Alembic Pharmaceuticals said that has received final approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Sacubitril and Valsartan Tablets.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Entresto Tablets of Novartis Pharmaceuticals Corporation (Novartis).
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older.
Sacubitril and Valsartan Tablets have an estimated market size of US$ 5.3 billion for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 202 ANDA approvals (174 final approvals and 28 tentative approvals) from US FDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
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The companys consolidated net profit increased jumped 48.01% to Rs 180.45 crore despite of 8.05% fall in revenue from operations to Rs 1,630.57 crore in Q3 FY24 over Q3 FY23.
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