Home NEWS Biocon API facility in Visakhapatnam receives 3 observations from USFDA inspection

Biocon API facility in Visakhapatnam receives 3 observations from USFDA inspection


Biotechnology firm Biocon Ltd on Saturday (June 15) said it received 3 observations from the US Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility at Site 6 in Visakhapatnam, Andhra Pradesh.

“This is to inform you that “the U.S. Food and Drug Administration (USFDA) concluded a GMP inspection of our API facility (Site 6), located at Visakhapatnam, Andhra Pradesh, on 14 June 2024,” according to a stock exchange filing.

“Three observations were cited at the end of the Inspection, which we will be addressing within the stipulated time. Biocon stands committed to Quality, Safety & Efficacy of the products manufactured,” the company said.

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Biocon reported a 56.77% year-on-year (YoY) drop in net profit at ₹135.5 crore for the fourth quarter that ended March 31, 2024. In the corresponding quarter, Biocon posted a net profit of ₹313.2 crore, the company said in a regulatory filing. CNBC-TV18 poll had predicted a profit of ₹179 crore for the quarter under review.

The company’s revenue from operations increased 3.8% to ₹3,917 crore compared to ₹3,773.9 crore in the corresponding period of the preceding fiscal. CNBC-TV18 poll had predicted a revenue of ₹3,840.8 crore for the quarter under review.

Adjusting for the licensing income of ₹175 crore and a gain of ₹109 crore on account of Bicara stake dilution, in Q4 of FY23, revenue in Q4FY24 reported an increase of 8% and EBITDA growth of 9%. The CNBC-TV18 poll had predicted an EBITDA of ₹826.5 crore for the quarter under review.

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Shares of Biocon Ltd ended at ₹334.65, down by ₹3.60, or 1.06% on the BSE on Friday (June 14).



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