Alembic Pharma receives USFDA approval for Haloperidol tablets

Alembic Pharmaceuticals announced that it has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) 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 the reference listed drug, Haldol Tablets, of Ortho McNeil Pharmaceutical. According to IQVIA data, the product had an estimated market size of approximately $27 million in the United States for the 12 months ended March 2026.

Following the approval, Alembic Pharmaceuticals has a cumulative total of 240 ANDA approvals from the USFDA, comprising 221 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.

The company?s consolidated net profit jumped 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026.

Shares of Alembic Pharmaceuticals rose 0.92% to Rs 742.50 on the BSE.

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