Alembic Pharmaceuticals Limited receives USFDA Final Approval for Prucalopride Tablets, 1 mg and 2 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) Prucalopride Tablets, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc. Prucalopride tablets are serotonin-4 receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Refer label for a detailed indication.

Prucalopride Tablets, 1 mg and 2 mg, have an estimated market size of US$ 100 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 245 ANDA approvals (225 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 802.15 as compared to the previous close of Rs. 811.60. The total number of shares traded during the day was 19512 in over 575 trades.

The stock hit an intraday high of Rs. 808.60 and intraday low of 799.70. The net turnover during the day was Rs. 15693499.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval PrucaloprideTablets