Alembic Pharma jumps over 6% on getting approval from USFDA for Mesalamine extended-release capsules

Shares of Alembic Pharmaceuticals rose as much as 6.4% to Rs 615.45 in Wednesday’s intraday trade after the pharmaceutical company received final approval from the US Food & Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) of 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,” the company said in a BSE filing.

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, the company said in a release.

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

At 11.35 am, the scrip was trading 6.42% higher at Rs 615.60 over its previous day’s closing price of Rs 578.45 apiece. However, the stock has fallen nearly 22% in the last six months while it has plunged about 24% year-to-date