The pharmaceutical company on Friday announced that its U.S. subsidiary, Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Sugammadex injection.
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
The company said that the drug will be manufactured at the group's injectables manufacturing facility at Jarod, India.
According to IQVIA MAT July 2022 data, Sugammadex injection had annual sales of $772 million in the United States.
The group now has 323 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04, the drug maker stated.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company's consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22.
Shares of Zydus Lifesciences were down 1.89% to Rs 364.05 on the BSE.
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