Aurobindo Pharma Shares Extend Two-Day Fall After USFDA Assigns OAI Status To Lannett Manufacturing Plant

Aurobindo Pharma shares fell again on Thursday, 12 November, following a regulatory update from the United States Food and Drug Administration (USFDA). The regulator has classified an inspection of Lannett Company LLC's manufacturing plant in Indiana as Official Action Indicated (OAI). Lannett is a step-down subsidiary of Aurobindo Pharma.

The share price of Aurobindo Pharma has fallen as much as 3% over the past two trading sessions following the regulatory update. At 1:09 pm IST on Thursday, the Aurobindo Pharma stock price was trading at ₹1,806.70 on the National Stock Exchange (NSE), down 1.14%.

Despite the recent losses, Aurobindo Pharma shares have gained around 51% so far in 2026.

Why Has The USFDA Classified The Lannett Facility Inspection As OAI?

In an exchange filing dated 11 November 2026, Aurobindo Pharma said the USFDA had inspected Lannett Company’s manufacturing facility in Seymour, Indiana, from 17 August to 21 August 2026. The inspection resulted in four observations. The company said it had submitted responses to all four within the stipulated time.

The USFDA has now classified the inspection as OAI, which means regulatory action has been recommended based on the inspection findings.

Lannett Company LLC is a wholly owned step-down subsidiary of Aurobindo Pharma USA Inc. The Seymour facility is therefore part of the company's subsidiary structure in the US.

The company had first informed the stock exchanges about the inspection on 24 August 2026.

What Has Aurobindo Pharma Said About The Regulatory Action?

Aurobindo Pharma said the USFDA's action would not affect its financials or operations. It also reiterated its commitment to maintaining quality and compliance standards across its manufacturing facilities.

The company added that it would inform the stock exchanges of any further developments, as required.

The OAI classification is the latest regulatory disclosure concerning the Lannett facility. Aurobindo Pharma has not indicated any financial or operational impact from the development in its exchange filing.

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