Aurobindo Pharma Limited has informed the Exchange regarding a press release dated February 26, 2026, titled "Submission of press release that Eugia Pharma receives USFDA Approval for Everolimus Tablets.".
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Aurobindo Pharma's wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final USFDA approval to manufacture and market Everolimus Tablets in 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg strengths. The product is bioequivalent and therapeutically equivalent to Novartis's Zortress Tablets, used to prevent organ rejection in adult kidney and liver transplant patients. The approval came from Eugia Unit-I, with an expected market launch in Q1FY27. The total addressable US market for this product is estimated at US$ 78 million (IQVIA MAT, 12 months ending December 2025). This marks the 184th ANDA approval (including 10 tentative) from Eugia Pharma's facilities.
This approval strengthens Aurobindo's US generic portfolio and adds a revenue opportunity of roughly US$ 78 million from a single product. While the actual market share captured will depend on competition and launch execution, the news is a positive operational update and reinforces the company's strong USFDA approval track record.