Alembic Pharmaceuticals receives USFDA Final Approval for Mesalamine Extended-Release Capsules USP, 0.375 g

Alembic Pharmaceuticals Limited (Alembic) today 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.

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 USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 578.45 as compared to the previous close of Rs. 549.95. The total number of shares traded during the day was 11144 in over 1186 trades.

The stock hit an intraday high of Rs. 583.50 and intraday low of 550.00. The net turnover during the day was Rs. 6284685.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA Mesalamine ExtendedReleaseCapsules