Overview
Glenmark Pharmaceuticals’ U.S. subsidiary has announced the launch of a new injectable formulation, 8.4% Sodium Bicarbonate Injection USP, designed for the management of metabolic acidosis. The product expands Glenmark’s presence in the injectable segment, reinforcing its focus on critical care therapies.
Details of the New Launch
The 8.4% Sodium Bicarbonate Injection USP (50 mEq/50 mL, 1 mEq/mL) is indicated for the treatment of metabolic acidosis, a condition resulting from excess acid accumulation in the body due to factors such as kidney disease, cardiac arrest, dehydration, uncontrolled diabetes, or shock.
Key product details:
- Concentration: 8.4%
- Strength: 50 mEq/50 mL (1 mEq/mL)
- Packaging: Single-dose vial
- Equivalence: Bioequivalent and therapeutically equivalent to the U.S. reference listed drug
- Launch timeline: November 2025
The launch will enhance treatment accessibility for healthcare providers and patients in emergency and intensive care settings.
Market Overview
According to IQVIA data for the 12 months ending August 2025, the total market for the 8.4% sodium bicarbonate injection (50 mEq/50 mL) in the U.S. was valued at approximately $63.8 million. The consistent demand for this formulation reflects its critical role in managing acid-base imbalances.
Glenmark confirmed that the product will be marketed strictly for approved therapeutic indications and adheres to U.S. regulatory standards.
Summary
Glenmark Pharma’s U.S. arm has launched the 8.4% Sodium Bicarbonate Injection USP to treat metabolic acidosis, expanding its injectable portfolio in critical care. The product, bioequivalent to the U.S. reference drug, enters a $63.8 million market, with distribution set to begin in November 2025.
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