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Marksans Pharma Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Omeprazole delayed-release tablets, a widely used treatment for acid reflux and related gastrointestinal conditions. The approval marks a significant milestone for the company’s expanding presence in the US generics market and reinforces its manufacturing capabilities in India. The product will be manufactured at Marksans’ state-of-the-art facility in Goa, which has consistently met stringent global regulatory standards.
Key Highlights from the Approval Announcement
- Marksans Pharma’s Goa-based unit received USFDA approval for Omeprazole delayed-release tablets
- The drug is used to treat acid reflux, ulcers, and other stomach-related disorders
- Approval was granted under the Abbreviated New Drug Application (ANDA) pathway
- The product is bioequivalent to the reference listed drug Prilosec by AstraZeneca
- Marksans continues to strengthen its US portfolio with high-demand OTC and Rx formulations
About Omeprazole and Its Market Significance
Omeprazole belongs to the class of proton pump inhibitors (PPIs) and is one of the most prescribed medications globally for acid-related disorders. It works by reducing the amount of acid produced in the stomach, providing relief from heartburn, difficulty swallowing, and chronic cough.
- The US market for PPIs remains robust, with Omeprazole among the top-selling OTC treatments
- Marksans’ version will be available in 20 mg delayed-release tablets
- The drug is expected to be sold under private label partnerships and retail chains across the US
Manufacturing and Regulatory Strength
The approved product will be manufactured at Marksans Pharma’s Goa facility, which has a strong track record of regulatory compliance:
- The facility recently received an Establishment Inspection Report (EIR) from the USFDA following a successful audit
- No Form 483 observations were issued, indicating full compliance with manufacturing standards
- The site is equipped to handle large-scale production of solid oral dosage forms for global markets
Strategic Impact on Marksans Pharma’s US Operations
This approval adds to Marksans Pharma’s growing list of USFDA-approved products and strengthens its position in the competitive US generics landscape:
- Marksans already markets several OTC and prescription drugs in the US through its subsidiaries Time-Cap Laboratories and Nova Pharmaceuticals
- The company has been focusing on expanding its gastrointestinal portfolio, which includes Esomeprazole and Lansoprazole
- The addition of Omeprazole is expected to contribute meaningfully to revenue in FY 2025–26
Market Reaction and Investor Sentiment
Following the announcement, Marksans Pharma’s stock showed modest movement on the BSE, reflecting cautious optimism among investors:
- The scrip traded at Rs 109, down 0.86%, amid broader market volatility
- Analysts expect the approval to support long-term earnings growth and margin expansion
- The company’s consistent regulatory success enhances its credibility in regulated markets
Conclusion
Marksans Pharma’s USFDA approval for Omeprazole tablets is more than just a regulatory win—it’s a strategic step toward deepening its footprint in the US gastrointestinal therapeutics market. With a compliant manufacturing base, a growing product pipeline, and a clear focus on global expansion, Marksans continues to position itself as a reliable player in the international pharma arena.
Source: Capital Market News
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