23-05-2025
Alembic Pharmaceuticals gets USFDA final approval for Amlodipine and Atorvastatin Tablets
By Aman Shukla Published on May 23, 2025, 12:01 IST
Alembic Pharmaceuticals Limited 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 product includes a range of dosage combinations: 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. These formulations are therapeutically equivalent to Caduet Tablets, the reference listed drug (RLD) marketed by Pharmacia and Upjohn Co. LLC.
Amlodipine and Atorvastatin Tablets are prescribed for patients who require treatment with both medications. The drug combines a calcium channel blocker and a statin to manage conditions such as high blood pressure and high cholesterol. The approval by the USFDA allows Alembic to market these tablets in the United States.
With this approval, Alembic now has a total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is an India-based pharmaceutical company involved in the development, manufacture, and marketing of generic pharmaceutical products. Established in 1907, the company is headquartered in Vadodara, Gujarat. Alembic operates research and manufacturing facilities that are approved by regulatory agencies including the USFDA and markets its products globally.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
