CAPLIN STERILES GETS USFDA APPROVAL FOR OFLOXACIN OPHTHALMIC SOLUTION

Chennai, April 16, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3% (eye drops), a generic therapeutic equivalent version of (RLD), OCUFLOX Ophthalmic Solution of Allergan Inc.

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers. According to IQVIATM (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% had US sales of approximately $52 million for the 12- month period ending December 2023.