Following a six-day inspection of the Norbitec biologics facility in Uetersen, Germany, the US Food and Drug Administration (FDA) has approved the STADA-controlled entity as a manufacturing and storage site for Retacrit (epoetin alfa-epbx) drug substance, an important therapy for anemia associated with chemotherapy and chronic kidney disease that has annual US sales in excess of US$ 300 million. Through the FDA certification, STADA will be able help ensure continued US patient access to one of the top-selling biosimilars in the US.
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