Zydus Lifesciences bags USFDA nod for Azithromycin Tablets to treat certain bacterial infections

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

Published On 2023-04-10 11:11 GMT   |   Update On 2023-10-10 06:55 GMT
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Ahmedabad: Drugmaker, Zydus Lifesciences Limited, has announced that the company 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 (STD), infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.

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The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Azithromycin Tablets USP, 500 mg had annual sales of USD 20 mn 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.

Read also: Zydus Lifesciences bags USFDA approval for Carbidopa and Levodopa Tablets to treat Parkinson's disease symptoms

Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.

Read also: Zydus Lifesciences secures USFDA approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg

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