Approval was granted for the sale of candesantan cilexetil in the dosage of 32 mg.
Candesartan cilexetil is used for treatment of hypertension in adults and children and treatment of heart failure.
The drug has an estimated market size of US$ 27 million, the Indian company said.
Alembic now has a total of 57 drug approvals (51 final approvals and 6 tentative approvals) from USFDA via its abbreviated new drug applications.
Abbreviated forms are submitted when the drug is not totally new, but is either a generic version of a drug already approved, or already present in the market in some other way.
Alembic Pharmaceuticals manufactures and markets generic pharmaceutical products all over the world and is one of India’s largest generic drug manufacturers.