The inspection was conducted between March 2, 2026 and March 7, 2026. Following the inspection, the US regulator issued Form 483, noting two observations at the facility.
The company said it will address the observations and respond to the US FDA within the stipulated timeframe. Lupin added that it remains committed to compliance with Current Good Manufacturing Practice (CGMP) standards across all its facilities.
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What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Post Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
Third Quarter Results
Lupin reported a consolidated net profit after tax of ₹1,175.6 crore in Q3 FY26, down sequentially from Q2 FY26 but up 37.5% compared to Q3 FY25. Consolidated revenue from operations stood at ₹7,167.5 crore, up 1.7% quarter-on-quarter and 24.3% year-on-year.
On a standalone basis, net profit after tax was ₹717.5 crore in Q3 FY26, down from ₹1,357.4 crore in Q2 FY26 and ₹1,114.7 crore in Q3 FY25. Standalone revenue from operations was ₹4,601.1 crore, up 12.5% sequentially and 9.3% year-on-year.
Exceptional items during the quarter included a provision of ₹449.4 crore for antitrust litigations and ₹134.8 crore toward a settlement with Astellas. The implementation of the New Labour Codes resulted in an incremental cost of ₹49.6 crore at the standalone level and ₹51.2 crore on a consolidated basis.
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The company also recorded gains from the divestment of its OTC and API R&D businesses, amounting to ₹658.9 crore and ₹3.7 crore, respectively. Additionally, a provision of ₹70 crore was made toward the diminution in the value of investment in a subsidiary.
On Friday (March 6), shares of Lupin Ltd ended at ₹2,335.55, up by ₹3.15, or 0.14%, on the BSE.
Also Read: Lupin gets Establishment Inspection Report from the USFDA for its Goa facility
(Edited by : Jomy Jos Pullokaran)
First Published: Mar 7, 2026 9:07 PM IST
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