Aurobindo’s Eugia Pharma Gains USFDA Approval for Everolimus Tablets
Filing Summary
Aurobindo Pharma Limited announced that its subsidiary, Eugia Pharma Specialities Limited, received approval from the USFDA to manufacture and market Everolimus Tablets in various dosages. The tablets are bioequivalent to Zortress Tablets by Novartis Pharmaceuticals. The approval is from Eugia Unit-I, with a market size estimated at USD 78 million as of December 2025. This marks the 184th ANDA approval for Eugia Pharma. The product is indicated for organ rejection prophylaxis in kidney and liver transplants. The launch is anticipated in Q1FY27.
Aurobindo Pharma Limited has reported that its wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Everolimus Tablets in dosages of 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Zortress Tablets, produced by Novartis Pharmaceuticals Corp.
The approval was granted to Eugia Unit-I, and the product is expected to be launched in the first quarter of the fiscal year 2027. The approved product has an estimated market size of USD 78 million for the twelve months ending December 2025, according to IQVIA MAT data. This approval represents the 184th Abbreviated New Drug Application (ANDA) approval for Eugia Pharma Specialities Group, which includes 10 tentative approvals. The group specializes in manufacturing both oncology oral and sterile specialty products.
The Everolimus Tablets are indicated for the prophylaxis of organ rejection in adult patients undergoing kidney and liver transplants. For kidney transplants, the tablets are used in patients at low to moderate immunologic risk, in combination with basiliximab, cyclosporine (at reduced doses), and corticosteroids. For liver transplants, the tablets are administered no earlier than 30 days post-transplant, in combination with tacrolimus (at reduced doses) and corticosteroids.
The approval of Everolimus Tablets adds to Aurobindo Pharma’s extensive portfolio of generic pharmaceuticals. The company operates over 30 manufacturing and packaging facilities approved by leading regulatory agencies, including the USFDA, UK MHRA, and others. Aurobindo Pharma’s product portfolio spans seven major therapeutic areas, including CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic products, supported by a robust R&D setup.
The timeline for the launch of Everolimus Tablets is set for the first quarter of the fiscal year 2027. The approval was received from Eugia Unit-I, which is part of the Eugia Pharma Specialities Group’s facilities. This development aligns with Aurobindo Pharma’s strategy to expand its product offerings in the US market.
Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients. Aurobindo Pharma operates in over 150 countries, focusing on expanding its product portfolio and strengthening its presence in key markets.