Product Launch Details
Glenmark Pharmaceuticals Inc., USA launched Calcium Gluconate Injection USP in three dosage formats:
- 1,000 mg/10 mL (100 mg/mL) Single-Dose Vials
- 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials
- 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package
The product is bioequivalent and therapeutically equivalent to the reference listed drug, Calcium Gluconate Injection of Fresenius Kabi USA, LLC [NDA 208418].
Market Context
According to IQVIA sales data for the 12-month period ending June 2026, the Calcium Gluconate Injection market (1,000 mg/10 mL, 5,000 mg/50 mL and 10,000 mg/100 mL) achieved annual sales of approximately $69.9 million. This includes brand and all available therapeutic equivalents.
Management Commentary
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."
Regulatory Notes
The product is only approved for the indication(s) listed in Glenmark's approved label, which may be different than the approved reference listed drug indications.
Company Background
Glenmark Pharmaceuticals Ltd. is a global, research-led pharmaceutical company with 11 world-class manufacturing facilities across four continents, six R&D centres, and commercial footprint in 80+ countries. The company focuses on respiratory, dermatology, and oncology therapeutic areas.