Caplin Steriles gets USFDA approval for Sodium Phosphate injection

Caplin Steriles gets USFDA approval for Sodium Phosphate injection

By: IPP Bureau

Last updated : February 25, 2026 7:15 am



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


Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, 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.

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.

Caplin Steriles Limited Caplin Point Laboratories Limited USFDA Sodium Phosphate

First Published : February 25, 2026 12:00 am