Lupin said that the United States Food and Drug Administration (USFDA) has completed a product-specific pre-approval inspection (PAI) at its Pune Biotech facility, conducted between 8 September and 19 September 2025.
The inspection concluded with 4 observations, the company said in a regulatory filing. These observations pertain to current good manufacturing practices (cGMP) but do not include any critical issues at this stage.
"We will address the observations and submit our response to the US FDA within the stipulated timeline," the company stated, adding that it remains committed to full compliance with cGMP quality standards across all its facilities.
The company did not disclose details of the specific product involved in the inspection.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
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The company's consolidated net profit jumped 52.13% to Rs 1,219.03 crore on an 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.
Shares of Lupin fell 0.56% to Rs 2,044.75 on the BSE.
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