Alembic Pharmaceuticals gets USFDA’s nod for Amlodipine and Atorvastatin Tablets

23 May 2025 Evaluate

Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg. 

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Caduet Tablets, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of Pharmacia and Upjohn Co. LLC. 

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Alembic has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from USFDA. 

Alembic Pharmaceuticals is principally engaged in the manufacturing and selling of pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.


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