Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azithromycin Tablets USP, 600 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zithromax Tablets, 600 mg, of Pfizer, Inc. (Pfizer).
Azithromycin Tablet is a macrolide antibacterial drug indicated for mild to moderate infections. Azithromycin Tablets USP, 600 mg have an estimated market size of $2 million for twelve months ending September 2019. The company has a cumulative total of 115 ANDA approvals (103 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
