Press Room

Press Release / May 20, 1996

Contrast Media and Custom Services are two key areas in Hovione's strategic analysis document

Contrast Media is one of two important areas that Hovione defined as key in its 1994 I&DEIA XXI strategic analysis document, the other being offering custom services to the US majors.

Hovione is a technology rich company excelling in both difficult chemistry as well as GMP and regulatory affairs.

By always tackling the products that others were not interested in because of their difficulty and always taking a pro-active attitude to meeting (instead of avoiding) FDA's increasing severity and tough standards, Hovione is now well equipped to serve the outsourcing needs of the largest US pharmaceuticals companies.

Contrast media is an area where no independent manufacturer of bulk existed, the first products to come off patent did so less than 12 months ago, so it was an obvious area where Hovione's skills could be turned into dollars. The surprise was how technically difficult this really was. A team of 60 researchers at Hovione worked non-stop for three years.

Contrast media is an area of very high barriers to entry: one needs large capacity (to be a player you need a capacity well in excess of 50 tonnes/year), great technical competence (to meet purity levels of 99.8% and near sterile quality of tonne size batches), know-how and the industrial scale technology to recycle tens of thousands of tonnes of solvents, and last but certainly not least you need to have the ability to prepare tens of kilos of paper meeting every one of FDA's requirements.

These products are in many occasions injected, in a single dose, in quantities of 150g. This is the largest parenteral administration of a chemical to a human. Clearly an area only for the most competent and quality generic firms, the market perceives Hovione as such a company.

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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