Lupin Ltd has received tentative approval from the US Food and Drug Administration (US FDA) for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL under the 505(b)(2) regulatory pathway.

The oral liquid formulation contains apixaban, the active ingredient in Bristol Myers Squibb’s Eliquis, and is intended to provide an alternative administration option for adults requiring anticoagulation therapy, including patients who may have difficulty swallowing tablets.

Lupin CEO Vinita Gupta said the tentative approval reflects the company’s focus on developing differentiated medicines aimed at addressing patient needs.

Upon final approval, the product will be manufactured at Lupin’s Somerset, New Jersey facility, leveraging the company’s US-based manufacturing capabilities to support product quality and supply reliability.