Risdiplam
Overview
Risdiplam is a small molecule designed to increase the production of the survival motor neuron (SMN) protein, thereby treating spinal muscular atrophy (SMA). It is an oral medication that modulates pre-mRNA splicing of the SMN2 gene to promote the inclusion of exon 7 during mRNA processing.
API suppliers (5)
Suppliers of Risdiplam 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 3 of 5 suppliers.
1 of 5 holds a GMP certificate on record in the EU or UK registers
- ALP PHARM BEIJING CO LTD1 active DMF
- TAPI NL BVNetherlands1 active DMF
- Natco PharmaIndia1 active DMF GMP on record
- SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDChina1 active DMF
- BIOPHORE INDIA PHARMACEUTICALS PVT LTD1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (2 approved US products), the latest listed US patent on Risdiplam expires 15 Apr 2041 and exclusivity 27 May 2029. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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