Palbociclib

Overview

Palbociclib is a selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor used in the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. It works by interfering with the growth and division of cancer cells.

API suppliers (24)

Suppliers of Palbociclib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• DR REDDYS LABORATORIES LTD1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• Apotex Inc.Canada1 active DMF
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• TAPI NL BVNetherlands1 active DMF
• Shandong Anhong Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• Hetero Labs LimitedIndia1 active DMF GMP on record
• SynthonNetherlands1 active DMF GMP on record
• CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD1 active DMF GMP on record
• SHIVALIK RASAYAN LTDIndia1 active DMF
• ZAKLADY FARMACEUTYCZNE POLPHARMA SA1 active DMF
• AARTI PHARMALABS LIMITEDIndia1 active DMF
• Zhejiang Ausun Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• SABA ILAC SANAYI VE TICARET AS1 active DMF
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• Intas Pharmaceuticals Ltd.India1 active DMF GMP on record
• Anhui Haoyuan Pharmaceutical Co., Ltd.China1 active DMF
• BIOPHORE INDIA PHARMACEUTICALS PVT LTD1 active DMF
• Zhejiang Hisun Pharmaceutical Co., Ltd.China GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (6 approved US products), the latest listed US patent on Palbociclib expires 19 Feb 2037 and exclusivity 16 Mar 2029. Generic API sourcing typically opens up once these lapse.

Therapeutic areas