Bengaluru-based biopharmaceutical company Bicon Biologics on Sunday informed the stock exchanges about the US FDA action. The company said that after investigation, the US drug regulator US FDA has classified the company's Bicon Park facility in Bengaluru as VAI. The facility was inspected during 15 - 26 July 2024.

Bicon's stock closed 2.26% lower at ₹320 per share on Friday. So far this year, Biocon's stock has seen a gain of 25%. This growth is only 5% in the last 6 months and 40% in 1 year.

In the information given to the stock exchanges on Sunday, the company said that the US FDA has classified Bengaluru-based Biocon Park as VAI. This VAI classification means that the US FDA will neither give any suggestions for improvement in this facility nor will take any regulatory action or administrative action. The US FDA will give the company an opportunity to correct the irregularities found on its own. Let us tell you that during 15 - 26 July, the US FDA conducted cGMP investigation and pre-licensing investigation. During this time, the US FDA inspected 6 biologics manufacturing units located in Biocon Park, which included 4 drug substance units and 2 drug product manufacturing plants. Apart from this, 5 quality control labs, 4 microbial labs and 2 warehouses have also been inspected. Biocon Biologics said that the company is committed to exceeding the quality and compliance of Globus Standard. How have been the company's results? In the second quarter of the financial year 2025, the company's consolidated income was ₹ 3,623 crores and EBITDA was ₹ 718 crores. During this period, the EBITDA margin was 20%. The company has recorded a loss of ₹ 16 crores in the second quarter.