Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has secured final approval from the USFDA for its potassium phosphates injection. The product is a generic equivalent of Fresenius Kabi USA’s reference drug.
The potassium phosphates injection, available in 5 mL, 15 mL, and 50 mL vials, is used to correct hypophosphatemia and provide parenteral nutrition for patients unable to take oral supplements. According to IQVIA, the injection had US sales of approximately $57 million for the 12-month period ending January 2026.
Caplin Steriles has developed and filed 54 ANDAs in the US, with 53 approvals to date. The company plans to file over 55 injectable and ophthalmic products in the next four years. Caplin Point Laboratories continues to expand its reach in regulated and non-regulated markets, including Australia, Canada, and several countries in Latin America and Africa.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).