Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Erlotinib Tablets, 25 mg, 100 mg, and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tarceva Tablets, 25 mg, 100 mg, and 150 mg, of OSI Pharmaceuticals, LLC.
Erlotinib Tablets, 25 mg, 100 mg, and 150 mg, have an estimated market size of $ 37 million for twelve months ending March 2021. Alembic has a cumulative total of 148 ANDA approvals (130 final approvals and 18 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
