Carbohydrates for injectable use are highly controlled pharmaceutical active ingredients that are essential in the preparation of large volume parenterals. These crucial life-saving medicines are taken for granted in all public health organisations and institutions.

The large volume injectable solutions prepared with these carbohydrates, mainly glucose solutions, are the sort of mass medication that is expected to be available everywhere and always of the highest quality. Poor quality or supply chain issues can lead to critical situations, which might endanger lives.

The paradox for carbohydrate producers is that these highly specialised and regulated ingredients are small scale when compared to the wider portfolio of products from the starch biorefinery industry, and organic growth is limited. This is further compounded by health suppliers, hospitals and clinics regarding them as commodities and as such a preferred target for price reductions.

Such a niche market is a challenging environment for investment. Roquette, however, decided to proceed with the investment as part of its long-term strategy to remain a responsible supplier in this demanding field. In fact, Roquette has pioneered the development of dextrose grades for the preparation of injectable and dialysis solutions over many decades and is the leader in the manufacturing of such carbohydrates in Europe.

This leadership position comes with a sense of corporate responsibility to ensure the continuity of these vital products and this in turn has lead to continuous investment and an identical facility in the US for international supply backup options.

The completion of the most recent investment phase at Lestrem on its injectable carbohydrate facility has just been announced. This major capital investment, which was approved in 2008, will support the increasingly sophisticated demands of the injectable industry in terms of quality. The facility will be of GMP standard, like the previous one, so that the integration into current production capacity will be seamless though 2011.

Such a major investment is a showcase for Roquette not only in terms of its manufacturing and engineering expertise but also of its understanding of the high quality required and proactive knowledge of changing European regulations to meet long-term demand for these life-saving medicines.

For more information please return to Roquette’s profile and click the ‘LYCADEX® PF pyrogen-free dextrose monohydrate’ link in the contact details section.