Alembic Pharmaceuticals 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.
Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, have an estimated market size of $27 million for twelve months ending March 2026 according to IQVIA. The company has a cumulative total of 240 ANDA approvals (221 final approvals and 19 tentative approvals) from USFDA.
Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
