Zydus Lifesciences has achieved a significant milestone with the final approval from the US Food and Drug Administration (USFDA) to manufacture Eluxadoline Tablets, 75 mg and 100 mg. This approval grants the company a competitive edge in the US market, reinforcing its presence in the pharmaceutical industry.

Final Approval Granted for Manufacturing

Zydus Lifesciences has received clearance to produce Eluxadoline Tablets, a mu-opioid receptor agonist indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be manufactured at the company’s Special Economic Zone (SEZ) facility in Ahmedabad.

The company was among the first to file a substantially complete Abbreviated New Drug Application (ANDA) with a Paragraph IV certification for these formulations. This strategic move positions Zydus favourably in the competitive generic drug market.

Market Impact and Competitive Advantage

With this approval, Zydus Lifesciences is entitled to 180 days of shared generic drug exclusivity, providing a crucial market advantage. Eluxadoline Tablets recorded annual sales of $243.7 million in the US, presenting a lucrative opportunity for the company.

Zydus continues to strengthen its footprint in the US generics sector, securing 419 approvals to date. Since initiating its ANDA filings in FY 2003-04, the company has submitted 483 applications as of 31 December 2024.

Zydus Share Performance 

As of March 17, 2025, at 11:15 AM, the shares of Zydus Lifesciences Ltd are trading at ₹894.00 per share, reflecting a surge of 1.23% from the previous closing price. Over the past month, the stock has registered a loss of 3.24%

Conclusion

The USFDA’s approval of Eluxadoline Tablets further solidifies Zydus Lifesciences’ leadership in the US pharmaceutical industry. This milestone enhances its product portfolio and market competitiveness, reinforcing its commitment to expanding its global reach.

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