Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated November 15, 2025, titled "Alembic Pharmaceuticals Limited announces USFDA Final Approval for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg".
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Awaiting price reaction for this filing.
Alembic Pharmaceuticals has received final approval from the USFDA for its generic Diltiazem Hydrochloride Tablets in four strengths: 30 mg, 60 mg, 90 mg, and 120 mg. Diltiazem is a widely used calcium channel blocker prescribed for high blood pressure and chest pain (angina). Final approval means Alembic can now commercially launch and sell this product in the US market. The company already has an established US generics business, and this addition strengthens its cardiology portfolio in that market. The size of the addressable US market for this molecule runs into tens of millions of dollars annually, though pricing will depend on existing competition from other generic players.
Mildly positive for shareholders — the approval adds another product to Alembic's US revenue pipeline, but the stock is unlikely to move sharply given that Diltiazem is a mature, highly competitive generic molecule with limited pricing power.