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Harika Enjamuri

20th Jun · SEBI-Registered Analyst

Aurobindo Pharma Subsidiaries Receive US FDA Observations, Operations Remain Unaffected

Aurobindo Pharma Ltd ($AUROPHARMA) announced that the US FDA completed a pre-approval inspection of Eugia Steriles Pvt. Ltd.’s manufacturing facility in Parawada Mandal, Anakapalli District, Andhra Pradesh, conducted between June 10 and June 19, 2026, and issued five observations. Eugia Steriles, a wholly owned subsidiary of Eugia Pharma Specialities Ltd, stated that it will address the observations within the prescribed timeline and confirmed that there is no impact on the company’s financials or operations. Separately, the US FDA recently classified the inspection of Eugia Pharma Specialities’ Unit-III facility in Pashamylaram, Telangana, as “Official Action Indicated” (OAI). That inspection was carried out from January 27 to February 6, 2026, and concluded with 11 observations, with the OAI classification being communicated on June 12, 2026. Despite these regulatory developments, Aurobindo Pharma reiterated its commitment to maintaining high manufacturing quality standards across its global facilities and stated that its business operations and financial performance remain unaffected while corrective actions are being undertaken. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.

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