Press release regarding receipt of final approval by our Subsidiary, Caplin Steriles Limited, from USFDA for Calcium Gluconate Injection USP
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Caplin Point's subsidiary Caplin Steriles has received final USFDA approval for its generic Calcium Gluconate Injection USP, available in 10mL, 50mL and 100mL vials. The drug is a therapeutic equivalent to Fresenius Kabi USA's Reference Listed Drug and is used to treat acute symptomatic hypocalcemia in pediatric and adult patients. According to IQVIA data, this injection had US sales of approximately $71 million for the 12-month period ending March 2026. This marks Caplin Steriles' 54th ANDA approval and expands their sterile injectable portfolio in the regulated US market.
This approval provides Caplin Point access to a $71 million annual US market for a sterile injectable product. As a generic entry, it could generate meaningful revenue contribution from the world's largest pharmaceutical market, benefiting from USD earnings. The approval reinforces the subsidiary's track record of USFDA clearances, supporting future growth prospects.