Ribociclib tablet 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 in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy.

Alembic has a cumulative total of 197 ANDA approvals (170 final approvals and 27 tentative approvals) from USFDA.