From its beginnings in the Villax family basement in Lisbon, Hovione has maintained an inherently global outlook — a vision that has served the company well for more than six decades.

Founded in Portugal in 1959 by Hungarian chemist Ivan Villax, his wife, Diane, and two other Hungarian refugees, Hovione initially sold antibiotics and other generic drugs. Its first major success came with betamethasone in Japan, where the country’s demanding quality standards helped shape Hovione’s approach — and establish its position in global markets.

Over the following decades, Hovione expanded its global footprint, opening its first manufacturing site in Loures, Portugal, in 1969, followed by facilities in Macau, China (1986), New Jersey, U.S., (2001) and Cork, Ireland (2009). Today, the company employs more than 2,600 people, including over 300 scientists, and counts 19 of the world’s 20 largest pharmaceutical companies among its customers.

After announcing a $100 million investment to expand its U.S. operations at the company’s East Windsor, New Jersey site last year, Hovione invited journalists for an exclusive sneak peek prior to the official ribbon-cutting in September 2026. During the tour, we suggested to David Basile, Hovione’s Vice President of Technical Operations for the Americas, that the company had timed the expansion perfectly to coincide with the growing list of pharmaceutical companies publicizing plans to bolster U.S. manufacturing.

Basile, who joined Hovione in 2021 to help strengthen the CDMO’s commercial manufacturing capabilities in the U.S., was quick to distinguish the company’s strategy from the current reshoring push. The timing, he acknowledged, may be coincidental. But the investment itself has been years in the making — part of a broader growth strategy Hovione set in motion long before U.S. reshoring became an industry-wide priority.

“This is not a reaction to reshoring. In pharmaceutical manufacturing, investment cycles are long; new capacity takes years to plan, build, qualify and bring online,” said Basile. “To be able to offer this additional capacity today, we had to make the decision several years ago, well before reshoring became a headline. We chose to expand in New Jersey because customers were already looking for the same capabilities on both sides of the Atlantic, as part of a more regional and resilient supply model. The current reshoring momentum reinforces the relevance of that decision, but it did not drive it.”

When completed, Hovione’s New Jersey campus facilities will span more than 200,000 square feet. But the expansion represents just one piece of a much larger investment plan. Hovione is simultaneously adding manufacturing capacity at its sites in Ireland and Portugal, with each location being developed to support the company’s full range of capabilities, from APIs and drug product intermediates to finished drug products.

The strategy is designed to create a network of manufacturing sites that can operate independently while adhering to the same quality standards, processes and procedures. Products manufactured in New Jersey should meet the same quality bar as those produced in Portugal or Ireland.

For Hovione, it’s less a story about geography and more about building a more flexible, interconnected manufacturing network — one in which multiple sites can independently take a project from raw ingredients through finished drug product, while maintaining consistent standards across the organization.

The NJ Expansion

Now one of the longest-established European CDMOs in the U.S., Hovione’s New Jersey site initially served as a technology transfer and process development center, supporting small-volume API manufacturing before the company began positioning it for large-scale commercial manufacturing.

The current expansion — with commercial operation already underway — includes a 31,000-square-foot facility that houses two commercial-scale size-3 spray dryers (PSD-3) capable of producing amorphous solid dispersions (ASDs). By turning poorly soluble drug ingredients into a more bioavailable form using ASDs, the spray dryers enable the CDMO to tackle one of the industry’s most persistent formulation challenges.

The initiative has successfully doubled Hovione’s spray-drying capacity in the U.S. at a time when approximately 70% of new small molecules in development consist of complex, difficult-to-formulate medicines.

Importantly, the new facility will operate under the same FDA registration number as the existing site, integrating the expansion into Hovione’s established New Jersey manufacturing operation and quality system. That means materials, processes and personnel can move more easily between the buildings, creating a streamlined path for customers from drug substance to drug product.

Hovione has also acquired 15 acres of neighboring land, and the new site will provide future support for PSD-4-scale commercial production, which will involve additional laboratories, commercial-scale spray drying and oral drug product manufacturing.

The Bigger Picture

As supply chain disruptions, geopolitical uncertainty and trade pressures persist, pharma companies are increasingly looking for qualified manufacturing capacity in multiple regions — creating demand for CDMOs that can offer ‘dual shore’ redundancy.

Dual shore goes beyond simply having multiple facilities. In order to provide true redundancy, the sites need to be sufficiently qualified and technically aligned to make the same product or perform the same critical process. Meaning, if something disrupts the European operation, production can potentially shift to the U.S., and vice versa.

“Two sites only give you redundancy if both are qualified to do the same work,” said Basile. “That means comparable equipment at comparable scale, the same procedures, and validation and comparability data for both sites. Anything short of that is just two addresses, not a backup.”

The U.S. expansion is just one part of Hovione’s investment spree. Over the next two years, the company is also set to bring several European projects online, including a recently completed $46+ million expansion of its tablet development and manufacturing center in Loures, Portugal; a $235 million facility in Seixal, Portugal, expected to be completed by 2027; and an $80 million expansion in Cork, Ireland, that will add a PSD-4 spray dryer and double the site’s spray-drying capacity by 2027.

Resilient manufacturing infrastructure within the same plant is also important. In the recent Loures project, Hovione chose to expand its batch tableting capacity by adding an additional line mirroring the original unit across every local operation: dispensing, blending, dry granulation, and tableting and film coating. The mirrored configuration provides both redundancy and like-for-like product transfers between lines, reducing the process risk that typically accompanies the move from development into commercial supply.

“Mirroring the line rather than simply adding equipment was a deliberate choice,” said Jorge Pastilha, Vice President of Technical Operations for Europe and Asia at Hovione. “It means a product validated on one line can move to the other without reformulation or process redevelopment, which gives customers continuity of supply.”

Home is Where You Need it to Be

More than six decades after Hovione’s humble basement beginnings, the company is still betting on the value of being global. But today, that means something different. It’s not simply about having manufacturing sites around the world. It’s about making those sites work both together and independently.

As pharma companies rethink where and how they manufacture, Hovione is positioning its network to offer something increasingly valuable: options. The U.S. expansion may have arrived at an opportune moment, but Hovione’s strategy predates the current reshoring wave. In many ways, it is less about bringing manufacturing home than making sure there is more than one place to go.

Read the full article at Tablets & Capsules Magazine