candidates have low water solubility. For more than two decades, the most successful particle engineering technology to improve drug solubility and bioavailability has been spray drying with an amorphous solid dispersion (ASD) platform. Spray drying improves the solubility of oral drugs, inhalable particles, and excipients, and increases the stability of heat-sensitive drug products. Hovione, recognized globally for its industry-leading spray drying capabilities, has recently completed a $100 million investment cycle to enhance its operations in New Jersey. This initiative has successfully doubled Hovione’s spray-drying capacity in the US, strengthening its position in the industry. Hovione’s Expanded U.S. Site in East Windsor, NJ  The first phase of the expansion in East Windsor, NJ, delivers a new 31,000 square foot facility and houses two size-3 spray dryers (PSD-3). This additional capacity allows Hovione to meet increasing customer demand for ASD development and good manufacturing practice (GMP) commercial production. GMP operations are scheduled to commence in the second quarter of 2026.  Hovione has also acquired 15 acres of neighboring land, strategically positioning itself for future growth and evolving customer needs for U.S. manufacturing. The newly acquired greenfield site will provide future support for PSD-4–scale commercial production as well as continuous and batch tableting production. It will also be a hub for centralized logistics, enhanced quality control laboratories, and next-generation research and development facilities.  A Global CDMO with a Growing U.S. Footprint  Hovione has operated in New Jersey for more than two decades, establishing itself with a strong U.S. presence for the production of drug substances, intermediates, and finished drug products. A continued emphasis on an integrated service offering, including spray drying, supports delivering innovative medicines to patients more quickly.  The expansion of the East Windsor site addresses the rising demand for U.S. manufacturing and is an integral part of the company's ongoing global growth strategy, with facilities in Portugal, Ireland, and Macau. The company continues to bolster a cohesive network for drug development and commercial manufacturing unified by a corporate quality system and governance framework.  The integrated offering enhances development speed and eases technology transfers by unifying the team's technical skills, proprietary technologies, and digital platforms to efficiently produce drug substance to drug products at a single-site, through Hovione’s “one site, one partner” vision. Furthermore, Hovione’s strategic partnership model offers customers exclusive access to advanced technologies and resources while aiding in the optimization of their development programs and ensuring sustained value creation.  End-to-End Spray Drying and Particle Engineering: From Grams to Tons Hovione is a global leader in spray drying and particle engineering. Services include solubility enhancement and controlled-modified release via development and production of ASDs of both small and large molecules, supporting various modalities. ASD-HIPROS, Hovione’s proprietary spray drying screening platform, identifies optimal formulations that offer optimal performance and stability. By increasing production volume in the US, Hovione will meet customer demand for spray drying services:  Development services in the laboratory (1 g – 1 kg batches)  Pilot scale production (0.5 – 25 kg batches)  Small-scale production (5 – 200 kg batches)  Large-scale commercial manufacturing (50 – 400 kg batches) A Commitment to Sustainability  Hovione’s core values include a commitment to sustainability at all facilities. This commitment is reflected in a business strategy that focuses on improving the communities where the company operates. Hovione’s sustainability policy and strategy align with the UN Sustainable Development Goals and include adherence to science-based targets in line with the Paris Agreement to address climate change. Meeting these goals has required a dedication to process intensification and ensuring sustainability of manufacturing processes. This has been possible through strategic planning and commitments from senior management to ensure sustainability is addressed throughout the drug development life cycle.  Partner with a Technology-Leading CDMO for U.S. Manufacturing   As demand for poorly water-soluble drug formulations continues to rise in the U.S., expanding spray drying throughput is essential to meet the need for innovative therapeutics. With proven leadership in spray drying to manufacture ASDs, Hovione is able to support pharmaceutical companies by solving their solubility challenges efficiently and reliably.  Partnering with a CDMO that combines global leadership, advanced technologies, and the necessary manufacturing capacity in the U.S., drug developers can expedite time to market, ensure quality, and deliver innovative medicines to patients faster.  If your company is seeking access to the latest spray-drying capabilities, expanded U.S. manufacturing capacity, and an accelerated path to regulatory filing and commercialization, contact our team today.     

News

Hovione is Expanding Spray Drying Capacity for U.S. Drug Manufacturing

Oct 27, 2025

Investment More Than Doubles Capacity for Spray Drying, a Critical Solubility Enhancement Technology That Could Benefit the Development of 70% of Drugs 27 October 2025 -- New Jersey, US -- 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 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 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 at www.hovione.com/contact-us to discuss potential collaborations. Read the full article at IPTOnline.com    

Press Clipping

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

Oct 27, 2025
Manufacturing Plant and R&D Center
Address

Hovione LLC
40 Lake Drive
East Windsor, NJ 08520
USA
Tel.: +1 609 918 2600
Email: contact@hovione.com
Location: 40°15'50.01" N  74°29'41.16" W

FDA logo | Hovione
VPP and C-TPAT logos | Hovione
Socma ChemStewards logos | Hovione

Other Locations

Hovione India

Office
Address

Hovione Holding Asia Limited
C/o WeWork, 2nd floor,
Oberoi Commerz - II,  1,
Off Western Express Highway,
Oberoi Garden City, Goregaon East,
Mumbai, Maharashtra 400063
India
Tel.: +919 561 830 188