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Zydus receives USFDA tentative approval for Sugammadex Injection; Stock drops ~3%

The drug will be manufactured at the group’s injectables manufacturing facility located at Jarod, India.

September 16, 2022 2:23 IST | India Infoline News Service
Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) announced on Friday that its US-based subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Sugammadex Injection USP 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vial (US RLD: Bridion).

As per the filing, Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. The drug will be manufactured at the group’s injectables manufacturing facility located at Jarod, India.

According to IQVIA MAT July 2022 data, Sugammadex Injection had annual sales of USD 772 mn 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.

On Friday, at around 2:26 PM, Zydus Lifesciences Ltd is currently trading at Rs360.40 down by Rs10.65 or 2.87% from its previous closing of Rs371.05 on the BSE.

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