Caplin Point Laboratories Limited — Updates, 05-02-2025: Press Release

Caplin Steriles Limited has received final approval from the USFDA for its Procainamide Hydrochloride Injection USP, 1g/10mL and 1g/2mL vials, a generic equivalent of PRONESTYL. This antiarrhythmic medication, which restores normal heart rhythm, had US sales of approximately $20 million for the 12-month period ending December 2024. With this approval, Caplin Steriles expands its portfolio and enhances its position in the US market. The company, part of Caplin Point Laboratories, has developed a strong pipeline with a total of 46 ANDAs filed, of which 33 have been approved. The ongoing expansion into sterile products positions Caplin for potential growth, and investors should monitor its market developments closely.