Marksans Pharma Gets USFDA Approval for Its Generic Version of Prilosec

Mumbai, August 8, 2025: Marksans Pharma Ltd’s subsidiary has received final approval from the US Food and Drug Administration (USFDA) for its Omeprazole Delayed-Release Tablets, 20 mg (over-the-counter). This means the company can now sell its generic version of the popular heartburn drug Prilosec in the US.

The approved medicine is bioequivalent to Prilosec. It is a widely used drug for treating heartburn and other conditions caused by excess stomach acid. Receiving this approval is a significant win for Marksans Pharma as it adds a key product to its US portfolio and strengthens its position in the market related to stomach-related medicines.

What Does This Mean For The Investors?

• Entry Into a Competitive US Market: The US OTC market for heartburn drugs is large and stable; entry provides long-term growth potential.
• Strengthens USFDA Track Record: Another successful USFDA approval strengthens Marksans’ compliance record and regulatory reputation.
• Product Portfolio Expansion: Broadens the company’s gastrointestinal segment, which is often a high-demand, high-volume category.
• Positive Signal for Future Growth: Reinforces investor confidence in continued international expansion and product pipeline execution.
• Stable Financials Support Expansion: Recent strong earnings provide a financial cushion for product launches and market growth.

About The Company

Marksans Pharma Limited is a generic pharmaceutical company based in Mumbai, India. It focuses on the research, manufacturing, and marketing of a wide range of generic medicines globally. The company has manufacturing facilities in India, the USA, and the UK, all of which are approved by major regulatory bodies. The company’s shares are listed on the NSE with the ticker symbol MARKSANS and on the BSE with the ticker 524404.

Share Price Performance

As of 12:11 pm, the shares of the company were down by 0.35%, or ₹0.75, and were trading at ₹213.60.

Financial Performance Snapshot

According to the company’s latest available financial results for the full financial year ended March 2025, Marksans Pharma showed strong growth. The company reported a total revenue of ₹2,622.8 crore, a solid 20.5% increase compared to the previous year. Net profit also saw a significant rise, coming in at ₹383 crore, up 21.6% year-over-year.

What’s Ahead For Marksans Pharma?

Marksans Pharma is well-positioned to benefit from this USFDA approval over the coming quarters. With Omeprazole 20 mg now added to its US portfolio, the company can tap into a large and consistent over-the-counter (OTC) market. This approval not only strengthens its product range in the gastrointestinal space but also boosts its credibility with global regulators. Given its strong financial performance in FY25 and expanding global footprint, Marksans is likely to continue launching new generic products across key markets.

REF: https://nsearchives.nseindia.com/corporate/MARKSANS_08082025104800_SEIntimation.pdf

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