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Alembic Pharmaceuticals Gets USFDA Approval for Haloperidol Tablets

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Alembic Pharmaceuticals (NSE:APLLTD, BOM:533573) received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Haloperidol Tablets in strengths of 1 mg, 2 mg, 5 mg, 10 mg and 20 mg, according to a Friday filing on Indian bourses.

The product is the generic equivalent of Haldol Tablets marketed by Ortho McNeil Pharmaceutical and is used for the management of psychotic disorders and Tourette's disorder, the company said in the filing.

The approved product has an estimated market size of about $27 million for the 12 months ended March 2026, the filing said, citing IQVIA data.

With this approval, Alembic has received a cumulative 240 ANDA approvals from the USFDA, comprising 221 final approvals and 19 tentative approvals.

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