Aurobindo Pharma announced that its wholly owned subsidiary, Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Everolimus Tablets, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zortress Tablets, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, of Novartis Pharmaceuticals Corp.
This approval has been received from Eugia Unit-I and is expected to be launched in Q1FY27.
The approved product has an estimated market size of US$ 78 million for the twelve months ending December 2025, according to IQVIA MAT.
This is the 184th ANDA approval (including 10 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Everolimus Tablets are Indicated for the prophylaxis of organ rejection in adult patients (i) Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (ii) Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids.