Caplin Steriles gets USFDA approval for Sodium Phosphates Injection

Caplin Steriles Limited (Caplin), 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) Sodium Phosphates Injection USP, 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) Single-Dose Vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Hospira, Inc., USA (NDA 018892).

Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. According to IQVIATM (IMS Health), Sodium Phosphates Injection USP, 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) Single-Dose Vials had total US sales of approximately $67 million for the 12-month period ending December 2025.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 1732.65 as compared to the previous close of Rs. 1690.75. The total number of shares traded during the day was 1433 in over 316 trades.

The stock hit an intraday high of Rs. 1741.10 and intraday low of 1687.00. The net turnover during the day was Rs. 2449955.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 Pharmaceuticals CaplinSteriles FinalApproval USFDA ANDA SodiumPhosphatesInjection