Glenmark Pharmaceuticals to Launch Sodium Phosphates Injection in USA
Filing Summary
Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd, announced the launch of its Sodium Phosphates Injection USP in April 2026. The product will be available in 15 mM P/5 mL, 45 mM P/15 mL, and 150 mM P/50 mL single-dose vials. This injection is bioequivalent to Hospira, Inc.’s reference drug. According to IQVIA data, the market for this product achieved annual sales of approximately $67 million as of December 2025. Glenmark aims to distribute this product within the institutional channel, expanding its portfolio in North America.
Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd, has announced the launch of its Sodium Phosphates Injection USP. The product will be available in three presentations: 15 mM P/5 mL, 45 mM P/15 mL, and 150 mM P/50 mL single-dose vials. The launch is scheduled for April 2026. The injection is bioequivalent and therapeutically equivalent to the reference listed drug by Hospira, Inc., with the same therapeutic effect as the listed drug product upon which the FDA relied for safety and effectiveness.
According to IQVIA sales data for the 12-month period ending December 2025, the market for Sodium Phosphates Injection USP achieved annual sales of approximately $67 million. The market includes the brand and all available therapeutic equivalents. Glenmark’s product is approved for the indications listed in its approved label and is not marketed for all reference listed drug indications.
The Sodium Phosphates Injection USP is designed for single-dose administration and is intended for use in institutional settings. The product’s bioequivalence to Hospira’s reference drug ensures that it meets the necessary therapeutic standards. Glenmark plans to distribute the product across its established channels in North America, focusing on providing quality and affordable alternatives for patients.
The launch of this product is part of Glenmark’s strategy to expand its portfolio within the institutional channel in North America. The company aims to leverage its manufacturing capabilities and distribution network to enhance its presence in the market. The introduction of the Sodium Phosphates Injection USP aligns with Glenmark’s commitment to delivering high-quality pharmaceutical products.
Glenmark Pharmaceuticals Inc., USA, will begin distribution of the Sodium Phosphates Injection USP in April 2026. The company has completed the necessary regulatory requirements and is prepared to supply the product to healthcare providers across the United States. The launch is expected to strengthen Glenmark’s position in the pharmaceutical market.
Glenmark Pharmaceuticals Ltd is a global, research-led pharmaceutical company focused on innovation and accessibility. The company develops transformative therapies and aims to expand access to high-quality and affordable medicines worldwide. With 11 manufacturing facilities and six R&D centers, Glenmark delivers a diversified portfolio across branded, innovative, generics, and consumer health products, focusing on respiratory, dermatology, and oncology.