Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Azithromycin Tablets USP, 500 mg. 

Azithromycin is indicated to treat certain bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STD), infections of the ears, lungs, sinuses, skin, throat, and reproductive organs. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad.

Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States (IQVIA MAT Feb. 2023).

The group now has 360 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04. (as of 31st December 2022).