NOTIFICATION TO STOCK EXCHANGE
Bengaluru, Karnataka, India, Jan 7, 2023
“The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for the Insulin-R product filed by Biocon Biologics. The CRL cites additional data required in the BLA submission and an expectation of a satisfactory implementation of a CAPA plan pertaining to the Pre-Approval Inspection of our Bangalore facilities in Aug’22. We are in the process of comprehensively addressing the CRL.”
– Company Spokesperson, Biocon Biologics.