It was recently revealed by the firm Genzyme Corp, which is the Cambridge segment of the French firm Sanofi, that their drug Fabrazyme has been approved by the FDA for starting production again. The firm recently said that this new drug, which is meant for the cure of Fabry disease, has been approved for production by the Food and Drug Administration in the United States.
A few weeks ago, the drug has also received a green signal from the European regulatory, for the production of the same in their country. It was in the year 2009, that there was a problem in the production of the disease, since there was a viral contamination in the equipment used for making drugs at the Allston landing plant. It was revealed in the month of December last year that firm is all set to start the production of their drug again.
“We are very pleased with the FDA approval of our Framingham plant as we continue our manufacturing recovery and path forward to serve the Fabry patient community. With this approval, we continue upon our 2012 plan to restore unconstrained supply”, said David Meeker, the CE and President of the company.
It was a hurdle that the firm had to cross so that it can start producing the drug again and can distribute it in different parts of the world. There was a major problem when the contamination had caused a scare about damamging the health of the users. This is why the plant had been shut, and has been opened now, after the regulatory firms have had a full analysis of the matter, and have passed the firm for authenticity. They are glad to have their rights back and are eager to do business in both, US, and Europe.












