Caplin Steriles Limited (CSL), a subsidiary of Caplin Point Laboratories, has secured final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Potassium Phosphates Injection USP. This generic product is therapeutically equivalent to the Reference Listed Drug marketed by Fresenius Kabi USA, LLC. The US market for this intravenous fluid, used to correct hypophosphatemia, showed sales of approximately $57 million for the 12 months ending January 2026.
USFDA Approval Secured for Potassium Phosphates Injection
Caplin Point Laboratories Limited announced on March 13, 2026, that its subsidiary, Caplin Steriles Limited (CSL), has received final approval from the United States Food and Drug Administration (USFDA).
The approval is for the Abbreviated New Drug Application (ANDA) for Potassium Phosphates Injection USP. This product is available in 5 mL, 15 mL, and 50 mL Vials, delivering phosphorus at 3 mmol/mL and potassium at 4.4 mEq/mL.
This generic formulation is a therapeutic equivalent to the Reference Listed Drug (RLD) previously supplied by Fresenius Kabi USA, LLC (NDA 212832).
Market Opportunity in the US
Potassium Phosphates Injection is crucial as a source of phosphorus in intravenous fluids for treating hypophosphatemia and for parenteral nutrition in patients unable to take oral supplements.
Market data from IQVIA for the 12-month period ending January 2026 indicated that the US sales for this specific formulation of Potassium Phosphates Injection USP reached approximately $57 million.
Company Background and Pipeline Strength
Caplin Point Laboratories is highlighted as a fast-growing pharmaceutical company focused predominantly on emerging markets in Latin America and Africa.
The subsidiary, Caplin Steriles Limited (CSL), specializes in sterile product manufacturing and has regulatory approvals from agencies including the US FDA, EU-GMP, ANVISA, and INVIMA.
- CSL has developed and filed 54 ANDAs in the USA to date, securing 53 approvals (including acquired ANDAs).
- CSL is currently developing a portfolio of over 55+ simple and complex Injectable and Ophthalmic products intended for filing over the next four years.
Furthermore, another subsidiary, Caplin One Labs Limited (COL), which operates the oncology unit, currently holds 5 approved ANDAs for Injectable products.
Forward-Looking Statement Disclaimer
The announcement concludes with a standard Cautionary Statement, noting that forward-looking statements are subject to inherent risks and uncertainties, and the actual results may differ substantially from projections.
Source: BSE
