
USFDA26 Feb 2026, 12:05 pm
Aurobindo Pharma's Subsidiary, Eugia Pharma, Receives USFDA Approval for Everolimus Tablets
AI Summary
Aurobindo Pharma Limited announced 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. This approval has been received from Eugia Unit-1 and is expected to be launched in Q1FY27. The approved product has an estimated market size of USS 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.
Key Highlights
- Eugia Pharma Specialities Limited, a subsidiary of Aurobindo Pharma, received USFDA approval for Everolimus Tablets
- The approval is for 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg strengths
- The approval is expected to be launched in Q1FY27
- The estimated market size of the approved product is USS 78 million for the twelve months ending December 2025
- This is the 184th ANDA approval (including 10 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities