Alembic Pharma gets tentative USFDA nod for breast cancer drug Ribociclib in March Quarter

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-04-02 09:47 GMT   |   Update On 2024-04-02 09:47 GMT
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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 31 st March, 2024

The product is the generic equivalent of Novartis Pharmaceuticals Corporation' Kisqali tablets.

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.
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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

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

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