Shares of Biocon rose by 5 percent on November 11 after the US Food and Drug Administration (FDA) granted its Bengaluru biologics unit a “Voluntary Action Indicated” (VAI) status. This designation is generally positive, indicating minor issues found during the inspection but no need for regulatory or enforcement action, allowing Biocon to continue operations smoothly.
At 09:27 am, Biocon’s shares were trading at Rs 335 on the NSE, with a strong year-to-date increase of over 33 percent. The FDA inspection, conducted between July 15-26, covered six biologics manufacturing units, including drug substance and drug product facilities, as well as various laboratories and warehouses.
The timely FDA clearance is in line with the fact that the Malaysia unit of Biocon was in the line of vision seeking regulatory approval, a key focus for investors.
On the contrary, Biocon reported an 84 percent YoY sharp decline in net profit to Rs 27.1 crore in Q2FY25 from Rs 172 crore, while EBITDA margin also fell at 19% versus 21% of the firm. Revenue rose a rather modest at 4% at Rs 3590.4 crore.
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