Aurobindo's Eugia Arm Secures USFDA Nod for Transplant Drug Everolimus
New Delhi: Aurobindo Pharma Limited announced that its wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food and Drug Administration (USFDA) for Everolimus Tablets in strengths of 0.25 mg, 0.5 mg, 0.75 mg and 1 mg.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zortress Tablets of Novartis Pharmaceuticals Corp.. The approval was granted for manufacturing from 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 ending December 2025, the approved strengths of Everolimus Tablets have an estimated US market size of approximately US$78 million.
This marks the 184th ANDA approval (including 10 tentative approvals) received by the Eugia Pharma Specialities Group (EPSG) facilities, which manufacture oncology oral and sterile specialty products.
Everolimus Tablets are indicated for the prophylaxis of organ rejection in adult patients. In kidney transplant patients at low-to-moderate immunologic risk, the drug is used in combination with basiliximab, reduced doses of cyclosporine and corticosteroids. In liver transplant patients, it is administered no earlier than 30 days post-transplant and used in combination with reduced doses of tacrolimus and corticosteroids.
Hyderabad-based Aurobindo Pharma Limited is an integrated global pharmaceutical company operating in over 150 countries. The company develops, manufactures and markets generic pharmaceuticals, branded specialty products and active pharmaceutical ingredients.
It operates more than 30 manufacturing and packaging facilities approved by leading regulatory authorities including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC and Brazil ANVISA. Its product portfolio spans major therapeutic areas such as CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterology, Anti-Diabetics and Anti-Allergic segments.
