Alembic Pharmaceuticals Limited (Alembic) has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for mesalamine extended-release capsules USP, 0.375 g.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso extended-release capsules, 0.375 g, of Salix Pharmaceuticals, Inc. (Salix). Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine extended-release capsules USP, 0.375 g, have an estimated market size of US$ 133 million for twelve months ending June 2022 according to IQVIA.
Alembic has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from US FDA.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907.Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
