Glenmark Pharmaceuticals Inc., USA, has announced the launch of its Calcium Gluconate Injection USP in multiple dosage forms. This product is bioequivalent and therapeutically equivalent to the reference listed drug from Fresenius Kabi USA. The launch is a strategic step to strengthen Glenmark’s U.S. injectables business and expand its hospital portfolio, targeting an estimated U.S. market of $69.9 million.
Glenmark Pharmaceuticals Inc., USA, Launches Calcium Gluconate Injection USP
Glenmark Pharmaceuticals Inc., USA, announced on August 21, 2026, the launch of its Calcium Gluconate Injection USP. The product is available in three formats: 1,000 mg/10 mL (100 mg/mL) Single-Dose Vials, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials, and 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package.
Product Equivalence and Market Opportunity
Glenmark’s Calcium Gluconate Injection USP has been confirmed as bioequivalent and therapeutically equivalent to the reference listed drug, Calcium Gluconate Injection, from Fresenius Kabi USA, LLC (NDA 208418). According to IQVIA® sales data for the 12-month period ending June 2026, the market for Calcium Gluconate Injection across these concentrations achieved annual sales of approximately $69.9 million.
Strategic Significance
Marc Kikuchi, President & Business Head, North America, stated, “The launch of Calcium Gluconate Injection USP marks another important step in strengthening Glenmark’s U.S. injectables business and expanding our hospital portfolio. It reflects the disciplined execution of our strategy to build a differentiated and sustainable injectables business – one that addresses institutional needs, supports greater supply resilience and deepens Glenmark’s relevance across the U.S. healthcare system.”
Product Approvals
It is noted that Glenmark’s Calcium Gluconate Injection USP is approved only for the indications listed in its approved label. The market data for sales includes brand and all available therapeutic equivalents. IQVIA® data is available for all approved RLD indications, but Glenmark’s product will be marketed only for its specific approved indications.
Source: BSE
