Caplin Point Laboratories’ subsidiary -- Caplin Steriles has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Labetalol Hydrochloride Injection USP, 100 mg/20 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) Multiple-dose Vials, a generic therapeutic equivalent version of (RLD), TRANDATE Injection, of Sebela Ireland.
Labetalol Hydrochloride Injection USP is indicated for control of blood pressure in severe hypertension. Labetalol hydrochloride Injection had US sales data of approximately $6 million for the 12-month period ending June 2021.
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.
