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FDA Inspects Aurobindo Unit: Four Observations Issued
27 Feb
Summary
- US FDA inspected Aurobindo's Eugia Pharma facility in Telangana.
- The inspection, from Feb 16-27, 2026, resulted in four observations.
- Aurobindo Pharma confirms no financial or operational impact from the inspection.
A formulation manufacturing facility of Aurobindo Pharma's subsidiary, Eugia Pharma Specialities Ltd., located in Telangana, India, was inspected by the United States Food and Drug Administration (US FDA). The inspection at Unit-I, situated in Kolthur Village, Shameerpet Mandal, Ranga Reddy, occurred from February 16 to February 27, 2026. It concluded with the issuance of four observations.
Aurobindo Pharma has stated that the inspection has no impact on the company's financial standing or ongoing operations. The pharmaceutical firm reaffirmed its dedication to upholding rigorous quality manufacturing standards across all its global facilities. Further updates will be provided to stock exchanges as necessary.
This inspection follows Eugia Pharma's recent receipt of final USFDA approval for Everolimus Tablets, a generic version of Zortress, expected to launch in the first quarter of FY27. The company has secured 184 ANDA approvals to date, including 10 tentative approvals.
