Caplin Point Laboratories Limited — Updates, 17-01-2025: Press Release

Caplin Steriles Limited has received final USFDA approval for its Abbreviated New Drug Application for Levetiracetam in Sodium Chloride Injection, available in 500mg/100mL, 1000mg/100mL, and 1500mg/100mL infusion bags. This product is a generic therapeutic equivalent of the reference drug from HQ Speciality Pharma Corp and represents the second approved Ready-To-Use Infusion bag by Caplin, with six additional products under FDA review. Levetiracetam is an important antiepileptic treatment, boasting US sales of approximately $19 million for the 12-month period ending November 2024.

Caplin Steriles has developed 45 ANDAs in the US, achieving 32 approvals, and plans to expand its injectable and ophthalmic products portfolio significantly. This strategic approval enhances Caplin's position in the fast-growing sterile market and could lead to a positive outlook for future revenues, driven by the ongoing demand for such drugs in the healthcare sector. Investors should watch closely for further developments in Caplin's expanding product lineup and ongoing FDA submissions.