The said injection is bioequivalent and therapeutically equivalent to the reference listed drug, Sodium Phosphates Injection USP, 45 mM P/15 mL (3 mM P/mL), of Hospira, Inc.
The company stated that the 15 mM P/5 mL and 150 mM P/50 mL presentations are expected to have the same therapeutic effect as the reference listed drug upon which the US Food and Drug Administration (FDA) relied as the basis for safety and effectiveness.
The pharma company will begin distribution in April 2026.
According to IQVIA sales data for the 12-month period ending December 2025, the Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials market achieved annual sales of approximately $66.8 million.
Marc Kikuchi, president & business head, North America said, “We look forward to the upcoming launch of Sodium Phosphates Injection USP, 15 mM P/5 mL, 45 mM P/15 mL and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials, strengthening our commitment to bring to market quality and affordable alternatives for patients, while also further expanding our portfolio of products within the institutional channel.”
Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.
The company’s consolidated net profit jumped 15.9% to Rs 403.21 crore on 17.8% increase in net sales to Rs 3888 crore in Q3 FY26 over Q3 FY25.
The counter shed 0.20% to Rs 2,122.80 on the BSE.