Zydus Lifesciences wins FDA nod for Valsartan Tablets

24 Jul 2024 , 08:55 AM

Zydus Lifesciences Ltd has obtained final approval from the United States Food and Drug Administration (FDA) for Valsartan Tablets, which are used to treat hypertension. The FDA has granted Zydus Lifesciences the go-ahead to manufacture and market Valsartan Tablets in dosages of 40 mg, 80 mg, 160 mg, and 320 mg.

The FDA’s final approval extends to all subsidiaries and affiliates of Zydus Lifesciences.

Valsartan Tablets are prescribed for managing hypertension in adults and pediatric patients aged one year and older. Additionally, they are used in adults to treat heart failure—a condition where the heart fails to pump sufficient blood to the body—and to improve survival following a heart attack.

Zydus Lifesciences will produce the Valsartan Tablets at its formulation manufacturing facility located in Ahmedabad SEZ – II, Gujarat.

According to IQVIA MAT data for May 2024, Azilsartan Medoxomil Tablets, a similar drug, have achieved annual sales of $149.5 million in the United States.

Zydus Lifesciences stock has gained a total of 87% in the last one year, and witnessed a 64% gain since the beginning of the year.

As of March 31, 2024, Zydus Lifesciences has received a total of 400 approvals and has filed over 460 Abbreviated New Drug Applications (ANDAs) since the process began in FY 2003-04.

For the quarter ending March 31, 2024, Zydus Lifesciences reported a 10% year-on-year (YoY) increase in total revenue, reaching ₹5,533.8 Crore. The company’s earnings before interest, taxes, depreciation, and amortisation (EBITDA) margin improved by 440 basis points YoY to 29.5%.

The company’s gross profit for the same period rose by 18.33% YoY to ₹3,922.3 Crore, up from ₹3,314.6 Crore in the previous year.

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company based in Ahmedabad. It focuses on manufacturing generic drugs.

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