Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Metronidazole Topical Cream, 0.75% (USRLD: MetroCream, 0.75%).
Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It is expected to help decrease redness, swelling and the number of pimples caused by rosacea and is believed to work by decreasing swelling (inflammation).
The drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India).
Metronidazole Topical Cream, 0.75% had annual sales of USD 25 mn in the United States (IQVIA MAT Feb. 2023).
The group now has 366 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
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