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Grand River Aseptic Manufacturing Receives Zero Observations from FDA Inspection

Aiding in the supply of Bavarian Nordic’s JYNNEOS.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Grand River Aseptic Manufacturing (GRAM), a sterile injectable pharmaceutical contract manufacturer of biologics, small molecules, and vaccines, announced the approval of Bavarian Nordic’s recent Biologics License Application (BLA) supplement authorizing the manufacture of JYNNEOS. In conjunction with that approval, GRAM recently hosted a regulatory inspection by the Center for Biologics Evaluation and Research (CBER) that resulted in zero observations and Federal Drug Administration (FDA) appro...

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