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Aurobindo Pharma has received final approval from the US health regulator to manufacture Esomeprazole Magnesium delayed-release capsules, used in treatment of frequent heartburn, in the US market.
The approved product is therapeutically equivalent generic version of AstraZeneca's Nexium 24HR capsules.
Aurobindo Pharma said the product will be launched immediately.
The company quoting IRI database said the approved product has an approximate annual sales of USD 300 million.
This is the 127th Abbreviated New Drug Application (ANDA), including 23 tentative approvals, to be approved out of Unit VII formulation facility in Hyderabad, used for manufacturing oral products.