Glenmark Pharmaceuticals Inc. Launches Sodium Bicarbonate Injection
Filing Summary
Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd, is set to launch the 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) Single-Dose Vial. This product is bioequivalent and therapeutically equivalent to the reference drug by Abbott Laboratories. Distribution will commence in November 2025. The market for this product, according to IQVIA® sales data, reached approximately $64 million for the year ending August 2025. This launch expands Glenmark’s injectable portfolio in the North American market.
Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd, has announced the launch of its 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) Single-Dose Vial. This product is bioequivalent and therapeutically equivalent to the reference listed drug by Abbott Laboratories, NDA – 019443. Distribution is scheduled to begin in November 2025.
According to IQVIA® sales data, the market for the 8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL) achieved annual sales of approximately $64 million for the 12-month period ending August 2025. This data includes both brand and all available therapeutic equivalents. Glenmark’s product is approved for specific indications as listed in its approved label.
The 8.4% Sodium Bicarbonate Injection USP is designed for therapeutic use and is packaged in a single-dose vial. The product’s bioequivalence to the reference drug ensures it meets the necessary standards for therapeutic efficacy. Glenmark’s launch of this product is part of its strategy to expand its injectable portfolio, providing alternatives in the pharmaceutical market.
Glenmark Pharmaceuticals Ltd is a research-led global pharmaceutical company with a presence across branded, generics, and OTC segments. The company focuses on therapeutic areas such as respiratory, dermatology, and oncology. Glenmark operates 11 manufacturing facilities across four continents and has a presence in over 80 countries.
The distribution of the 8.4% Sodium Bicarbonate Injection USP will commence in November 2025. Glenmark Pharmaceuticals Inc., USA, is responsible for the distribution in the North American market. This launch is part of Glenmark’s ongoing efforts to provide quality pharmaceutical products to meet market demands.
Glenmark Pharmaceuticals Ltd is committed to expanding its product offerings in the pharmaceutical industry. The company focuses on research and development to bring innovative and affordable healthcare solutions to the market. Glenmark continues to enhance its global presence and strengthen its position in key therapeutic areas.