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FDA approves STADA-controlled Norbitec biologics facility to manufacture and store Pfizer’s Retacrit® (epoetin alfa-epbx) biosimilar to Amgen’s Epogen®/Procrit®

May 26, 2023

The Pharma Letter has reported that the STADA-controlled Norbitec biologics facility in Uetersen, Germany, has been approved by the FDA to manufacture and store Pfizer’s Retacrit® (epoetin alfa-epbx), biosimilar to Amgen’s Epogen®/Procrit®.  The approval followed a six-day FDA inspection of the German site.