Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 mg (USRLD: Chantix Tablets). The product will be launched shortly. Varenicline tablets is indicated to treat smoking addiction. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Varenicline Tablets, 0.5 mg and 1 mg had annual sales of $501 million in the United States (IQVIA MAT March 2023). The group now has 374 approvals and has so far filed over 442 (as of March 31, 2023) ANDAs since the commencement of the filing process in FY 2003-04
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
