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Home Industry News Shire receives EMA backing for new Replagal site

Shire receives EMA backing for new Replagal site

27th June 2011

Shire has been granted European Medicines Agency (EMA) clearance for its plans to manufacture the drug Replagal at its new facility in the US.

The European regulator has approved the firm's plans to utilise the Lexington site to purify the Fabry disease treatment, making it the first product that will be made available from the factory.

It means that Shire now has two facilities which it can use to purify Replagal, with the cell culture portion of the manufacturing process set to continue to take place at its Alewife site in Cambridge, Massachusetts.

This will help the company to meet growing demand for the drug, while it also expects to receive approval for plans to manufacture Vpriv at the facility before the end of the year.

Bill Ciambrone, senior vice-president of technical operations at Shire, said: "We are pleased that we were able to accelerate the construction and approval of our new manufacturing facility in order to provide rapid access to important therapies for patients in need."

Last week, the company announced the launch of a new international awards programme designed to highlight and reward the work of non-professional carers worldwide. ADNFCR-8000103-ID-800600077-ADNFCR

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