Caplin Point Laboratories Limited has informed the Exchange regarding a press release dated May 05, 2026, titled "Receipt of final approval by our Subsidiary, Caplin Steriles Limited, from the USFDA for Calcium Gluconate Injection USP".
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Caplin Point's subsidiary, Caplin Steriles Limited, has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Calcium Gluconate Injection USP, available in 10mL, 50mL, and 100mL vials. The drug is a generic equivalent of Fresenius Kabi USA's Reference Listed Drug (NDA 208418) and is used to treat acute symptomatic hypocalcemia in pediatric and adult patients. According to IQVIA data, this injection generated approximately $71 million in US sales over the 12 months ending March 2026, indicating a meaningful addressable market. Caplin Steriles now has 54 ANDA approvals in total and has filed 54 ANDAs in the US.
The USFDA approval opens a significant revenue opportunity in the US market for a product with ~$71 million in annual sales. This strengthens Caplin Steriles' sterile injectables portfolio and adds to the parent's growing US generic pipeline, which is positive for shareholders.