The FDA has granted acceptable status, under its current regulatory guidelines, to Eurogentec’s Seraing, Belgium drug substance manufacturing facility. The status will allow Eurogentec to manufacture a commercial bulk parenteral biopharmaceutical for one of its clients for the US market. Eurogentec CEO Jean-Pierre Delwart said they anticipate it as one of several future inspections as they work to bring other products closer to commercialization with their clients. Eurogentec Business Unit Director Ingrid Dheur said this demonstrates the strict cGMP compliant manufacturing and quality management system maintained at Eurogentec.
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