Alembic Pharma gets US FDA nod for mesalamine ER capsules
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.
Let’s apply Data-Driven Pricing to Your APIs
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions!
Learn More!