Press Room

Article / Sep 23, 2003

Simvastatin - Supply Chain Reliability

CPhI 2003, 23 September 2003

Hovione for CPhI 2003

Cholesterol lowering agents (HMG CoA reductase inhibitors) recorded sales close to US$19 bil. in 2002 according to IMS Health figures. Atorvastatin from Pfizer and Simvastatin from Merck are the top two drugs of this therapeutic class, indeed they rank in the top two drugs in sales worldwide. They account for 71% of this market followed by Bristol-Myers Squibb’s Pravastatin. In the US alone the statins reached sales of nearly US$12 bil. in 2002 – well over one hundred tons of API.

The generic versions of Merck’s Zocor®, the second biggest product in worldwide sales, entered the German and UK markets last May, after Merck’s patent expired, rapidly achieving sales of about Euro 30 mil. in Germany in the first month alone (IMS Health). The performance of the generic versions of simvastatin in the first quarter after launch already suggested that the impact of the generic entry may not stay confined to this molecule, but might affect the overall statins class market. Indeed recent price pressures have seen growth in generic lovastatin prescriptions; which might indicate that generic simvastatin is likely to cannibalise some of the sales of Lipitor, if not even Zetia…

We are currently 2 years away from the simvastatin generic entry in the US, where approximately 40 tonnes of API were sold in 2002. Traditionally, after a US generic entry the volume of scripts more than doubles and the price more than halves. It should not come as a surprise that simvastatin might grow into a product of more than 100 tons of API. Capacity is very likely to be an enduring issue because simvastatin is technically difficult to make and the supplies of lovastatin limited.

European pharmaceutical generic companies entered the market using registrations developed outside Europe by integrated houses able to make the API and the formulations. This is a normal course of action in Europe and enabled a very fast access to the market. As the quick entry focus looses ground to serving the market and expanding share – reliable supply will become a major concern.

The competitive landscape looks to us to be as follows:

Simvastatin - Supply Chain Reliability | Hovione

* : The issue as to whether a supplier is a “partner or a competitor” is a very sensitive one. In the USA this is addressed earlier than Europe as most Generic firms usually develop their dossiers and source bulk. However given the high probability of a scenario of simvastatin API shortage it is very likely that an integrated player -both API producer and seller of formulations- will give preference to its own needs, to the detriment of supplying other generic firms.

Choosing the right API supplier has significant long-term impact.

Hovione is fully committed to supplying simvastatin bulk, and has no involvement in the dosage form business. This position, allied with a strong partnership with CKD that ensures the control and supply of the Lovastatin starting material, enables Hovione to present to customers a unique differentiation that guarantees a reliable supply of simvastatin API.

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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  

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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  

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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    

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