Zydus Lifesciences Ltd has received a “No Observation” from the US Food and Drug Administration (US FDA) following a surveillance inspection of its API manufacturing facility in Ambernath, Maharashtra. This is a significant achievement, as it demonstrates the company’s compliance with US pharmaceutical manufacturing regulations. The company’s formulation sales in the US market reached USD 285 million in the third quarter of fiscal year 2025, a 29% year-over-year (YoY) increase, exceeding market estimates of USD 270 million.

The company’s Q3 FY25 revenue grew 17% YoY to ₹5,269 crore, driven by strong performance across all segments. Net profit jumped 30% YoY to ₹1,023 crore, boosted by improved forex gains and robust sales increase. The company’s forex gain was ₹183 crore, a significant improvement from ₹21 crore in the same period last year. Earnings before interest, taxes, depreciation, and amortization (EBITDA) increased to ₹1,387 crore, reflecting improved operational efficiency and cost management.

The company’s EBITDA margin expanded 200 basis points to 26.3%, demonstrating better cost management and increasing profitability. The net debt to equity ratio improved to negative 0.14 times as of December 13, compared to negative 0.47 times last year, indicating a solid financial position. Overall, Zydus Lifesciences Ltd’s performance is strong, with revenue and profit growth driven by the US market, robust sales, and improved foreign exchange gains, underscoring its solid financial position.