Caplin Steriles gets USFDA approval for Potassium Phosphates Injection

Caplin Steriles Limited (CSL), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), 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.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 1688.60 as compared to the previous close of Rs. 1687.30. The total number of shares traded during the day was 2932 in over 400 trades.

The stock hit an intraday high of Rs. 1699.45 and intraday low of 1660.80. The net turnover during the day was Rs. 4937775.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 Pharmaceuticals CaplinSteriles USFDA Approval PotassiumPhosphatesInjection