USFDA13 Mar 2026, 12:03 pm
Caplin Steriles Limited Receives USFDA Approval for Potassium Phosphates Injection USP
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Potassium Phosphates Injection USP. This injection is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Fresenius Kabi USA, LLC. The injection is used as a source of phosphorus in intravenous fluids to correct hypophosphatemia and as parenteral nutrition in adults and pediatric patients who cannot take oral supplements. According to IQVIA™, the injection had US sales of approximately $57 million for the 12-month period ending January 2026.
Key Highlights
- Caplin Steriles Limited receives final approval from USFDA for Potassium Phosphates Injection USP
- Potassium Phosphates Injection USP is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Fresenius Kabi USA, LLC
- The injection is used as a source of phosphorus in intravenous fluids to correct hypophosphatemia and as parenteral nutrition in adults and pediatric patients
- According to IQVIA™, the injection had US sales of approximately $57 million for the 12-month period ending January 2026
- Caplin Steriles Limited is a fast growing sterile product manufacturing company approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA