Zydus Lifesciences Gains USFDA Nod for Eluxadoline, Stock Signals 32% Upside

Published 16-03-2025, 07:12 pm
© Reuters.

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.

Image Source: InvestingPro

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.

Investors looking to identify undervalued stocks can leverage InvestingPro’s advanced stock analysis tools, including its Fair Value feature, which utilizes multiple financial models to determine realistic valuations. To make informed decisions, InvestingPro offers insights into thousands of listed companies, helping investors separate overvalued stocks from hidden gems like Zydus Lifesciences.

Currently, InvestingPro is running an exclusive sale with discounts of up to 45%, making it the perfect time to subscribe and access top-tier stock analysis tools. Don’t miss out—unlock powerful investment insights today!

Read More: This Stock Falls 32% in 3 Months; Fair Value Depicts “Great” Upside!

X (formerly, Twitter) - Aayush Khanna

LinkedIn - Aayush Khanna

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2025 - Fusion Media Limited. All Rights Reserved.