The inspection was conducted from August 17 to August 21, 2026, at AuroPeptides’ manufacturing facility in Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana. The facility manufactures peptide Active Pharmaceutical Ingredients (APIs).
“The United States Food and Drug Administration (US FDA) conducted a routine inspection at AuroPeptides Ltd, a manufacturer of Peptide APIs, located at Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana – 502329, from 17th to 21st August, 2026,” according to a stock exchange filing.
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According to Aurobindo Pharma, the sole observation related to facility and equipment maintenance. The company said the observation does not pertain to data integrity or related Good Manufacturing Practices (GMP) compliance.
Aurobindo Pharma also said corrective action had already been initiated during the course of the inspection. The company will submit its formal response within the stipulated timeline.
This week, Aurobindo Pharma Ltd said the company’s US-based facility received its Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), closing the inspection.
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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. 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 Ltd ended at ₹1,619.95, up by ₹13.55, or 0.84%, on the BSE.
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