Caplin Steriles, a subsidiary of Caplin Point Laboratories Limited, has been granted final approval from the US Food and Drug Administration (FDA) 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 Limited.

Labetalol Hydrochloride Injection USP is indicated for the control of blood pressure in severe hypertension.

According to IQVIATM (IMS Health), Labetalol hydrochloride Injection had US sales data of approximately US $ 6 million for the 12 months ending June 2021.

Caplin Steriles Limited, has developed and filed 20 ANDAs in USA on its own and with partners, with 17 approvals so far. Out of the 17 approvals, 12 belong to Caplin Steriles. The company is also working on a portfolio of 45 simple and complex Injectable and Ophthalmic products.