Next generation continuous direct compression (CDC) platform, jointly developed with GEA, to bring a continuous tableting line to Hovione's recently opened 89 Twin Rivers facility
Investment to strengthen an integrated U.S. pathway from amorphous solid dispersion via spray drying to tablet production at a single site, under one quality system
Continuous and batch operation will be available on this single system, with flexible throughputs from 1 to 200 kg/h, enabling customers with complex and diverse pipelines to progress from development to commercial production without traditional scale-up

EAST WINDSOR, N.J., Oct. 5, 2026 /PRNewswire/ -- Hovione, a globally integrated pharmaceutical contract development and manufacturing organization (CDMO), today announced it will commission the world's first ConsiGma® CDC Flex - a next generation continuous tableting line - at its East Windsor, New Jersey campus in late 2027. The line will be installed at 89 Twin Rivers, Hovione´s recently opened facility, expanding the company´s drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the U.S.

The project represents an investment of $35 million. Once installed it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production.

"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-Chief Executive Officers of Hovione. "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."

The new ConsiGma® CDC Flex will operate in continuous or batch modes across a very broad throughput range (from 1 to 200 kg/h). Customers will be able to develop a formulation using small quantities of material, down to 1.5 kg, and then run from very small clinical batches to large commercial batches using the same equipment. This is enabled by specialized design within the ConsiGma® CDC Flex to effectively switch between continuous blenders of various sizes. Additionally, the line will be installed for containment to 1 µg/m³, supporting highly potent compounds.

"Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated U.S. development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Americas for Hovione. "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."

Continuous tableting is reshaping manufacturing of oral solid dosage medicines and is well suited to programs in which speed, supply resilience and efficient use of high-value active pharmaceutical ingredients (APIs) are priorities. Inline process analytical technology (PAT) and automated controls also provide real-time quality monitoring. In parallel, the 2022 adoption of ICH Q13 regulatory framework, guidance specifically for continuous manufacturing of drug substances and drug products, provides harmonization across the U.S., Europe and Japan. As of 2024, 17 products manufactured under the international guidance have been approved by the U.S. Food and Drug Administration (FDA) alone.

Developed jointly with GEA, the ConsiGma® CDC Flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply. Designed for versatility and ease of use, these innovative developments simplify operation, improve efficiency and containment, and enhance operator safety.

Today, Hovione partners with 19 of the world's 20 largest pharmaceutical companies, and it is involved in up to ten percent of medicines approved annually by the U.S. Food and Drug Administration.

About Hovione's Collaboration with GEA

Hovione and GEA established a strategic collaboration in 2022 to advance continuous tableting, combining Hovione's pharmaceutical development and manufacturing experience with GEA's process-engineering expertise. The partnership is focused on simplifying the technology, increasing its flexibility and accelerating its adoption by the pharmaceutical industry. In 2024, the collaboration entered a new phase with the launch of a first-generation ConsiGma® CDC Flex and the installation of a lab-scale R&D continuous tableting rig at Hovione's facilities in Portugal. In 2025, the two companies introduced further developments to the platform, including SimpleCT, a suite of automated tools designed to simplify operation, enhance efficiency and containment, and improve operator safety. Hovione currently operates ConsiGma® technology end-to-end for commercial continuous tableting at its Loures site in Portugal and is the only CDMO offering this capability. The planned installation at East Windsor represents the next stage of the collaboration and will extend this capability to the U.S. when commissioned in 2027.

About Hovione

Hovione is an international company with over 65 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO), the company has a fully integrated offering of services for drug substances, particle engineering and drug products. Hovione has four FDA inspected sites in the U.S., Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey in the U.S. with a fifth site expected to be commissioned in 2027. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. Hovione also offers a complete range of inhalation services, from API, formulation development and manufacturing, to capsule filling and devices. The company is dedicated to patients, innovation and technology, international growth, and the creation of sustainable value for its customers, partners and shareholders. For more information, please visit www.Hovione.com.

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