Caplin Point’s arm gets USFDA’s approval for Procainamide Hydrochloride Injection

05 Feb 2025 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) Procainamide Hydrochloride Injection USP, 1g/10mL and 1g/2mL Vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRONESTYL, from Apothecon Inc.

Procainamide hydrochloride Injection is an antiarrhythmic medicine used to treat certain arrhythmia (abnormal heart rhythm). It restores normal heart rhythm by blocking abnormal electrical signals in the heart. According to IQVIATM (IMS Health), Procainamide hydrochloride Injection had US sales of around $20 million for the 12-month period ending December 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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