Zydus Lifesciences’ Ahmedabad Facility Clears USFDA Inspection with Zero Observations

15 Feb 2025 , 12:14 AM

Zydus Lifesciences Ltd announced that the United States Food and Drug Administration (USFDA) has successfully completed an inspection at its Ahmedabad-based facility with zero observations. The company’s Topical Manufacturing facility situated at Changodar in Ahmedabad was inspected for routine surveillance from February 10 to February 14, 2025.

The US health regulator did not raise any observations regarding compliance during the inspection, which ended on February 14, 2025. With this clean USFDA inspection record, investor confidence is likely to cement and the company’s regulatory standing in the US market would get a boost, Zydus Lifesciences said.

Zydus Lifesciences announced it’s Q3 FY25 and net profit grew by 30% YoY. Net profit for the quarter ended December 31, 2024, was at ₹1,023 crore, compared to ₹789 crore during same period previous year. The growth in net profit was driven by a massive forex gain of ₹183 crore, which was an impressive 771.42% growth YoY from ₹21 crore in Q3 FY24.

Q3 FY25 performance demonstrated strong operational performance with revenue growing by 17% YoY to ₹5,269 crore. December quarter US formulation sales grew 29% YoY to $285 million. The US market continues to be a significant revenue contributor, accounting for almost 47% of Zydus Lifesciences’ total topline.

In Q3 of FY25, the company reported a Year-on-Year (YoY) increase of 25.9% in Earnings before Interest, Tax, Depreciation and Amortisation (EBITDA) to ₹1,387 crore from ₹1,102 crore for the same period last fiscal. The EBITDA margin of the company improved 200 bps YoY to 26.3% in Q3 FY25 from 24.5% in Q3 FY24.

Expenses, on the other hand, were influenced by high sales growth in the US, market share gain in India’s major therapy sectors, and targeted growth in international markets Managing Director Sharvil Patel attributed the financial performance to good execution in the US market, market share gain in some of India’s major therapy segments, as well as demand-driven expansion into international markets. This confirms continuing growth momentum at Zydus Lifesciences, supported by compliance in regulatory and marketing, revenue growth, and increasing market presence.