Caplin Steriles, a subsidiary of Caplin Point Laboratories, has been granted final 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.

The product is a generic therapeutic equivalent version of Trandate injection of Sebela Ireland. It is indicated for control of blood pressure in severe hypertension.

According to IQVIA (IMS Health) data, labetalol hydrochloride injection had US sales data of approximately $6 million for the 12-month period ending June 2021.

On a consolidated basis, Caplin Point Laboratories' net profit increased 29.9% to Rs 70.85 crore on a 25.1% rise in net sales to Rs 300.44 crore in Q1 FY22 over Q1 FY21.

Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa.