In early trading on October 18, Biocon shares plummeted by more than 6% following the revelation that its Malaysian insulin manufacturing facility received an “Official Action Indicated” (OAI) status from the US Food and Drug Administration (FDA) after a July 2023 inspection. The OAI classification might result in delays or withholding of pending product approvals, causing concern among investors.
Biocon has taken proactive steps to address the concerns raised by the FDA following its July inspection. The company has submitted a comprehensive Corrective and Preventive Action (CAPA) plan and is committed to completing all necessary actions as per the plan. Biocon continues its open dialogue with the FDA, aiming to swiftly resolve any remaining issues.
Importantly, Biocon reassures stakeholders that these developments will not have a significant impact on its US market operations, ensuring ongoing stability in its commercial product manufacturing and distributioN.
At 2:00 pm, Biocon’s shares were trading nearly 7% lower than the previous day, closing at Rs 237.10 on the NSE.
