Caplin Point Laboratories gets FDA final approval for Rocuronium Bromide Injection
Caplin Point Laboratories said that Caplin Steriles has been given final approval for Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL Multi-dose Vials from the US Food and Drug Administration (FDA).
Caplin Steriles is a sterile product manufacturing company owned by Caplin Point Laboratories.
Rocuronium Bromide Injection is a generic therapeutic equivalent version of ZEMURON Injection of Organon USA.
It is a neuromuscular blocking agent which has approval in the US to be used as an adjunct to general anesthesia to enable rapid sequence as well as routine tracheal intubation.
Rocuronium Bromide Injection is also indicated to deliver skeletal muscle relaxation during surgery or mechanical ventilation.
As per IQVIATM (IMS Health), the sales of Rocuronium Bromide Injection in the US for the 12-month period ending September 2022 was around $53 million.
C. C. Paarthipan — Caplin Point Laboratories Chairman said: “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.”