Alembic Pharmaceuticals Secures US FDA Approval For Generic Entresto Tablets

This USFDA approval strengthens Alembic's position in the US market, granting it access to market opportunity for Sacubitril and Valsartan tablets.

Alembic Pharmaceuticals Limited (Alembic) has announced in its latest exchange filing that it received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan Tablets. These formulations are available in 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. The approved generic version is therapeutically equivalent to Entresto Tablets, a reference listed (RLD) drug manufactured by Novartis Pharmaceuticals Corporation

Sacubitril and Valsartan tablets are primarily prescribed to reduce the risk of cardiac death and hospitalization in adult patients with chronic heart failure in addition to treating systemic left ventricular systolic dysfunction symptomatic heart failure in pediatric patients they are one year and beyond as ended by IQVIA by March 2024. Twelve Sacubitril and Valsartan Tablets market size will be 5.0. It is estimated at $3 billion.

This recent approval brings Alembic's cumulative ANDA approvals from the USFDA to a total of 202, including 174 final approvals and 28 provisional approvals.

Founded in 1907, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, the company is publicly listed and has a global footprint in the manufacturing and marketing of generic pharmaceutical products. Alembic's state-of-the-art research and manufacturing facilities have received approvals from regulatory authorities in many developed countries, including the USFDA.

Alembic’s extensive portfolio of brands is supported by a dedicated marketing team of over 5,000 professionals, earning widespread recognition and trust from doctors and patients alike.