Aurobindo Pharma Clarification Issued on Recent Media Report Regarding US FDA Inspection

Aurobindo Pharma Limited provided a formal clarification today in response to a news item published on ndtvprofit.com concerning the US FDA inspection at its Unit-VII. The company confirmed it is adhering to all stipulated timelines to submit its response to the US FDA following the completion of the inspection on February 10, 2026. Aurobindo asserted that it has made timely disclosures of all material information and currently has no further material event requiring disclosure.

Response to Market Queries

Aurobindo Pharma Limited issued this clarification on February 18, 2026, in response to specific queries received from both the National Stock Exchange (NSE) and the Bombay Stock Exchange (BSE) regarding a news item circulating online. The company reaffirmed its commitment to maintaining transparency and providing timely disclosures of all relevant events.

US FDA Inspection Status

The company referenced its earlier intimation to the stock exchanges dated February 10, 2026, confirming the completion of the US FDA inspection at its Unit-VII facility. Aurobindo stated explicitly that it is in the process of preparing and submitting its official response to the US FDA within the regulatory timelines prescribed. Furthermore, the company noted that regulatory inspections are a routine part of its global operations.

Disclosure Status

Aurobindo confirmed that, at the present time, there is no material event or information that requires further disclosure under the applicable regulations, beyond what has already been communicated to the exchanges. The organization assured regulators that it manages observations arising from such inspections through established processes and discloses information as required by law.

Source: BSE

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