Biocon Receives Voluntary Action Indicated Status from USFDA for API Facility

Biocon, a global biopharmaceutical leader, announced that it has received a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (FDA) for its Active Pharmaceutical Ingredient (API) facility located in Bengaluru, Karnataka. This follows a surveillance inspection conducted between September 23-27, 2024.

Inspection Outcome and Status

The surveillance inspection conducted by the FDA at Biocon’s API facility (Site 2) resulted in a Voluntary Action Indicated (VAI) status.

VAI signifies that while the facility has met certain regulatory requirements, some areas of concern may need corrective action, although no official action from the FDA is mandated.

Biocon has acknowledged the findings and will address the issues highlighted in the Establishment Inspection Report (EIR) promptly.

Biocon Q2FY25 Financial Highlights

For the quarter ended September 2024, Biocon reported flat total revenue of ₹3,623 crore, with a 4% year-on-year growth in revenue from operations at ₹3,590 crore.

However, net profit declined sharply by 84.3% YoY to ₹27.1 crore, and profit before tax (PBT) fell 54.08% YoY to ₹98.4 crore.

The company’s EBITDA stood at ₹718 crore, reflecting a 20% margin. Despite the revenue stability, the significant drop in profitability was attributed to higher expenses and margin pressures across its business segments.

Biocon Share Price Performance

On December 09, 2024, Biocon share price was trading 3.07% lower at ₹368.25 at 10:30 AM on the NSE. The stock opened at ₹370.05 higher from its previous close of ₹379.90.

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