Zydus Gets USFDA Approval for Niacin Extended-Release Tablets

On April 30, 2025, Zydus Lifesciences Ltd., based in Ahmedabad, announced it has received final approval from the  USFDA (U.S. Food and Drug Administration) to manufacture and sell Niacin Extended-Release Tablets in the U.S. market. The approved doses are 500 mg, 750 mg, and 1,000 mg—similar to the brand Niaspan®.

Use of the Medicine

Niacin is used to improve cholesterol levels. It helps lower bad cholesterol (LDL), total cholesterol, triglycerides, and apolipoprotein B, while increasing good cholesterol (HDL). The drug is also prescribed to minimise the risk of heart attacks in patients with high cholesterol and a previous history of heart attacks. It can also treat patients with very high triglyceride levels.

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Manufacturing Details

Zydus will manufacture the Niacin Extended-Release Tablets at its facility in Moraiya, Ahmedabad.

According to IQVIA data from February 2025, the U.S. market for Niacin Extended-Release Tablets is worth about USD 5.5 million annually.

Zydus’ Growing U.S. Portfolio

With this approval, Zydus now has 425 drug approvals from the USFDA. The company has filed a total of 492 Abbreviated New Drug Applications (ANDAs) since it began submissions in the 2003–04 financial year.

About Zydus Lifesciences Limited

Zydus Lifesciences Limited, previously called Cadila Healthcare Limited, is a global pharmaceutical company based in Ahmedabad, India. It mainly focuses on producing generic medicines and was ranked 100th on the Fortune India 500 list in 2020.

As of April 30, 2025, Zydus Lifesciences share price is trading at ₹896.40, with a 52-week high of ₹1,324.30 and a 52-week low of ₹795.00.

Conclusion

The approval strengthens Zydus’ position in the U.S. generics market and reflects its continued momentum in expanding its cardiovascular drug portfolio. With 425 approvals and growing, Zydus remains a key player in the global pharma landscape.

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