Andexxa is indicated for patients treated with FXa inhibitors (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

"The receipt of this permission paves way for the launch of Andexanet alfa powder for solution for infusion 200 mg (Andexxa) in India for the specified indication, subject to the receipt of related statutory approvals, if any,” Astrazeneca Pharma said in a statement.

Astrazeneca Pharma is engaged in the business of manufacture, distribution and marketing of pharmaceutical products and co-ordinates clinical trial services with an overseas group company. The major therapy areas where the company operates are onocology, alimentary & metabolism, cardio vascular, renal, diabetes, respiratory and oncology.

The company's standalone net profit jumped 25% to Rs 40.71 crore on a 31.7% increase in net sales to Rs 311.07 crore in Q2 FY24 over Q2 FY23.