Zydus Lifesciences gets USFDA’s final approval for Eluxadoline tablets

17 Mar 2025 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Eluxadoline Tablets, 75 mg and 100 mg (USRLD: Viberzi Tablets, 75 mg and 100 mg). Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D). Eluxadoline tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad.

The company was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Eluxadoline Tablets, 75 mg and 100 mg. With this approval, the company is eligible for 180 days of shared generic drug exclusivity for Eluxadoline Tablets, 75 mg and 100 mg. 

Eluxadoline tablets had annual sales of $243.7 million in the United States (IQVIA MAT January 2025). The group now has 419 approvals and has so far filed 483 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.


Zydus Lifesciences Share Price

922.45 -1.25 (-0.14%)
11-Dec-2025 16:59 View Price Chart
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