Zydus Lifesciences gets USFDA approval for high BP drug

26 Nov 2025 , 11:18 AM

Zydus Lifesciences Ltd announced that it has secured final approval from the United States Food and Drug Administration (FDA) for verapamil hydrochloride extended-release tablets USP. These are available in 120 mg, 180 mg and 240 mg strengths.

The approved product is a biosimilar of the US reference listed drug Calan SR extended-release tablets in the same vials.

Verapamil hydrochloride is used for the treatment of high blood pressure, reducing the risk of serious cardiovascular conditions such as strokes and heart attacks.

The company said that it plans to manufacture the product at its facility situated in Baddi, Himachal Pradesh.

As per the data released by IQVIA MAT as of September 2025, verapamil hydrochloride tablets recorded annual sales of $24.50 Million in the US market. With this approval from USFDA, the company has now secured 428 final approvals and has filed 487 ANDAs since the beginning of its filing process in FY2003-04.

In its results for the quarter ended September 2025, the company registered a net profit of ₹1,259 Crore. This is a growth of 39% on a year-on-year basis against ₹911 Crore in the previous corresponding period.

The growth was fueled by a robust business momentum globally and a sharp increase in forex gains. The company’s revenue for the quarter stood at ₹6,123 Crore. This marks a growth of 17% on a year-on-year basis against Q2 FY25.

At around 11.11 AM, Zydus Lifesciences was trading 1.11% higher at ₹938.85, against the previous close of ₹928.50 on NSE. The counter touched an intraday high and low of ₹942.85, and ₹932.05, respectively.

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