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Aurobindo Pharma receives USFDA approval for azithromycin oral suspension

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Mumbai | Thursday, Oct 11 2018 IST
Pharma major Aurobindo Pharma Limited said that company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin OralSuspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension IS a generic version of Pfizer Inc's Zithromax oral suspension. The product will be launched in November 2018, company said in a filing with BSE.

Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections. The approved product has an estimated market size of USD 71 million for the twelve months ending August 2018, according to IQVIA.

This is the 125th Abbreviated New Drug Application (ANDA) (including 11 tentative approvals) to be approved out of Unit III formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 386 ANDA approvals (357 Final approvals including 19 from Aurolife Pharma LLC and 29 tentative approvals) from USFDA.

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