Bivalirudin
Overview
Bivalirudin is a protein active pharmaceutical ingredient (ChEMBL CHEMBL5314348).
API suppliers (9)
Suppliers of Bivalirudin 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 7 of 9 suppliers.
3 of 9 hold a GMP certificate on record in the EU or UK registers
- TAPI NL BVNetherlands1 active DMF
- DR REDDYS LABORATORIES LTD1 active DMF GMP on record
- ALP PHARM BEIJING CO LTD1 active DMF
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- SCINOPHARM TAIWAN LTDTaiwan1 active DMF
- HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDChina1 active DMF
- Shenzhen Salubris Pharmaceuticals Co., Ltd.China1 active DMF
- BACHEM INCSwitzerland1 active DMF GMP on record
- SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDChina1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (9 approved US products), the latest listed US patent on Bivalirudin expires 20 May 2039. Generic API sourcing typically opens up once these lapse.
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