Caplin Point Laboratories announced that its subsidiary Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Potassium Phosphates Injection USP .
The approval covers phosphorus 3 mmol/mL and potassium 4.4 mEq/mL formulations available in 5 mL, 15 mL and 50 mL vials. The product is a generic therapeutic equivalent of the reference listed drug marketed by Fresenius Kabi USA.
Product use and market opportunity
Potassium Phosphates Injection is used as a source of phosphorus in intravenous fluids, helping correct hypophosphatemia and providing parenteral nutrition support for adults and pediatric patients who cannot take oral supplements.
According to IQVIA data cited in the company's press release, the U.S. market for the injection recorded sales of approximately $57 million for the 12-month period ending January 2026.
Caplin Steriles portfolio
Caplin Steriles, the injectable manufacturing arm of Caplin Point Laboratories, has built a strong regulatory track record with approvals from agencies including USFDA, EU-GMP, ANVISA and INVIMA. The subsidiary has filed 54 ANDAs in the U.S., with 53 approvals (including acquired ANDAs) so far.
The company is also working on a pipeline of more than 55 injectable and ophthalmic products expected to be filed over the next four years, while continuing expansion across regulated and emerging markets.
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