Aurobindo Pharma Shares Trade Lower as Arm Secures 11 Observations 

February 9, 2026February 9, 2026

Shares of Aurobindo Pharma Ltd were trading in the red and 1% lower on 9 February after the US Food and Drug Administration (USFDA) inspected the company’s Unit III production plant.

The US FDA inspected Unit-III, Aurobindo Pharma’s formulation manufacturing facility at Phase-III, TSIIC, EPIP, IDA, Pashamylaram in Telangana’s Sangareddy district, from 27 January to 6 February, 2026.

In its regulatory filing, the company said the inspection ended with 11 observations, which it described as procedural. Aurobindo Pharma stated that it will submit its responses within the prescribed timelines.

This development occurs against a backdrop of increased regulatory monitoring at the facility. In May 2024, the facility obtained an Official Action Indicated status, which was followed by a warning letter from the USFDA in August 2024.

The company clarified that the inspection outcome has no impact on its financial performance or operations. It reiterated its commitment to upholding high-quality manufacturing standards across its global facilities and said it will update stock exchanges on any further developments.

Separately, Aurobindo Pharma noted that the US FDA had completed an inspection of Unit-V, an API manufacturing facility of its wholly owned subsidiary Apitoria Pharma Private Limited, in Telangana last year. The inspection took place between 1 December and 12 December, 2025, at the facility located in the Industrial Development Area, Chemical Zone, Pashamylaram.

At the end of that inspection, the FDA issued a Form 483 with three observations, which the company also termed procedural. Aurobindo Pharma said it would respond to the regulator within the stipulated timeframe and added that the observations did not affect the facility’s operations. The company reaffirmed its commitment to maintaining the highest manufacturing quality standards across all its global sites.

However, at 1:12 pm, the shares of Aurobindo Pharma were trading 1.22% higher at Rs 1,205.50 on NSE.

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