USFDA gives nod for Azithromycin, used in bacterial infections

The company informed that the drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad.

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USFDA Approval
USFDA Approval

Last Updated on October 11, 2024 by The Health Master

Ahmadabad: Zydus Lifesciences Ltd. (Zydus) announced that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Azithromycin tablets, USP, 500 mg (USRLD: Zithromax Tablets).

Azithromycin is indicated to treat certain bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STDs), infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.

The company informed that the drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad.

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

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

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