Aurobindo Pharma has announced that its wholly owned subsidiary company, Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Votrient Tablets, 200 mg, of Novartis Pharmaceuticals Corporation.

The product is expected to be launched in Q4FY25. The approved product has an estimated market size of USD 106 million for the twelve months ending October 2024.

This is the 179th ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.

Pazopanib Tablets, 200 mg are indicated for treating adults with Advanced Renal Cell Carcinoma (RCC), and Advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy.

Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries.

The company has 29 manufacturing and packaging facilities approved by leading regulatory agencies, including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.

The company’s robust product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.