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About Rivaroxaban API

Product
  • Therapeutic CategoryCardiovascular

  • CAS Number

    366789-02-8

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    USDMF, CEP Submitted, Brazil DMF, Canada DMF, Russia DMF

Mechanism of Action

XARELTO is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.

Indication

XARELTO is a factor Xa inhibitor indicated:

  • To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
  • For the treatment of deep vein thrombosis (DVT)
  • For the treatment of pulmonary embolism (PE)  
  • For the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months  
  • For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery

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Related Resources

Rivaroxaban from Dr.Reddy’s: Full basket offerings of API and Finished formulations

Rivaroxaban from Dr.Reddy’s: Full basket offerings of API and Finished formulations

Dr. Reddy’s is among the earliest generic API manufacturers globally for Rivaroxaban API and filed the USDMF in March 2014. Dr. Reddy’s process involves a selective and efficient chemical transformations that offer distinctive advantage for quality and manufacturability. The process eliminates the potential impurities formed in the process, and can be robust and safely operated at a commercial scale.In selected markets, we can also provide the formulated drug product of Rivaroxaban and will support you in all regulatory aspects from filing to registration.To know more about our Rivaroxaban offerings, read the tech sheet by filling the contact form below. 
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.