Press Room

Press Release / Jul 20, 2004

Hovione Group sales grow 9% to reach USD75 million for the fiscal year 2003/04

Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2004 amounted to US$75m, representing a growth of 9% over the previous year.

Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2004 amounted to US$75m, representing a growth of 9% over the previous year.

Guy Villax, CEO of Hovione noted that “2003 was an excellent year. In the context of an adverse market environment sales grew and gross margins improved, but more significantly Hovione delivered on its goals in terms of strategy, cost cutting and productivity.

During 2003 the sales evolution to the Innovator segment, to which Hovione supplies R&D and contract manufacturing was in its 3rd year of crisis with FDA approving half the usual number of new pharmaceuticals. On the other hand sales to the Generics segment presented vigorous growth. In terms of geography, our sales remained close to the proportion to the pharmaceutical market sizes with North America accounting for 48%, Europe 22% and Asia 21% – with Japan showing greater than usual growth. Small Pharma and the quality Generic Houses remain the Customers that best benefit from Hovione’s value proposition.

Capital expenditure reached $13m, and the focus remains one of consolidation and of pay-back on the significant investments of the last 4 years: The Technology Transfer Centre in New Jersey, USA; the significant investments in IT and R&D capabilities in Loures and the doubling of the plant capacity and improved environmental protection systems in Macau. Equity and long-term debt remains 68% of our net balance sheet; and the net debt / EBITDA ratio remains at a low 2.2 multiple. Despite the focus on minimizing expense in capital items, Hovione remains keen to invest in process technology whenever this can provide further value to our Customers. During 2003 a $3.3m investment in particle design technology was again evidence of this technology early-adopter mentality that Hovione has demonstrated in its 40 years of pharmaceutical chemistry specialization.

Hovione is now organized by profit centres and has extended its decade old process of continuous improvement to include balance sheet objectives. As a result good management of current assets released $11m over last year’s performance. Sofia Lee, responsible for Finance and Treasury at Hovione commented: “Unfortunately the strength of the Euro reduced Hovione competitiveness: For every 5 centimes of strength vis-a-vis the US $ Hovione loses about $1m of profitability in cash terms. This negative exchange environment together with important start-up-losses from the US operations were a drain on our EBITDA, this reached $18m or 24% of sales – a level we consider wholly unsatisfactory but which is justified under the current circumstances. … The 2005 deadline for the adoption of the IFRS is an issue we solved several years ago”. Hovione’s financial statements have been prepared according to the International Financial Reporting Standards since 2000.

www.hovione.com includes additional information on quality, health, safety and environmental performance.

Hovione is an international group dedicated to the process development and synthesis of APIs (active pharmaceutical ingredients) serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service and quality. Hovione’s capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards.

Also in the Press Room

See All

Key Takeaways Commissioning a US-based ConsiGma CDC Flex line enables end-to-end spray drying-to-tablet manufacture within a single site and quality system, reducing comparability and technology-transfer burdens. Elimination of conventional scale-up is enabled by using the same equipment from early development through commercial supply, minimizing engineering runs and conserving scarce API. Operational flexibility spans batch or continuous modes and 1–200 kg/h throughput, with scale adjustment achieved by switching continuous blenders rather than replatforming processes. High-containment design to 1 µg/m³ expands suitability for highly potent oral solid-dose programs while maintaining integrated development-to-commercial workflows. Regulatory momentum for continuous manufacturing is supported by ICH Q13 harmonization, increasing FDA approvals, and platforms leveraging inline PAT and automated control suites for real-time quality assurance. Hovione announced on Oct. 5, 2026, that it will commission the ConsiGma CDC Flex, a next-generation continuous direct compression tableting platform jointly developed with GEA. The investment is designed to link amorphous solid dispersion manufacturing via spray drying with commercial tablet production at a single US site operating under one quality system. The line will run in either continuous or batch mode at throughputs from 1 to 200 kg/h. Formulation development can begin with as little as 1.5 kg of material, and the same equipment can then support everything from very small clinical batches to large commercial runs, enabled by a design that allows the system to switch between continuous blenders of different sizes. The installation will also be contained to 1 µg/m³ to accommodate highly potent compounds. "Hovione will be the first company in the world to offer the ConsiGma® CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs, Hovione, said in a press release. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." What Does a Single Development-To-Commercial Line Change? For formulators and process engineers, the most consequential claim is the removal of traditional scale-up. Moving a process from development equipment to commercial equipment typically requires engineering runs, bridging work, and consumption of scarce API, all of which weigh heavily on early programs with limited material. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated US development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Hovione, in the press release. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Co-locating spray drying and tableting is also significant because amorphous solid dispersions remain a primary solubility-enhancement route for poorly soluble molecules, and transferring intermediates between sites or vendors adds technology transfer and comparability burdens. The new line builds on the company's earlier US expansion; Hovione recently completed a $100 million investment to bolster US capacity in particle design, amorphous solid dispersions via spray drying, and batch and continuous tableting. How Is the Regulatory Environment Shaping Continuous Tableting Adoption? The company points to the 2022 adoption of ICH Q13, which provides harmonized guidance for continuous manufacturing of drug substances and drug products across the US, Europe, and Japan. Hovione reports that, as of 2024, FDA alone had approved 17 products manufactured under the guidance. Speaking on ICH Q13, FDA's Kelley Burridge, PhD, "Perceived barriers to continuous manufacturing have been falling one by one," and noted an FDA publication showing faster approval times for products with continuous manufacturing elements than for comparable batch products. The platform incorporates inline process analytical technology and automated controls for real-time quality monitoring, along with SimpleCT, an automation and control suite intended to support a single process from development through commercial supply. For sponsors weighing supply resilience and regional sourcing, the East Windsor installation extends a capability that Hovione says only it currently offers as a contract development and manufacturing organization.   Read the full article at PharmTech.com  

Press Clipping

Can Continuous Tableting End Scale-Up for Complex Oral Drugs?

Oct 05, 2026

The company is building out more than 200,000 square feet of space in New Jersey. In April, Contract Pharma had the opportunity to tour Hovione’s expanded manufacturing facility in East Windsor, NJ. The company is planning a formal ribbon-cutting this fall; before that, we got an inside look at some new features. Having established United States operations in 2002, Hovione now has more than 200,000 square feet of space in New Jersey. This will be developed into a large, integrated campus in the next five to ten years. Overall, the company’s recent NJ expansion, which began in 2025, has tripled its total spray-drying capacity in the U.S. Future Facility Upgrades A 125,000-square-foot greenfield acquired by Hovione at the East Windsor campus will eventually be a large-scale production site. This includes enhanced quality control and R&D capabilities. Together, all this adds to Hovione’s stable of manufacturing sites, R&D centers, and other offices spread across three continents. Key to the expansion is a targeted reduction of Hovione’s carbon footprint by 40% by the year 2030. Part of this goal is embracing new and/or changing solvent types to help meet sustainability standards. Additionally, the company says automation that has been put in place at its Portugal site will be replicated in NJ. Hovione Aligns NJ Operations At the Drug, Chemical & Associated Technologies Association (DCAT) Week in New York in March, Contract Pharma met with Hovione. There, David Basile, Vice President of Technical Operations—Americas, further illustrated the New Jersey expansion. “Hovione aims to build an equivalent manufacturing network, where clients can go to any site across the globe,” Basile said. “The design of the facility has been well-thought through with material flows [and] gravity-fed processes. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets.” Ultimately, with these moves and a strategic partnership model, Hovione aims to provide customers an opportunity to co-invest and access the company’s proprietary knowledge and assets to accelerate programs and create long-term value. Read the full article at ContractPharma.com    

Press Clipping

Hovione Planning Ribbon-Cutting at NJ Facility – A Behind-the-Scenes Preview

Jul 31, 2026