Press Room

Press Release / Oct 31, 2001

Hovione's factory in Macau supplies antibiotic against anthrax

Anthrax fear increases sales dramatically

Hovione PharmaScience Ltd., with a manufacturing site in Taipa Island, Macau, increased its doxycycline production in order to meet increased demands from US, provoked by the bioterrorists attacks with Anthrax. Together with Bayer’s Ciprofloxacine, the product manufactured by Hovione is an antibiotic specifically approved by the US FDA (Food and Drug Administration) to fight Anthrax in its three forms of infection: cutaneous, gastric or inhaled.

This product has more than three decades of commercial activity (which is already a remarkable survival for an antibiotic) Hovione has had a stable production of doxycycline for more than 10 years. In these last three weeks, Hovione received purchase orders similar to 3 times the annual sales to the US. It is enough quantity to treat more than two millions patients, during the 60 days advised treatment. Hovione Macau confirms its engagement in supplying these needs and to assure there will no shortage of doxycycline in the drugstores, either in the US or in any other country.

Hovione supplies this product to more than 30 countries, in the Americas, Europe, Australia, and Asia, including Pakistan, India and Iran, being concerned with the supply of pharmaceuticals in accordance to human health needs. An increase in demand has also occurred in the second half of the 90s, with an outbreak of plague in India, and also before the Gulf War.

Legislation and flexibility benefits production in Macau

In September, ways to supply the foreseen increase in demand after the first strikes, were analyzed and the alterations to the production of the Macau site, the site more suitable to manufacture doxycycline, were authorized. These changes naturally forced a complex re-structuring of our priorities, in order to meet and supply at fast as possible the American market. This task will continue until the end of this year.

Accordingly to Carlos Costa, Director of Hovione Macau: “ We have in Macau a more favorable legislation which allows to change rapidly the production plans. In Lisbon, we are obliged to inform the authorities of the nature and quantities of all new products that we are going to manipulate in the future. Well, this only our clients know, we cannot guess.” The European legislation, named EINECS, requires that extensive studies are carried out on any new product which crosses European borders, delaying in many months any investigational project or production line. Similarly, IPPC, which regulates industrial licensing, makes any new industrial project more bureaucratic, slowing the process and hindering its flexibility.

The Hovione Macau site began its active pharmaceutical ingredients production in December 1986 and was approved by the FDA the following year. This site today has 150 professionals and manufactures the more stable Hovione products. The Macau factory is responsible for one third of Hovione total production. With a sales volume of 15 million dollars (16,5m Euro), Hovione in Macau will make additional sales of doxycycline corresponding to 4,5 million dollars (5m Euro).

Hovione is an international company, which develops and produces with high quality and state-of-the-art technology active pharmaceutical ingredients. Founded in 1959, Hovione has two approved factories by the FDA, in Loures (Portugal) and in Macau, and a Technology Transfer Center in New Jersey (USA).

Hovione began its activity with the manufacture of generic products, developing in its R&D laboratories its own chemical synthesis processes. In the 90s, the company developed the second part of the business, with outsourcing to the large pharma and biotech companies. In outsourcing, Hovione develops all technical services, since laboratorial development until the regulatory approval and commercial production, becoming the essential link to the pharmaceutical multinationals that research new medicines.

Hovione is the biggest investor in R&D in the Portuguese pharmaceutical industry and already developed more than 100 chemical synthesis process and has more than 500 patents all over the world, of which 400 are still in use.

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Hovione, a globally integrated pharmaceutical contract development and manufacturing organisation (CDMO), will commission the world’s first ConsiGma CDC flex – a next generation continuous tableting line – at its East Windsor, New Jersey (USA) 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 US. CDC ConsiGma flex system 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. The new flex will operate in continuous or batch modes across a very broad throughput range (from one 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 specialised design within the 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. Continuous tableting is reshaping manufacturing of oral solid dosage medicines and is well suited to programmes 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 harmonisation across the US, Europe and Japan. As of 2024, 17 products manufactured under the international guidance have been approved by the US 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. Read the full article at Pharma Press UK 

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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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