Biocon Biologics Statement on Complete Response Letter from USFDA

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.

Shares of Biocon Limited was last trading in BSE at Rs. 256.30 as compared to the previous close of Rs. 260.40. The total number of shares traded during the day was 152426 in over 4250 trades.

The stock hit an intraday high of Rs. 261.45 and intraday low of 254.65. The net turnover during the day was Rs. 39293566.00.

Source : Equity Bulls

Keywords

Biocon INE376G01013 BioconBiologics USFDa CompleteResponseLetter LicenseApplication InsulinR