Zydus Lifesciences Limited (ZYDUSLIFE) announced the conclusion of a USFDA cGMP inspection at its manufacturing plant in SEZ II, Ahmedabad. The inspection, conducted from September 21 to 28, 2026, closed with one observation. Notably, there were no data integrity-related observations. The company will closely collaborate with the USFDA to address the observation promptly.

Inspection Highlights

The USFDA’s inspection focused on the company’s compliance with current Good Manufacturing Practices (cGMP). The inspection duration was a week, and it concluded with a single observation. Zydus Lifesciences Limited remains committed to maintaining high standards of manufacturing and quality control.

No Data Integrity Issues

One of the critical aspects of the inspection was the verification of data integrity. Fortunately, there were no data integrity-related observations, which is a significant positive outcome for the company. This ensures that the company’s manufacturing processes are robust and reliable.

Forward-Looking Statement

Zydus Lifesciences Limited will work closely with the USFDA to address the observation expeditiously. The company remains dedicated to ensuring compliance and enhancing its manufacturing processes to meet the highest standards.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Zydus Lifesciences Limited

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

Zydus rises 9.2% over three months, with buying pressure holding steady. The PEG of 0.73 signals undervaluation relative to growth. It is a potential re-rating candidate. The business compounds revenue at 16.5% and profits at 37.0% CAGR. That is strong double-digit growth on both counts. Buyers show up with 1.8x the volume of sellers. Moreover, they dominated on 18 of recent sessions versus 12 for sellers — a healthy accumulation pattern. Both the business and the stock move in the right direction. Revenue grows at 16.5%, profits at 37.0%, and the PEG sits at 0.73 — below its growth rate. That combination is rare. Check Fundamentals of Zydus Lifesciences Limited.

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.