365Telugu.com online news ,Mumbai, 23rd May 2025: Alembic Pharmaceuticals Limited announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amlodipine and Atorvastatin Tablets USP. The approved strengths include 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 product is therapeutically equivalent to the Reference Listed Drug (RLD), Caduet Tablets, marketed by Pharmacia and Upjohn Co. LLC. Amlodipine and Atorvastatin tablets are prescribed for patients requiring both medications as part of their treatment regimen.
With this approval, Alembic now has a cumulative total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals.