Alembic Pharma secures USFDA okay for Mesalamine ER Capsules
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Vadodara: Alembic Pharmaceuticals Limited today announced that the company has received final approval from the US Food & Drug Administration (USFDA) 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,...
Vadodara: Alembic Pharmaceuticals Limited today announced that the company has received final approval from the US Food & Drug Administration (USFDA) 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.
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 the USFDA.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. It is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
Products under International Generics are manufactured across its world-class facilities in Panelav, Karkhadi, and Jarod in Gujarat. Under this vertical, the company also has R&D facilities in Vadodara (Gujarat), Hyderabad (Telangana), and New Jersey (USA).
Read also: Alembic Pharma Vadodara facility concludes USFDA inspection with zero observations
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