Caplin Steriles Secures USFDA Green Light for Difluprednate Eye Drops

Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, received FDA approval for its generic Difluprednate eye drops. This corticosteroid treats inflammation and pain from ocular surgery. The drug, equivalent to DUREZOL by Sandoz Inc, saw US sales of USD 21 million till October 2024.

Caplin Point Laboratories Ltd announced a significant milestone for its subsidiary Caplin Steriles Ltd, as the latter received U.S. FDA approval for its generic Difluprednate eye drop. This approval marks a crucial step for the company's expansion into the U.S. pharmaceutical market.

The approved drug, an equivalent to the Reference Listed Drug DUREZOL by Sandoz Inc, is used to treat inflammation and pain resulting from ocular surgery, as well as internal eye inflammation. The green light from the FDA was for the new drug application of Difluprednate Ophthalmic Emulsion, 0.05%.

Caplin Chairman CC Paarthipan expressed satisfaction with the first cycle approval and anticipates further approvals for a range of emulsion and suspension products aimed at bolstering the company's market presence in the U.S. and other emerging markets. The drug reportedly achieved U.S. sales of approximately USD 21 million for the year ending October 2024, according to IQVIA.

(With inputs from agencies.)