India Pharma Outlook Team | Thursday, 14 August 2025
Indoco Remedies Ltd. has obtained final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to distribute Rivaroxaban Tablets USP of strengths 2.5 mg, 10 mg, 15 mg, and 20 mg. The approval enables Indoco to introduce a generic equivalent of the reference listed drug (RLD), Xarelto Tablets, which is made by Janssen Pharmaceuticals.
The Rivaroxaban Tablets approved are therapeutically and bioequivalent to Xarelto and meet all the regulatory requirements of quality, safety, and effectiveness. Manufacturing will be carried out from Indoco's state-of-the-art facility in Verna, Goa, India.
Rivaroxaban is an oral anticoagulant that is prescribed to treat and prevent venous thromboembolism (VTE), a condition that encompasses deep vein thrombosis and pulmonary embolism. Rivaroxaban is also used for the prevention of recurrence of VTE.
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Speaking of the approval, Indoco Remedies' Managing Director Aditi Panandikar said, "Besides showing Indoco Remedies' ability to deliver high-quality standards of product, this development also boosts our growth prospects in a leading market such as the US."
The approval by the USFDA reinforces Indoco's position within the American generics market and consistent with its strategic intent of growing its global portfolio. Entering the high-demand anticoagulant space, Indoco is well placed to enhance its export revenues while enabling enhanced access to cost-effective treatment for United States patients.
