Aurobindo Pharma 's wholly owned subsidiary Eugia Pharma Specialities Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Everolimus Tablets across four dosage strengths. This regulatory milestone opens access to a substantial US$ 78 million market opportunity.

Product Specifications and Approval Details

The USFDA approval covers Everolimus Tablets in 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg dosages, which are bioequivalent and therapeutically equivalent to Novartis Pharmaceuticals Corp's reference listed drug Zortress Tablets. The approval has been received from Eugia Unit-I facility.

Market Opportunity and Commercial Strategy

The approved product targets an estimated market size of US$ 78 million for the twelve months ending December 2025, according to IQVIA MAT data. The company plans to launch the product in Q1 FY27, positioning itself in the competitive US generic pharmaceutical market.

Therapeutic Applications

Everolimus Tablets are indicated for prophylaxis of organ rejection in adult patients undergoing kidney and liver transplants. For kidney transplant patients at low-moderate immunologic risk, the medication is used in combination with basiliximab, cyclosporine, and corticosteroids. For liver transplant patients, it is administered no earlier than 30 days post-transplant in combination with tacrolimus and corticosteroids.

Strategic Significance for Eugia Pharma

This approval represents the 184th ANDA approval for Eugia Pharma Specialities Group facilities, including 10 tentative approvals received. The milestone strengthens the company's portfolio in oncology oral and sterile specialty products, demonstrating its regulatory expertise and manufacturing capabilities in the US market.

Aurobindo Pharma Limited witnessed significant institutional activity with a major block trade executed on the National Stock Exchange (NSE). The transaction represents substantial trading volume in the pharmaceutical company's shares.

Block Trade Details

The block trade involved a considerable volume of shares with specific pricing parameters that highlight the scale of institutional interest in the stock.

Transaction Significance

Block trades are large-volume transactions typically executed by institutional investors, mutual funds, or other large stakeholders. These trades are conducted outside regular market hours to minimize market impact and provide liquidity for substantial share transfers.

The transaction price of ₹1211.50 per share reflects the valuation at which institutional participants were willing to execute this significant trade. The substantial volume of 883,262 shares indicates meaningful institutional activity in Aurobindo Pharma's stock.

Market Activity

The ₹107.01 crore transaction value demonstrates the scale of institutional participation in Aurobindo Pharma shares. Such block trades often signal portfolio restructuring activities by large investors or strategic stake adjustments by institutional holders.