Thursday, December 12, 2024

Aurobindo Pharma wins USFDA approval for generic cancer drug

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Aurobindo Pharma Limited announced today that its subsidiary Eugia Pharma Specialities Limited has received US Food & Drug Administration (USFDA) final approval to manufacture and market Pazopanib Tablets, 200 mg.

The shares of Aurobindo Pharma Limited were trading at ₹1,243.90 up by ₹15.50 or 1.23 per cent on the NSE today at 3 pm.

The generic drug is bioequivalent to Novartis Pharmaceuticals’ Votrient Tablets and is indicated for treating advanced Renal Cell Carcinoma (RCC) and Soft Tissue Sarcoma (STS) in adult patients who have undergone prior chemotherapy.

According to market research firm IQVIA, the product has an estimated market size of US$ 106 million for the twelve months ending October 2024. Aurobindo plans to launch the medication in the fourth quarter of fiscal year 2025.

This approval marks the 179th Abbreviated New Drug Application (ANDA) for Eugia Pharma Specialities Group, which manufactures oncology oral and sterile specialty products.

Aurobindo Pharma, headquartered in Hyderabad, is an integrated global pharmaceutical company with 29 manufacturing facilities approved by major international regulatory agencies. The company develops and commercialises generic pharmaceuticals across seven therapeutic areas in over 150 countries.







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