Lupin shares rise nearly 3% after its Pune Bioresearch Centre receives Zero Observations from USFDA

Shares of Global pharma major Lupin Limited gained as much as 2.83% to touch an intraday high of ₹2,028 per equity share on the National Stock Exchange (NSE). At 2:15 PM, shares of Lupin Limited were trading 2.44% higher at ₹2,019.90 apiece.

The rise in the share price is attributed to the U.S. Food and Drug Administration's completion of an onsite clinical inspection at its Bioresearch Centre in Pune from November 3 to November 6, 2025. The inspection concluded with zero 483 observations. The company also said a bio-analytical Remote Regulatory Assessment was conducted from October 30 to November 7, 2025.

This assessment concluded with no observations. Both reviews pertained to Lupin’s Bioresearch Centre in Pune and, according to the company, have closed with the outcomes noted above.

Nilesh Gupta, Managing Director, Lupin, said, “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.”

The drug maker reported a 73.34% year-on-year (YoY) increase in its consolidated net profit to ₹1,477.92 crore in the September quarter of FY26, led by robust sales in the US and emerging markets.

During the corresponding period of the 2024-25 fiscal year (Q2FY25), its net profit stood at ₹852.63 crore.

The Mumbai-based drug manufacturer witnessed a 24.3% YoY surge in its sales, which stood at ₹6,831.43 crore during the quarter under review, compared to ₹5,497.01 crore in the second quarter of the previous fiscal year.

On a geographic scale, the United States contributed 40% to its sales, followed by India at 30%, other emerging markets (Latin America, South Africa, the Philippines, and the rest of the world) at 14%, other developed markets (Canada, Australia, Europe, and others) at 12%, and API at 4%.

At an operational level, its EBITDA (earnings before interest, tax, depreciation, and amortisation), also known as operating profit, was at ₹2,431.3 crore in Q2FY26, representing a 75.8% YoY jump from ₹1,382.7 crore in the year-ago period.

Its EBITDA margin expanded by 1,040 basis points (bps) annually to 35.6% during the quarter, as against 25.2% in Q2FY25.

Lupin share price

Over the last five days, shares of Lupin have surged 1.03%. The scrip has further advanced 3.06% in the last month. On the other hand, Lupin shares have declined 1.01% in the last 6 months and the year-to-date drop stands at 14.62%.

The stock touched its 52 week high of ₹2,402.90 on January 2, 2025 and its 52 week low of ₹1,795.20 on April 7, 2025.The company’s market capitalisation is ₹92,476.07 crore.