Pharmaceutical Company Gets USFDA Approval for Sodium Phosphates Injection

Caplin Steriles Limited, a subsidiary of IPOint-caplin-point-laboratories-ltd-124742">Caplin Point Laboratories, has achieved a significant regulatory milestone with the final USFDA approval for its Abbreviated New Drug Application (ANDA) for Sodium Phosphates Injection USP. This generic therapeutic equivalent to Hospira’s Reference Listed Drug (RLD) will be available in 15mM, 45mM and 150mM single-dose vials. The injection serves as a critical phosphorus source for patients with restricted oral intake, helping to prevent or treat hypophosphatemia when added to large-volume intravenous fluids. This approval allows Caplin to provide an essential additive for customised parenteral nutrition formulas when standard electrolyte solutions are insufficient for patient needs.

Financially, this approval positions Caplin Steriles to capture a share of a lucrative market, as IQVIA™ data indicates that Sodium Phosphates Injection generated approximately $67 million in US sales during the 12-month period ending December 2025. By securing this authorisation, the company continues to expand its robust injectable portfolio in the United States, building on its existing track record of successful filings and approvals. This development underscores Caplin Point’s strategic focus on high-quality sterile manufacturing and its commitment to addressing specialised medical needs within the regulated US healthcare landscape.

About the Company

Caplin Point Laboratories Limited is a rapidly expanding pharmaceutical entity distinguished by its specialized business model focused on emerging markets across Latin America and Africa, supported by advanced manufacturing facilities for a comprehensive range of finished dosage forms. Demonstrating 15 years of consistent growth in revenue, profitability and cash flows, the company operates primarily through key subsidiaries: Caplin Steriles Limited (CSL), which manages a robust portfolio of sterile injectables and ophthalmics with 51 US FDA-approved ANDAs and a pipeline of over 55 upcoming products for global markets including Australia, Canada and the Middle East; and Caplin One Labs Limited (COL), which is currently advancing its oncology and specialty product unit in Kakkalur with five approved ANDAs already in its portfolio.

The company has a market cap of over Rs 13,000 crore and has delivered good profit growth of 21 per cent CAGR over the last 5 years. The company's shares have an ROE of 23 per cent and an ROCE of 26 per cent. The stock gave multibagger returns of 160 per cent in 3 years and a whopping 270 per cent in 5 years.

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