Caplin Steriles Limited, a wholly owned subsidiary of Caplin Point Laboratories Limited (BSE: 524742 | NSE: CAPLIPOINT), has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sodium Phosphates Injection USP in multiple strengths.
The approval covers 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) single-dose vials. The product is a generic therapeutic equivalent of the Reference Listed Drug (RLD) marketed by Hospira Inc. in the United States under NDA 018892.
Sodium Phosphates Injection is indicated as a source of phosphorus and is administered as an additive to large volume intravenous fluids. It is primarily used to prevent or treat hypophosphatemia in patients who have restricted or no oral intake. The drug is also utilised in preparing customised parenteral nutrition formulations when standard electrolyte or nutrient solutions do not adequately meet patient needs. The product is widely used in hospital and critical care settings, where maintaining electrolyte balance is crucial.
According to IQVIA (IMS Health) data, the approved strengths of Sodium Phosphates Injection USP recorded total US sales of approximately $67 million for the 12-month period ending December 2025. The approval opens up a sizeable opportunity for Caplin Steriles in the US hospital injectable segment.