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Zydus Lifesciences Secures FDA Approval for Verapamil ER Tablets

26 Nov 2025
Admin
News Article

Zydus Lifesciences Secures FDA Approval for Verapamil ER Tablets

Zydus Lifesciences has added another win to its U.S. portfolio. The FDA has granted final approval for the company’s Verapamil Hydrochloride Extended-Release Tablets in 120 mg, 180 mg, and 240 mg strengths. These tablets reference Calan SR, a well-established USRLD product.

Why This Matters?

High blood pressure remains one of the biggest silent risks worldwide. Verapamil ER helps lower blood pressure, reducing the chances of severe complications such as:

Stroke
Heart attack
Long-term cardiovascular damage

With this approval, Zydus strengthens its cardiovascular portfolio at a time when demand for reliable hypertension therapies continues to grow.

Manufacturing and Scale

The approved Verapamil ER tablets will be manufactured at Zydus Lifesciences’ Baddi facility in Himachal Pradesh. This site remains one of the company’s key U.S. supply locations.

Zydus continues to expand its regulatory footprint with impressive consistency:

428 total FDA approvals to date
487 ANDA filings since FY 2003–04

This approval reinforces Zydus’ position as one of India’s most dependable exporters of complex and high-quality generics.

The Bottom Line

Zydus is quietly building a strong U.S. generics pipeline. The approval of Verapamil ER adds another trusted cardiovascular therapy to its growing portfolio, helping U.S. patients access affordable and effective hypertension management.