Zydus Lifesciences gets final FDA nod for high BP drug verapamil hydrochloride

Drug maker Zydus Lifesciences Ltd on Tuesday (November 25) said it has received final approval from the United States Food and Drug Administration (FDA) for verapamil hydrochloride extended-release tablets

USP in 120 mg, 180 mg and 240 mg strengths.

The approved product corresponds to the US reference listed drug Calan SR extended-release tablets in the same strengths. Verapamil hydrochloride extended-release tablets are administered to lower high blood pressure, reducing the risk of serious cardiovascular conditions such as strokes and heart attacks.

Zydus said the product will be manufactured at its facility in Baddi, Himachal Pradesh.

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According to IQVIA MAT September 2025 data, verapamil hydrochloride extended-release tablets recorded annual sales of $24.5 million in the US market. With this approval, the group now has 428 final approvals and has filed 487 ANDAs since it began the filing process in FY2003-04, as of September 30, 2025.

Second Quarter Results

Zydus Lifesciences' consolidated net profit rose 39% year-on-year to ₹1,259 crore, compared with ₹911 crore in the same period last year. The growth was supported by healthy business momentum across geographies and a sharp rise in forex gains.

The company recorded a foreign exchange gain of ₹414 crore, compared with ₹45 crore in the previous year. Research and development (R&D) expenditure stood at ₹482 crore, or 7.9% of revenue, reflecting continued investment in innovation and complex generics.

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Revenue for the quarter climbed 17% year-on-year to ₹6,123 crore, led by strong performance in the company’s US and India formulations businesses. Operating profitability improved significantly, with EBITDA surging 38% to ₹2,014 crore, while margins expanded to 32.9% from 27.9% a year earlier, aided by a richer product mix and disciplined cost control.

Shares of Zydus Lifesciences Ltd ended at ₹927.50, up by ₹0.90, or 0.097%, on the BSE today, November 25.