Lupin has announced receiving tentative approval from the United States Food and Drug Administration (U.S. FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL via the 505(b)(2) pathway. According to reports from Business Standard, this regulatory milestone represents a significant step forward for the pharmaceutical company's anticoagulation therapy portfolio. The approval was granted on September 28, 2026, marking a key development in the company's specialty portfolio expansion.
Lupin's Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, the active ingredient in Eliquis (apixaban) of Bristol Myers Squibb. As reported by Business Standard, this product provides an alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets. The suspension formulation offers a convenient alternative to traditional tablet administration for patients requiring blood-thinning medication. The company stated that this development reinforces its commitment to building a differentiated portfolio that addresses meaningful patient needs, specifically targeting segments underserved by standard tablet formulations. 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, leveraging the company's U.S.-based manufacturing expertise to support high-quality standards and supply reliability. According to Business Standard, this strategic manufacturing approach positions the company to serve the U.S. market with locally produced anticoagulation therapy options. The facility location ensures the company can meet regulatory requirements while maintaining supply chain efficiency for the American market.
Vinita Gupta, CEO of Lupin, noted that the tentative approval reflects the company's continued focus on developing medicines that solve specific clinical challenges. As reported by Business Standard, this development positions Lupin to capture demand in segments underserved by standard tablet formulations. "This tentative approval reflects our continued focus on developing differentiated medicines that address meaningful patient needs," Gupta stated. The move aligns with the company's broader strategy to expand its specialty portfolio and strengthen its presence in the U.S. market. Lupin Limited, headquartered in Mumbai, operates as a global pharmaceutical leader with products distributed in over 100 markets and maintains strong leadership positions across core therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health.
