Caplin Point’s arm gets USFDA’s approval for Phenylephrine Hydrochloride Ophthalmic Solution

24 May 2024 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles (Caplin) has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops), a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from Alcon Research LLC.

Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is indicated to dilate the pupil of the eyes. According to IQVIA (IMS Health), Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% had US sales of approximately $32 million for the 12-month period ending March 2024.

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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