Alembic Pharma Receives Tentative Approval for Ribociclib Tablets

Vadodara: Alembic Pharma has informed in a BSE filing that the Company has received tentative approval for Ribociclib Tablets, 200 mg, from the US Food & Drug Administration (USFDA) during the quarter ended 31st March, 2024. The product is the generic equivalent of Novartis Pharmaceuticals Corporation's Kisqali tablets.

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

Company Achievements and Appointments

Alembic has a cumulative total of 197 ANDA approvals (170 final approvals and 27 tentative approvals) from USFDA. The Company has also recently appointed Manish Kejriwal as an Independent Director of the company for the period of five consecutive years effective from March 31, 2024. Kejriwal brings over 30 years of experience in private equity investments and is currently the founder and Managing Partner of Kedaara Capital.

Read also: Alembic Pharma ropes in Manish Kejriwal as Independent Director

About Alembic Pharmaceuticals

Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. The company was founded in 1907. Alembic's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

Read also: Alembic Pharma Slashes the Price of Tofastar by 50% for Benefit of Rheumatoid Arthritis Patients