Shares of Aurobindo Pharma Ltd were trading almost 1% lower on Monday, 8 September, after the company received eight observations from the United States Food and Drug Administration (USFDA).

The USFDA visited the company’s Unit-XII, which includes oral solids and injectable manufacturing, in Bachupally, Medchal Malkajgiri District, Telangana, from 25 August to 5 September 2025.

At the conclusion of the present inspection, a ‘Form 483’ was issued with a total of 8 observations for both (oral solids and injectable).

All observations are procedural in nature, and the company stated that it will react to the US FDA within the timeframe specified.

Earlier, on 29 August, the USFDA issued a Form 483 with five remarks after visiting Unit-I, an API production facility of the company’s affiliate Apitoria Pharma in Sangareddy, Telangana, from 21 August to 29 August.

The observations were procedural in nature, and no data integrity concerns were raised.

At 1:16 pm, the shares of Aurobindo Pharma were trading 0.12% higher at Rs 1,045.40 on NSE.

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