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The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Votrient Tablets, of Novartis Pharmaceuticals Corporation.
Pazopanib Tablets, is indicated for the treatment of adults with advanced renal cell carcinoma (RCC), and advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
The product is expected to be launched in Q4 FY25. The approved product has an estimated market size of $106 million for the twelve months ending October 2024, according to IQVIA.
This is the 179 th ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services.
The pharma major reported 7.95% rise in consolidated net profit to Rs 817.38 crore on a 6.93% increase in revenue from operations to Rs 7,646.21 crore in Q2 FY25 over Q2 FY24.
Shares of Aurobindo Pharma declined 0.98% to Rs 1,245.70 on the BSE.
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