Press Room

Press Release / Sep 15, 2003

Hovione generic product portfolio update

Press Release, 15 September 2003

New Generic Drug Developments

  • Mometasone: Hovione’s DMF has been filed worldwide; it had been accessed and all deficiencies satisfactorily and promptly addressed. The relevant pre-approval inspection did not result in a Form 483 being issued. The product is now in routine manufacture
     
  • Fluticasone: Hovione filed a DMF for Fluticasone at the FDA in 2002. This product is currently in commercial manufacture addressing the needs of 3rd parties for early intermediates and API for use in clinical supplies and registration.
    Fluticasone was developed by Glaxo Wellcome and is currently marketed as Flonase®, Flovent® and Cutivate® by GlaxoSmithKline. Its worldwide sales amount to USD3bn.
     
  • Simvastatin: Validation for this new generic compound as been successfully completed and a DMF has been filed. Hovione and CKD Bio, a Korean Company with extensive experience in fermentation of APIs, have established a joint collaboration to produce and market Simvastatin. This collaboration guarantees an integrated supply chain for Simvastatin with CKD Bio producing lovastatin that Hovione further transforms into Simvastatin. This collaboration has as primary objective manufacturing capacity and reliability of supply. Availability of API and a challenging specification remain the key issues surrounding this block-buster generic – a matter Hovione has addressed.
    Simvastatin was developed by Merck and is currently marketed as Zocor®, by Merck & Co. and was the largest selling prescription drug in worldwide sales (USD6.67bn) in 2001. The markets of United States, France, Germany, United Kingdom and Japan account for 58 tons of API annual consumption.

Capacity increase for production of Minocycline

  • In order to meet market demands, a project to increase the production capacity of minocycline by 40% is currently underway. This increase in the production line installation represents a significant investment, improving solid handling conditions and increasing the hydrogenation, filtration and drying operations. The additional capacity will go on stream as of Q3 2004 in phases and we expect stepwise increases as from the end of this year.

Sales:

  • Hovione has announced sales for the year ended 31st March 2003 amounting to US$70. Generic products for multi-customer remain with the largest share, however custom synthesis business continues to grow at a faster rate. Hovione is committed to serving both segments of the pharmaceutical industry with equal priority.

Commercial Products

  • Simvastatin 
    Sancycline
    Roxithromycin 
    Ivermectin
    Methacycline hydrochloride
    Minocycline hydrochloride
    Doxycycline hyclate
    Doxycycline monohydrate 
    Beclomethasone dipropionate monohydrate
    Beclomethasone dipropionate
    Betamethasone dipropionate
    Betamethasone valerate
    Betamethasone acetate
    Betamethasone disodium phosphate
    Clobetasol propionate
    Dexamethasone dipropionate
    Mometasone furoate 
    Fluticasone propionate
    Halobetasol propionate 
    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.

Note:
Hovione does not sell or offer to sell products to countries where they are protected by patents.

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
PharmTech, 5 October 2026

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

Oct 05, 2026

Formulation Development/Drug Product Manufacturing  Hovione Completes $46-M Tablet Mfg Facility Expansion  Hovione, a CDMO of drug substances and drug products, has completed an expansion of its tablet development and manufacturing center at its main global campus in Loures, Portugal, adding 25% more commercial-scale batch tableting capacity for oral solid dosage products. The expansion strengthens integrated manufacture of amorphous solid dispersions by spray drying and tableting at a single site. The recently inaugurated expansion completes an investment cycle of more than EUR 40 million ($46 million).  Hovione expanded its batch tableting capacity by adding an additional line mirroring the original unit across every local operation: dispensing, blending, dry granulation, tableting, and film coating. The mirrored configuration reinforces capacity at the 300 kg to 400 kg batch scale and provides both redundancy and like-for-like product transfers between lines. Supporting areas, including in-process control and staging space sized to the increased production capacity, were also added as part of the expansion.  Read the full article at DCATVCI.org  

Press Clipping
DCAT Value Chain Insights, 3 September 2026

Supplier News: Lonza, Evonik, Hovione, Catalent & More

Sep 03, 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
Contract Pharma, 31 July 2026

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

Jul 31, 2026

Also in Events

See All