Zydus receives final approval from the USFDA for Sugammadex Injection, Single-Dose Vial

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") has received final approval from the United States Food and Drug Administration (USFDA) for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vial (USRLD: Bridion® Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL)).

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. The injection will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.

Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), SingleDose Vial had annual sales of USD 986 mn in the United States (IQVIA MAT Aug 2023).

The group now has 381 approvals and has so far filed over 444* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 603.55 as compared to the previous close of Rs. 604.65. The total number of shares traded during the day was 96397 in over 3264 trades.

The stock hit an intraday high of Rs. 610.25 and intraday low of 599.95. The net turnover during the day was Rs. 58167893.00.

(*as of 30th June 2023)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA FinalApproval SugammadexInjection