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Article / Oct 10, 2022

Hovione’s Continuous Manufacturing Facility, Loures, Portugal

Pharmaceutical Technology, 10 October 2022

Hovione has expanded its continuous tableting capacity with a state-of-the-art manufacturing facility at its site in Loures, Portugal.

Portuguese pharmaceutical contract development and manufacturing company Hovione has built a state-of-the-art continuous tableting manufacturing facility at its existing site in Loures, Portugal, to expand its continuous manufacturing offering and services.

The company invested $70m to develop the facility, which is part of its broader $170m investment programme to increase its production capacity by around 25% by 2023. The investment will enable Hovione to develop differentiated and empowering capabilities and assets to meet customers’ specific requirements for manufacturing oral dosage forms.

The new drug manufacturing facility came online in September 2022.


Details of the pharmaceutical facility expansion

Hovione Loures was expanded with a manufacturing building and eight-lab quality control facility. The company also upgraded its labs with the tools required to support the drug product lifecycle to ensure competency and capacity through research and development (R&D) to the production stage. In addition, it established an experienced, multi-disciplinary global team in continuous tableting to further improve its capabilities.

Hovione has designed a commercial continuous tableting platform that facilitates key control requirements and offers operational ease, mechanistic modelling, and appropriate process analytical technology to its customers. The features of its quality system include automated in-process controls, real-time release deployment, and compliant digital infrastructure. These are designed to support the release of continuous tableting products.

The company’s technology offers features and benefits such as faster development of simpler processes, rapid manufacturing of variable demand, strong control strategies and high process quality standards.


Details of Hovione’s existing site in Loures

Hovione’s existing manufacturing plant at Loures has been operational since 1969 and has been continuously upgraded by adding new facilities. The plant was first approved by the US Food and Drug Administration (FDA) in 1982 and is inspected regularly.

The manufacturing plant supports the development, piloting and full commercialisation of drug substances and product intermediates. It has an extensive capacity of 430m³ of vessels, ranging from 50lt to 14,000lt, along with a complete range of spray dryers with sizes ranging from lab-scale to industrial sizes.

The site also features highly potent active pharmaceutical ingredient (API) handling, cryogenic, hydrogenation, corticosteroid, and potent spray-drying capabilities. It is staffed by highly skilled and experienced process development and analytical development teams that assist with the drug substance and particle engineering disciplines.

The plant and the quality control labs operate 24 hours a day, seven days a week.

The Loures site has been certified by the Health, Safety and Environment Management System in compliance with OHSAS18001 and ISO14001. It is also a certified Authorised Economic Operator.


Marketing commentary on Hovione

Established in 1959, Hovione is an integrated contract development and manufacturing company (CDMO) with more than 60 years of experience. It offers services for drug substances, drug product intermediates and drug products.

The company currently operates four FDA-inspected facilities in the US, China, Ireland and Portugal, as well as development laboratories in Lisbon, Portugal, and New Jersey, US.

The opening of Hovione’s first manufacturing plant in Loures, Portugal, in 1969 was followed by its second manufacturing site in Macau, China, in 1986. The company subsequently opened plants in New Jersey in 2001 and Cork, Ireland, in 2009.

Under the company’s $170m investment programme, Hovione is investing $50m in its manufacturing facility in East Windsor, New Jersey. This expansion will add two spray dryers to the facility and triple its capacity, as well as expand its capacity for research and small-scale API production. The company is investing a further $50m to add a spray dryer and upgrade its high-potency API production in Cork, Ireland, as part of the investment programme.


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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at  


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