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 [email protected] or Elise Titan, Director – U.S. Communications, Lupin, at [email protected].

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.

Morepen Laboratories Limited (NSE: MOREPENLAB) has made a significant stride in its contract development and manufacturing offerings by submitting its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for Sitagliptin Tablets USP in 25 mg, 50 mg, and 100 mg strengths. This milestone advances the company’s API-to-finished dosage development capabilities.

Enhanced CDMO Capabilities

The submission marks a pivotal moment for Morepen as it extends its expertise into integrated finished dosage development and regulatory filing. The Sitagliptin program involves formulation development, scale-up, analytical method development, impurity control, stability studies, and manufacture of regulatory batches under GMP systems. This comprehensive approach strengthens Morepen’s ability to support specialized CDMO assignments across API development, finished dosage formulation, and regulatory submission.

Strategic Growth Trajectory

Mr. Sanjay Suri, Managing Director, emphasized that capability building is central to Morepen’s next phase of growth. He stated, ‘Our first ANDA submission brings together the scientific, manufacturing, and regulatory skills needed to take an API through finished dosage development to a U.S. filing.’ Morepen plans to build on this foundation through customer development programs, technology transfer, co-development, and licensing opportunities.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Morepen Laboratories Limited

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

Morepen gains 126.5% over three months and trades near its 52-week highs. Thin margins at 7.2% leave limited room for error — any demand softness or cost spike hits the bottom line hard. The PEG of 1.34 sits close to fair value. The stock is neither a clear buy nor obviously expensive. Buyers show up with 1.9x the volume of sellers. Moreover, they dominated on 18 of recent sessions versus 12 for sellers — a healthy accumulation pattern. The stock rises 126.5% in three months on 8.4% revenue growth. As a result, the market gives it more credit than the fundamentals strictly justify. Watch the next quarterly results. If growth accelerates, the move makes sense. If not, expect some gains to unwind. Check Fundamentals of Morepen Laboratories Limited.

Sun Pharmaceutical Industries Limited (SUNPHARMA) has announced a significant global licensing agreement with LIB Therapeutics for Lerodalcibep, a PCSK9 inhibitor. This agreement grants Sun Pharma rights to commercialize and manufacture Lerodalcibep worldwide, excluding the United States and China. The move strengthens Sun Pharma’s Innovative Medicines portfolio and aims to address a significant unmet need in cardiovascular care.

Global Market Expansion

Lerodalcibep, marketed as Lyrokaul in the EU and Lerochol in the US, is a once-monthly PCSK9 inhibitor for LDL-C lowering. The agreement provides Sun Pharma access to a US$3.7 billion market outside the US and China, which is growing at a CAGR of 38%. This expansion is expected to bolster Sun Pharma’s presence in the rapidly growing PCSK9 inhibitor market, which is projected to reach US$7 billion by 2026.

Addressing Unmet Needs in Cardiovascular Care

The partnership aims to bridge the gap between treatment goals and real-world control of LDL-C levels in patients at high cardiovascular risk. According to the DA VINCI observational study, only 33% of patients on stable oral lipid-lowering therapy achieved their recommended LDL-C goals in Europe. With additional therapies like PCSK9 inhibitors, Sun Pharma and LIB Therapeutics aim to provide more effective treatment options for these patients.

Kirti W Ganorkar, Managing Director of Sun Pharma, emphasized the importance of this agreement in enhancing their global Innovative Medicines portfolio, particularly in cardiovascular care. Evan Stein, MD, PhD, Chief Operating and Scientific Officer of LIB Therapeutics, highlighted the potential of this collaboration to expand access to Lerodalcibep for patients worldwide.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Sun Pharmaceutical Industries Limited

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

Sun holds in the upper half of its 52-week range, a sign the market backs the stock. The PEG reaches 3.47. The stock trades on brand and index weight, not on growth. Premium net margins of 20.2% demonstrate strong cost discipline and a wide competitive moat. The stock holds at 61% of its 52-week range with RSI at 43. In other words, neither side has a clear edge right now. Revenue grows at 10.4% and profits at 10.6%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of Sun Pharmaceutical Industries Limited.