French drug-maker Sanofi, which acquired Genzyme Corp, has announced that the Food and Drug Administrator (FDA) has given approval to its new plant to manufacture Fabrazyme, a drug used for the treatment of Fabry disease.
Earlier, the company received permission from the European regulators to manufacture the drug.
The approval by the U.S. regulator is regarded as a vital step to resolve the manufacturing problems that affected the production of the drug before Sanofi acquired the U.S.-based biotechnology company last year.
In 2009, owing to the virus contamination of a manufacturing plant in Massachusetts, there was much shortage in the production of Fabrazyme and another drug, Cerezyme. This led to reduced revenue for the company, and the company's shares fell.
It was due to this reduction that Sanofi took over the company last year for $20.1 billion. However, to return to normal capacity, Sanofi now requires the approval of the new facility.
Genzyme was an important acquisition for Sanofi and today's announcement shows its recovery is on track, Eric Le Berrigaud, an analyst at Bryan, Garnier & Co. told Bloomberg Businesweek. Sanofi managed to keep its commitment. It's important.