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Hovione is a Contract Development and Manufacturing Organization (CDMO) with services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the United States, Portugal, Ireland and China development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione is also present in the inhalation area, and provides a complete range of services, from active pharmaceutical ingredients (APIs), formulation development and devices. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corporation (certification), is a member of Rx-360[1] and EFCG.[2]

Key Information

History

[edit]
Ivan Villax - 1950

Hovione was established in Portugal in 1959 by Ivan Villax with his wife, Diane Villax, and two other Hungarian refugees: Nicholas de Horthy and Andrew Onody, the first two letters of the three founders’ names: HO, VI and ON were used to create the name Hovione.[3]

Hovione continues to be a privately held company with 5 plants - in Portugal (1969), Macao (1986), and New Jersey (2001) expanded in 2016,[4] Taizhou in mainland China (2008) and Cork, Ireland (2009) - have a total reactor capacity of 1300 m³ and 1100 people worldwide. Since Hovione started operations in 1959, the company has patented more than 100 innovative chemical processes and produced industrially over 45 different APIs. All Hovione sites have been successfully inspected either by the FDA, the European Medicines Agency or the PMDA Japanese agency.[5][6][7][8]

Hovione is a major source of semi-synthetic tetracyclines and corticosteroids, and is the largest independent supplier of contrast agents – these three families of compounds make up most of its generic product portfolio. The other half of the business focuses on exclusive projects including the development of innovator APIs and particle engineering.[9][10]

Research and development

[edit]

Hovione has two R&D centers with a team of over 270 scientists, one in Portugal - Loures and another one in its facilities in New Jersey. Hovione has international partnerships, including with Cambridge and MIT.[11] In 2016, 7 PhDs were simultaneously running and it launched a scientific program named "9oW",[12] which challenges scientific and academic communities to help overcome technological challenges. Also, Hovione is already the largest private employer of doctorates in Portugal (57 doctorates in Loures).[13]

Strategy

[edit]

Hovione was present in the pharmaceutical industry offering products and services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product. In the area of technology, it has capabilities, among others, in spray drying, controlled crystallization, microfluidization, and continuous tabletting.[14] Hovione invested about $100 million in 2017 and plans to spend as much again in 2019 and 2020. The plan over the next three years is to continue investing, especially in Portugal, where the firm will add 165 m3 of chemical synthesis capacity, a spray-dryer building, and a 1,200-m2 analytical lab.[15]

References

[edit]
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Hovione

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Hovione is a privately held international Development and (CDMO) specializing in the development and production of active pharmaceutical ingredients (APIs), drug product intermediates, and finished for the . Founded in 1959 in , , by Ivan Villax, Diane Villax, Nicholas de Horthy, and Andrew Onody, the company has grown into a global leader with over 66 years of experience, employing approximately 2,400 people (as of 2025) across four FDA-inspected manufacturing sites in , (), (), and Cork (). Hovione's core operations focus on supporting pharmaceutical clients in bringing both innovative new chemical entities (NCEs)—having supported over 70 in development historically—and off-patent generic drugs to market faster and more affordably, emphasizing , , and reliable delivery. The company offers end-to-end services, including contract manufacturing for highly potent compounds, niche generic APIs, and comprehensive solutions for drug , where it stands as a unique independent provider. Its technological expertise spans corticosteroids, long-acting beta-agonists (LABA)/long-acting muscarinic antagonists (), antibiotics, and mectins, supported by a total manufacturing capacity of over 1,000 cubic meters (as of ). Key milestones in Hovione's expansion include the establishment of its first manufacturing plant in in 1969, FDA approval of that facility in 1982, the opening of a site in in 1986, entry into the U.S. market with a facility in 2001, and the addition of the Cork site in 2009. Additional growth involved acquiring Hisyn in in 2008, opening an R&D center in , and establishing offices in (1979), (2011), and (2016). In 2025, Hovione completed a $100 million expansion at its site to double capacity and received the Prize for innovation. As a family-owned business guided by the principle of "In it for life," Hovione maintains memberships in industry organizations like Rx-360 and the European Fine Chemicals Group (EFCG), underscoring its commitment to high standards in .

Company Overview

Founding and Early Development

Hovione was founded in 1959 in , , by Ivan Villax, his wife Diane Villax, and two fellow Hungarian refugees, Nicholas de Horthy and Andrew Onody. The company's name is derived from the first two letters of each of the three male founders' surnames: HO from Horthy, VI from Villax, and ON from Onody, forming "Hovione." As a family-oriented chemical enterprise, it began operations in the basement of the Villax family home, reflecting the founders' determination to build a stable business amid post-World War II displacement. Ivan Villax, a trained and who had fled in 1956, brought expertise in pharmaceutical synthesis, while the group's shared refugee background fostered a collaborative spirit. In its early years, Hovione concentrated on basic chemical manufacturing, producing semi-synthetic tetracyclines and anti-inflammatory corticosteroids under license. These initial products targeted the growing demand for affordable antibiotics and steroids, with operations emphasizing small-scale synthesis and quality control to meet international standards. Over time, the company shifted its focus toward pharmaceuticals, securing patent licenses and initiating exports to markets in Europe and beyond, which laid the groundwork for its transition into specialized drug substance production. This evolution was driven by the founders' recognition of the pharmaceutical sector's potential for sustainable growth, prioritizing reliable supply chains over commodity chemicals. A pivotal milestone came in 1969 with the construction of Hovione's first dedicated manufacturing plant in , a suburb north of . This facility marked the company's shift from rudimentary lab-based production to industrial-scale operations, enabling expanded capacity for active pharmaceutical ingredients (APIs) and enhancing its competitiveness in the global market. From the outset, the founders instilled an emphasis on quality and innovation, aiming to forge long-term partnerships with pharmaceutical firms by tackling complex manufacturing challenges. As Diane Villax later reflected, the objective was "always... within the field of pharmaceuticals, giving our clients ever better service and supplying them with the products they require." This vision positioned Hovione as a trusted partner in , setting the stage for its role as a contract development and manufacturing organization (CDMO).

Mission and Core Values

Hovione's mission is to passionately turn any challenge into a solution by collaborating with partners to create great medicines, encapsulated in its tagline "In it for life," which underscores enduring partnerships with pharmaceutical clients throughout the and manufacturing lifecycle. This commitment reflects the company's dedication to helping clients bring both innovative new drugs and off-patent generics to market faster and more affordably, fostering long-term relationships that prioritize reliability and shared success over 60 years of operation. The core values, established by founder Ivan Villax in , form the foundation of Hovione's operational and have remained consistent amid global growth. These include , , uncompromising quality, and a strong emphasis on employee through principles such as , transparency, , , and never giving up. Grouped into three pillars—Principled (, , transparency, , , never give up), Think Differently (team-thinking wins, innovate everywhere, driven by diversity, dare to do the impossible), and Deliver (passion and rigor, uncompromising quality, committed to customers)—these values guide decision-making and interactions, ensuring scientific rigor and customer orientation at every level. Hovione's culture retains a family-oriented structure rooted in its origins, evolving into professional while upholding ethical consistency and . This ethos promotes employee , such as through an Ethics Line for reporting concerns, and diversity-driven creativity to address complex challenges in pharmaceutical services. By integrating these elements, Hovione maintains a that balances personal with collective , contributing to its reputation as a reliable partner in the industry.

Global Presence and Operations

Hovione maintains its headquarters in , , serving as the central hub for strategic oversight and administrative functions. The company's major manufacturing facilities are strategically located across four key sites: in , which hosts extensive drug substance production capabilities; in , focused on API manufacturing for the Asian market; East Windsor in , , emphasizing R&D and advanced processing technologies; and Cork in Ireland, dedicated to high-potency synthesis. These sites form the backbone of Hovione's global operations, enabling efficient service delivery to pharmaceutical clients worldwide. In addition to its manufacturing footprint, Hovione operates sales and support offices in , , , and to facilitate regional and . These offices provide localized support for , regulatory compliance, and project coordination, enhancing the company's responsiveness in key pharmaceutical hubs across . The global network underscores Hovione's commitment to bridging international markets with its European and North American production strengths. As a fully integrated contract development and manufacturing organization (CDMO), Hovione employs approximately 2,400 professionals across its sites (as of 2025), fostering expertise in end-to-end services from active pharmaceutical ingredient (API) development to finished drug product manufacturing. The company's total manufacturing capacity exceeds 1,000 cubic meters (as of 2023), supporting scalable production for both branded and generic pharmaceuticals. All four manufacturing sites have undergone successful inspections by the U.S. Food and Drug Administration (FDA), ensuring compliance with stringent regulatory standards. In 2025, Hovione completed a significant expansion at its New Jersey site with a $100 million investment to enhance spray drying capabilities.

History

Establishment and Initial Growth (1959–1980s)

Hovione was founded on January 1, 1959, in , , as a small chemical firm specializing in the production of semi-synthetic tetracyclines and corticosteroids. Established in the basement of the Villax family home by Hungarian refugees Villax, his wife Diane Villax, de Horthy, and Onody—whose initials formed the company name—the venture emerged during 's post-World War II economic recovery, which saw gradual growth through increased exports and industrialization under the Estado Novo regime. This period of cautious prosperity provided a stable environment for small-scale chemical enterprises to develop, aligning with the founders' expertise in pharmaceutical intermediates amid Europe's rebuilding efforts. By the late 1960s, Hovione had expanded its operations to meet growing demand in the active pharmaceutical ingredients (API) market. In 1969, the company constructed its first dedicated industrial plant in Loures, Portugal, just outside Lisbon, which marked a significant step toward scalable pharmaceutical production and solidified its position as a reliable supplier of high-quality chemical compounds. This facility enabled Hovione to transition from artisanal beginnings to more structured manufacturing, focusing on precision processes essential for pharmaceutical-grade outputs during a decade of Portugal's economic liberalization and foreign investment inflows. The 1970s brought opportunities for international outreach, driven by successes in key markets. In 1979, Hovione opened an office in to capitalize on Asian expansion, particularly following strong sales of betamethasone products in , which highlighted the company's emerging global footprint in corticosteroids. This move reflected strategic foresight in accessing Asia's burgeoning pharmaceutical sector while maintaining roots in European production. Entering the 1980s, Hovione achieved critical regulatory milestones that affirmed its quality standards and market entry into regulated territories. In 1982, the U.S. Food and Drug Administration (FDA) approved the plant, enabling the launch of production for the U.S. market shortly after the original patent expired; this entry diversified Hovione's portfolio and established it as a key player in generics. Building on this momentum, the company established a second manufacturing site in , , in 1986, to support expanded API production and leverage proximity to Asian supply chains, further enhancing operational capacity during a period of increasing global trade.

International Expansion (1990s–2010s)

During the 1990s, Hovione began its international expansion by enhancing its core manufacturing capabilities in Portugal, marking a pivotal step toward global operations. In 1997, the company expanded its Loures facility with the addition of a 200 m³ automated plant, significantly increasing its capacity for active pharmaceutical ingredient (API) production to meet growing demand from outsourced pharmaceutical manufacturing. This upgrade allowed Hovione to scale operations efficiently while maintaining high standards of quality and compliance. The early 2000s saw Hovione extend its footprint beyond to , establishing a presence closer to key regulatory bodies and major clients. In 2001, the company opened its third manufacturing site in , , which commenced operations in 2002 and was designed to serve North American pharmaceutical companies by providing process development and small-volume manufacturing. This strategic location offered proximity to the U.S. (FDA), facilitating faster regulatory interactions and inspections, with the site receiving its first FDA approval in 2007. In 2008, Hovione acquired a 75% stake in Hisyn Pharmaceutical Co. Limited in Taizhou, , to bolster its API manufacturing capabilities in Asia. By the end of the decade, Hovione further diversified in 2009 by acquiring and opening its fourth facility in Cork, , specializing in high-potency APIs and ensuring compliance with stringent European regulatory standards through regular inspections by the Health Products Regulatory Authority (HPRA). Entering the 2010s, Hovione continued its global outreach by establishing sales offices in emerging and established Asian markets to bolster and customer support. In 2011, the company opened a sales in , , enhancing its ability to engage with the rapidly growing Indian pharmaceutical sector and providing localized support for . In 2018, Hovione established an in Shanghai, China, to better understand local customer needs and support R&D and manufacturing services in the Chinese market. This was followed in 2016 by the inauguration of a sales and customer support in Osaka, , aimed at strengthening ties in the region and facilitating regulatory affairs for Japanese clients. These expansions during the 1990s and 2010s transformed Hovione from a family-owned enterprise into a professional contract development and manufacturing organization (CDMO), with a sharpened focus on complex APIs and production. The shift emphasized integrated services for both innovator and off-patent molecules, positioning the company as a reliable global partner in pharmaceutical supply chains.

Recent Milestones (2020s)

In 2025, Hovione completed an initial $100 million investment cycle to expand its manufacturing operations at the East Windsor site in , , more than doubling the facility's footprint to over 200,000 square feet. This expansion includes a new 31,000-square-foot building equipped with two production-scale spray dryers for amorphous solid dispersions, alongside a 125,000-square-foot greenfield development reserved for future additions such as continuous and batch lines, laboratories, and areas. Construction is underway, with operations scheduled to commence in the second quarter of 2026, enhancing the company's capacity to support integrated drug substance and product manufacturing in the United States. Also in 2025, Hovione announced progress on its new Hovione Tejo Campus in , , entering the final stage of for the first phase with an approximate €200 million investment. Spanning 42 hectares to allow for future expansions, the campus will feature state-of-the-art facilities focused on advanced technologies, including and particle engineering for final . Commissioning of the initial phase is set for mid-2027, positioning the site as a key hub for sustainable, automated production to meet growing global demand. These developments have bolstered Hovione's expertise in and particle , enabling the creation of complex products such as dry powder inhalers through enhanced capabilities for improvement and controlled release. By 2025, the company had grown its global workforce to 2,300 employees and expanded its total manufacturing capacity to more than 590 cubic meters, reflecting sustained investment in operational scale to align with its broader growth strategy.

Services and Products

Drug Substance Development and Manufacturing

Hovione provides comprehensive services for the development and manufacturing of active pharmaceutical ingredients (APIs), covering the full lifecycle from route scouting and process development to commercial-scale production. This includes initial route identification to optimize synthetic pathways, followed by process optimization using (QbD) principles and Process Analytical Technologies (PAT) to ensure robust, scalable processes. With over 50 years of experience, the company supports clients in developing APIs for clinical trials through to market supply, emphasizing efficiency and throughout. The firm specializes in complex molecules, including highly potent APIs (HPAPIs) and challenging chemistries such as , fluorination, , and membrane technologies. Hovione's expertise extends to handling HPAPIs with occupational exposure limits (OEL) as low as 1.0 μg/m³, utilizing dedicated facilities for safe containment and purification via techniques like . This capability enables the production of sophisticated intermediates and APIs that require precise control over reaction conditions, such as cryogenic reactions at -150°C in vessels up to 10,000 liters or hydrogenations under pressures up to 25 bar in reactors up to 6,000 liters. Manufacturing occurs across four GMP-compliant sites on three continents—Loures, ; Cork, ; , ; and East Windsor, New Jersey, —each inspected and approved by the FDA, with additional approvals from the EMA and Japanese authorities for commercial production. These facilities offer scalable capacity exceeding 1,000 cubic meters in total reactor volume, enabling output from gram-scale for early development to hundreds of metric tons annually for commercial needs, supported by 24/7 operations. Recent expansions, including a $100 million investment in the New Jersey site completed in 2025, have enhanced capabilities for integrated drug substance processing. Supporting technologies include continuous flow manufacturing for improved process robustness and for amorphous solid dispersions to enhance drug in API development. These tools are integrated into the to facilitate seamless scale-up, with flexible allowing adaptation to diverse client requirements while maintaining high standards of quality and safety.

Drug Product Services

Hovione provides comprehensive drug product services encompassing the full lifecycle of and , from pre- studies through supplies to commercial-scale production. These services integrate advanced particle engineering techniques to enhance bioavailability and performance, particularly for complex molecules requiring optimized delivery systems. The company's capabilities extend to both oral and inhaled , leveraging in-house expertise to develop stable, patient-friendly products that meet stringent pharmaceutical requirements. A key specialization lies in and nasal drug products, where Hovione serves as the only independent full-service provider offering end-to-end solutions, including engineering, development, device integration, and filling operations. This includes a range of dry powder inhalers such as disposable, capsule-based, blister, and large-dose variants, designed for efficient pulmonary delivery of therapeutics like respiratory medications. Hovione's services emphasize principles to ensure robust processes and optimal product performance, supported by dedicated facilities for control and analytical characterization. Hovione excels in handling highly potent active pharmaceutical ingredients (APIs) within product , with capabilities to compounds down to occupational exposure limits (OEL) of 30 ng/m³ using specialized systems like precision capsule fillers equipped for net weight verification. The company also supports biologics intermediates through innovative approaches, such as for stabilization and delivery of biopharmaceuticals, incorporating proprietary sugars to address challenges in and shelf-life. Particle engineering is central to these efforts, enabling amorphous solid dispersions and composite particles that improve and absorption for poorly bioavailable drugs. All drug product operations adhere to current (cGMP) standards across Hovione's global sites, including sterile and non-sterile filling processes to ensure product integrity and regulatory compliance. Sterile capabilities feature aseptic followed by vial filling for sensitive formulations, while non-sterile lines support high-volume oral and capsule production. This integrated approach allows seamless scale-up from lab to commercial batches, minimizing risks and accelerating time-to-market for clients.

Generic API Portfolio

Hovione maintains a portfolio of off-patent active pharmaceutical (APIs) focused on niche, high-value categories that require advanced expertise. These generics are developed and produced to support global pharmaceutical clients in creating cost-effective alternatives to branded drugs, with an emphasis on complex multi-step synthesis and precise particle engineering to achieve optimal and formulation performance. The portfolio spans several therapeutic areas, including corticosteroids for applications, long-acting beta agonists/long-acting muscarinic antagonists (LABA/) for respiratory treatments, antibiotics for bacterial infections, and mectins for uses. Examples of marketed products include betamethasone acetate and betamethasone disodium phosphate in the corticosteroids category, vilanterol trifenatate and umeclidinium bromide for LABA/ combinations, hyclate and monohydrate as antibiotics, and as a mectin. These APIs are supplied in various grades tailored for oral, topical, , and injectable formulations, with many holding regulatory approvals for generic and veterinary medicines. Hovione's approach to these high-barrier generics prioritizes overcoming challenges in synthesis complexity and polymorph control, enabling reliable commercial-scale production at facilities compliant with FDA and EMA standards. The company provides these APIs through long-term supply agreements, ensuring stability and via Certificates of Suitability (CEP) and Drug Master Files (DMF) filings across major markets. This positions Hovione as a trusted partner for developers seeking robust, high-purity ingredients that meet stringent regulatory and performance criteria.

Research and Development

Key Facilities and Capabilities

Hovione's primary R&D hub is the Lumiar Campus in , , which serves as the center for early-stage and houses specialized laboratories dedicated to innovative research. This facility, comprising two interconnected buildings, supports a range of activities from concept to pilot-scale testing, with an emphasis on collaborative environments that foster interdisciplinary work among researchers. In the United States, Hovione's R&D capabilities are anchored at its site, where labs expansion is underway as part of a $100 million cycle completed in 2025 to incorporate next-generation technologies for advanced development processes, with operations planned to start in Q2 2026. This upgrade enhances the site's role in supporting U.S.-based projects with integrated research infrastructure, including enhanced analytical and testing spaces. Key capabilities across these hubs include state-of-the-art analytical laboratories equipped for comprehensive and assessment during development phases. Pilot plants at both locations enable seamless scale-up from lab to demonstration batches, with automated systems handling volumes from 100 liters to 3,000 liters to simulate commercial processes efficiently. Additionally, specialized for handling highly potent compounds, achieving occupational exposure limits as low as 0.03 µg/m³, ensures safe and compliant operations for sensitive materials. Hovione integrates digital tools such as software to optimize development workflows, reducing material use and accelerating timelines in R&D activities. These investments in digital infrastructure are directly linked to site expansions, including the upgrades underway as of 2025. The facilities feature dedicated collaboration spaces, such as open-plan areas and shared laboratories at the Lumiar Campus, designed to promote knowledge exchange among approximately 220 scientists, including 60 PhDs, stationed there. These spaces facilitate cross-functional teamwork, supporting Hovione's broader research network.

Focus Areas in Innovation

Hovione's innovation efforts in particle engineering center on enhancing through techniques such as and , which enable the creation of dispersions and controlled distributions to improve for poorly soluble compounds. , a core technology employed by Hovione for over 19 years, facilitates the production of microencapsulated particles and inhaled powders suitable for thermally labile materials, addressing challenges in oral and pulmonary administration. via jet milling further supports this by achieving uniform reduction through high-velocity air collisions, optimizing dissolution rates and formulation stability without introducing contaminants. These approaches prioritize BCS Class II and IV drugs, where particle morphology directly influences therapeutic efficacy. In , Hovione emphasizes formulations for dry powder inhalers (DPIs), metered-dose inhalers (MDIs), and nebulizers, with a strong focus on targeted delivery systems that enhance deposition and Fine Particle Fraction (FPF). Particle plays a pivotal role here, enabling the design of carrier-based or drug-alone powders with aerodynamic properties optimized for deep penetration, particularly for respiratory therapies. Hovione's expertise extends to composite particles and spray-dried formulations that support high-dose delivery in DPIs, reducing variability in patient dosing for conditions like and . For MDIs and nebulizers, innovations include suspension to ensure consistent and stability, aligning with the need for precise control in inhaled therapeutics. Hovione invests in complex active pharmaceutical ingredient () synthesis targeting , respiratory, and infectious diseases, leveraging its capabilities in handling highly regulated, multi-step chemical processes to produce high-purity intermediates and final APIs. In , collaborations such as the 2025 with Firstgene Life Sciences advance platforms for treatments, integrating synthesis with delivery innovations. For respiratory diseases, Hovione specializes in synthesizing corticosteroids and bronchodilators like tiotropium and fluticasone, engineered for inhalation-grade performance to combat conditions such as COPD and . In infectious diseases, the company's portfolio includes APIs for antiviral and antibacterial applications, supporting synthesis of compounds used in treatments for , , and respiratory infections through scalable, cGMP-compliant processes. As emerging areas, biologics and antibody-drug conjugates (ADCs) represent expanding frontiers for Hovione, with R&D directed toward integrating small-molecule expertise into biologic formulations, particularly for inhalation delivery. Spray emerges as a gentle technique for stabilizing biologics like peptides and proteins, enabling pulmonary administration to bypass enzymatic degradation and improve patient compliance. In ADCs, Hovione's supports linker-payload conjugation for applications, though primary focus remains on small-molecule payloads to enhance targeted while maintaining stability. These efforts build on Hovione's established to explore hybrid modalities, prioritizing enhancement and controlled release in biologic-drug combinations.

Technological Advancements

Hovione has developed advanced platforms that enable the production of dispersions (ASDs), which significantly enhance the and of poorly water-soluble active pharmaceutical ingredients (APIs). These platforms utilize proprietary processes to create stable ASDs by rapidly drying solutions or suspensions containing the drug and a carrier, resulting in particles with optimized amorphous structures that prevent recrystallization. For instance, Hovione's technology has been ed for forming solid ASDs of low-solubility drugs, addressing challenges in particle handling and integration. In addition to batch processes, Hovione incorporates continuous techniques in its spray drying operations, allowing for uninterrupted production that improves efficiency and scalability. This continuous approach involves inline preparation of spray solutions, reducing variability and enabling real-time , which is particularly beneficial for complex formulations. Hovione has pioneered continuous manufacturing processes for both APIs and tablets, transitioning from traditional batch methods to streamline production, lower operational costs, and ensure greater consistency in product quality. For drug substances, continuous flow chemistry enables precise control over reaction parameters, facilitating the synthesis of high-purity APIs with reduced waste and faster development timelines. In tablet production, Hovione's continuous line integrates feeding, blending, , , and compression into a single, end-to-end process, which has been scaled up through partnerships to support commercial volumes while minimizing downtime and material loss. These advancements have been implemented in facilities equipped for potent compound handling, ensuring safe processing of high-potency APIs without compromising yield or uniformity. For inhalation drug delivery, Hovione employs specialized technologies such as multi-nozzle spray dryers to engineer particles with tailored aerodynamic properties, optimizing performance for dry powder inhalers. This includes advanced analytical characterization methods, including cascade impaction with biorelevant throat models and in vitro dissolution tools like DissolvIt® integrated with PreciseInhale®, which simulate absorption to predict behavior and refine particle design. These techniques support the development of inhalation-grade APIs with controlled size distribution and surface properties, enhancing deposition efficiency. Hovione holds numerous patents in particle design and potency handling, including innovations for deagglomeration to improve powder flow and dispersibility, as well as containment strategies for safe handling of highly potent compounds during continuous processes. Examples of technology transfers include seamless handovers to clients for commercial-scale of ASDs and continuous of formulations, where Hovione's proprietary methods have accelerated market entry for partnered products by integrating development directly into protocols.

Business Strategy

Growth and Investment Approach

Hovione, as a privately owned , benefits from a structure that supports long-term without the pressures of short-term expectations, allowing for sustained investments in capacity and . This ownership model has enabled the to pursue a consistent strategy focused on expanding capabilities across its global sites to meet evolving client demands in the pharmaceutical sector. The company's investment approach emphasizes organic expansion through targeted site developments, including a $100 million commitment to its facility in the United States, which more than doubles U.S. capacity for dispersions and enhances integrated drug substance and product services. Similarly, the €200 million Tejo Campus project in , , set to open in mid-2027, will expand industrial capacity in and particle while creating approximately 100 skilled jobs. These initiatives form part of a broader multi-year program to bolster infrastructure without relying on acquisitions, prioritizing self-funded growth to maintain operational control and agility. Hovione's growth strategy balances services for innovative drugs—such as highly potent active pharmaceutical ingredients (HPAPIs) and complex formulations—with its established generic API portfolio, enabling diversified revenue streams while leveraging expertise in high-value CDMO segments like drug delivery and potent compound handling. This dual focus allows the company to support both novel therapies requiring advanced particle engineering and cost-effective production of off-patent molecules. By targeting these areas, Hovione addresses client needs in high-demand therapeutic markets, including respiratory conditions through specialized technologies and via solubility-enhancing for poorly soluble compounds, positioning itself to capture growth in the CDMO market, projected to reach USD 9.13 billion in 2025, and the rising demand for potent APIs in targeted therapies.

Sustainability and Compliance

Hovione integrates into its core operations through initiatives focused on principles in active pharmaceutical ingredient (API) synthesis, emphasizing processes that minimize environmental impact. For instance, the company employs mechanochemical methods to produce APIs with reduced use and generation, as demonstrated in comparative studies of nine APIs where mechanosynthesis achieved higher metrics than traditional routes. Additionally, Hovione has partnered with Technologies to implement micellar chemistry, enabling water-based reactions that significantly lower carbon footprints compared to conventional organic processes. reduction efforts include site-specific procedures following a hierarchy of prevention, minimization, reuse, and recycling, resulting in a 10.6% decrease in total from 2018 to 2020, with over 80% of recycled or recovered during that period. To enhance energy efficiency, Hovione has installed photovoltaic panels at its Loures manufacturing plant and Lumiar R&D center in , contributing to 43% consumption across operations in 2020. These measures support broader environmental goals, including the use of the PRIME tool in R&D to evaluate and select lower-impact chemical processes. Hovione maintains a strong compliance record, with over 40 U.S. (FDA) inspections since 1982 across its sites in , , , and the , 18 of which resulted in no Form 483 observations, and the rest receiving approvable letters without critical findings. Inspections by other agencies, such as Japan's (PMDA) and 's INFARMED, have similarly yielded no critical or major observations in recent evaluations, including PMDA's 2017 review of the site. The company actively participates in industry organizations like Rx-360 and the European Fine Chemicals Group (EFCG) to advance global quality standards. As part of its environmental, social, and governance (ESG) framework, Hovione has committed to science-based targets (SBTs) for (GHG) emissions reduction in alignment with the , building on a 21% absolute reduction in Scope 1, 2, and 3 emissions from a 2016 baseline achieved by 2020. This exceeds its initial 15% target set for 2021 and supports ongoing efforts to minimize use and impacts, with total GHG emissions at 65,244 tons CO2 equivalent in 2020. On the social front, the workforce reflects 35 nationalities, with women comprising 36% of employees and 29% of board members in 2020, alongside commitments to reinforced by Top Employer certifications across all sites, including the 2025 certification. Hovione's quality systems are uniformly integrated across all global sites to ensure adherence to current good practices (cGMP), encompassing and management controls to prevent safety, environmental, or business risks. These systems comply with regulatory requirements from agencies like the FDA and , facilitating reliable and drug product .

Partnerships and Market Position

Hovione has established long-term partnerships with leading pharmaceutical firms and technology providers, particularly in specialized areas such as and advanced technologies. For instance, in May 2023, Hovione extended its collaboration with H&T Presspart to develop high-efficiency dry powder devices, combining Hovione's particle engineering expertise with Presspart's device capabilities to accelerate and delivery innovations. Similarly, the company formed a with Zerion Pharma in 2022, expanded in 2024, to commercialize the Dispersome® technology platform for enhancing drug solubility in respiratory and applications, granting Hovione exclusive rights in these fields. These alliances, along with recent agreements like the September 2024 with iBET to create ViSync Technologies for cell and solutions, underscore Hovione's role in supporting over 100 active development projects across its global client base. As a mid-sized contract development and manufacturing organization (CDMO), Hovione holds a strong market position in niche segments such as generics and drug products, bolstered by its leadership in and particle engineering. The company's expansions, including a $100 million completed in October 2025 to double U.S. spray-drying capacity at its site, are projected to drive revenue growth by enhancing production for high-demand areas like enhancement. With annual revenues reaching $750 million as of September 2025, Hovione differentiates itself from larger CDMOs through its independence as a family-controlled entity, enabling full end-to-end integration from development to drug product manufacturing. This structure facilitates faster speed-to-market and greater agility in responding to client needs, as evidenced by its 2023 CDMO Leadership Award wins in all six categories—capability, compatibility, expertise, quality, reliability, and service—from industry evaluators. Hovione actively contributes to the through participation in key conferences, such as RDD Europe 2025, where it served as an exhibitor and conference supporter to advance discussions on respiratory innovations. These engagements highlight its competitive advantages in fostering collaborative ecosystems that prioritize sustainable and efficient technologies over the scale-driven approaches of bigger competitors.

References

  1. https://www.hovione.com/about-hovione/what-we-do
  2. https://www.hovione.com/about-us/about-hovione/history-hovione
  3. https://www.hovione.com/sites/default/files/assets/files/hovione_-_drug_substance_contract_manufacturing_services.pdf
  4. https://www.hovione.com/press-room/press-release/hovione-completes-initial-100m-investment-cycle-expand-us-operations-new-jersey-manufacturing-site
  5. https://www.hovione.com/press-room/press-release/hovione-honored-leonardo-da-vinci-prize-2025
  6. https://www.hovione.com/press-room/news/today-we-celebrate-our-62nd-anniversary
  7. https://cen.acs.org/articles/87/i23/50-Hovione-Takes-Big-Step.html
  8. https://www.hovione.com/locations/hovione-loures
  9. https://www.hovione.com/about-hovione/mission-vision-and-values
  10. https://www.hovione.com/it-life
  11. https://www.hovione.com/about-hovione
  12. https://www.hovione.com/hovione-worldwide
  13. https://www.hovione.com/locations/hovione-macau
  14. https://www.hovione.com/locations/hovione-new-jersey
  15. https://www.hovione.com/locations/hovione-hong-kong
  16. https://www.hovione.com/locations/hovione-india
  17. https://www.hovione.com/locations/hovione-japan
  18. https://www.hovione.com/press-room/press-release/hovione-certified-top-employer-all-its-manufacturing-sites
  19. https://www.hovione.com/press-room/news/hovione-expanding-spray-drying-capacity-us-drug-manufacturing
  20. https://www.cvce.eu/en/recherche/unit-content/-/unit/a7b75b14-91dc-48dd-9df0-a0d51a9edfef/63dfd5f2-b99e-4d5e-a7ee-528a8e0a23b9
  21. https://macaomagazine.net/nearly-four-decades-of-macao-made-medicine/
  22. https://www.hovione.com/press-room/press-release/hovione-buys-drug-manufacturing-facility-china
  23. https://www.hovione.com/locations/hovione-cork
  24. https://www.hovione.com/locations/hovione-shanghai
  25. https://www.hovione.com/press-room/press-release/hovione-opens-new-sales-and-customer-support-office-japan
  26. https://www.hovione.com/
  27. https://www.hovione.com/press-room/press-release/hoviones-new-campus-seixal-enters-final-stage-construction-set-open-mid-2027
  28. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-substance/drug-substance-development
  29. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-substance/drug-substance-capabilities
  30. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-substance/drug-substance-manufacturing
  31. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-substance/drug-substance-technologies
  32. https://www.hovione.com/products-and-services/contract-manufacturing-services/particle-engineering/technologies/spray-drying
  33. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-product
  34. https://www.hovione.com/press-room/press-release/hovione-strengthens-inhalation-services-portfolio
  35. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-product/inhalation-and-nasal
  36. https://www.hovione.com/press-room/article/fresh-thinking-biologic-drug-formulation
  37. https://www.hovione.com/press-room/press-release/hovione-acquires-extremochem-and-its-portfolio-proprietary-sugars-support-customers-stabilization-and-delivery-biopharmaceuticals
  38. https://www.hovione.com/press-room/press-release/aseptic-spray-drying-hoviones-latest-offering
  39. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-product/oral/drug-product-manufacturing
  40. https://www.hovione.com/products-and-services/patent-api-products
  41. http://go.hovione.com/api-product-portfolio
  42. https://www.hovione.com/products-and-services/patent-api-products/api-portfolio
  43. https://www.hovione.com/api/betamethasone-disodium-phosphate
  44. https://www.hovione.com/api/ivermectin
  45. https://go.hovione.com/sustainability-report-2019-2020
  46. https://www.hovione.com/products-and-services/supporting-capabilities/quality-and-compliance/regulatory-affairs/certificate-suitability-cep
  47. https://www.hovione.com/locations/hovione-lumiar
  48. https://www.hovione.com/products-and-services/supporting-capabilities/analytical-support/capabilities
  49. https://www.hovione.com/knowledge-center/article/handling-potent-drug-materials
  50. https://www.hovione.com/press-room/article/efficiency-demands-drive-advances-api-labs
  51. https://www.hovione.com/products-and-services/contract-manufacturing-services/particle-engineering/technologies/jet-milling
  52. https://www.pharmaexcipients.com/wp-content/uploads/attachments/Pulmonary%2BDrug%2BDelivery%25E2%2580%2594Particle%2BEngineering%2Bfor%2BInhaled%2BTherapeutics.pdf?t=1429594744
  53. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-product/inhalation-and-nasal/particle-engineering-inhalation-and-nasal
  54. https://www.hovione.com/knowledge-center/article/spray-drying-enabling-technology-inhalation-drug-delivery
  55. https://www.pharmtech.com/view/pulmonary-drug-delivery-particle-engineering-inhaled-therapeutics
  56. https://www.hovione.com/press-room/press-release/hovione-and-firstgene-announce-strategic-collaboration-advance-virus-particle-platform-liver-cancer
  57. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-product/inhalation-and-nasal/api
  58. https://www.worldscientific.com/doi/pdf/10.1142/S0219030307000298
  59. https://www.hovione.com/press-room/article/outsourcing-formulation-development-manufacturing-specialized-capabilities-small-large-molecules
  60. https://www.hovione.com/approach-product-development
  61. https://patents.google.com/patent/US10383941B2/en
  62. https://www.hovione.com/knowledge-center/patent/spray-drying-process-continuous-preparation-spray-solution
  63. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-substance/continuous-flow
  64. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-product/continuous-tableting-drug-product
  65. https://www.hovione.com/press-room/press-release/hovione-and-gea-strengthen-partnership-advance-continuous-tableting-technology
  66. https://patents.google.com/patent/WO2015150761A1/en
  67. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-product/inhalation-and-nasal/analytical-characterization
  68. https://www.pharmtech.com/view/hovione-technology-granted-patent-for-deagglomeration-method
  69. https://patents.justia.com/assignee/hovione-scientia-limited
  70. https://www.hovione.com/press-room/press-release/hovione-expands-drug-product-offering-new-manufacturing-line-dedicated-continuous-tableting
  71. https://www.hovione.com/sites/default/files/assets/files/epm_-_making_a_success.pdf
  72. https://www.hovione.com/about
  73. https://www.hovione.com/products-and-services/contract-manufacturing-services/drug-substance/drug-substance-capabilities/hpapi-highly-potent-api
  74. https://www.hovione.com/press-room/press-clipping/inhalation-cdmo-market-growth-analysis-forecast-2025-2035
  75. https://www.hovione.com/knowledge-center/article/comparison-traditional-and-mechanochemical-production-processes-nine-active-pharmaceutical-ingredients-apis
  76. https://www.hovione.com/press-room/press-release/hovione-partners-dragonfly-technologies-offer-micellar-chemistry-technology-customers-sustainable-alternative-conventional-chemical-processes
  77. https://www.hovione.com/products-and-services/supporting-capabilities/quality-and-compliance/quality/inspections-history
  78. https://www.hovione.com/press-room/news/hovione-commits-science-based-targets-greenhouse-gas-ghg-emissions
  79. https://www.hovione.com/press-room/press-release/hovione-strengthens-its-global-position-top-employer-third-consecutive-year
  80. https://www.hovione.com/products-and-services/supporting-capabilities/quality-and-compliance/quality
  81. https://www.hovione.com/press-room/press-release/hovione-and-ht-presspart-extend-partnership-advance-high-efficiency-device-technology-dry-powder-inhalation-formulation-delivery
  82. https://www.hovione.com/press-room/press-release/zerion-pharma-and-hovione-extend-partnership-cover-use-dispersome-technology-platform-nutraceuticals
  83. https://www.hovione.com/press-room/press-release/hovione-and-zerion-pharma-create-joint-venture-further-expand-use-dispersome-technology
  84. https://www.hovione.com/press-room/press-release/hovione-and-ibet-announce-establishment-visync-technologies-venture-cell-and-gene-therapy-solutions
  85. https://finance.yahoo.com/news/hovione-completes-initial-100m-investment-113000737.html
  86. https://leadiq.com/c/hovione/5a1d96632300005c0085090c
  87. https://www.hovione.com/press-room/press-release/hovione-receives-2023-cdmo-leadership-award-all-six-categories-and-champion-compatibility-and-expertise
  88. https://www.hovione.com/press-room/events/rdd-europe-2025
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