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Levetiracetam API Manufacturers & Suppliers

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Distributor
Produced in  China
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Employees: 50+

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CoA
Producer
Produced in  India
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Employees: 19

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CoA

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Produced in  India
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Employees: 5

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BSE/TSE
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CoA
Producer
Produced in  India
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Employees: 200+

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MSDS
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BSE/TSE
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CoA

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CoA
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Produced in  India
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CoA

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CoA
Distributor
Produced in  India
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Employees: 25

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Distributor
Produced in  India
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Employees: 10

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MSDS
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CoA

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Distributor
Produced in  Unknown
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Employees: 50+

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MSDS
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BSE/TSE
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CoA

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coa

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Produced in  India
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Employees: 21,650

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Produced in  India
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Employees: 4,000

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WC
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Produced in  India
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Produced in  Unknown
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CEP
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coa
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Produced in  India
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CoA

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Produced in  China
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CoA

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Producer
Produced in  China
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WC
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coa

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Producer
Produced in  China
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WC
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CoA

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KDMF
Producer
Produced in  China
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CEP
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KDMF
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WC
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coa

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GMP
CEP
KDMF
WC
coa
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Producer
Produced in  Mexico
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WC

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coa

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Produced in  China
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Produced in  India
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Produced in  India
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WC
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CoA

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WC
CoA
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Producer
Produced in  India
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FDA
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CEP
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USDMF
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KDMF

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coa
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WC

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Produced in  Italy
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CoA
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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

AcetamidesAmidesAnticonvulsantsCentral Nervous System AgentsCentral Nervous System DepressantsDecreased Central Nervous System Disorganized Electrical Activity
Generic name
Levetiracetam
Molecule type
small molecule
CAS number
102767-28-2
DrugBank ID
DB01202
Approval status
Approved drug
ATC code
N03AX14

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 (CAS 102767-28-2) is a pyrrolidine derivative used globally as an adjunctive therapy for epilepsy. It is indicated for partial onset seizures in patients one month of age and older, for myoclonic seizures in juvenile myoclonic epilepsy from 12 years of age, and for primary generalized tonic‑clonic seizures in idiopathic generalized epilepsy from 6 years of age. An orally disintegrating formulation is approved for adjunctive treatment of partial onset seizures in patients 4 years and older who weigh more than 20 kg.

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

SummaryLevetiracetam 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 actionThe 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.
PharmacodynamicsLevetiracetam 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
TargetOrganismActions
Voltage-dependent N-type calcium channel subunit alpha-1BHumansinhibitor
Synaptic vesicle glycoprotein 2AHumansagonist

ADME / PK

AbsorptionLevetiracetam 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-lifeThe 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 bindingLevetiracetam and its metabolites are largely unbound to plasma proteins (<10%).
MetabolismLevetiracetam 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 eliminationApproximately 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 distributionThe volume of distribution of levetiracetam is approximately 0.5 to 0.7 L/kg.
ClearanceThe 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

LifecycleSeveral 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.
MarketsCanada, US, EU
Supply Chain
Supply chain summaryLevetiracetam 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.

Safety

ToxicityThe 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.
High Level Warnings:
  • 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

Certificate of Analysis

A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
 

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.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
China China CEP, CoA, WC1 products
Producer
India India BSE/TSE, CoA, GMP, MSDS14 products
Producer
India India CoA, FDA, GMP, ISO9001, Other, KDMF, USDMF, WC47 products
Producer
India India BSE/TSE, CEP, CoA, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC170 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products
Producer
India India BSE/TSE, CoA, GMP, MSDS166 products
Producer
India India CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC90 products
Producer
China China CEP, CoA, GMP4 products
Producer
China China CoA15 products
Producer
India India CEP, CoA, FDA, GMP, KDMF, USDMF, WC155 products
Producer
India India CoA, GMP, WC14 products
Producer
India India CEP, CoA, WC201 products
Producer
India India CEP, CoA5 products
Distributor
United States Unknown BSE/TSE, CoA, GMP, MSDS, USDMF166 products
Producer
India India BSE/TSE, CEP, CoA, GDP, GMP, ISO9001, MSDS, USDMF, WC, WHO-GMP3 products
Producer
India India CoA, FDA, GMP515 products
Producer
China China CEP, CoA, GMP, KDMF, WC4 products
Producer
Italy Italy CoA, GMP47 products
Producer
Mexico Mexico CoA, USDMF42 products
Distributor
China China CEP, CoA, GMP, ISO9001, USDMF762 products
Distributor
India India BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP24 products
Producer
India India CoA, GMP, USDMF12 products
Producer
India Unknown CEP, CoA, GMP, KDMF14 products
Producer
India India CoA, GMP, USDMF, WC219 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, MSDS263 products
Producer
India India CoA, GMP50 products
Producer
India India CoA, GMP, MSDS, USDMF, WC37 products
Producer
India India CoA, USDMF15 products
Producer
China China CEP, CoA, FDA, USDMF15 products
Producer
China China CEP, CoA, FDA, GMP19 products
Producer
China China CEP, CoA, FDA, WC9 products
Producer
China China CEP, CoA, FDA, GMP, KDMF, WC7 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.

Frequently asked questions about Levetiracetam API


Sourcing

What matters most when sourcing GMP-grade Levetiracetam?
Key considerations include confirming GMP compliance and meeting regulatory requirements for Canada, the US, and the EU. Suppliers should demonstrate clear lineage of the Levetiracetam API, given that it originates from a single producer but is distributed through many packagers and generic manufacturers. Verification of quality documentation, audit history, and consistency of supply is essential in a market with broad generic availability and expired core patents.
Which documents are typically required when sourcing Levetiracetam API?
Request the core API documentation set: CoA (31 companies), GMP (23 companies), CEP (15 companies), USDMF (14 companies), WC (13 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Levetiracetam API?
Known or reported manufacturers for Levetiracetam: Tresinde Biotech, Global Pharma Tek, Pharm Rx Chemical Corp, SETV Global, Sinoway industrial Co.,Ltd, Tenatra Exports Private Limited, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Levetiracetam 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 Levetiracetam manufacturers?
Audit reports may be requested for Levetiracetam: 10 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Levetiracetam API on Pharmaoffer?
Reported supplier count for Levetiracetam: 31 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Levetiracetam API?
Production countries reported for Levetiracetam: India (18 producers), China (9 producers), Mexico (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Levetiracetam usually hold?
Common certifications for Levetiracetam suppliers: CoA (31 companies), GMP (23 companies), CEP (15 companies), USDMF (14 companies), WC (13 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Levetiracetam (CAS 102767-28-2) used for?
Levetiracetam is an antiepileptic API used as adjunctive therapy for partial‑onset seizures in patients one month of age and older, myoclonic seizures in juvenile myoclonic epilepsy from 12 years of age, and primary generalized tonic‑clonic seizures in idiopathic generalized epilepsy from 6 years of age. An orally disintegrating form is also approved for adjunctive treatment of partial‑onset seizures in patients 4 years and older who weigh more than 20 kg. Its therapeutic effect is linked to high‑affinity binding to SV2A, which helps suppress hypersynchronous neuronal firing.
Which therapeutic class does Levetiracetam fall into?
Levetiracetam belongs to the following therapeutic categories: Acetamides, Amides, Anticonvulsants, 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 Levetiracetam mainly prescribed for?
The primary indications for Levetiracetam: 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. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Levetiracetam work?
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.
What should someone know about the safety or toxicity profile of Levetiracetam?
Levetiracetam has a wide therapeutic index and low acute oral toxicity, but excessive exposure can produce CNS‑depressant effects such as somnolence, reduced consciousness, respiratory depression, or coma. Overdose presentations may include agitation or aggression, consistent with known neurobehavioral adverse effects. The drug carries a class warning for increased risk of suicidal ideation or behavior, so monitoring for mood or behavioral changes is advised. Because it is primarily renally cleared and dialyzable, dose adjustments are necessary in renal impairment.
What are important formulation and handling considerations for Levetiracetam as an API?
Levetiracetam’s high aqueous solubility allows simple development of oral solutions, granules, and conventional tablets without complex solubilization strategies. Concentrated oral and IV solutions are feasible, though IV formulations require pH control and osmolarity adjustment for compatibility. The API is chemically stable and generally does not need special protection from light or oxidation during handling.
Is Levetiracetam a small molecule?
Levetiracetam is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Levetiracetam?
Oral Levetiracetam is a chemically stable, highly water‑soluble molecule, so it generally does not present special stability concerns in standard solid or liquid formulations. It is not sensitive to light or oxidation and typically does not require protective packaging. Formulations mainly focus on maintaining simple aqueous solutions or conventional tablets without the need for complex stabilization measures.

Regulatory

Where is Levetiracetam approved or in use globally?
Levetiracetam 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.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Levetiracetam procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Levetiracetam. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Levetiracetam included in the PRO Data Insights coverage?
PRO Data Insights coverage for Levetiracetam: 6438 verified transactions across 1369 suppliers and 560 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Levetiracetam?
Market report availability for Levetiracetam: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.