Zydus Lifesciences Topical acne treatment gel gets USFDA okay

The drug will be manufactured at group’s topical facility at Ahmedabad.

Published On 2022-06-07 07:40 GMT   |   Update On 2022-06-07 07:40 GMT
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Ahmedabad: Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (USRLD: Epiduo Forte).

A combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to decrease the number and severity of acne pimples. Adapalene works by affecting the growth of cells and decreasing swelling and inflammation and Benzoyl Peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off.

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Read also: Zydus Wellness net profit rises 160 per cent to Rs 309 crore

The drug will be manufactured at group's topical facility at Ahmedabad.

Adapalene and Benzoyl Peroxide Topical Gel had a market size of USD 195 mn (as per IQVIA MAT April 22). The group now has 315 approvals and has so far filed over 420* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: USFDA nod to Zydus Lifesciences Famotidine Tablets

Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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