Caplin Steriles Limited (CSL), a subsidiary company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Potassium Phosphates Injection USP, (phosphorus 3 mmol/mL and potassium 4.4 mEq/mL in 5 mL, 15 mL and 50 mL Vials), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Fresenius Kabi USA, LLC (NDA 212832).

Potassium Phosphates Injection is used as a source of phosphorus in intravenous fluids to correct hypophosphatemia and as parenteral nutrition in adults and pediatric patients, who cannot take oral supplements. According to IQVIATM (IMS Health), Potassium Phosphates injection USP, (phosphorus 3 mmol/mL and potassium 4.4 mEq/mL in 5 mL, 15 mL and 50 mL Vials) had US sales of approximately $57 million for the 12-month period ending January 2026.