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Riluzole API from France Manufacturers & Suppliers
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Distributor
Produced in
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Employees: 25
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CoA
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Produced in
India|
Employees: 19
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CoA
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China|
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Taiwan|
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CoA
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India|
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WC|
CoAAll certificates
GMP
USDMF
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CoA
Producer
Produced in
India|
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Certifications:
USDMF
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CoAAll certificates
USDMF
CoA
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WC|
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CoA
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Producer
Produced in
Czech Republic|
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CoAAll certificates
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CoA
Producer
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WC|
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CoA
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Riluzole | CAS No: 1744-22-5 | GMP-certified suppliers
A medication that supports the management of amyotrophic lateral sclerosis by helping extend functional survival in patients with this progressive neurodegenerative disease across major regulated markets.
Therapeutic categories
AnticonvulsantsBCRP/ABCG2 SubstratesBenzothiazolesCentral Nervous System AgentsCentral Nervous System DepressantsCompounds used in a research, industrial, or household setting
Generic name
Riluzole
Molecule type
small molecule
CAS number
1744-22-5
DrugBank ID
DB00740
Approval status
Approved drug, Investigational drug
ATC code
N07XX02
Primary indications
- For the treatment of amyotrophic lateral sclerosis (ALS, Lou Gehrig's Disease)
Product Snapshot
- Riluzole is an oral small‑molecule API available in tablet and liquid suspension formulations
- Its primary therapeutic use is support of amyotrophic lateral sclerosis management
- It is approved in the US, EU, and Canada, with some investigational status in other markets
Clinical Overview
Riluzole (CAS 1744-22-5) is a benzothiazole derivative used for the treatment of amyotrophic lateral sclerosis. It is approved to modestly extend survival or delay the need for tracheostomy in ALS, a progressive neurodegenerative disorder characterized by loss of upper and lower motor neurons. The compound has also shown neuroprotective effects in experimental models of excitotoxic injury, although the pathophysiology of ALS remains incompletely understood.
Riluzole’s mechanism of action is not fully defined. Current evidence indicates that it reduces glutamatergic neurotransmission through inhibition of presynaptic glutamate release and enhancement of glutamate reuptake. It also inactivates voltage‑dependent sodium channels and may modulate intracellular signaling following activation of excitatory amino acid receptors. Through these combined effects, it is believed to mitigate excitotoxic stress that contributes to motor neuron injury.
Absorption occurs after oral administration, with systemic exposure influenced by hepatic first‑pass metabolism. Riluzole is extensively metabolized in the liver, primarily via CYP1A2, producing inactive metabolites. It is a substrate of the BCRP transporter. The elimination half‑life is moderate, and metabolites are excreted mainly in urine. Food effects and smoking status can alter exposure due to CYP1A2 variability.
Safety considerations include the potential for hepatic enzyme elevations, necessitating routine monitoring of liver function. Neutropenia has been reported rarely. Dose adjustments or careful assessment are required in patients with hepatic impairment. Drug interactions may occur with strong CYP1A2 inhibitors or inducers, which can increase or decrease riluzole exposure.
Riluzole is commercially available in several regions, with Rilutek being a well‑established reference product. Its use is confined to specialist management of ALS.
For API procurement, sourcing should prioritize suppliers with demonstrated control of benzothiazole‑related impurities, validated processes for CYP1A2‑sensitive materials, and full regulatory documentation, including stability data and evidence of GMP‑compliant manufacturing.
Riluzole’s mechanism of action is not fully defined. Current evidence indicates that it reduces glutamatergic neurotransmission through inhibition of presynaptic glutamate release and enhancement of glutamate reuptake. It also inactivates voltage‑dependent sodium channels and may modulate intracellular signaling following activation of excitatory amino acid receptors. Through these combined effects, it is believed to mitigate excitotoxic stress that contributes to motor neuron injury.
Absorption occurs after oral administration, with systemic exposure influenced by hepatic first‑pass metabolism. Riluzole is extensively metabolized in the liver, primarily via CYP1A2, producing inactive metabolites. It is a substrate of the BCRP transporter. The elimination half‑life is moderate, and metabolites are excreted mainly in urine. Food effects and smoking status can alter exposure due to CYP1A2 variability.
Safety considerations include the potential for hepatic enzyme elevations, necessitating routine monitoring of liver function. Neutropenia has been reported rarely. Dose adjustments or careful assessment are required in patients with hepatic impairment. Drug interactions may occur with strong CYP1A2 inhibitors or inducers, which can increase or decrease riluzole exposure.
Riluzole is commercially available in several regions, with Rilutek being a well‑established reference product. Its use is confined to specialist management of ALS.
For API procurement, sourcing should prioritize suppliers with demonstrated control of benzothiazole‑related impurities, validated processes for CYP1A2‑sensitive materials, and full regulatory documentation, including stability data and evidence of GMP‑compliant manufacturing.
Identification & chemistry
| Generic name | Riluzole |
|---|---|
| Molecule type | Small molecule |
| CAS | 1744-22-5 |
| UNII | 7LJ087RS6F |
| DrugBank ID | DB00740 |
Pharmacology
| Summary | Riluzole is a benzothiazole agent used in amyotrophic lateral sclerosis, thought to act primarily by modulating glutamatergic neurotransmission. It inhibits glutamate release, inactivates voltage‑dependent sodium channels, and affects intracellular signaling linked to excitatory amino acid receptors. Its pharmacodynamic profile aligns with reducing excitotoxic stress on motor neurons, consistent with its use in ALS. |
|---|---|
| Mechanism of action | The mode of action of riluzole is unknown. Its pharmacological properties include the following, some of which may be related to its effect: 1) an inhibitory effect on glutamate release (activation of glutamate reuptake), 2) inactivation of voltage-dependent sodium channels, and 3) ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors. |
| Pharmacodynamics | Riluzole, a member of the benzothiazole class, is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Riluzole extends survival and/or time to tracheostomy. It is also neuroprotective in various <i>in vivo</i> experimental models of neuronal injury involving excitotoxic mechanisms. The etiology and pathogenesis of amyotrophic lateral sclerosis (ALS) are not known, although a number of hypotheses have been advanced. One hypothesis is that motor neurons, made vulnerable through either genetic predisposition or environmental factors, are injured by glutamate. In some cases of familial ALS the enzyme superoxide dismutase has been found to be defective. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 5 subunit alpha | Humans | inhibitor |
| Cystine/glutamate transporter | Humans | inducer |
ADME / PK
| Absorption | Riluzole is well-absorbed (approximately 90%), with average absolute oral bioavailability of about 60% (CV=30%). A high fat meal decreases absorption, reducing AUC by about 20% and peak blood levels by about 45%. |
|---|---|
| Half-life | The mean elimination half-life of riluzole is 12 hours (CV=35%) after repeated doses. |
| Protein binding | 96% bound to plasma proteins, mainly to albumin and lipoprotein over the clinical concentration range. |
| Metabolism | Riluzole is extensively metabolized to six major and a number of minor metabolites, which have not all been identified to date. Metabolism is mostly hepatic, consisting of cytochrome P450–dependent hydroxylation and glucuronidation. CYP1A2 is the primary isozyme involved in N-hydroxylation; CYP2D6, CYP2C19, CYP3A4, and CYP2E1 are considered unlikely to contribute significantly to riluzole metabolism in humans. |
Formulation & handling
- Oral small-molecule benzothiazole with poor aqueous solubility, requiring solubility‑enhancing strategies for solid and liquid formulations.
- Absorption is reduced by food, so formulations may need to consider administration relative to meals to maintain consistent exposure.
- Chemically stable solid API; handle as a lipophilic compound (LogP 3.4) with appropriate excipients to control dissolution and variability.
Regulatory status
| Lifecycle | Most core patents for the API expired between 2012 and 2013 in Canada and the United States, with one secondary U.S. patent extending protection to 2024 and another to 2029. Across the US, Canada, and EU markets, the product is largely mature with expected generic availability except for elements still covered by the later‑expiring U.S. patent. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Riluzole supply is anchored by an originator manufacturer with additional production from generic firms such as Impax, supported by several secondary packagers. Branded and generic products are established across the US, EU, and Canada, indicating broad global availability. Multiple core patents have expired, and although a later‑expiring US patent remains in force until 2029, the presence of approved generics suggests ongoing competition. |
|---|
Riluzole is a type of Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Riluzole API manufacturers & distributors
Compare qualified Riluzole API suppliers worldwide. We currently have 11 companies offering Riluzole API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Alkem Labs. | Producer | India | India | CoA, USDMF | 22 products |
| Apotex Pharmachem | Producer | India | India | CoA, GMP, USDMF, WC | 10 products |
| Farmak | Producer | Czech Republic | Czech Republic | CoA, GMP | 19 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, USDMF, WC | 98 products |
| Sanofi | Producer | France | France | CoA, GMP | 93 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA | 762 products |
| Standard C&P | Producer | Taiwan | Taiwan | CoA, USDMF | 4 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
When sending a request, specify which Riluzole API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Riluzole API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Riluzole API
Sourcing
What matters most when sourcing GMP-grade Riluzole?
When sourcing GMP-grade Riluzole, confirm the supplier’s compliance with Canada, US, and EU regulatory standards. Assess supply stability by verifying that material originates from established manufacturers or approved generic producers. It is also important to account for the existing US patent lasting until 2029, as it may influence sourcing pathways despite the availability of generics.
Which documents are typically required when sourcing Riluzole API?
Request the core API documentation set: CoA (11 companies), GMP (8 companies), USDMF (5 companies), WC (3 companies), FDA (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Riluzole API?
Known or reported manufacturers for Riluzole: Global Pharma Tek, SETV Global, Sinoway industrial Co.,Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Riluzole API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Riluzole manufacturers?
Audit reports may be requested for Riluzole: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Riluzole API on Pharmaoffer?
Reported supplier count for Riluzole: 11 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Riluzole API?
Production countries reported for Riluzole: India (6 producers), China (1 producer), France (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Riluzole usually hold?
Common certifications for Riluzole suppliers: CoA (11 companies), GMP (8 companies), USDMF (5 companies), WC (3 companies), FDA (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Riluzole (CAS 1744-22-5) used for?
Riluzole is used for the treatment of amyotrophic lateral sclerosis, where it helps modestly extend survival or delay the need for tracheostomy. It acts by reducing glutamatergic neurotransmission and inactivating voltage‑dependent sodium channels, thereby mitigating excitotoxic motor‑neuron injury.
Which therapeutic class does Riluzole fall into?
Riluzole belongs to the following therapeutic categories: Anticonvulsants, BCRP/ABCG2 Substrates, Benzothiazoles, Central Nervous System Agents, Central Nervous System Depressants. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Riluzole mainly prescribed for?
The primary indications for Riluzole: For the treatment of amyotrophic lateral sclerosis (ALS, Lou Gehrig's Disease). These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Riluzole work?
The mode of action of Riluzole is unknown. Its pharmacological properties include the following, some of which may be related to its effect: 1) an inhibitory effect on glutamate release (activation of glutamate reuptake), 2) inactivation of voltage-dependent sodium channels, and 3) ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors.
What should someone know about the safety or toxicity profile of Riluzole?
Riluzole’s main safety concerns include dose‑related elevations in hepatic enzymes, which require baseline and periodic liver function monitoring. Rare cases of neutropenia have been reported, so unexplained fever or infection should prompt evaluation. Exposure can increase or decrease with CYP1A2 inhibitors or inducers, and hepatic impairment may necessitate dose adjustments. Food effects and smoking status can also alter drug levels due to CYP1A2 variability.
What are important formulation and handling considerations for Riluzole as an API?
Important considerations include its poor aqueous solubility, which requires solubility‑enhancing approaches such as appropriate solid dispersion or wetting agents to ensure consistent dissolution. Because food reduces absorption, formulations should support administration on an empty stomach to limit variability in exposure. The API is chemically stable but lipophilic, so it should be handled with excipients suited for lipophilic compounds and processed to maintain uniformity and control dissolution performance.
Is Riluzole a small molecule?
Riluzole is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Riluzole?
Oral Riluzole has poor aqueous solubility, so solid and liquid formulations require solubility‑enhancing approaches and excipients that support controlled dissolution of this lipophilic compound. Although the API is chemically stable in solid form, food—especially high‑fat meals—reduces absorption, so administration relative to meals should be considered to maintain consistent exposure. These factors, rather than intrinsic chemical instability, are the primary formulation‑related stability concerns.
Regulatory
Where is Riluzole approved or in use globally?
Riluzole is reported as approved in the following major regions: Canada, US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Riluzole right now?
Riluzole is approved for use in Canada, the United States, and the European Union. Its original patents have expired, and the ingredient is widely available in generic form. Current regulation focuses on maintaining quality and compliance with regional manufacturing and labeling standards across these markets.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Riluzole procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Riluzole. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Riluzole included in the PRO Data Insights coverage?
PRO Data Insights coverage for Riluzole: 258 verified transactions across 78 suppliers and 59 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Riluzole?
Market report availability for Riluzole: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
