Zydus receives final approval from the USFDA for Estradiol Transdermal System which will be manufactured at the Moraiya plant

Zydus receives final approval from the USFDA for Estradiol Transdermal System which will be manufactured at the Moraiya plant Ahmedabad, India, 2 December, 2022 Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (USRLD: Vivelle-Dot® Transdermal System). Estradiol Transdermal System is indicated to treat moderate to se vere symptoms of menopause which includes feelings of warmth in the face, neck and chest or sudden strong f eelings of heat, hot flushes and vaginal dryness in women. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India. The group now has 336 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04. (*as of 30th September 2022) ***

The release as fetched from its publisher. zyduslife.com ↗