In a major regulatory milestone, Zydus Lifesciences Ltd announced on April 30, 2025, that it has received final approval from the United States Food and Drug Administration (USFDA) for Niacin Extended-Release (ER) Tablets USP. The approval allows the Indian pharmaceutical major to manufacture and market the drug in 500 mg, 750 mg, and 1000 mg strengths in the United States.

A Strategic Step in Cardiovascular Care

The approved Niacin ER tablets are intended for the treatment of multiple cholesterol-related conditions, including:

• Primary hyperlipidaemia

• Mixed dyslipidaemia

• Severe hypertriglyceridemia

• Reducing the risk of recurrent myocardial infarction (MI) in patients with a history of MI and lipid disorders

Niacin, also known as vitamin B3, has long been used for managing lipid levels in the bloodstream. It helps:

• Lower total cholesterol (TC)

• Reduce LDL cholesterol

• Decrease apolipoprotein B and triglycerides

• Increase HDL cholesterol, the "good" cholesterol

This approval aligns with the company’s ongoing focus on expanding its cardiovascular product portfolio in the US generics market.

Manufacturing at Zydus’ Moraiya Plant

Zydus stated that the Niacin ER tablets will be manufactured at its topical manufacturing facility located in Moraiya, Ahmedabad. The facility is part of Zydus' high-capacity infrastructure developed over the years to meet both domestic and international demand.

This manufacturing site has been involved in several approved formulations in the past, supporting the company’s regulatory compliance standards and high-volume production capabilities.

Financial Scope of the Product

As per IQVIA MAT data for February 2025, the market size for Niacin ER tablets in the US stood at approximately $5.5 million annually. While the product may not be a blockbuster in revenue terms, it adds steady value to Zydus' growing US generics pipeline, especially within the cardiovascular therapeutics segment.

Expanding US Portfolio

With the latest approval, Zydus Lifesciences has now received a total of 425 final approvals since the beginning of its ANDA (Abbreviated New Drug Application) journey in FY 2003-04. The company has filed a total of 492 ANDAs to date, showcasing its aggressive and sustained focus on capturing a meaningful share of the regulated US generics market.

USFDA Inspection at Dabhasa API Facility

On April 29, 2025, just a day before the approval announcement, Zydus also confirmed the successful conclusion of a USFDA surveillance inspection at its Active Pharmaceutical Ingredient (API) manufacturing site in Dabhasa, Gujarat. The inspection, conducted between April 21–25, ended with six observations.

The company clarified that none of the observations involved data integrity issues, and it remains confident in addressing all comments to the satisfaction of the regulator.

This underscores Zydus' commitment to maintaining global compliance standards and regulatory transparency, essential for sustaining business in key regulated markets like the US.

Market Sentiment and Stock Performance

Following the announcement of the drug approval and the positive update on the USFDA inspection, shares of Zydus Lifesciences Ltd were trading 0.89% higher at ₹895.85 on the Bombay Stock Exchange (BSE) as of 11:40 AM on April 30.

The stock has witnessed steady investor interest owing to the company’s:

• Diversified product pipeline

• Consistent regulatory approvals

• Growth in key markets including the US and India

Regulatory Resilience and Future Outlook

The latest regulatory success further boosts Zydus' credibility as a leading Indian player in the US generics landscape. Over the past few years, the company has managed to navigate through:

• Regulatory audits

• Market fluctuations

• Pricing pressures in the US market

By continuing to receive USFDA approvals for niche and high-value products, Zydus is creating a balanced and sustainable growth strategy for its international business.

The Niacin ER approval reinforces its intent to:

• Tap into therapies with cardiovascular and metabolic relevance

• Serve patient populations with chronic lifestyle disorders

• Grow revenues from non-acute therapeutic segments

Conclusion

Zydus Lifesciences’ recent USFDA nod for Niacin Extended-Release tablets not only enhances its US offerings but also reflects its strength in navigating stringent regulatory frameworks. With consistent filings, infrastructure to support exports, and a clear focus on cardiovascular health, Zydus is well-positioned to enhance its market share in regulated territories.

This development, coupled with a positive inspection outcome at its Dabhasa plant, highlights the company’s robust compliance track record and manufacturing resilience, further strengthening investor and stakeholder confidence.

As Zydus continues on its trajectory of product innovation and regulatory success, stakeholders can expect more high-value approvals, expanded footprints, and a deeper penetration into therapeutic areas that matter most in today’s global healthcare market.

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