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Glenmark Pharmaceuticals Expands U.S. Portfolio with Launch of Metabolic Acidosis Drug

By Poonam Singh , 6 November 2025
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Glenmark Pharmaceuticals, a leading global pharmaceutical company, has launched its latest therapeutic product in the United States — Sodium Bicarbonate Tablets, USP — used in the treatment of metabolic acidosis. The launch strengthens the company’s position in the U.S. generics market, expanding its footprint in the nephrology and metabolic care segments. Glenmark’s introduction of this drug underscores its continued focus on broadening access to affordable healthcare while enhancing its presence across high-demand therapeutic categories. The launch also reaffirms the company’s strategy to leverage its strong research, manufacturing, and regulatory capabilities to grow its U.S. product portfolio.

Strengthening Glenmark’s U.S. Generics Footprint

The U.S. market remains a key growth driver for Glenmark Pharmaceuticals, contributing significantly to the company’s global revenues. The launch of Sodium Bicarbonate Tablets, USP, which are therapeutically equivalent to Nephro-Tech, Inc.’s reference product, represents another milestone in Glenmark’s efforts to expand its generics portfolio in the country.

The tablets are indicated for the management of metabolic acidosis, a condition arising from kidney disease, severe dehydration, or uncontrolled diabetes, where the body produces excessive acid or the kidneys fail to remove enough from the bloodstream. By offering this treatment, Glenmark aims to provide a cost-effective therapeutic alternative for patients dealing with critical metabolic imbalances.

According to market data cited by the company, the annual sales of Sodium Bicarbonate Tablets (650 mg) in the U.S. were estimated at USD 14.1 million (approximately Rs. 118 crore) for the 12 months ending September 2024, based on IQVIA MAT data.

Expanding Therapeutic Reach and Market Strategy

With this latest addition, Glenmark’s U.S. portfolio now includes over 190 approved products and 50+ pending Abbreviated New Drug Applications (ANDAs) awaiting approval from the U.S. Food and Drug Administration (FDA). The launch not only reflects the company’s expanding product base but also its commitment to introducing therapeutically relevant, high-quality, and cost-efficient drugs in one of the world’s largest pharmaceutical markets.

Glenmark’s focus on metabolic and renal care complements its broader global strategy of strengthening its presence in chronic therapeutic areas, including dermatology, oncology, and respiratory medicine. By prioritizing niche and essential drug categories, the company is working to consolidate its reputation as a reliable generics manufacturer with a growing pipeline of complex formulations.

Commitment to Accessibility and Affordability

In line with its mission to make quality healthcare more accessible, Glenmark continues to leverage its vertically integrated manufacturing capabilities and strong regulatory framework to maintain affordability without compromising efficacy. The Sodium Bicarbonate Tablets will be produced at Glenmark’s manufacturing facility in Goa, India, which has received multiple international regulatory approvals.

By manufacturing the product domestically and exporting it to the U.S., Glenmark is optimizing cost structures and ensuring global supply chain efficiency. This aligns with the company’s long-term vision of building a sustainable international generics business centered on innovation, quality, and reliability.

Industry Context: Glenmark’s U.S. Growth Trajectory

The U.S. pharmaceutical landscape continues to present opportunities for Indian generics manufacturers as patent expiries and rising healthcare costs drive demand for affordable alternatives. Glenmark, like several of its domestic peers, has strategically positioned itself to benefit from this shift by investing in complex generics, injectables, and value-added formulations.

Over the past few years, Glenmark has steadily increased its U.S. presence through targeted product launches and regulatory clearances. The company’s ability to consistently roll out new products, particularly in chronic and specialty care segments, has solidified its standing as a competitive player in the global generics industry.

Conclusion: Reinforcing Leadership in Affordable Therapeutics

Glenmark’s launch of Sodium Bicarbonate Tablets in the U.S. marks another step in its commitment to improving access to essential medicines for patients worldwide. By addressing a critical therapeutic need and offering a lower-cost alternative to branded formulations, the company reinforces its dual focus on innovation and accessibility.

As Glenmark continues to diversify its U.S. portfolio and strengthen its presence in emerging therapeutic areas, the company’s sustained momentum in product development and regulatory compliance positions it for long-term growth in an increasingly competitive pharmaceutical landscape.

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