Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg. The approved 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.
Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of $33 million for twelve months ending September 2020. The company has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
