NOTIFICATION TO STOCK EXCHANGE
Bengaluru, Karnataka, India, February 9, 2024
“The U.S. Food and Drug Administration (US FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for bBevacizumab. The CRL did not identify any outstanding scientific issues on the dossier and informs the need for the completion of a pre-approval inspection of the bBevacizumab manufacturing facility.
“The Company continues to be engaged with the US FDA and looks forward to bringing our high-quality, affordable biosimilar bevacizumab to market in the United States.”
– Company Spokesperson
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