Caplin Point Laboratories Share Price in Focus as Subsidiary Receives USFDA Approval for Sodium Phosphates Injection

Caplin Point Laboratories Limited has 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 for Sodium Phosphates Injection USP. 

USFDA Approval for Sodium Phosphates Injection 

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 version of the reference listed drug from Hospira, Inc., USA under (NDA 018892). 

Sodium Phosphates Injection is indicated as a source of phosphorus for addition to large volume intravenous fluids. It is used to prevent or correct hypophosphatemia in patients with restricted or no oral intake and for preparation of specific parenteral fluid formulas. 

Market Data and Sales Figures 

According to IQVIA data, the approved product recorded total US sales of approximately $67 million for the 12 month period ending December 2025. The approval allows Caplin Steriles to market the product in the United States. 

Read More: Alembic Pharma Share Price in Focus; Receives USFDA Final Approval for Efinaconazole Topical Solution, 10%!  

ANDA Portfolio of Caplin Steriles 

Caplin Steriles has filed 54 ANDAs in the United States, either independently or with partners. The company has received 51 approvals, including acquired ANDAs. It is also working on a portfolio of 55+ injectable and ophthalmic products for filing in regulated and other markets. 

Caplin Point Laboratories operates manufacturing facilities catering to multiple finished dosage forms and focuses on emerging markets including Latin America and Africa. Its subsidiaries also have regulatory approvals from agencies such as US FDA, EU GMP, ANVISA and INVIMA. 

Caplin Point Laboratories Share Price Performance  

As of February 24, 2026, at 3:30 PM, Caplin Point Laboratories share price on NSE was closed at ₹1,712.60 down by 0.98% from the previous closing price. 

Conclusion 

The USFDA approval for Sodium Phosphates Injection strengthens Caplin Steriles’ portfolio of injectable products in the United States. The product had recorded $67 million in US sales for the 12 month period ending December 2025, according to IQVIA data. 

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