Caplin Point Laboratories Limited has informed the Exchange regarding a press release dated March 13, 2026, titled "Receipt of final approval by our Subsidiary, Caplin Steriles Limited, from the USFDA for the Potassium Phosphates Injection USP".
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Caplin Point Laboratories' subsidiary, Caplin Steriles Limited, has received final approval from the USFDA for its generic Potassium Phosphates Injection USP. The product will be available in 5 mL, 15 mL, and 50 mL vials, and is a generic equivalent of Fresenius Kabi USA's reference drug. According to IQVIA, the US market for this product was approximately $57 million for the 12-month period ending January 2026. The injection is used to treat low phosphorus levels and for parenteral nutrition in patients who cannot take oral supplements. Caplin Steriles has now secured 53 ANDA approvals out of 54 filings, with a pipeline of 55+ injectable and ophthalmic products planned over the next four years.
This approval allows Caplin Steriles to launch a generic version in a ~$57 million US market, which could add to US revenue and earnings. Positive for the stock, as US generic approvals are key growth drivers for the subsidiary, though actual revenue will depend on market share capture and competition.