Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Calcium Gluconate Injection USP.

The approval covers 100 mg/mL strengths in 10 mL, 50 mL, and 100 mL vial presentations and represents a generic therapeutic equivalent of the reference listed drug from Fresenius Kabi USA, LLC.

Calcium Gluconate Injection is indicated for treating acute symptomatic hypocalcemia in both pediatric and adult patients.

According to IQVIA data, the product recorded US sales of approximately $71 million during the 12-month period ending March 2026.

The latest approval further strengthens Caplin Steriles’ injectable portfolio in the United States market and expands its pipeline of hospital-focused generic products.