Caplin Point Laboratories Limited — Updates, 16-12-2024: Press Release

Caplin Steriles Limited has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion, 0.05%. This product is a generic version of DUREZOL and is indicated for treating inflammation and pain associated with ocular surgery. The US market for this product generated approximately $21 million in sales over the last 12-month period ending October 2024. Caplin's Chairman highlighted that this approval marks a first cycle success for a complex emulsion product, with more similar products in the pipeline which could further enhance their portfolio in the US and emerging markets. Overall, this development signals a positive outlook for Caplin Steriles and could lead to increased market penetration and revenue growth for the company.