Shire applies for approval for new Vpriv production arrangements
24 November 2011 00:00 in Pharmaceutical Company Product News
Shire has submitted regulatory applications for approval of a major new manufacturing arrangement for its Gaucher disease therapy Vpriv.
Filings have been made with both the European Medicines Agency and US Food and Drug Administration to expand production of the drug to the state-of-the-art manufacturing facility in Lexington, Massachusetts.
If approval is granted as expected in early 2012, it will allow the pharmaceutical company to greatly improve the manufacturing capacity for Vpriv, thus allowing for increased global supply.
The submissions also pertain to making further capacity available to produce Replagal at the Shire Alewife site.
Bill Ciambrone, senior vice-president for technical operations at Shire, said: "Shire remains committed to meeting the unique needs of patients living with rare diseases."
Last week, the company announced a new alliance with Japanese company Shionogi and Co for the development and commercialisation of new attention deficit hyperactivity disorder drugs.
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