Caplin Point Laboratories announced that its subsidiary, Caplin Steriles Limited, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Sodium Phosphates Injection USP. This injectable generic, equivalent to Hospira Inc.’s RLD, is indicated for treating hypophosphatemia. The approved product addresses a market segment that recorded approximately $67 million in US sales for the 12 months ending December 2025.
USFDA Final Approval Secured by Subsidiary
Caplin Point Laboratories Limited confirmed on February 24, 2026, that its subsidiary, Caplin Steriles Limited (CSL), has been granted final approval from the United States Food and Drug Administration (USFDA). This approval pertains to the Abbreviated New Drug Application (ANDA) for Sodium Phosphates Injection USP.
The approved product is available in 15mM P/5mL, 45mM P/15mL, and 150mM P/50mL (3mM P/mL) Single-Dose Vials. It is positioned as a generic therapeutic equivalent to the Reference Listed Drug (RLD) originally held by Hospira, Inc., USA (NDA 018892).
Market Significance and Indication
Sodium Phosphates Injection is vital for correcting or preventing hypophosphatemia in patients unable to take phosphorus orally, often requiring addition to large volume intravenous fluids. The market potential is substantial, as the US sales for the approved USP strengths totaled approximately $67 million for the 12-month period ending December 2025, according to IQVIA™ data.
Company Growth and Regulatory Capabilities
Caplin Point Laboratories continues its trajectory as a fast-growing pharmaceutical company focusing primarily on emerging markets in Latin America and Africa. CSL, the sterile product manufacturing subsidiary, has demonstrated strong regulatory competence, holding approvals from agencies like the US FDA, EU-GMP, ANVISA, and INVIMA.
CSL currently has 51 approvals in the US market (including acquired ANDAs) out of 54 ANDAs filed on its own and with partners. The subsidiary manages a development portfolio exceeding 55+ simple and complex Injectable and Ophthalmic products slated for future filings over the next four years.
About Caplin Point Laboratories
Caplin Point Laboratories has achieved consistent high-quality growth in cash flows, profitability, and revenues for over 15 years. The company has been recognized internationally, appearing on Forbes “Asia’s 200 Best Under a Billion” list an unprecedented 7th time in the last decade.
Additionally, the group includes Caplin One Labs Limited (COL), which operates the oncology unit in Kakkalur and currently holds 5 approved ANDAs for Injectable and Ophthalmic products, supporting the regulated and other markets segment of the business.
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