Alembic Pharmaceuticals Limited has received final approval from the United States 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 approval further expands the company’s portfolio of generic medicines available in the United States and reinforces its commitment to providing high-quality and affordable treatment options across therapeutic categories.
The approved product is therapeutically equivalent to Haldol Tablets, marketed by Ortho McNeil Pharmaceutical, and is intended for the management of manifestations of psychotic disorders. The medication is also indicated for the control of tics and vocal utterances associated with Tourette’s Disorder in both children and adults. Healthcare professionals are advised to refer to the approved prescribing information for complete usage guidelines and safety information.
The approval represents another significant milestone for Alembic as it continues to strengthen its presence in regulated international markets. According to IQVIA data for the twelve-month period ending March 2026, the U.S. market for Haloperidol Tablets across the approved strengths is estimated at approximately US$27 million.
With this latest approval, Alembic has achieved a cumulative total of 240 ANDA approvals from the USFDA, comprising 221 final approvals and 19 tentative approvals. The milestone reflects the company’s sustained focus on product development, regulatory compliance, and manufacturing excellence.
Alembic’s research and development capabilities continue to play a central role in its global growth strategy. The company maintains advanced research centers and manufacturing facilities that comply with stringent international regulatory standards, enabling it to serve patients and healthcare providers across numerous markets worldwide.
The addition of Haloperidol Tablets to Alembic’s U.S. portfolio strengthens the company’s offering in the central nervous system (CNS) therapeutic segment while supporting broader efforts to improve access to essential medicines. The approval also highlights the company’s ability to navigate complex regulatory pathways and deliver products that meet the quality, safety, and efficacy standards required in highly regulated healthcare markets.
Established in 1907, Alembic Pharmaceuticals Limited is a vertically integrated pharmaceutical company engaged in research, development, manufacturing, and marketing of generic medicines. Headquartered in India, the company operates across global markets and is recognized as one of the leading branded generic pharmaceutical companies in the country. Supported by state-of-the-art manufacturing facilities and a field force of more than 5,500 professionals, Alembic continues to expand its presence while delivering innovative and accessible healthcare solutions to patients around the world.
