Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection

Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL Multi-dose Vials, a generic therapeutic equivalent version of (RLD), ZEMURON Injection, of Organon USA.

Rocuronium Bromide Injection is a neuromuscular blocking agent, indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. According to IQVIA (IMS Health), Rocuronium Bromide Injection had US sales of approximately $53 million for the 12-month period ending September 2022.

CC Paarthipan, Chairman of Caplin Point Laboratories commented, “This is an important product in our anesthesia portfolio for global markets, and we look forward to launching it in the US in the coming months.”