Caplin Point Laboratories’ arm gets USFDA’s final approval for Ofloxacin Otic Solution

08 Jan 2024 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ofloxacin Otic Solution 0.3%, a generic therapeutic equivalent version of (RLD), FLOXIN Otic Solution of Daiichi Pharmaceuticals Inc. 

Ofloxacin Otic Solution 0.3% is used as anti-infective (antibacterial) for otic (ear) use. According to IQVIA (IMS Health), Ofloxacin Otic Solution 0.3% had US sales of around $36 million for the 12-month period ending June 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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