Aurobindo Pharma arm Eugia Pharma unit-I inspected by US FDA; 4 observations reported

Pharmaceutical firm Aurobindo Pharma Ltd on Friday (February 27) said the United States Food and Drug Administration (US FDA) inspected Unit-I, a formulation manufacturing facility of its wholly owned subsidiary, Eugia Pharma Specialities Ltd.The facility is located at Kolthur Village, Shameerpet Mandal, Ranga Reddy, Telangana. The inspection took place from February 16 to February 27, 2026, and concluded with four observations. The company said it will respond to the US FDA within the stipulated timelines.

The company confirmed there is no impact on its financials or operations due to the inspection. Aurobindo Pharma stated its commitment to maintaining high-quality manufacturing standards across all its facilities worldwide and said it will update the stock exchanges if there is any further information.Also Read: Aurobindo Pharma’s P Sarath Chandra Reddy acquitted in Delhi Liquor Scam case

Yesterday, Aurobindo Pharma said its wholly-owned subsidiary, Eugia Pharma Specialities, has received final approval from the US Food and Drug Administration (USFDA) for Everolimus Tablets, the generic version of Zortress. The approval has been granted to Eugia Unit-I, with the product launch expected in the first quarter of FY27.The company has received clearance to manufacture and market Everolimus Tablets in strengths of 0.25 mg, 0.5 mg, 0.75 mg and 1 mg. The product is bioequivalent and therapeutically equivalent to the reference listed drug, Zortress Tablets, marketed by Novartis Pharmaceuticals Corp.

According to IQVIA MAT data, the approved product has an estimated market size of $78 million for the 12 months ended December 2025. With this, Eugia Pharma Specialities Group has received its 184th ANDA approval, including 10 tentative approvals, across facilities that manufacture oncology oral and sterile speciality products.

Also Read: Aurobindo Pharma shares drop 4% after US FDA flags lapses at Unit-7

Everolimus Tablets are indicated for the prophylaxis of organ rejection in adult patients undergoing kidney transplant at low to moderate immunologic risk, to be used in combination with basiliximab, reduced-dose cyclosporine and corticosteroids. The drug is also indicated for use in liver transplant patients.

Shares of Aurobindo Pharma Ltd ended at ₹1,220.70, down by ₹1.30, or 0.11%, on the BSE.