Alembic Pharmaceuticals Ltd announces USFDA Final Approval Dexlansoprazole Delayed Release Capsules, 30 mg and 60 mg

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) Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: (i) Healing of all grades of erosive esophagitis (EE), (ii) Maintenance of healed EE and relief of heartburn, and (iii) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). Refer label for a detailed indication.

Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg, have an estimated market size of US$ 285 million for twelve months ending September 2025 according to IQVIA.

Alembic has a cumulative total of 229 ANDA approvals (209 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 917.10 as compared to the previous close of Rs. 916.65. The total number of shares traded during the day was 2148 in over 300 trades.

The stock hit an intraday high of Rs. 924.90 and intraday low of 912.85. The net turnover during the day was Rs. 1970653.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval Dexlansoprazole DelayedReleaseCapsules