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The approval has been granted in the strengths of 250 mg and 500 mg, and the product will be launched this month, Aurobindo Pharma said in a BSE filing.
The approved product is generic equivalent of Pfizer Inc’s Zithromax tablet, it added.
Quoting IQVIA sales data, the company said, the approved product has an estimated market size of USD 132 million for the 12 months ending May 2018.
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Stock of Aurobindo Pharma was trading 0.06 per cent lower at Rs 616.90 on BSE.