Azacitidine

Overview

Azacitidine is a chemical compound used primarily in the treatment of myelodysplastic syndromes. It is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity.

API suppliers (18)

Suppliers of Azacitidine 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
• OLON SPAItaly1 active DMF GMP on record
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• CHEMWERTH INCFrance1 active DMF
• SUZHOU YIFAN PHARMACEUTICAL CO LTD1 active DMF
• TAPI NL BVNetherlands1 active DMF
• Laurus Labs LimitedIndia1 active DMF GMP on record
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• Intas Pharmaceuticals Ltd.India1 active DMF GMP on record
• Chongqing Sintaho Pharmaceutical Co., Ltd.China1 active DMF
• Shandong Anhong Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• Hetero Labs LimitedIndia1 active DMF GMP on record
• Reliance Life Sciences Pvt. Ltd.India1 active DMF GMP on record
• ARTHUR GROUP LLCAustralia1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• MYLAN LABORATORIES LTD GMP on record
• EUTICALS SPAItaly

Patent & exclusivity (US)

Per the FDA Orange Book (16 approved US products), the latest listed US patent on Azacitidine expires 3 Jun 2030 and exclusivity 20 May 2029. Generic API sourcing typically opens up once these lapse.

Therapeutic areas