Indoco Remedies Limited has informed the Exchange regarding a press release dated August 13, 2025, titled "Indoco Remedies receives final ANDA approval from USFDA forRivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg".
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Indoco Remedies has received final approval from the USFDA for its generic version of Rivaroxaban Tablets USP in four strengths — 2.5 mg, 10 mg, 15 mg, and 20 mg. This is the generic equivalent of Janssen's blockbuster brand Xarelto, used for treating blood clots (venous thromboembolism). The tablets will be manufactured at the company's Goa facility. The approval covers all four dosage strengths, making it a comprehensive market entry. The company's Managing Director highlighted this as a reflection of Indoco's quality capabilities and a boost to its growth plans in the US market.
This approval allows Indoco to launch a generic equivalent of a widely prescribed drug in the lucrative US market, potentially adding meaningful revenue from a large addressable opportunity. The news is positive for shareholders as it expands Indoco's US product portfolio and supports its international growth aspirations.