Alembic Pharmaceuticals 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.
Amlodipine and Atorvastatin tablets are a combination medication used to treat high blood pressure (hypertension) and high cholesterol (hyperlipidemia).
The approved product is therapeutically equivalent to the reference listed drug, Caduet Tablets, marketed by Pharmacia and Upjohn Co. LLC.
The company now has a cumulative total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.
The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.
The counter shed 0.13% to Rs 971.25 on the BSE.
