Caplin Steriles Gets USFDA Approval for Phosphate Injection Drug

Caplin Steriles Limited has secured USFDA approval for its Sodium Phosphates Injection USP, strengthening the company’s growing presence in the U.S. injectable drugs market.

The approval from the U.S. Food and Drug Administration (USFDA) allows the company to market the product in multiple strengths supplied in single-dose vials.

The approved Sodium Phosphates Injection USP will be available in three strengths: 15 mM P/5 mL, 45 mM P/15 mL, and 150 mM P/50 mL (3 mM P/mL). The product is used as a phosphorus supplement in intravenous fluids and plays an important role in treating patients with hypophosphatemia, a condition marked by low phosphate levels in the body.

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With this USFDA approval, Caplin Steriles can supply the injectable drug to hospitals and healthcare providers in the United States. The product is commonly used for patients who are unable to consume nutrients orally and require phosphate supplementation through parenteral nutrition or specialized IV solutions.

The approved injection is a generic version of a reference listed drug marketed in the U.S. by Hospira. According to IQVIA data, the combined U.S. market for the approved strengths of Sodium Phosphates Injection USP generated around $67 million in sales for the 12 months ending December 2025.

This development marks another step in Caplin Steriles’ strategy to expand its injectables portfolio in regulated markets. The company continues to focus on increasing its pipeline of complex injectable products and strengthening its footprint in the highly regulated U.S. pharmaceutical market.