Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated Jun 05, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Haloperidol Tablets, USP."
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Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for Haloperidol Tablets, USP. Haloperidol is a generic antipsychotic medication used to treat schizophrenia and other psychiatric conditions. With this approval, Alembic can now manufacture and market this product in the US market. This adds to the company's growing portfolio of USFDA-approved generic products. The approval strengthens Alembic's presence in the US generics market and supports its export-driven revenue model.
This is a positive development for shareholders as it opens up a new revenue stream from US generic sales. The US market is a key growth area for Indian pharma companies, and such approvals typically contribute incrementally to top-line growth, though the exact revenue impact depends on market share captured and pricing.