Zydus Lifesciences gets approval from USFDA for generic drug

The drug will be manufactured at Zydus group's formulation manufacturing facility at Moraiya, Ahmedabad.

FPJ Web DeskUpdated: Friday, December 02, 2022, 08:18 PM IST
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The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat./ Representative image | Pixabay

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market Estradiol Transdermal System, used to treat moderate to severe symptoms of menopause, in the American market.

The drug firm has received final approval from the US Food and Drug Administration (USFDA) to market the drug in multiple strengths, the company said in a regulatory filing.

What is the medication for?

The medication is indicated to treat moderate to severe symptoms of menopause, which includes feelings of warmth in the face, neck and chest or sudden strong feelings of heat, hot flushes and vaginal dryness in women.

The drug will be manufactured at Zydus group's formulation manufacturing facility at Moraiya, Ahmedabad.

The group now has a total of 336 approvals and has filed over 431 ANDAs since 2003 when the filing proces bagen.

Zydus Lifescience

Zydus Lifesciences is a global discovery-driven lifescience company that discovers, develops, markets and manufactures a broad range of healthcare therapies. The group has production and research facilities in Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim.

Zydus Lifescience earnings

In the second quarter of this financial year, the company's consolidated net profits went down by 82.6 per cent to Rs 522.50 crore. This was despite the 10 per cent increase in total revenue from operations to Rs 4,134.7 crore.

The shares of the company went down 0.21 per cent to Rs 410.45.

With inputs from PTI

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