Zydus Lifesciences bags USFDA nod for Norelgestromin, Ethinyl Estradiol Transdermal System to prevent pregnancy
The transdermal patch will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad.
Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day (USRLD: Ortho Evra Transdermal System, 150 mcg/35 mcg per day).
Norelgestromin and Ethinyl Estradiol Transdermal System contains combination hormone medication and is used to prevent pregnancy. This is the third hormonal transdermal patch to be approved from Zydus’ generics portfolio.
The transdermal patch will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.
Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of USD 330 mn in the United States (IQVIA MAT July 2023). The group now has 380 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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