Caplin Point's arm Caplin Steriles gets USFDA nod for Sodium Phosphates Injection

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sodium Phosphates Injection USP.

The approval covers Sodium Phosphates Injection USP in strengths of 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), approved under NDA 018892 and marketed by Hospira, Inc., USA.

Sodium Phosphates Injection is indicated as a source of phosphorus for addition to large volume intravenous fluids to prevent or treat hypophosphatemia in patients with limited or no oral intake. It is also used in the preparation of customised parenteral nutrition formulations when standard electrolyte or nutrient solutions are inadequate to meet patient requirements.

 

According to IQVIA (IMS Health) data, the approved strengths of Sodium Phosphates Injection recorded total US sales of approximately $67 million for the 12-month period ended December 2025.

Caplin Point Laboratories is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company also has a growing presence in the regulated markets such as US through its subsidiary Caplin Steriles and Caplin Steriles USA Inc.

The company's consolidated net profit rose 17.9% to Rs 163.88 crore while net sales increase 10.1% to Rs 542.77 crore in Q3 FY26 over Q3 FY25.

The counter declined 1.49% to Rs 1,706.90 on the BSE.

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