Aurobindo Pharma shares drop 5% amid reports of USFDA observations

Shares of Aurobindo Pharma Ltd. fell nearly 5 per cent on Wednesday after reports said that the US Food and Drug Administration (USFDA) issued several observations at its unit. 

 

The pharma major's stock fell as much as 4.85 per cent during the day to ₹1,129.2 per share, the biggest intraday fall since February 10 this year. The stock pared losses to trade 4.2 per cent lower at ₹1,136.5 apiece, compared to a 0.08 per cent decline in Nifty 50 as of 11:10 AM. 

 

Shares of the company snapped a two-day winning streak and currently trade at 1.8 times the average 30-day trading volume, according to Bloomberg. The counter has fallen 3.5 per cent this year, compared to a 1.5 per cent decline in the benchmark Nifty 50. Aurobindo Pharma has a total market capitalisation of ₹66,240.43 crore.

Aurobindo Pharma gets observations from the USFDA

According to media reports, the USFDA inspected its Unit-7 facility from January 28 to February 10, 2026, and issued observations at the end of the inspection.

 

The reports added that the regulator flagged that equipment and utensils were not cleaned at regular intervals and that appropriate controls were not exercised over computer systems and related processes. It also noted that master manufacturing records lacked adequate manufacturing and control instructions.

 

The US FDA further observed that complaint records did not include findings of investigations and follow-up actions, and that unexplained discrepancies were not adequately reviewed, with certain quality control procedures not being followed, reports said. In addition, the regulator cited deficiencies in laboratory records and said established laboratory control mechanisms were not adhered to. It was also observed that a microbiologist responsible for sample collection had falsified sample collection data.

Aurobindo Pharma Q3 results 

Aurobindo reported a single-digit 8.4 per cent year-on-year (Y-o-Y) growth in revenue at ₹8,646 crore due to softness in the US (43 per cent of the revenues), which grew 2 per cent to ₹3,739 crore. Europe formulations revenue increased by 27.4 per cent Y-o-Y to ₹2,703 crore, while growth markets revenue remained flat Y-o-Y at ₹865 crore.

 

Earnings before interest, taxes, depreciation, and amortisation (Ebitda) grew 9 per cent Y-o-Y to ~₹1,773 crore while Ebitda margins increased 11 bps to 20.5 per cent. Profit after tax grew 7.6 per cent Y-o-Y to ₹910 crore.