Zydus Passes US FDA Inspection at Ambernath Facility with Zero Observations

16 Feb 2025 , 10:53 AM

Zydus Lifesciences Ltd received the “No Observation” from US Food and Drug Administration in its recently concluded surveillance inspection of its API (Active Pharmaceutical Ingredients) manufacturing facility at Ambernath in Maharashtra. Between February 10-14, 2025, the US FDA conducted an inspection to ensure compliance with US pharmaceutical manufacturing regulations.

US formulation sales for Zydus were USD 285 million in 3Q FY25, up 29% YoY, higher than market estimated USD 270 million. The US market is a key growth driver for the company, accounting for almost 47% of Zydus Lifesciences’ revenue.

Q3 FY25 revenue growth of 17% YoY, at ₹5,269 crore was driven by robust business performance across segments. Net profit jumped 30% on-year (YoY) to ₹1,023 crore year-end, and from ₹789 crore in the corresponding period last year, driven on the back of improved forex gains and robust sales rise.

Forex gain came in at ₹183 crore in Q3 FY25 much higher than ₹21 crore in Q3 FY24, aiding overall profitability. EBITDA increased to ₹1,387 crore (₹1,102 crore), also showing improved operational efficiency. EBITDA margin expanded 200 basis points to 26.3% from 24.5%, demonstrating better cost management and increasing profitability.

Net debt to equity ratio increased and was negative 0.14 times on December 13, improved compared to negative 0.47 times last year, demonstrating solid financial position.