Caplin Steriles, a subsidiary of Chennai-based Caplin Point Laboratories Ltd. on Saturday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Rocuronium Bromide Injection, a neuromuscular blocking agent provided during surgery or mechanical ventilation.
The pharmaceutical company said, the US drug regulator has approved its Abbreviated New Drug Application (ANDA) for Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL multi-dose vials. The injection is a generic therapeutic equivalent version of Organon USA Inc’s Zemuron injection.
“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 in the release.
According to IQVIATM (IMS Health), Rocuronium Bromide Injection had US sales of approximately $53 million for the 12-month period ended September 2022.
In February, Caplin Steriles received US drug regulator’s final approval for Carboprost Tromethamine Injection, which is used to treat severe bleeding after childbirth (postpartum).
Stocks of Caplin Point Laboratories closed at ₹659.05 on NSE, up by 0.50 per cent over the previous day’s close.