Lupin's Bioresearch Center Aces U.S. FDA Inspection with Zero Observations

Lupin Limited , a global pharmaceutical leader, has announced a significant milestone for its Bioresearch Center in Pune. The facility successfully completed a United States Food and Drug Administration (U.S. FDA) inspection, receiving zero observations - a testament to the company's commitment to maintaining high-quality standards and regulatory compliance.

Inspection Details

The U.S. FDA conducted two separate assessments:

An onsite clinical inspection from November 3 to November 6
A bio-analytical Remote Regulatory Assessment from October 30 to November 7

Both inspections concluded with no Form 483 observations, indicating that the facility met all regulatory standards during the FDA's review process.

Management's Perspective

Nilesh Gupta, Managing Director of Lupin, expressed his satisfaction with the outcome:

"The successful outcome of the onsite clinical inspection and bio-analytical assessment by the U.S. FDA at our Bioresearch Centre is testament to our ongoing commitment to quality and compliance. We remain focused on improving the lives of our patients globally."

Implications for Lupin

This successful inspection is a significant achievement for Lupin, as it:

Reinforces the company's reputation for maintaining high-quality standards
Potentially streamlines future regulatory approvals for drugs developed at this facility
Demonstrates Lupin's ability to meet stringent international regulatory requirements

About Lupin Limited

Lupin Limited is a prominent player in the global pharmaceutical industry:

Key Information	Details
Headquarters	Mumbai, India
Global Presence	Products distributed in over 100 markets
Specializations	Branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients
Key Markets	Strong position in India and the U.S.
Therapy Areas	Respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health
Global Footprint	15 state-of-the-art manufacturing sites and 7 research centers
Workforce	Over 24,000 professionals

Lupin continues to focus on improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

This latest achievement underscores Lupin's ongoing efforts to maintain high standards in its research and development facilities, which is crucial for its continued success in the highly regulated pharmaceutical industry.

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
+0.83%	+0.42%	+2.44%	-4.81%	-6.62%	+114.80%

Lupin Limited , a global pharmaceutical leader, has announced robust financial results for the second quarter of fiscal year 2026, demonstrating significant growth and improved profitability.

Key Financial Highlights

Metric	Q2 FY26	Q2 FY25	YoY Growth
Sales	₹68,314.00	₹54,970.00	24.3%
EBITDA	₹21,376.00	₹13,083.00	63.4%
EBITDA Margin	31.3%	23.8%	750 bps
Net Income	₹14,779.00	₹8,526.00	73.3%

Lupin's sales reached ₹68,314.00 million in Q2 FY26, representing a strong 24.3% year-over-year growth. The company's EBITDA saw a substantial increase of 63.4%, reaching ₹21,376.00 million, with the EBITDA margin expanding by 750 basis points to 31.3%. Net income also showed impressive growth, rising 73.3% to ₹14,779.00 million.

Business Segment Performance

North America: Grew 46% YoY to ₹28,720.00 million
India: Increased 3% YoY to ₹20,777.00 million
LATAM: Surged 81% YoY to ₹3,443.00 million
APAC: Remained flat at ₹2,995.00 million
EMEA: Grew 68% YoY to ₹2,729.00 million

Key Developments

Product Launches: Lupin successfully launched Liraglutide Injection and Risperidone Injection in the U.S. market during the quarter.
Global Expansion: The company strengthened its global specialty ophthalmology business through the VISUfarma acquisition.
Strategic Partnerships: Lupin entered an out-licensing partnership with Sandoz for Ranibizumab Biosimilar across multiple regions.
Regulatory Approvals:
- Received approval from Taiwan FDA for Pithampur Unit-I
- Obtained approval from ANVISA for Dabhasa facility
- Mexico operations received no observations from Cofepris
R&D Investment: The company invested ₹5,091.00 million (7.5% of sales) in research and development during the quarter.

Management Commentary

Mr. Nilesh Gupta, Managing Director of Lupin Limited, stated, "We are delighted to present one of our strongest performances ever in this second quarter of FY26. We continue to see robust growth in revenues and EBITDA led by strong performance across the board, in the U.S., emerging markets, other developed markets and in India, supported by higher operational efficiencies and sustained investments. We intend to leverage the performance of H1 to deliver a strong FY26."

Outlook

Lupin's strong performance in Q2 FY26 positions the company well for continued growth. The management's focus on operational efficiencies, strategic investments, and expansion in key markets is expected to drive further improvements in the coming quarters.

As Lupin continues to strengthen its global presence and expand its product portfolio, investors and stakeholders may anticipate sustained growth and value creation in the pharmaceutical sector.