Zydus Lifesciences Receives USFDA Approval for Valsartan Tablets

On July 23, 2024, Zydus Lifesciences Limited, along with its subsidiaries, announced that it had received final approval from the USFDA (United States Food and Drug Administration ) to market Valsartan Tablets USP in dosages of 40 mg, 80 mg, 160 mg, and 320 mg, which are equivalent to Diovan® tablets.

Valsartan tablets treat high blood pressure in adults and children aged 1 year and older. They are also used in adults to manage heart failure and increase survival rates after a heart attack.

These tablets will be manufactured at Zydus’s Ahmedabad SEZ – II facility in India. In the past year, Valsartan tablets generated sales of USD 149.5 million in the United States.

As of July 23, 2024, Zydus has received 400 approvals and filed over 460 Abbreviated New Drug Applications (ANDAs) since they began the process in the 2003-04 fiscal year.

In their recent press release, On July 22, 2024, Zydus Lifesciences Limited announced that COFEPRIS, the Mexican regulatory authority, has approved BhavaTM, a biosimilar of Bevacizumab. BhavaTM will be available in strengths of 100 mg/4 ml and 400 mg/16 ml and is used to treat non-squamous non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, glioblastoma, ovarian cancer, advanced or metastatic renal cell carcinoma.

Zydus first introduced its Bevacizumab biosimilar, BryxtaTM, which was developed by the Zydus Research Centre in India in 2015. Since then, approximately 50,000 patients have been treated with this therapy.

About Zydus Lifesciences Limited

Zydus Lifesciences Limited (Zydus) is a leading pharmaceutical company in India that develops and markets a wide range of pharmaceutical products. Zydus is a top player in several market segments, with many of its brands leading their respective categories. The company has a strong presence in various therapeutic areas, including pain management, cardiovascular diseases, urology, and anti-infectives. Zydus also offers over-the-counter healthcare products. Its medicines are available through retail pharmacies, hospitals, and clinics across India and are exported to multiple countries worldwide.

On July 23, 2024, the share price of Zydus Lifesciences Ltd opened at ₹1,156.00, touching the day’s low of ₹1,124.30 as of 01:34 PM on the NSE.

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