Biocon Biologics, a subsidiary of Biocon, has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru. The inspection was conducted between 10 September and 19 September 2019. Biocon Biologics has responded to the regulator on the eight observations from this inspection, in the month of October 2019.
Subsequent to the above inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the U.S. FDA in 2019. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection. This is an endorsement of our commitment to global standards of Quality and Compliance.
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