Zydus Lifesciences Successfully Clears USFDA Inspection at Ambernath Facility

Zydus Lifesciences Ltd has successfully completed a surveillance inspection by the US Food and Drug Administration (USFDA) at its active pharmaceutical ingredient (API) manufacturing facility in Ambernath, Maharashtra. Conducted from 10 to 14 February 2025, the inspection concluded with no observations, reaffirming the company’s commitment to regulatory compliance.

USFDA Inspection and Operational Excellence

The recent USFDA inspection at Zydus Lifesciences’ Ambernath API facility resulted in zero observations, highlighting the company’s adherence to global manufacturing and quality standards. The successful completion of this inspection reinforces Zydus’ credibility in the pharmaceutical sector and ensures seamless operations for its API exports.

Strong Financial Performance

Zydus Lifesciences reported financial growth in the third quarter, with US formulation sales reaching $285 million. The US market contributes approximately 47% to the company’s overall revenue. During the quarter, the company’s revenue grew by 17% to ₹5,269 crore, while net profit rose to ₹1,023 crore. A forex gain of ₹183 crore further supported profitability. The EBITDA for the quarter stood at ₹1,387 crore, with margins expanding by 200 basis points to 26.3%.

Zydus Lifesciences Share Performance

As of February 17, 2025, at 9:15 AM, the shares of Zydus Lifesciences are trading at ₹910 per share, reflecting a surge of 0.90% from the previous closing price. Over the past month, the stock has declined by 8.51%.

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