GroPep announces US FDA approval of biopharmaceutical that uses its cell culture product
GroPep Limited (ASX: GRO) has today announced that a seventh biopharmaceutical product that uses the Company's Cell Culture Products in its manufacturing process, has obtained regulatory approval by the Food and Drug Administration (FDA) in the United States.
An application to market the product in the European Union has also been submitted, for which approval is expected in 2006.
Confidentiality agreements prevent GroPep from naming the specific product or company.
While this approval is not likely to generate significant revenue growth for GroPep, CEO Mr Bob Finder said that the approval is further evidence of the growing international recognition of the superiority of GroPep's Cell Culture Products in the manufacturing of certain biopharmaceutical products.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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