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Zydus receives final approval from US FDA for Estradiol Transdermal System

Zydus receives final approval from US FDA for Estradiol Transdermal System

Estradiol transdermal system is indicated for the prevention of postmenopausal osteoporosis. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad.

Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of $1.9 million in the US.

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.

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US FDA Zydus
More news about: quality / gmp | Published by Sudeep Soparkar | April - 19 - 2023 | 401

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