Q1 2012 Sales (Ipsen) - May 3, 2012 - Increlex / Ipsen; Roche; Products manufactured for the US in Hopkinton facility are currently on hold, Anticipated FDA inspection of US Hopkinton facility and results before the end of H1 2012
Anticipated FDA decision • Growth Hormone
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Increlex
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The marketing of certain products by the Group has been and could be affected by supply shortages and other disruptions. Such difficulties may be of both a regulatory nature (the need to correct certain technical problems in order to bring production sites into compliance with applicable regulations) and a technical nature (difficulties in obtaining supplies of satisfactory quality or difficulties in manufacturing active ingredients or drugs complying with their technical specifications on a sufficiently reliable and uniform basis). This situation may result in inventory shortages and/or in a significant reduction in the sales of one or more products. More specifically, in US Hopkinton facility, Lonza, supplier of IGF-1 (Increlex® active ingredient), is facing a regulatory challenge by the Food and Drug Administration. Products manufactured for the US in this plant are currently on hold. The follow-up inspection and its result are expected before the end of the first half of 2012.
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