During the quarter ended March 31, 2024, Alembic Pharmaceuticals, a pharmaceutical company, announced the receipt of a product approval from the US Food and Drug Administration (USFDA). The approval, albeit tentative, marks a notable milestone for the company's pharmaceutical portfolio.

The approved product, Ribociclib Tablets (200 mg), is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib is to be used in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy. The innovator of this product is Novartis Pharmaceuticals Corporation, under the brand name Kisqali Tablets.

Alembic has a cumulative total of 197 Abbreviated New Drug Application (ANDA) approvals from the USFDA. Among these, 170 are final approvals, while 27 are tentative approvals.

Alembic Pharmaceuticals continues to expand its presence in the pharmaceutical market, leveraging its expertise in research, development, and regulatory compliance.