Hovione reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey.
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.