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.
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.
Aurobindo Pharma recently reported December quarter earnings that were largely ahead of estimates, while margins were in-line.
Growth during the quarter was driven by a strong performance in Europe, where revenues rose 27% YoY, while the ARV segment expanded 22.5% YoY.
The US business also surpassed analyst expectations. R&D spending stood at 4.7% of sales, amounting to ₹409 crore.
