Shares of Zydus Lifesciences Ltd (NSE:ZYDU) surged 2% after the company received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Eluxadoline Tablets (75 mg and 100 mg), a crucial treatment for irritable bowel syndrome with diarrhea (IBS-D) in adults. This regulatory milestone is expected to enhance the company’s presence in the U.S. generics market and contribute positively to its revenue stream.
Eluxadoline, a mu-opioid receptor agonist, is widely prescribed for managing IBS-D symptoms, a condition affecting millions globally. Zydus will manufacture the tablets at its Special Economic Zone (SEZ) facility in Ahmedabad, reinforcing its supply chain capabilities. Notably, the company was one of the first abbreviated new drug application (ANDA) filers with a Paragraph IV certification, allowing it to benefit from an exclusive 180-day shared generic drug marketing period. This exclusivity is particularly significant as Eluxadoline tablets had annual sales of $243.7 million in the U.S., making it a lucrative opportunity for Zydus.
Additionally, Zydus recently announced that the USFDA has successfully completed a surveillance inspection at its Active Pharmaceutical Ingredient (API) Unit 1 in Ankleshwar, Gujarat. The inspection, conducted from March 10 to March 14, 2025, concluded with zero observations, marking a major regulatory milestone.
The absence of any adverse remarks reinforces Zydus’ commitment to maintaining global quality and compliance standards, a key factor for pharmaceutical companies operating in the U.S. market. This regulatory approval and successful inspection have driven positive sentiment around the stock, leading to a 2% rise in today’s trading session.
