Imatinib
Overview
Imatinib is a tyrosine kinase inhibitor used in the treatment of multiple cancers, most notably chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It works by inhibiting the BCR-ABL tyrosine kinase, which is critical for the proliferation of cancer cells.
API suppliers (14)
Suppliers of Imatinib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 13 of 14 suppliers.
8 of 14 hold a GMP certificate on record in the EU or UK registers
- FIS FABBRICA ITALIANA SINTETICI SPAItaly2 active DMF GMP on record
- Hetero Labs LimitedIndia2 active DMF GMP on record
- Natco Pharma Usa2 active DMF
- ACEBRIGHT INDIA PHARMA PRIVATE LTDIndia2 active DMF
- Zydus Lifesciences LimitedIndia1 active DMF GMP on record
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
- Shandong Anxin Pharmaceutical Co., Ltd.China1 active DMF GMP on record
- Laurus Labs LimitedIndia1 active DMF GMP on record
- Cipla USA, Inc.USA1 active DMF
- TAPI NL BVNetherlands1 active DMF
- SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
- WAVELENGTH ENTERPRISES LTDIsrael GMP on record
- Intas Pharmaceuticals Ltd.India GMP on record
- Cadila Healthcare LimitedIndia
Patent & exclusivity (US)
Per the FDA Orange Book (27 approved US products), the latest listed US patent on Imatinib expires 27 Apr 2040. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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