Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP, 0.014 mg/day (weekly) (USRLD: Menostar Transdermal System).
Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of $1.9 million in the United States (IQVIA MAT February 2023). The group now has 363 approvals and has so far filed over 440 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.