Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 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) Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Haldol Tablets, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, of Ortho McNeil Pharmaceutical (Ortho McNeil). Haloperidol Tablets are indicated for: i) use in the management of manifestations of psychotic disorders and ii) the control of tics and vocal utterances of Tourette's Disorder in children and adults. Refer label for a detailed indication.

Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, have an estimated market size of US$ 27 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 240 ANDA approvals (221 final approvals and 19 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 736.95 as compared to the previous close of Rs. 735.70. The total number of shares traded during the day was 21359 in over 303 trades.

The stock hit an intraday high of Rs. 744.70 and intraday low of 728.20. The net turnover during the day was Rs. 15642571.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 FinalApproval USFDA ANDA HaloperidolTablets