Caplin Steriles Receives USFDA Clearance for Rocuronium Bromide Injection

Caplin Steriles, a subsidiary of Chennai-based Caplin Point Laboratories Ltd., announced Saturday that it has received final U.S. Food and Drug Administration (USFDA) approval for its rocuronium bromide injection, a neuromuscular blocking agent used during given during surgery or mechanical ventilation.

The pharmaceutical company said the US Food and Drug Administration has approved its abbreviated application for marketing authorization (ANDA) for rocuronium bromide injections, 10 mg/mL in 5-mL and 10-mL multidose vials. The injection is a generic, therapeutically equivalent version of the Zemuron injection from Organon USA Inc.

“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,” CC Paarthipan, chairman of Caplin Point Laboratories, was quoted as saying in the press release.

According to IQVIATM (IMS Health), Rocuronium Bromide Injection had US sales of approximately US$53 million for the 12 months ended September 2022.

In February, Caplin Steriles received final US drug regulatory approval for Carboprost Tromethamine Injection, used to treat severe postpartum bleeding.

Caplin Point Laboratories shares closed at £659.05 on the NSE, up 0.50 percent from the previous day’s close.