Fulvestrant

Overview

Fulvestrant is an estrogen receptor antagonist used in the treatment of hormone receptor-positive metastatic breast cancer. It binds to estrogen receptors and promotes their degradation, thereby inhibiting their biological activity.

API suppliers (14)

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

• STEROID SPAItaly1 active DMF GMP on record
• STERLING SPAItaly1 active DMF GMP on record
• INDUSTRIALE CHIMICA SRLItaly1 active DMF GMP on record
• TAPI NL BVNetherlands1 active DMF
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• WAVELENGTH ENTERPRISES LTDIsrael1 active DMF GMP on record
• GLAND PHARMA LTDIndia1 active DMF GMP on record
• HANGZHOU JIUYUAN GENE ENGINEERING CO LTDChina1 active DMF
• FARMABIOS SPAItaly1 active DMF
• SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDChina1 active DMF
• Jiangsu Hansoh Pharmaceutical Group Company LimitedChina1 active DMF GMP on record
• CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO LTDChina1 active DMF
• CHEM WERTH INC
• Teva Pharmaceutical Industries Ltd.Israel GMP on record

EU CEP holders (9)

Companies holding a valid EU Certificate of Suitability (CEP) for Fulvestrant, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (15 approved US products), the latest listed US patent on Fulvestrant expires 17 May 2034. Generic API sourcing typically opens up once these lapse.

Therapeutic areas