Aurobindo Pharma receives USFDA Approval for Azithromycin Tablets
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture Azithromycin tablets 250 mg and 500 mg. Azithromycin tablets are an AB-rated generic equivalent of Pfizer Inc's Zithromax tablets. The product will be launched in July 2018.
Azithromycin tablets are indicated for the treatment of patients with mild to moderate infections. The approved product has an estimated market size of US$ 132 million for the twelve months ending May 2018 according to IQVIA.
This is the 146th ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 377 ANDA approvals (344 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.
Shares of AUROBINDO PHARMA LTD. was last trading in BSE at Rs.617.25 as compared to the previous close of Rs. 623.15. The total number of shares traded during the day was 146220 in over 3403 trades.
The stock hit an intraday high of Rs. 628.2 and intraday low of 614.45. The net turnover during the day was Rs. 90523665.