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The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Zaroxolyn tablets 2.5 mg, 5 mg, and 10 mg, of Lannett Company, Inc.
The drug is indicated for treating salt and water retention including edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. It is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.
Metolazone tablets have an estimated market size of $33 million for twelve months ending September 2020 according to IQVIA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from US Food & Drug Administration (USFDA).
Alembic Pharma reported a 35.4% jump in consolidated net profit to Rs 333.37 crore on 17.4% rise in net sales to Rs 1,457.10 crore in Q2 September 2020 over Q2 September 2019.
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