Aurobindo Pharma receives USFDA Approval for Azithromycin Oral Suspension

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin Oral Suspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension, a generic version of Pfizer Inc's Zithromax® oral suspension. The product will be launched in November 2018.

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

This is the 125th 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.

Shares of AUROBINDO PHARMA LTD. was last trading in BSE at Rs.778.25 as compared to the previous close of Rs. 763.35. The total number of shares traded during the day was 241000 in over 4253 trades.

The stock hit an intraday high of Rs. 782.7 and intraday low of 761.6. The net turnover during the day was Rs. 186534726.