Grifols awarded EU licence for Flebogammadif

Grifols has been awarded a licence from the European Medicines Agency (EMEA) for Flebogammadif, its new generation of intravenous immunoglobulin (IVIG), with the company planning to start distribution of this product on the continent in 2008.

The EMEA approval for the compound relates to primary and secondary immmunodeficiencies as well as immunomodulation treatment in autoimmune diseases and allogeneic bone marrow transplantation.

Flebogammadif is the sole available polyvalent IVIG that incorporates two specific inactivation stages while it is being produced, while its safety margin is further increased through its nanofiltration.

“In addition, the production process, which is the result of research carried out and patented by Grifols, is more efficient and significantly improves the yield per litre of plasma, ensuring more efficient use of the raw material over the medium term,” the company reports.

The company manufactures the compound at its plant in Barcelona, with current production capacity of 12 million grammes to be increased as part of the strategic growth plans.

In March 2007, Grifols announced the validation of its MiniFrac site at its Los Angeles manufacturing complex, increasing its plasma throughput by 700,000 litres.

Furthermore, the firm announced the standardisation of albumin production at its Spanish sites.