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Aurobindo Pharma says USFDA inspection at Lannett ended with 4 observations

The inspection covered Aurobindo Pharma US subsidiary Lannett Company LLC for 17th to 21st August 2026, and the company said it will respond within the USFDA’s timeline.

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Aurobindo Pharma said the US Food and Drug Administration completed a routine inspection of its wholly owned step-down subsidiary, Lannett Company LLC, in Seymour, Indiana, from 17th to 21st August 2026, with four observations. In an exchange filing on 24 August, the company said the observations were procedural and that it will submit its response to the USFDA within the stipulated timeline.

The filing added that Aurobindo Pharma is committed to maintaining robust quality and compliance standards across its manufacturing facilities. The company also noted a separate routine USFDA inspection of AuroPeptides Ltd, a manufacturer of peptide APIs, in Telangana, which concluded with one observation related to facility and equipment maintenance.

Aurobindo Pharma shares rose about 1% in morning trade on the BSE on 24 August, after opening near ₹1,619.75 and moving to an intraday high of ₹1,637.75. The stock has hit a 52-week high of ₹1,682 on 13 August and a 52-week low of ₹1,017 on 2 September last year, according to the report.

Year-to-date, the shares are up 36%, versus a 9% decline in the Sensex, while over the past year they have gained 54% compared with a 5% decline in the Sensex, according to LiveMint Markets.

Latest closeSensex 78,079.96 ▲0.1%

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