Aurobindo Pharma's US subsidiary gets US FDA's Official Action Indicated classification

Résumé détaillé

The US FDA conducted the inspection between August 17 and 21, 2026, and issued four observations after its completion. Aurobindo Pharma said it had responded to all four observations within the stipulated time.

Drug maker Aurobindo Pharma Ltd on Wednesday (November 11) said the US Food and Drug Administration (US FDA) has classified the inspection of its step-down wholly owned subsidiary, Lannett Company LLC, as “official action indicated” (OAI), following an inspection at its Seymour facility in Indiana, US, in August 2026.

The US FDA conducted the inspection between August 17 and 21, 2026, and issued four observations after its completion. Aurobindo Pharma said it had responded to all four observations within the stipulated time.

The company received the latest communication from the US regulator on November 11, 2026, confirming the OAI classification. Aurobindo Pharma said the action would have no impact on the company's financials or operations.

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Lannett Company LLC is a wholly owned step-down subsidiary of Aurobindo Pharma USA Inc., which is a subsidiary of Aurobindo Pharma Ltd.

The company said it remains committed to maintaining quality and compliance standards across its manufacturing facilities and will inform the stock exchanges of any further developments, as required under applicable regulations.

Given that violations found on-site require further administrative sanctions and mandatory corrective actions.

Shares of Aurobindo Pharma Ltd ended at ₹1,825.00, down by ₹18.00, or 0.98%, on the BSE.

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