Zydus Lifesciences (NSE:ZYDU) Limited has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Eluxadoline Tablets (75 mg and 100 mg), a key treatment for irritable bowel syndrome with diarrhea (IBS-D) in adults. This milestone strengthens Zydus’ position in the U.S. generics market and is expected to boost its revenue stream.
Eluxadoline, a mu-opioid receptor agonist, is prescribed to manage symptoms of IBS-D, a condition affecting millions of patients. Zydus will manufacture the tablets at its Special Economic Zone (SEZ) facility in Ahmedabad, reinforcing its global supply chain capabilities. 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 significant, given that Eluxadoline tablets had annual sales of $243.7 million in the U.S., presenting a lucrative market opportunity.
This latest approval adds to Zydus’ growing portfolio of complex generics and high-value formulations, strengthening its foothold in the U.S. pharmaceutical market. The company’s ability to secure early ANDA filings demonstrates its R&D capabilities and strategic focus on capturing market exclusivity for critical therapies.
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From an investment perspective, Zydus Lifesciences appears undervalued at its current market price. According to InvestingPro’s Fair Value feature, the fair value of Zydus Lifesciences stands at INR 1,173.9 per share, indicating a strong 32.9% upside potential from the current market price (CMP) of INR 883.1. This suggests that the stock is trading below its intrinsic value, making it an attractive opportunity for investors seeking growth in the pharmaceutical sector.
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