Ahmedabad, India, 17 March, 2025:Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) 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 diarrhea (IBS-D). Eluxadoline tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.

Zydus 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, Zydus is eligible for 180 days of shared generic drug exclusivity for Eluxadoline Tablets, 75 mg and 100 mg.