Lupin Limited (NSE: LUPIN) announced today 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 1.25mg/mL via the 505(b)(2) pathway. This marks a significant milestone for the company as it provides an alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets.

Tentative Approval Milestone

This approval reflects Lupin’s ongoing commitment to developing differentiated medicines that address meaningful patient needs. The Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, the active ingredient in Eliquis® (apixaban) of Bristol Myers Squibb. 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.

CEO Statement

“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,” said Vinita Gupta, CEO, Lupin.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women’s health. With 15 state-of-the-art manufacturing facilities, 6 research centers, and a dedicated workforce of over 26,000 professionals, Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company’s business strategy.

For further information or queries, please contact Rajalakshmi Azariah, Vice President & Global Head – Corporate Communications, Lupin, at rajalakshmiazariah@lupin.com or Elise Titan, Director – U.S. Communications, Lupin, at elisetitan@lupin.com.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Lupin Limited

Lupin Limited belongs to the Healthcare › Drug Manufacturers – Specialty & Generic sector. Here’s a quick read on where the business and the stock stand today.

Lupin falls 10.7% over three months and has not found a floor yet. The PEG of 0.13 is extremely low. Either the market misses the growth story, or there is a catch worth investigating. The business compounds revenue at 19.1% and profits at 131.5% CAGR. That is strong double-digit growth on both counts. The stock holds at 30% of its 52-week range with RSI at 39. In other words, neither side has a clear edge right now. Revenue grows at 19.1% and profits at 131.5% CAGR — a genuinely strong business. Nevertheless, the stock drops 10.7% in three months. The market sells the stock, not the story. Watch whether that changes at the next earnings. Check Fundamentals of Lupin Limited.