India Pharma Outlook Team | Friday, 05 June 2026
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Haloperidol Tablets in multiple strengths, marking another addition to its regulated market product pipeline.
The approved product includes Haloperidol Tablets USP in 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg strengths.
The generic version is therapeutically equivalent to the reference listed drug (RLD), Haldol Tablets, originally marketed by Ortho-McNeil Pharmaceutical.
Haloperidol is used in the treatment of psychotic disorders and is also prescribed for controlling tics and vocal utterances associated with Tourette’s disorder in children and adults.
The approval further strengthens Alembic Pharma’s presence in the US generics market, one of the most competitive and regulated pharmaceutical markets globally.
The segment continues to remain a key growth driver for Indian drugmakers with strong regulatory capabilities.
As per industry estimates, the Haloperidol tablet market is valued at around USD 27 million for the twelve months ending March 2026 (IQVIA), reflecting steady demand in the central nervous system (CNS) therapeutic category.
With this addition, Alembic continues to build depth in niche therapeutic segments while expanding its portfolio of complex and high-barrier generics in regulated markets.
Alembic Pharmaceuticals has maintained a strong approval track record with the USFDA, securing a cumulative total of 240 ANDA approvals, including 221 final approvals and 19 tentative approvals.
In recent years, the company has steadily expanded its US product basket with multiple generic launches across therapeutic areas, including cardiovascular, anti-infectives, dermatology, and CNS segments. Its strategy has focused on developing difficult-to-manufacture generics and improving scale in regulated markets rather than high-volume commodity products.
The latest approval aligns with this approach, reinforcing Alembic’s position as a consistent filer and approver in the US generics space.
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Going forward, Alembic Pharma is expected to continue focusing on complex generics, niche molecules, and high-entry-barrier products in the US market, where competition is relatively lower compared to commoditised generics.
The company’s pipeline is likely to remain anchored in CNS, anti-infectives, and dermatology segments, along with select differentiated formulations aimed at improving margin stability. Increasing regulatory approvals from the USFDA also strengthen its ability to scale launches in the coming quarters.
However, pricing pressure in the US generics market remains a structural challenge, making continuous product approvals and portfolio diversification critical for sustaining growth momentum.
The USFDA approval for Haloperidol Tablets adds to Alembic Pharma’s expanding US portfolio and reinforces its regulatory strength. With a steady pipeline of complex generics and a focus on niche therapeutic areas, the company is positioned to maintain a stable growth trajectory in the competitive US market.
Alembic Pharmaceuticals is a vertically integrated Indian pharmaceutical company engaged in research, development, manufacturing, and global marketing of generic formulations and APIs. Headquartered in Vadodara, it has a strong presence in regulated markets, especially the US, with a wide therapeutic portfolio.
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