Zydus Lifesciences Limited on 6 October announced that it had received the final approval from the USFDA (the United States Food and Drug Administration) for its sugammadex injection, which is a post-surgery drug.
The injection is used to reverse the effect of muscle relaxants such as vecuronium and rocuronium in adult patients who are undergoing surgery.
The injections will be manufactured at the company’s injectable manufacturing facility in Jarod, near Vadodara. The drug will be sold in 2 mL/200 mg and 5 mL/500 mg and single-dose vials by the company.
The Sugammadex injection had annual sales of $ 986 million within the United States, according to IQVIA MAT August data.
The group has a total of 381 approvals and has filled for over 444 ANDAs (Abbreviated New Drug Applications) since the beginning of its filing process in FY 2003 -04.