Zydus bags USFDA approval for Sugammadex Injection
Ahmedabad: Zydus Lifesciences Limited has announced that the company 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.
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Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The Company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.
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