Highlights

• Zydus receives USFDA approval for Verapamil ER tablets across three dosage strengths.
• Approved product targets USD 24.5 million US market with established cardio demand.
• Total ANDA approvals reach 428, reinforcing Zydus’ strong US generics franchise.

Zydus Lifesciences Limited (NSE:Zyduslife) announced on 25 November 2025 that it has received final approval from the United States Food and Drug Administration (USFDA) for Verapamil Hydrochloride Extended-Release Tablets USP in strengths of 120 mg, 180 mg, and 240 mg. The approved product is the generic equivalent of Calan SR Extended-Release Tablets, a well-established treatment in cardiovascular care.

This regulatory clearance further enhances Zydus’ footprint in the US formulations market, which remains a key growth engine for the company’s global business.

Product Perspective: Addressing Chronic Cardiac Needs

Verapamil Hydrochloride Extended-Release Tablets are prescribed primarily to manage high blood pressure, thereby reducing the risk of serious cardiovascular events such as strokes and heart attacks. The extended-release formulation allows sustained drug delivery, improving patient adherence in chronic therapy segments.

The product will be manufactured at Zydus Lifesciences’ formulation facility in Baddi, Himachal Pradesh, highlighting continued regulatory confidence in the company’s Indian manufacturing infrastructure.

As per IQVIA data, the product recorded annual sales of approximately USD 24.5 million in the United States for the 12 months ended September 2025, indicating a stable and addressable market opportunity.

US Generics Strategy Remains on Track

With this latest approval, Zydus now holds a cumulative total of 428 ANDA approvals in the US. Since initiating the ANDA filing process in FY 2003–04, the group has filed 487 ANDAs, underscoring its consistent focus on building a diversified and scalable US generics pipeline.

The approval aligns with Zydus’ strategy of expanding its presence in chronic therapy areas, particularly cardiovascular and metabolic segments, which offer long-term volume-led growth.

Financial Snapshot Reflects Operating Momentum

Zydus continues to demonstrate healthy financial performance. Total revenues grew from INR 1,72,374 million in FY23 to INR 2,32,415 million in FY25, reflecting steady topline expansion. During H1 FY26, revenues stood at INR 1,26,969 million.

Profitability has also improved, with reported PAT rising from INR 20,919 million in FY23 to INR 24,027 million in FY25, while EBITDA margins strengthened significantly, supported by operational efficiencies and a richer product mix. The company’s ROCE improved to 24.7% in FY25, indicating effective capital deployment.

Share Price Snapshot

Zyduslife was trading 1.25% higher at ₹ 939 per share at the time of writing on 25 November 2025.