Levetiracetam API from Chinese Manufacturers & Suppliers
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Levetiracetam | CAS No: 102767-28-2 | GMP-certified suppliers
A medication that supports epilepsy management by providing adjunctive control of partial onset, myoclonic, and primary generalized tonic‑clonic seizures across key patient groups.
Therapeutic categories
Primary indications
- Levetiracetam is indicated as an adjunctive therapy in the treatment of partial onset seizures in epileptic patients who are one month of age and older
- Additionally, it is indicated as an adjunct in the treatment of myoclonic seizures in patients with juvenile myoclonic epilepsy who are 12 years of age and older, and in primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy who are 6 years of age and older
- Levetiracetam is also available as an orally dissolvable tablet that is indicated as an adjunct in the treatment of partial onset seizures in patients with epilepsy who are 4 years of age and older and weigh more than 20kg
Product Snapshot
- Levetiracetam is an oral and parenteral small‑molecule anticonvulsant supplied in tablets, solutions, granules, and injectable concentrates
- It is used as adjunct therapy for partial‑onset, myoclonic, and primary generalized tonic‑clonic seizures across multiple epilepsy subtypes
- It is approved in major regulated markets including the US, EU, and Canada
Clinical Overview
Levetiracetam has a pharmacological profile distinct from other antiepileptic drugs. It suppresses hypersynchronized epileptiform burst firing without impairing normal neuronal transmission. The exact mechanism remains incompletely defined, but high‑affinity binding to synaptic vesicle protein 2A appears central to its anticonvulsant action. SV2A is widely expressed in the central nervous system and participates in vesicle exocytosis and synaptic vesicle availability. Levetiracetam may inhibit excessive neurotransmitter release under pathological conditions without altering physiologic signaling. Additional experimental findings include indirect modulation of GABAergic neurotransmission and inhibition of N‑type calcium channels, though their relevance to clinical efficacy is not established.
Levetiracetam displays predictable pharmacokinetics, minimal metabolism, and low potential for drug interactions. Absorption after oral administration is rapid and extensive. It has limited protein binding, is primarily excreted unchanged in urine, and has linear dose–exposure relationships. These features contribute to its wide therapeutic index.
Safety considerations include the class warning for increased risk of suicidal ideation or behavior. Monitoring for mood changes, behavioral abnormalities, and emerging depressive symptoms is recommended. Levetiracetam is generally not associated with significant pharmacokinetic interactions, but dose adjustments may be required in renal impairment due to its predominant renal clearance.
For API procurement, emphasis should be placed on verifying impurity profiles, particle‑size consistency for solid oral formulations, and compliance with pharmacopeial specifications and regional regulatory requirements to support global manufacturing and submission needs.
Identification & chemistry
| Generic name | Levetiracetam |
|---|---|
| Molecule type | Small molecule |
| CAS | 102767-28-2 |
| UNII | 44YRR34555 |
| DrugBank ID | DB01202 |
Pharmacology
| Summary | Levetiracetam is an anti‑seizure agent whose activity is primarily linked to high‑affinity binding to synaptic vesicle protein 2A, a regulator of vesicle exocytosis and neurotransmitter release. This interaction is thought to modulate hypersynchronized neuronal firing under pathophysiologic conditions while sparing normal synaptic transmission. Additional observations include effects on N‑type calcium channels and indirect modulation of GABAergic signaling, though their contributions to its therapeutic action remain unclear. |
|---|---|
| Mechanism of action | The exact mechanism through which levetiracetam exerts its anti-epileptic effects is unclear, but is thought to be unique amongst other anti-epileptic medications. Current knowledge suggests that levetiracetam’s binding to synaptic vesicle protein 2A (SV2A) is a key driver of its action. SV2A is a membrane-bound protein that is found on synaptic vesicles and is ubiquitous throughout the CNS- it appears to play a role in vesicle exocytosisand in the modulation of synaptic transmission by increasing the available amount of secretory vesicles available for neurotransmission.Stimulation of pre-synaptic SV2A by levetiracetam may inhibit neurotransmitter release,but this action does not appear to affect normal neurotransmission. This has led to the suggestion that levetiracetam exclusively modulates the function of SV2A only under pathophysiological conditions.Levetiracetam and related analogues showed a correlation between affinity for SV2A and anti-epileptic potency, further suggesting that action at this site contributes to the anti-epileptic activity of the drug. Levetiracetam has also been shown to indirectly affect GABAergic neurotransmission (despite having no direct effect on GABAergic or glutamatergic receptors) and modulate ionic currents.Similarly, levetiracetam has been shown in vitro to inhibit N-type calcium channels.How, or even if, these actions are implicated in its anti-epileptic action have yet to be elucidated. |
| Pharmacodynamics | Levetiracetam appears to prevent seizure activity via the selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission, though the exact mechanism through which this occurs is unclear.The therapeutic index of levetiracetam is wide,making it relatively unique amongst other anti-epileptic medications. Anti-epileptic drugs, including levetiracetam, may increase the risk of suicidal ideation or behaviour - patients taking levetiracetam should be monitored for the emergence or worsening of depressive symptoms, suicidal ideation, and behavioural abnormalities. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Voltage-dependent N-type calcium channel subunit alpha-1B | Humans | inhibitor |
| Synaptic vesicle glycoprotein 2A | Humans | agonist |
ADME / PK
| Absorption | Levetiracetam is rapidly and nearly completely absorbed following oral administration, with a reported absolute oral bioavailability of essentially 100%.T<sub>max</sub> is approximately 1.3 hours after dosing, and C<sub>max</sub> is 31 μg/mL following a single 1000mg dose and 43 μg/mL following repeated dosing.Co-administration of levetiracetam with food delays T<sub>max</sub> by approximately 1.5 hours and decreases C<sub>max</sub> by 20%. |
|---|---|
| Half-life | The plasma half-life of levetiracetam is 6-8 hours and is not affected by dose or repeat administration. Half-life is increased in the elderly (by about 40%)and those with renal impairment. |
| Protein binding | Levetiracetam and its metabolites are largely unbound to plasma proteins (<10%). |
| Metabolism | Levetiracetam is minimally metabolized within the body - the major metabolic pathway appears to be the enzymatic hydrolysis of its acetamide group which produces an inactive carboxylic acid metabolite, L057, which accounts for approximately 24% of the total administered dose.The specific enzyme(s) responsible for this reaction are unclear, but this pathway is known to be independent of hepatic CYP enzymes and has been proposed to be driven primarily by type B esterases in the blood and other tissues.Two minor metabolites involving modifications to the pyrrolidone ring have been identified, one involving hydroxylation of the ring (constituting 1.6% of the total dose) and the other involving opening of the ring structure (constituting 0.9% of the total dose). |
| Route of elimination | Approximately 66% of the administered dose of levetiracetam is excreted in the urine as unchanged drug,while only 0.3% of the total dose is excreted via the feces.The primary inactive metabolite of levetiracetam, L057, is also found in the urine as approximately 24% of the administered dose. |
| Volume of distribution | The volume of distribution of levetiracetam is approximately 0.5 to 0.7 L/kg. |
| Clearance | The total plasma clearance of levetiracetam is 0.96 mL/min/kg, with renal clearance comprising 0.6 mL/min/kg.The primary inactive metabolite of levetiracetam, L057, has a renal clearance of 4 mL/min/kg. Given the relatively high proportion of drug undergoing renal clearance, overall clearance of levetiracetam is reduced in patients with renal impairment. |
Formulation & handling
- Oral formulations are straightforward due to high aqueous solubility and minimal food effect, enabling simple solution, granule, and conventional tablet designs.
- The API’s high water solubility supports concentrated oral and IV solutions, but IV products require pH control and osmolarity adjustment to maintain compatibility.
- As a small, chemically stable molecule, it has low sensitivity to handling and typically does not require special protection from light or oxidation during formulation.
Regulatory status
| Lifecycle | Several U.S. patents supporting the API extend into 2028, 2031, and 2034, indicating that portions of its intellectual‑property estate remain active despite earlier expirations in 2018. With availability across Canada, the US, and the EU, the product is in a mature, globally established phase while still partially protected in the US. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Levetiracetam is produced by a single originator, with a large number of packagers and generic manufacturers now supplying the active ingredient and finished products worldwide. Branded and generic versions are established in the US, EU, and Canada, reflecting broad global availability. Core composition‑of‑matter patents have expired, and while some later‑expiring patents remain in force, the market already supports extensive generic competition. |
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Safety
| Toxicity | The oral TDLO of levetiracetam in humans is 10 mg/kg.Symptoms of levetiracetam overdose are consistent with its adverse effect profile and may include agitation, aggression, somnolence, decreased level of consciousness, respiratory depression, or coma.There is no antidote for levetiracetam overdose, therefore management should involve general supportive measures and symptomatic treatment. Hemodialysis results in significant clearance of plasma levetiracetam (approximately 50% within 4 hours) and should be considered in cases of overdose as indicated by the patient's status. |
|---|
- Exhibits low acute oral toxicity (human TDLO ~10 mg/kg), but high exposures can produce CNS‑depressant effects including somnolence, reduced consciousness, respiratory depression, and coma
- Overdose presentations align with known neurobehavioral adverse effects such as agitation and aggression, indicating the need for controlled handling to limit unintended exposure
- Compound is dialyzable
Levetiracetam is a type of Anticonvulsants
Anticonvulsants are a vital category of pharmaceutical Active Pharmaceutical Ingredients (APIs) used for the treatment of seizures and epilepsy. These APIs play a crucial role in managing and preventing convulsions, which are characterized by abnormal electrical activity in the brain. With a significant demand for effective anticonvulsant medications, these APIs hold immense importance in the pharmaceutical industry.
Anticonvulsant APIs work by stabilizing the excessive electrical activity in the brain, preventing or reducing seizures. They achieve this by targeting specific receptors or channels involved in the regulation of neuronal excitability. Some commonly used anticonvulsant APIs include phenytoin, valproic acid, carbamazepine, and lamotrigine.
Pharmaceutical companies utilize these APIs to formulate various dosage forms, such as tablets, capsules, and oral suspensions, ensuring convenient administration for patients. Additionally, anticonvulsant APIs may also be employed in the development of extended-release formulations, providing sustained and controlled drug release.
The market for anticonvulsant APIs continues to grow due to the rising prevalence of epilepsy and other seizure disorders. Moreover, ongoing research and development efforts aim to enhance the efficacy, safety, and tolerability of these APIs, ensuring better treatment outcomes for patients.
In conclusion, anticonvulsant APIs are a crucial pharmaceutical category used to manage seizures and epilepsy. With their ability to stabilize brain activity, these APIs play a pivotal role in improving the quality of life for individuals living with these conditions. The pharmaceutical industry's continued focus on research and development in this area ensures the availability of advanced and effective anticonvulsant medications for patients in need.
Levetiracetam API manufacturers & distributors
Compare qualified Levetiracetam API suppliers worldwide. We currently have 32 companies offering Levetiracetam API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| ABA Chemicals | Producer | China | China | CEP, CoA, WC | 1 products |
| Atom Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 14 products |
| Divis Labs. | Producer | India | India | CoA, FDA, GMP, ISO9001, Other, KDMF, USDMF, WC | 47 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 170 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 90 products |
| Huadong Medicine | Producer | China | China | CEP, CoA, GMP | 4 products |
| Jiangxi Bioman Pharma Lim... | Producer | China | China | CoA | 15 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 155 products |
| Malladi Drugs & Pharma | Producer | India | India | CoA, GMP, WC | 14 products |
| Mylan | Producer | India | India | CEP, CoA, WC | 201 products |
| Phalanx Labs | Producer | India | India | CEP, CoA | 5 products |
| Pharm Rx Chemical Corp | Distributor | United States | Unknown | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Rui Laboratories Private ... | Producer | India | India | BSE/TSE, CEP, CoA, GDP, GMP, ISO9001, MSDS, USDMF, WC, WHO-GMP | 3 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shangyu Jingxin | Producer | China | China | CEP, CoA, GMP, KDMF, WC | 4 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 762 products |
| Solfyn International LLP | Distributor | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 24 products |
| Srini Pharma | Producer | India | India | CoA, GMP, USDMF | 12 products |
| Strides Pharma Science | Producer | India | Unknown | CEP, CoA, GMP, KDMF | 14 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CoA, GMP, MSDS, USDMF, WC | 37 products |
| Wanbury | Producer | India | India | CoA, USDMF | 15 products |
| Zhejiang Apeloa Tospo-Jia... | Producer | China | China | CEP, CoA, FDA, USDMF | 15 products |
| Zhejiang Changming | Producer | China | China | CEP, CoA, FDA, GMP | 19 products |
| Zhejiang Huayi | Producer | China | China | CEP, CoA, FDA, WC | 9 products |
| Zhejiang Jiangbei | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, WC | 7 products |
When sending a request, specify which Levetiracetam 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 Levetiracetam 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.
