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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
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’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. |
|---|
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
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 | 758 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
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Technical
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Regulatory
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