Biocon shares gain 2% after USFDA inspection at Bengaluru facility; details

The inspection covered various aspects of operations including drug substance manufacturing units, analytical quality control laboratories, microbiology laboratories, and warehouses

Biocon share price today: Shares of pharmaceutical company Biocon were in demand on the bourses on Friday, September 5, after the company announced that the US Food and Drug Administration (FDA) had completed its inspection at Biocon Biologics’ facility in Bengaluru.  The company’s share price advanced by 2.22 per cent to record an intra-day high of ₹364.80 per share on the NSE during Friday’s trading session. As of 11:38 AM, Biocon shares were trading at ₹361.10 per share, up 1.47 per cent from their previous close of ₹356.85 on the NSE. By that time, a combined total of approximately 1.17 million equity shares of Biocon, estimated to be worth around ₹42.4 crore, had changed hands on the NSE and BSE.  CATCH STOCK MARKET LIVE UPDATES TODAY

 

USFDA inspection at Biocon facility

Biocon, in a regulatory filing, has informed the exchanges that the US FDA had completed a routine current Good Manufacturing Practices (cGMP) inspection at Biocon Biologics’ Drug Substance facility, located at Biocon Campus in Bengaluru, India. The inspection was conducted between August 26, 2025, and September 3, 2025. It covered various aspects of operations including drug substance manufacturing units, analytical quality control laboratories, microbiology laboratories, and warehouses.

 

At the conclusion of the inspection, the US FDA issued a Form 483 with five observations. According to the company’s filing, these observations are procedural in nature and do not relate to data integrity, systemic non-compliance, or quality oversight. Biocon Biologics will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline. The company expressed confidence in its ability to address all observations swiftly and stated that it does not anticipate any impact on the supply of its commercial products.  ALSO READ | Netweb surges 25% in 1 week; what's driving IT enabled services stock?

Biocon Q1FY26 results

For the first quarter of the financial year 2025–26 (Q1 FY26), Biocon reported a 95.2 per cent year-on-year (Y-o-Y) decline in consolidated net profit, which stood at ₹31 crore, compared to ₹660 crore in the same quarter last year. It is important to note that the profit in Q1 FY25 included a one-time divestment gain, which inflated the previous year’s base and contributed to the sharp decline in the current year’s net profit.

 

Despite the drop in net profit, Biocon’s consolidated revenue rose by 15 per cent to ₹4,022 crore on a like-for-like basis, after adjusting for the one-time gain in the base quarter. Additionally, the company’s earnings before interest, taxes, depreciation, and amortisation (Ebitda) rose by 19 per cent Y-o-Y to ₹829 crore, indicating continued operational strength.

Biocon Share price history

Over the past year, Biocon’s share price performance has been mixed. In the last one month, the stock has declined nearly 23 per cent, reflecting near-term investor caution. However, over the past six months, the stock has appreciated by nearly 11 per cent. On a year-over-year basis, Biocon shares have declined by approximately 5 per cent.

 

For the year till date, Biocon shares have posted a drop of 1.6 per cent. In contrast, the benchmark NSE Nifty 50 index has gained nearly 4 per cent over the same period.