Aurobindo Pharma’s Subsidiary Eugia Pharma Secures USFDA Approval for Pazopanib Tablets

Aurobindo Pharma Limited, through its wholly owned subsidiary Eugia Pharma Specialities Limited, has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg. This approval signifies an important achievement for the company in its specialty pharmaceuticals segment. As of December 5, 2024, Aurobindo Pharma’s stock was trading at ₹1250.20, down 0.80%.
About Pazopanib Tablets and Its Indications
Pazopanib Tablets, 200 mg, are bioequivalent and therapeutically equivalent to Votrient Tablets, a product developed by Novartis Pharmaceuticals. This medication is primarily indicated for the treatment of adults with advanced renal cell carcinoma (RCC) and advanced soft tissue sarcoma (STS) who have undergone prior chemotherapy.
Market Potential and Launch Plans
The approved product, with an estimated market size of $106 million for the twelve months ending October 2024 (IQVIA data), is expected to be launched in Q4FY25. This development could enhance Aurobindo Pharma’s portfolio in oncology and specialty products.
A Testament to Eugia Pharma’s Capabilities
This is the 179th ANDA (Abbreviated New Drug Application) approval for Eugia Pharma Specialities Group, showcasing its robust capabilities in oncology oral and sterile products.
About Aurobindo Pharma Limited
Aurobindo Pharma Limited, a Hyderabad-based global pharmaceutical giant, develops and commercializes a wide range of generic and specialty pharmaceuticals. With 29 manufacturing facilities approved by leading global regulatory agencies, the company operates across seven therapeutic segments, including CNS, Anti-Retroviral, CVS, and more.
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Published on: Dec 5, 2024, 3:47 PM IST
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