Alembic Pharma gets USFDA nod for Tourette's Disorder treatment drug

Shares of Alembic Pharmaceuticals Ltd. rose from the day's lows on Friday, June 5, after the drugmaker received final approval from the US Food and Drug Administration (USFDA) for its generic version of Haloperidol Tablets.

In an exchange filing, the company said it has received USFDA approval for Haloperidol Tablets USP in strengths of 1 mg, 2 mg, 5 mg, 10 mg and 20 mg.

The approved product is therapeutically equivalent to Haldol Tablets, manufactured by Ortho McNeil Pharmaceutical, and will be marketed in the United States through the abbreviated new drug application (ANDA) route.

Haloperidol is used in the treatment of psychotic disorders and for the control of tics and vocal utterances associated with Tourette's Disorder in both children and adults.

According to IQVIA data cited by the company, the approved product has an estimated market size of $27 million in the United States for the 12 months ended March 2026.

The latest approval adds to Alembic's growing US generics portfolio. The company said it has now received a cumulative 240 ANDA approvals from the USFDA, comprising 221 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated pharmaceutical company engaged in the development, manufacturing and marketing of generic medicines across global markets, with a significant presence in the United States.

For the March quarter, the pharma company reported a 29% year-on-year growth in its consolidated net profit to ₹202 crore

from ₹157 crore a year earlier. Revenue rose 4.4% to ₹1,848 crore from ₹1,770 crore in the year-ago period. EBITDA declined 16.2% year-on-year to ₹228 crore from ₹272 crore, while EBITDA margin narrowed to 12.3% from 15.4% last year.

Shares of Alembic Pharmaceuticals gained following the announcement, and were trading 0.6% up at ₹742 as of 11.27 am. The stock has declined more than 11% so far this year.

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