USFDA nod to Zydus Lifesciences Estradiol Transdermal System for postmenopausal osteoporosis prevention
The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.
Ahmedabad: Zydus Lifesciences Limited 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 USD 1.9 mn in the United States (IQVIA MAT Feb. 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 Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. 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.
Read also: USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections
