On Friday, September 5, Biocon share price (NSE: BIOCON) gained after the company announced that the US Food and Drug Administration (USFDA) had completed an inspection at Biocon Biologics’ facility in Bengaluru.
The stock rose 2.22% to hit an intra-day high of ₹364.80 on the NSE before trading at ₹361.10, up 1.47% from the previous close of ₹356.85. By mid-day, nearly 1.17 million shares worth about ₹42.4 crore had changed hands across NSE and BSE.
The USFDA conducted a routine current Good Manufacturing Practices (cGMP) inspection at Biocon Biologics’ Drug Substance facility in Bengaluru between August 26 and September 3, 2025. The inspection covered manufacturing units, quality control and microbiology labs, and warehouses.
At the end of the inspection, the USFDA issued a Form 483 with 5 observations. Biocon clarified these were procedural issues and not linked to data integrity or quality oversight. The company said it will submit a Corrective and Preventive Action (CAPA) plan soon and confirmed there would be no disruption in product supply.
In Q1 FY26, Biocon’s net profit fell sharply by 95.2% YoY to ₹31 crore from ₹660 crore in Q1 FY25, which had included a one-time divestment gain. After adjusting for that gain, revenue still grew 15% to ₹4,022 crore. Ebitda also increased 19% YoY to ₹829 crore, showing strong operational performance.
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Biocon’s stock has had a mixed performance. It dropped nearly 23% in the past month but gained 11% over six months. On a yearly basis, shares are down about 5%. Year-to-date, the stock has slipped 1.6%, underperforming the NSE Nifty 50, which is up nearly 4% during the same period.
Biocon’s share price reacted positively to the completion of the USFDA inspection, despite procedural observations. With strong revenue growth and steady operations, the company remains confident of addressing compliance issues without affecting product supply.
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Published on: Sep 5, 2025, 2:21 PM IST
Kusum Kumari
Kusum Kumari is a Content Writer with 4 years of experience in simplifying financial market concepts. Currently crafting insightful content at Angel One, She specialise in breaking down complex topics into easy-to-understand pieces, blending expertise in market fundamentals and technical analysis.
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