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Aurobindo Pharma Secures USFDA Approval for Rivaroxaban Tablets

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Aurobindo Pharma Ltd ( (IN:AUROPHARMA) ) has issued an announcement.

Aurobindo Pharma Limited has received final approval from the USFDA to manufacture and market Rivaroxaban Tablets USP, 2.5 mg, which is equivalent to Janssen Pharmaceuticals Inc.’s XARELTO®. The product is set to launch in Q1FY26 and has an estimated US market size of $447 million. Additionally, the company received tentative approval for 10 mg, 15 mg, and 20 mg strengths, with the total market size for all strengths estimated at $8.5 billion. This approval strengthens Aurobindo’s position in the US market and expands its portfolio of ANDA approvals, which now totals 540.

More about Aurobindo Pharma Ltd

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. It develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries. The company operates 30 manufacturing and packaging facilities approved by leading regulatory agencies and offers products across seven major therapeutic areas, supported by a strong R&D setup.

YTD Price Performance: -19.89%

Average Trading Volume: 30,012

Current Market Cap: 613.6B INR

For detailed information about AUROPHARMA stock, go to TipRanks’ Stock Analysis page.

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