Alembic Pharmaceuticals Limited 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. According to the company's latest announcement, the approved product is therapeutically equivalent to the reference listed drug, Haldol Tablets, of Ortho McNeil Pharmaceutical. The product is indicated for use in the management of manifestations of psychotic disorders and the control of tics and vocal utterances of Tourette's Disorder in children and adults. As per IQVIA data, the approved product had an estimated market size of approximately $27 million in the United States for the 12 months ended March 2026.
As reported by IQVIA data, the approved product had an estimated market size of approximately $27 million in the United States for the 12 months ended March 2026. This approval expands Alembic Pharmaceuticals' portfolio in the psychiatric medications segment and adds to the company's growing US generics portfolio. The product addresses a significant market need in the treatment of psychotic disorders and Tourette's Disorder management across both pediatric and adult populations.
Following this approval, Alembic Pharmaceuticals has achieved a cumulative total of 240 ANDA approvals from the USFDA, comprising 221 final approvals and 19 tentative approvals, according to CNBC TV18, HDFC Securities, and Capital Market News. The company operates as a vertically integrated research and development pharmaceutical company that manufactures and markets generic pharmaceutical products globally, with a significant presence in the United States.
According to Capital Market News, Alembic Pharmaceuticals delivered robust financial results in Q4 FY26, with consolidated net profit jumping 29.19% to ₹202.70 crore compared to ₹156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year-on-year to ₹1,847.72 crore in the quarter ended March 31, 2026. The company's research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.
According to Capital Market News, Alembic Pharmaceuticals shares rose 0.92% to ₹742.50 on the BSE following the regulatory update, demonstrating positive investor sentiment towards the company's US generics business expansion. The stock has gained following the announcement, though it has declined more than 11% so far this year. The counter recovered from early session lows and moved above ₹740 during midday trade as investors tracked developments in the company's US generics business.
