Riluzole
Overview
Riluzole is a drug that modulates glutamatergic neurotransmission and is primarily used in the treatment of amyotrophic lateral sclerosis (ALS), a disease that affects the nerve cells in the brain and spinal cord. It works by diminishing the release of glutamate, which is often associated with the neurodegenerative processes in ALS.
API suppliers (9)
Suppliers of Riluzole 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.
6 of 9 hold a GMP certificate on record in the EU or UK registers
- ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- Alkem Laboratories LimitedIndia1 active DMF GMP on record
- SYN-TECH CHEM AND PHARM CO LTDTaiwan1 active DMF
- SCINOPHARM TAIWAN LTDTaiwan1 active DMF
- Hetero Drugs LimitedIndia1 active DMF GMP on record
- Apotex Pharmachem India Pvt. Ltd.India
- DR REDDYS LABORATORIES LTD GMP on record
- ESTEVE QUIMICA SA GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (6 approved US products), the latest listed US patent on Riluzole expires 12 Mar 2029. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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