Eugia Pharma receives USFDA Approval for Everolimus Tablets

Aurobindo Pharma Limited is pleased to announce 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, 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.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1214.00 as compared to the previous close of Rs. 1164.85. The total number of shares traded during the day was 50628 in over 2820 trades.

The stock hit an intraday high of Rs. 1217.00 and intraday low of 1154.25. The net turnover during the day was Rs. 60777392.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 Pharmaceuticals EuguaPharmaSpecialities USFDA Approval EverolimusTablets