Hyderabad, April 7 -- :Aurobindo Pharma Limited on Tuesday said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets in 5 mg and 10 mg strengths.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Farxiga of AstraZeneca, the Hyderabad based pharma company said in a release here.
The company said the product will be manufactured at Unit-IV of APL Healthcare Limited, its wholly owned subsidiary, and will be launched immediately.
According to industry estimates, the approved product has a market size of about $10.2 billion for the 12 months ending February 2026.
Aurobindo Pharma said it now has a total of 579 ANDA appro...