Alembic Pharma gets USFDA approval for Mesalamine extended-release capsules; Stock zooms ~6%

2 Nov 2022 , 10:57 AM

Alembic Pharmaceuticals Limited on Wednesday has announced that it 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. (Salix). Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

According to IQVIA report, Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of US$ 133 million for twelve months ending June 2022.

Alembic has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA, the company mentioned.

At around 10:59 AM, Alembic Pharmaceuticals Ltd is currently trading at Rs612.05 per share up by Rs33.6 or 5.81% from its previous closing of Rs578.45 per share on the BSE.

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