The approval covers 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 (RLD), Zortress Tablets, marketed by Novartis Pharmaceuticals Corp.
Everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients undergoing kidney and liver transplants. For kidney transplant patients at low-to-moderate immunologic risk, the drug is used in combination with basiliximab, reduced-dose cyclosporine and corticosteroids. For liver transplant patients, it is administered no earlier than 30 days post-transplant, in combination with reduced-dose tacrolimus and corticosteroids.
The approval was granted to Eugia Unit-I, and the product is expected to be launched in the first quarter of FY27. According to IQVIA MAT data for the twelve months ended December 2025, the approved product has an estimated market size of $ 78 million.
With this approval, Eugia Pharma Specialities Group has received a total of 184 ANDA approvals, including 10 tentative approvals, across its facilities manufacturing oncology oral and sterile specialty products.
Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services.
The company’s consolidated net profit rose 7.6% to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25.