Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Haldol Tablets, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, of Ortho McNeil Pharmaceutical (Ortho McNeil).
Haloperidol Tablets are indicated for: i) use in the management of manifestations of psychotic disorders and ii) the control of tics and vocal utterances of Tourette’s Disorder in children and adults.
Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, have an estimated market size of $27 million for twelve months ending March 2026 according to IQVIA. The company has a cumulative total of 240 ANDA approvals (221 final approvals and 19 tentative approvals) from USFDA.
Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1783.55 |
| Dr. Reddys Lab | 1277.80 |
| Cipla | 1400.70 |
| Zydus Lifesciences | 1088.90 |
| Lupin | 2268.10 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: