Aurobindo Pharma announced that a routine US Food and Drug Administration inspection at its subsidiary AuroPeptides Ltd concluded with one observation related to facility and equipment maintenance. According to the company's stock exchange filing, the inspection was conducted from August 17 to August 21, 2026, at the manufacturing facility in Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana. The facility manufactures peptide Active Pharmaceutical Ingredients (APIs).
As reported by Aurobindo Pharma, the sole observation did not relate to data integrity or Good Manufacturing Practices (GMP) compliance. The company stated that corrective action had already been initiated during the course of the inspection. Aurobindo Pharma will submit its formal response within the stipulated timeline to address the single observation.
This week, Aurobindo Pharma announced that its US-based facility received its Establishment Inspection Report (EIR) from the US Food and Drug Administration. According to the company, 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 issued a Form 483 with 11 observations, but the facility has now been classified as 'Voluntary Action Indicated' (VAI) and the inspection has been concluded.
Shares of Aurobindo Pharma Ltd ended at ₹1,619.95, up by ₹13.55, or 0.84%, on the BSE following the announcement. The positive market reaction reflects investor confidence in the company's regulatory compliance and the resolution of recent inspection matters. With the Raleigh facility now 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.
