Alembic Pharmaceuticals’ stock inched over 2% higher after the company announced that it has secured final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg and 120 mg strengths. This approval clears Alembic to market the drug as a therapeutically equivalent version of Cardizem, the reference medicine sold by Bausch Health US, LLC.
Diltiazem Hydrochloride Tablets are widely prescribed to manage chronic stable angina and angina triggered by coronary artery spasms. The complete prescribing information is available on the official product label, but the approval essentially gives Alembic another steady opportunity within the cardiovascular drug segment in the US market.
With this clearance, Alembic’s cumulative number of approved ANDAs in the US now reaches 230, out of which 210 are final approvals and 20 are tentative. The company continues to expand its portfolio in regulated markets, strengthening its footprint in complex and competitive therapeutics.
Alembic Pharmaceuticals shares were up 2.19% at ₹923.85 apiece around 10.00 am. It has declined 11.93% this year, so far.
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