Caplin Point Laboratories’ arm gets final approval from USFDA for Ofloxacin Ophthalmic Solution

16 Apr 2024 Evaluate

Caplin Point Laboratories’ subsidiary company -- Caplin Steriles (Caplin) 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 IQVIA (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% had US sales of around $52 million for the 12- month period ending December 2023.

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.


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