Pharm'Up 
Indoco Remedies Ltd. has announced the final approval of its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, available in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths, to market a generic version of the reference listed drug (RLD), Xarelto Tablets, also in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths, manufactured by Janssen Pharmaceuticals, Inc. (Janssen), as granted by the USFDA.
Rivaroxaban Tablets USP, in all specified strengths, are bioequivalent and therapeutically equivalent to the reference listed drug, Xarelto Tablets, produced by Janssen Pharmaceuticals, Inc. (Janssen).
The production of Rivaroxaban Tablets USP will be handled by Indoco Remedies Limited at their state-of-the-art manufacturing facility situated at L-14, Verna Industrial Area, Verna, Goa – 403722, India. This medication is primarily indicated for the treatment of venous thromboembolism (VTE).
Commenting on this milestone, Ms. Aditi Panandikar, Managing Director, stated, “This approval not only underscores Indoco Remedies’ ability to produce pharmaceuticals meeting stringent quality standards but also significantly propels our growth ambitions in a key market like the United States.”
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