Aurobindo Pharma gets 3 observations after FDA scan of Telangana unit

Aurobindo Pharma Ltd said the United States Food and Drug Administration (FDA) has completed its inspection of Unit-V, an API manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Private Limited, in Telangana.

The inspection was conducted from December 1-12, 2025, at the facility located in the Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District.

At the conclusion of the inspection, the FDA issued a Form 483, citing three observations,

described by the company as procedural in nature. Aurobindo Pharma said it will respond to the regulator within the stipulated timelines.

The company added that the development does not impact the operations of the facility. It reaffirmed its commitment to maintaining the highest quality manufacturing standards across all its global facilities.

The shares of the company ended close to 2% in the green on Friday, December 12. The stock has fallen over 11% in the year so far.

Also Read:Granules India arm passes US FDA quality check for Hyderabad unit