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Modafinil | CAS No: 68693-11-8 | GMP-certified suppliers
A medication that supports improved wakefulness in patients with excessive daytime sleepiness linked to narcolepsy, serving key needs for sleep‑wake disorder management.
Therapeutic categories
Benzene DerivativesBenzhydryl CompoundsCentral Nervous System AgentsCentral Nervous System StimulantsCentral Nervous System StimulationCentrally Acting Sympathomimetics
Generic name
Modafinil
Molecule type
small molecule
CAS number
68693-11-8
DrugBank ID
DB00745
Approval status
Approved drug, Investigational drug
ATC code
N06BA07
Primary indications
- To improve wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy
Product Snapshot
- Modafinil is an oral small‑molecule product supplied mainly as tablets and liquid‑filled capsules
- Its primary use is to promote wakefulness in excessive daytime sleepiness associated with narcolepsy
- It is marketed in the US and Canada with both approved and investigational regulatory statuses
Clinical Overview
Modafinil (CAS 68693-11-8) is a diphenylmethane derivative classified as a centrally acting wakefulness‑promoting agent. It is approved to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Clinical use is focused on mitigating pathological sleep–wake disruption rather than treating general fatigue or nonspecific low energy.
Modafinil’s pharmacological profile reflects stimulant and sympathomimetic activity with a mechanism that remains only partially defined. In vitro studies show inhibition of dopamine reuptake through binding to the dopamine transporter, leading to increased extracellular dopamine. Additional findings include activation of glutamatergic pathways and suppression of GABAergic transmission. Modafinil also activates orexin neurons, which are central to wakefulness regulation. Indirect modulation of noradrenergic signaling in the ventrolateral preoptic area and partial alpha‑1B adrenergic agonist effects have been described.
Available pharmacodynamic evidence indicates lower euphoric potential than classical psychostimulants, although psychoactivation can occur. Beyond approved indications, modafinil has been examined in investigational settings such as hypersomnia and substance use disorders, without constituting established therapeutic uses.
Absorption is generally adequate after oral administration, and the compound undergoes hepatic metabolism involving multiple cytochrome P450 pathways, including CYP3A substrates and inducer activity, and inhibitory or inducer effects on CYP1A2, CYP2B6, CYP2C9, and CYP2C19. These interactions can influence co‑administered drugs and warrant attention in clinical and formulation planning. Elimination occurs primarily via metabolism, with renal excretion of metabolites.
Safety considerations include headache, insomnia, anxiety, and, less frequently, dermatologic or hypersensitivity reactions. Cardiovascular monitoring may be warranted in susceptible populations due to sympathomimetic effects. Modafinil is controlled or prescription‑restricted in many jurisdictions.
Commonly referenced brand contexts include formulations historically marketed for narcolepsy management.
For API procurement, suppliers should demonstrate control of stereochemical purity, residual solvent compliance, and analytical methods aligned with pharmacopoeial or regulatory expectations, supported by complete stability data and a transparent impurity profile.
Modafinil’s pharmacological profile reflects stimulant and sympathomimetic activity with a mechanism that remains only partially defined. In vitro studies show inhibition of dopamine reuptake through binding to the dopamine transporter, leading to increased extracellular dopamine. Additional findings include activation of glutamatergic pathways and suppression of GABAergic transmission. Modafinil also activates orexin neurons, which are central to wakefulness regulation. Indirect modulation of noradrenergic signaling in the ventrolateral preoptic area and partial alpha‑1B adrenergic agonist effects have been described.
Available pharmacodynamic evidence indicates lower euphoric potential than classical psychostimulants, although psychoactivation can occur. Beyond approved indications, modafinil has been examined in investigational settings such as hypersomnia and substance use disorders, without constituting established therapeutic uses.
Absorption is generally adequate after oral administration, and the compound undergoes hepatic metabolism involving multiple cytochrome P450 pathways, including CYP3A substrates and inducer activity, and inhibitory or inducer effects on CYP1A2, CYP2B6, CYP2C9, and CYP2C19. These interactions can influence co‑administered drugs and warrant attention in clinical and formulation planning. Elimination occurs primarily via metabolism, with renal excretion of metabolites.
Safety considerations include headache, insomnia, anxiety, and, less frequently, dermatologic or hypersensitivity reactions. Cardiovascular monitoring may be warranted in susceptible populations due to sympathomimetic effects. Modafinil is controlled or prescription‑restricted in many jurisdictions.
Commonly referenced brand contexts include formulations historically marketed for narcolepsy management.
For API procurement, suppliers should demonstrate control of stereochemical purity, residual solvent compliance, and analytical methods aligned with pharmacopoeial or regulatory expectations, supported by complete stability data and a transparent impurity profile.
Identification & chemistry
| Generic name | Modafinil |
|---|---|
| Molecule type | Small molecule |
| CAS | 68693-11-8 |
| UNII | R3UK8X3U3D |
| DrugBank ID | DB00745 |
Pharmacology
| Summary | Modafinil is a wakefulness‑promoting agent that enhances dopaminergic signaling primarily through inhibition of the dopamine transporter, with additional effects on noradrenergic, glutamatergic, and GABAergic pathways. It also activates orexin-producing neurons involved in maintaining arousal. These combined actions support its use in conditions characterized by excessive daytime sleepiness. |
|---|---|
| Mechanism of action | The exact mechanism of action is unclear, although <i>in vitro</i> studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA. Modafinil is thought to have less potential for abuse than other stimulants due to the absence of any significant euphoric or pleasurable effects. It is possible that modafinil acts by a synergistic combination of mechanisms including direct inhibition of dopamine reuptake, indirect inhibition of noradrenalin reuptake in the VLPO and orexin activation. Modafinil has partial alpha 1B-adrenergic agonist effects by directly stimulating the receptors. |
| Pharmacodynamics | Modafinil is a stimulant drug marketed as a 'wakefulness promoting agent' and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. The prexin neuron activation is associated with psychoactivation and euphoria. Modafinil is not indicated for complaints of lack of energy or fatigue; but it appears to be very helpful for some patients. Also, it has been used in the treatment of hypersomnia, a disorder in which patients lack the capacity for meaningful sleep and may require ten or more hours per day. Recent studies have have found that modafinil may help recovering cocaine addicts fight their addiction. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent dopamine transporter | Humans | inhibitor |
| Alpha-1B adrenergic receptor | Humans | partial agonist |
ADME / PK
| Absorption | Rapid following oral administration. |
|---|---|
| Half-life | 23-215 hours |
| Protein binding | 60% |
| Metabolism | Hepatic |
| Route of elimination | The major route of elimination is metabolism (~90%), primarily by the liver, with subsequent renal elimination of the metabolites. |
| Volume of distribution | * 0.9 L/kg |
Formulation & handling
- Oral small‑molecule API with moderate lipophilicity and low aqueous solubility, often requiring solubility‑enhancing excipients for tablet or capsule formulations.
- Chemical and physical stability are generally good for solid oral dosage forms, with no special food‑related absorption concerns.
- Handling as a crystalline solid is straightforward, though attention to uniform dispersion is needed for low‑solubility actives in high‑load formulations.
Regulatory status
| Lifecycle | The API is long off‑patent in Canada and became fully non‑patent‑protected in the United States after the final expiry in 2024. With marketing limited to Canada and the US, the product now sits in a mature, post‑exclusivity phase across both markets. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Modafinil was originally developed and commercialized by a single originator company, with a wide network of secondary manufacturers and packagers supporting distribution. Branded and generic products are established in the US and Canada, indicating mature market penetration beyond the originator. Key patents have already expired in both regions, with the final US patent ending in 2024, supporting the presence and continued expansion of generic competition. |
|---|
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Modafinil 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.
Modafinil API manufacturers & distributors
Compare qualified Modafinil API suppliers worldwide. We currently have 5 companies offering Modafinil API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Flamma | Producer | Italy | Italy | CoA, GMP | 6 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Mylan | Producer | India | India | CEP, CoA, USDMF, WC | 201 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| ZCL Chemicals | Producer | India | India | CoA, Other, FDA, ISO9001 | 30 products |
When sending a request, specify which Modafinil 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 Modafinil 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 Modafinil API
Sourcing
What matters most when sourcing GMP-grade Modafinil?
Key considerations include verifying that the manufacturer operates under GMP standards recognized in the US and Canada and can provide complete regulatory documentation. It is also important to confirm traceability through a reliable supply chain, as Modafinil now has multiple generic producers following patent expiry. Consistent quality, validated processes, and compliance with regional import requirements help ensure suitability for pharmaceutical use.
Which documents are typically required when sourcing Modafinil API?
Request the core API documentation set: CoA (5 companies), GMP (3 companies), USDMF (2 companies), CEP (2 companies), FDA (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Modafinil API?
Known or reported manufacturers for Modafinil: SETV Global, LGM Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Modafinil 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 Modafinil manufacturers?
Audit reports may be requested for Modafinil: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Modafinil API on Pharmaoffer?
Reported supplier count for Modafinil: 5 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Modafinil API?
Production countries reported for Modafinil: India (3 producers), Italy (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Modafinil usually hold?
Common certifications for Modafinil suppliers: CoA (5 companies), GMP (3 companies), USDMF (2 companies), CEP (2 companies), FDA (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Modafinil (CAS 68693-11-8) used for?
Modafinil is used to promote wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Its clinical role is limited to addressing pathological sleep–wake disruption rather than general fatigue.
Which therapeutic class does Modafinil fall into?
Modafinil belongs to the following therapeutic categories: Benzene Derivatives, Benzhydryl Compounds, Central Nervous System Agents, Central Nervous System Stimulants, Central Nervous System Stimulation. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Modafinil mainly prescribed for?
The primary indications for Modafinil: To improve wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Modafinil work?
The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA. Modafinil is thought to have less potential for abuse than other stimulants due to the absence of any significant euphoric or pleasurable effects. It is possible that Modafinil acts by a synergistic combination of mechanisms including direct inhibition of dopamine reuptake, indirect inhibition of noradrenalin reuptake in the VLPO and orexin activation. Modafinil has partial alpha 1B-adrenergic agonist effects by directly stimulating the receptors.
What should someone know about the safety or toxicity profile of Modafinil?
Modafinil’s safety profile includes headache, insomnia, anxiety, and occasional dermatologic or hypersensitivity reactions. Its sympathomimetic activity means cardiovascular monitoring may be appropriate for susceptible individuals. Because it induces or inhibits several CYP450 enzymes, clinically relevant drug–drug interactions are possible. It is prescription‑restricted in many regions due to psychoactive properties, although its euphoric potential appears lower than classical stimulants.
What are important formulation and handling considerations for Modafinil as an API?
Modafinil’s low aqueous solubility and moderate lipophilicity often require solubility‑enhancing excipients to achieve uniform dissolution in tablet or capsule formulations. Its solid‑state stability supports conventional oral dosage manufacturing, but careful dispersion is important when processing high‑load blends. Standard handling of the crystalline powder is generally sufficient, with attention to maintaining uniformity during mixing and compression.
Is Modafinil a small molecule?
Modafinil is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Modafinil?
Oral Modafinil generally shows good chemical and physical stability in solid dosage forms. Its low aqueous solubility may require solubility‑enhancing excipients, and uniform dispersion of the crystalline API should be maintained during formulation. No special stability issues related to food or routine handling are noted for the oral form.
Regulatory
Where is Modafinil approved or in use globally?
Modafinil is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Modafinil right now?
In the United States and Canada, Modafinil is regulated as a prescription drug. The original Modafinil patents have expired in both markets, and the product is available in generic form. Regulatory oversight focuses on quality, safety, and adherence to prescription‑only status.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Modafinil procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Modafinil. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Modafinil included in the PRO Data Insights coverage?
PRO Data Insights coverage for Modafinil: 586 verified transactions across 143 suppliers and 105 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Modafinil?
Market report availability for Modafinil: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
