Biocon shares surged by 3% after the company announced that the U.S. Food and Drug Administration (FDA) classified its biologics manufacturing site in Johor Bahru, Malaysia, as “Voluntary Action Indicated” (VAI). This classification followed a cGMP inspection conducted by the FDA from September 15 to September 27, 2024.
The inspection covered multiple key areas, including a Drug Substance Unit, Drug Product Manufacturing Unit, Medical Device Assembly Unit, Analytical Quality Control Laboratory, Microbiological Control Laboratories, and Warehouses. While the FDA observed some issues, they were deemed minor and not serious enough to trigger any regulatory or enforcement actions.
Biocon shares opened at today at ₹371, reaching a high of ₹374 and a low of ₹364.10. The stock remains near its 52-week high of ₹395.80, showcasing strong market performance, while its 52-week low stands at ₹244.55.
As of 9:28 AM, Biocon shares were trading 3.17% higher at Rs 372.40.
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