Lupin shares fall as firm gets six USFDA observations at Nagpur injectable facility; details here

The drugmaker said the USFDA carried out an inspection at the Nagpur plant between September 8 and September 16. The company did not specify the nature of the observations raised by the regulator.

On the inspection, the company stated: "We will address the observations and respond to the USFDA within the stipulated timeframe. We are committed to be compliant with current good manufacturing practices (CGMP) quality standards across all our facilities," in an exchange filing.

On Wednesday morning, Lupin shares were trading lower, down 0.97% at ₹2,032 apiece around 10.31 am. The counter opened at ₹2,030, down from the previous close of ₹2,051.80.

In the last five trading sessions, the pharma major’s shares have advanced 1.99%. The scrip also rose 3.24% in the last one month. On the other hand, the year-to-date drop stands at 14.08%. The market capitalisation of Lupin Limited is ₹92,830.79 crore as on September 17, 2025.

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.

Earlier this month, the USFDA had granted approval for Lupin’s abbreviated new drug application (ANDA) for Risperidone Injectable, indicated for the treatment of schizophrenia and bipolar disorder. The injectable is the bioequivalent to the reference-listed drug Risperdal Consta Long-Acting Injection. Lupin said it received approval for Risperidone extended-release injectable suspension in single-dose vials of 25 mg, 37.5 mg and 50 mg.

Lupin Q1 results:

The drug marker reported a 77% year-on-year (YoY) rise in its consolidated net profit to ₹801 crore in the June quarter of FY26, compared to ₹452 crore in the same period a year ago.

The company’s total revenue from operations surged 16.3% YoY to ₹5,600 crore during the quarter under review, as against ₹4,814 crore in the first quarter of FY25.

At an operating level, its EBITDA (earnings before interest, tax, depreciation and amortisation) was up by 22.9% YoY at ₹1,240.9 crore in Q1FY26, compared to ₹856.3 crore in the corresponding period a year earlier.

During the reporting quarter, Lupin invested 6.3% of its sales (equivalent to ₹350 crore) in research and development. While its formulation sales in North America surged 28.3% YoY ₹2,040.8 crore, domestic sales grew by 17.5% to ₹1,925.9 crore.

Its total US sales rose to $227 million, up from $181 million a year ago and $209 million in the previous quarter.