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Pharma major Alembic Pharmaceuticals on Saturday, November 15, announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA).
The approval is for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg, and 120 mg strengths.
Diltiazem hydrochloride tablets are used to treat high blood pressure and angina.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina caused by coronary artery spasm.
Alembic now holds a cumulative total of 230 ANDA approvals from the USFDA, including 210 final approvals and 20 tentative approvals.
Shares of Alembic Pharmaceuticals Ltd. settled 1.28% lower on Friday at ₹904.20. The stock has declined 14% so far in 2025.
The approval is for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg, and 120 mg strengths.
Diltiazem hydrochloride tablets are used to treat high blood pressure and angina.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina caused by coronary artery spasm.
Alembic now holds a cumulative total of 230 ANDA approvals from the USFDA, including 210 final approvals and 20 tentative approvals.
Shares of Alembic Pharmaceuticals Ltd. settled 1.28% lower on Friday at ₹904.20. The stock has declined 14% so far in 2025.
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