Alembic Gets USFDA Approval for generic high blood pressure treatment drug

Key Highlights:

• Alembic Pharma receives USFDA final approval for its generic version of Amlodipine and Atorvastatin tablets.
• This marks Alembic’s 199th final ANDA approval, reinforcing its robust regulatory track record in the U.S. market.
• Despite sales growth in Q4 FY25, the company posted a 12% drop in net profit; stock closed slightly lower on the BSE.

Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amlodipine and Atorvastatin Tablets USP. 

This combination medication is used to allow for the treatment of two common cardiovascular conditions, hypertension and hyperlipidemia. As a result of this regulatory approval, Alembic’s formulation is now therapeutically equivalent to the reference listed drug, Caduet Tablets, which was marketed by Pharmacia and Upjohn Co. LLC.

Also read: Business Impact of USFDA Approvals on Indian Pharma Companies

The latest approval further consolidates Alembic Pharmaceuticals’ record of success in the U.S. generics market.  Alembic’s cumulative total of 223 ANDA approvals from the USFDA consists of 199 final approvals and 24 tentative approvals and represents the strength of the company’s regulatory history, and subsequent ability to provide high quality generic medications to global markets.

Alembic Pharmaceuticals is a research-based, vertically integrated pharmaceutical company with the ability to provide generic formulations in international markets. Alembic's facilities have received approvals from many health authorities including the USFDA, among others.