Biocon has informed that it enclosed the Company Statement. ‘The US 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. The above information will also be available on the website of the Company at www.biocon.com.
The above information is a part of company’s filings submitted to BSE.
