Lupin Secures US FDA Approval for Rivaroxaban, Production Set for Aurangabad

Lupin Limited has received approval from the US Food and Drug Administration for its Rivaroxaban tablets, marking a significant milestone in the company’s expansion into the anticoagulant market. The tablets will be manufactured at Lupin’s Aurangabad facility in India, reinforcing the country’s growing role in global pharmaceutical production.  

 

Advancing Cardiovascular Treatment  

- Rivaroxaban is a widely used anticoagulant prescribed for reducing the risk of stroke, deep vein thrombosis, and pulmonary embolism  

- Lupin’s version is bioequivalent to Xarelto, a leading brand by Janssen Pharmaceuticals  

- The approval allows Lupin to enter the competitive US market, offering a cost-effective alternative to existing treatments  

 

Strategic Expansion and Market Impact  

- The Aurangabad facility has undergone rigorous inspections to meet US FDA standards, ensuring high-quality production  

- Lupin’s entry into the anticoagulant segment strengthens its cardiovascular portfolio, complementing its existing range of medications  

- Analysts anticipate strong demand for Rivaroxaban, given the rising prevalence of cardiovascular diseases globally  

 

With this approval, Lupin continues to expand its footprint in the US pharmaceutical market, reinforcing its commitment to delivering high-quality, affordable healthcare solutions.  

 

Sources: Express Pharma, Lupin, Economic Times, The Health Master