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Biocon has received Establishment Inspection Report (EIR), from the US health regulator for its manufacturing facility in Bengaluru. The EIR is received on closure of inspection of its sterile drug product manufacturing facility in Bengaluru.
In a BSE filing the company’s spokesperson stated, “The company confirms that Biocon has received an EIR from the US Food and Drug Administration (USFDA), for its sterile drug product manufacturing facility in Bangalore, following the US FDA pre-approval/inspection of this facility in April/May 2018.” Further it added that, the EIR notified that the “inspection stands closed.”
