Date: 5th June, 2026
Regulatory Approval Details
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Haloperidol Tablets, USP. The approval covers five dosage strengths: 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 of Ortho McNeil Pharmaceutical, in the same dosage strengths.
Product Information and Market Size
Haloperidol Tablets are indicated for:
- Management of manifestations of psychotic disorders
- Control of tics and vocal utterances of Tourette's Disorder in children and adults
According to IQVIA data, the estimated market size for Haloperidol Tablets, USP is US$ 27 million for the twelve months ending March 2026.
Company Approval Milestone
This approval brings Alembic Pharmaceuticals' cumulative total ANDA approvals from USFDA to 240, consisting of:
- 221 final approvals
- 19 tentative approvals
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide and is one of the leaders in branded generics in India. Alembic markets its brands through a field force of over 5,500 representatives.
The company's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.