Alembic Pharma gains on USFDA nod for Mesalamine capsules

Alembic Pharmaceuticals advanced 6.22% to Rs 614.45 after the drug maker received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mesalamine extended-release capsules.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso extended-release capsules of Salix Pharmaceuticals, Inc. (Salix).

Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

According to IQVIA, Mesalamine extended-release capsules had an estimated market size of $133 million for twelve months ending June 2022.

Alembic Pharma has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

The company reported a consolidated net loss of Rs 65.88 crore in Q1 FY23 as against a net profit of Rs 164.52 crore posted in Q1 FY22. Net sales fell 4.8% year on year to Rs 1,262.14 crore in the quarter ended 30 June 2022.

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