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Lupin receives tentative approval for anticoagulant Apixaban from US FDA

28-Sep-2026 | 14:33
Lupin said that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its new drug application for Apixaban oral suspension.

Apixaban is an oral liquid formulation of apixaban, the active ingredient in Eliquis (apixaban) of Bristol Myers Squibb. The drug provides an alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets.

Apixaban is an oral anticoagulant used to prevent and treat blood clots and reduce the risk of stroke in people with nonvalvular atrial fibrillation.

Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility.

Vinita Gupta, CEO, Lupin, said: This tentative approval reflects our continued focus on developing differentiated medicines that address meaningful patient needs.

Apixaban oral suspension expands the ways in which this important therapy could be administered, while reinforcing our commitment to building a differentiated portfolio.

Lupin is a global pharmaceutical company focused on branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients across multiple therapeutic segments.

The company?s consolidated profit after tax stood at Rs 1,415 crore in Q1 FY27, up 16.08% from Rs 1,219.03 crore in Q1 FY26. Net sales rose 33.32% to Rs 8,217.23 crore in Q1 FY27 as compared with Q1 FY26.

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