Aurobindo Pharma shares in focus after USFDA closes Raleigh unit inspection with 11 observations

Shares of Aurobindo Pharma Ltd. will be in focus on Monday, August 17, after the company's US-based facility received its Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), closing the inspection.

The USFDA had inspected the Raleigh plant in North Carolina, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma, from March 24 to April 10, 2025.

The facility manufactures inhalers, dermatology and transdermal products. At the end of the inspection, the USFDA had issued a Form 483 with 11 observations.

The facility has now received its EIR, with the USFDA classifying the site as "Voluntary Action Indicated" (VAI) and concluding the inspection.

With the facility classified as VAI, pending applications for multiple inhalers and other dosage forms filed from the site can now progress through the USFDA's review process, the company said.

Shares of Aurobindo Pharma settled 2.26% lower at ₹1,625.80 on Friday. The stock has gained more than 36% so far this year.