Lupin receives Form 483 with 2 observations after US FDA inspection at Ankleshwar facility

Drug firm Lupin Ltd on Saturday (March 7) said the US Food and Drug Administration (US FDA) has concluded an inspection of its manufacturing facility in Ankleshwar, India, issuing a Form 483 with two observations.

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.

Also Read: Lupin says GST inspection at Maharashtra office underway; business, finances unaffected, shares rise

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.

Also Read: Lupin shares may see up to 16% upside post Q3, analysts say — should you buy?

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.

The company reported a gross profit of ₹5,222.4 crore in Q3 FY2026 compared to ₹3,897 crore in Q3 FY2025, with a gross margin of 73.5%. Personnel cost stood at ₹1,143.3 crore, accounting for 16.1% of sales, compared to ₹984.4 crore in the year-ago quarter.

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