Caplin Point Laboratories Limited has informed the Exchange regarding a press release dated February 24, 2026, titled "Receipt of final approval by our Subsidiary, Caplin Steriles Limited, from the USFDA for the Sodium Phosphates Injection USP "
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Caplin Point Laboratories' subsidiary Caplin Steriles Limited has received final approval from the USFDA for its generic Sodium Phosphates Injection USP in three strengths (15mM P/5mL, 45mM P/15mL, and 150mM P/50mL) as single-dose vials. The product is a generic equivalent of Hospira's reference listed drug used for treating low phosphate levels in patients. According to IQVIA data, this product had total US sales of approximately $67 million for the 12-month period ending December 2025. This approval takes Caplin Steriles' total USFDA approvals to 51 out of 54 ANDAs filed, strengthening its injectable product portfolio in the US market.
This is a positive development for shareholders as it allows Caplin Steriles to immediately launch the product in the US generics market, tapping into a ~$67 million opportunity. The approval reinforces the subsidiary's strong USFDA track record and adds to its growing portfolio of complex injectable products, supporting future revenue growth from regulated markets.