Cladribine
Overview
Cladribine is a chemotherapeutic agent used for the treatment of hairy cell leukemia and as an immunosuppressive agent in multiple sclerosis. It works by interfering with the growth of certain white blood cells, which helps in reducing the proliferation of cancer cells.
API suppliers (7)
Suppliers of Cladribine 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 5 of 7 suppliers.
3 of 7 hold a GMP certificate on record in the EU or UK registers
- BIOPHORE INDIA PHARMACEUTICALS PVT LTD1 active DMF
- SCINOPHARM TAIWAN LTDTaiwan1 active DMF
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
- RELIABLE BIOPHARMACEUTICAL CORPUnited States1 active DMF
- Zhejiang Hisun Pharmaceutical Co., Ltd.China1 active DMF GMP on record
- AXITEC CO LTD
- CILAG AGSwitzerland GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (6 approved US products), the latest listed US patent on Cladribine expires 10 Sept 2041. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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