Caplin Steriles Limited (CSL), the wholly owned subsidiary of Caplin Point Laboratories Limited, has secured 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 multiple dosage formats — 100 mg/mL in 10 mL, 50 mL, and 100 mL vials — and marks another step in CSL’s expansion within the regulated US generics market.
The approved product is a therapeutic equivalent to the Reference Listed Drug (RLD) from Fresenius Kabi USA (NDA 208418). Calcium Gluconate Injection is widely used in both pediatric and adult patients for the treatment of acute symptomatic hypocalcemia, a condition marked by low calcium levels in the blood.
According to data from IQVIA (IMS Health), the US market for Calcium Gluconate Injection in the specified strengths recorded sales of approximately $71 million for the 12-month period ending March 2026. This provides a measurable commercial opportunity for CSL as it enters a competitive but essential hospital-use segment.
The latest USFDA approval reinforces Caplin Steriles’ growing footprint in sterile injectable products, a category that typically requires stringent manufacturing standards and regulatory compliance. With multiple approvals in recent quarters, the company continues to strengthen its presence in high-entry-barrier segments of the pharmaceutical industry.