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 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg strengths.
The ANDA is therapeutically equivalent to the reference listed drug product Haldol Tablets of Ortho McNeil Pharmaceutical. Haloperidol Tablets are indicated for management of manifestations of psychotic disorders. The tablets are also indicated for control of tics and vocal utterances of Tourette's Disorder in children and adults.
Haloperidol Tablets had an estimated US market size of US$ 27 million for the twelve months ending March 2026, based on IQVIA data. The figure captures sales across all approved strengths in the US market.
With this approval, Alembic's cumulative ANDA approvals from the USFDA total 240. This includes 221 final approvals and 19 tentative approvals.
Alembic Pharmaceuticals Limited has been operational since 1907 and is headquartered in Vadodara, India. Alembic is a vertically integrated company that manufactures and markets generic pharmaceutical products globally. Alembic's research and manufacturing facilities are approved by regulatory authorities including the USFDA.
Alembic is among the leaders in branded generics in India. Alembic's brands are marketed through a field force of over 5,500 representatives.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.