Levetiracetam

Epilepsy remains a prevalent neurological disorder worldwide, affecting people of all ages. Among the various antiepileptic drugs (AEDs) available, Levetiracetam has emerged as a well-tolerated and highly effective option for controlling seizures across a wide spectrum of epileptic syndromes. Known for its favorable pharmacokinetic profile, minimal drug interactions, and safety in both pediatric and adult populations, Levetiracetam is now a first-line choice in epilepsy management globally.

At BluepillExpress, we specialize in the third-party manufacturing of high-quality Levetiracetam formulations for domestic and international markets. Our state-of-the-art, WHO-GMP-certified manufacturing facilities enable us to produce bulk quantities of Levetiracetam under strict quality controls, ensuring product consistency, compliance, and market-readiness for our partners.

Product Overview

Generic Name: Levetiracetam
Therapeutic Category: Antiepileptic / Anticonvulsant
Pharmacological Class: Pyrrolidine derivative (Unique mechanism among AEDs)

Available Dosage Forms:

• Levetiracetam Tablets (Immediate Release)
• Levetiracetam Oral Solution / Syrup
• Levetiracetam Extended Release Tablets (on request)
• Levetiracetam Injection (IV solution)

Strengths Offered:

• Tablets: 250 mg, 500 mg, 750 mg, 1000 mg
• Syrup: 100 mg/ml
• Injection: 500 mg/5 ml, 1000 mg/5 ml, 1500 mg/15 ml

Pharmacopoeial Compliance: IP / USP / BP / EP (as per market requirement)
Packaging Options:

• Tablets: Alu-Alu or PVC-Alu blister packs
• Syrups: PET/HDPE bottles with calibrated measuring cap
• Injections: Glass ampoules or vials with flip-off seals
• Customized mono cartons and inserts available

Branding: Available under private label or for institutional supply

Pharmacology and Mechanism of Action

Levetiracetam is structurally unrelated to other antiepileptic drugs and exhibits a unique mechanism of action. It binds to the synaptic vesicle protein SV2A in the brain, modulating neurotransmitter release and synaptic transmission. This results in a reduction of neuronal hyperexcitability, thereby preventing seizure propagation.

Unlike other AEDs, Levetiracetam does not affect sodium or calcium channels directly and has minimal influence on hepatic enzymes, making it a safer option in polytherapy regimens.

Indications

Levetiracetam is indicated for the treatment of:

• Partial-onset seizures (with or without secondary generalization)
• Myoclonic seizures in patients with juvenile myoclonic epilepsy
• Primary generalized tonic-clonic seizures in adults and children
• Adjunctive therapy in epilepsy of various origins
• Monotherapy (in certain regions) for newly diagnosed epilepsy
• Seizure prophylaxis in post-traumatic brain injury (off-label)

Dosage and Administration

Dosage must be individualized according to patient response, age, weight, and renal function.

Adults and Adolescents (≥16 years):
Initial dose: 500 mg twice daily
Maintenance dose: Up to 1500 mg twice daily
Maximum: 3000 mg/day

Pediatric Dosing:
Syrup form (100 mg/ml) is used based on body weight
20 mg/kg/day in two divided doses, titrated as needed
Extended-release tablets are used in select adult patients requiring once-daily dosing

IV Injection:
Used when oral administration is temporarily not possible
Same dosing as oral, infused over 15 minutes

Renal Impairment:
Dose adjustment required based on creatinine clearance
No hepatic dose adjustment generally needed

Pharmacokinetics

• Bioavailability: ~100% (oral)
• Tmax: 1.3 hours (tablets), 0.5–1 hour (solution)
• Half-life: ~6–8 hours
• Protein binding: <10%
• Metabolism: Minimal hepatic metabolism
• Excretion: Primarily renal (unchanged drug and metabolites)

This favorable profile supports safe and predictable dosing across various patient populations.

Advantages of Levetiracetam

• Unique mechanism of action with broad-spectrum efficacy
• Fewer drug-drug interactions (no CYP450 enzyme induction or inhibition)
• Minimal sedation and cognitive impairment
• Suitable for monotherapy or adjunctive therapy
• Safe for children, elderly, and patients with hepatic disease
• Available in multiple dosage forms for individualized treatment

These features contribute to its rapid global acceptance and listing on the WHO Model List of Essential Medicines.

Why Partner with BluepillExpress for Levetiracetam Manufacturing?

1. WHO-GMP Certified Manufacturing Units
Our modern facilities are designed to meet global quality standards with cutting-edge infrastructure for solid, liquid, and injectable manufacturing. We maintain robust quality assurance systems for every batch produced.

2. Formulation Flexibility
We offer customized solutions including:

• Sugar-free and alcohol-free syrup formulations
• Extended-release tablets
• Pediatric-friendly taste masking
• Ready-to-dilute injection vials

3. Regulatory and Dossier Support
We provide complete support for product registration and tender documentation, including:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Stability Data (Accelerated and Real-Time)
• CTD / ACTD formatted dossiers
• MOH registration assistance

4. Global Export Expertise
Levetiracetam from BluepillExpress is exported to over 40 countries including:

• Africa (Nigeria, Ghana, Kenya, Ethiopia, Sudan)
• Southeast Asia (Vietnam, Cambodia, Myanmar, Philippines)
• Middle East (UAE, Iraq, Jordan, Yemen)
• CIS and Latin America (Kazakhstan, Bolivia, Guatemala)
  We provide market-specific packaging, regulatory advice, and logistics coordination for smooth supply.

5. Private Labeling and Branding Services
Whether you’re launching your brand or supplying to government institutions, we help design:

• Custom logo and packaging artwork
• Multilingual labels and inserts
• QR codes and track-and-trace options
• Secure serialization and holograms (on request)

Quality Control and Assurance

We follow a multi-tier quality process that ensures consistent batch-to-batch performance and international compliance.

Testing Parameters Include:

• Assay of active ingredients
• Dissolution profile and disintegration time
• pH and viscosity (for solutions)
• Microbial limit testing
• Stability under ICH zones I–IV
• Packaging integrity and compatibility

Every batch is backed by validated SOPs and maintained records, ensuring traceability and regulatory compliance.

Contract Manufacturing Process with BluepillExpress

Step 1: Consultation and Agreement
We assess your needs, dosage preferences, and documentation requirements. A confidentiality agreement is signed.

Step 2: Customization and Pricing
Product strength, packaging style, flavoring, and regulatory preferences are finalized. Quotation and timelines are shared.

Step 3: Sample Development
Pilot batch and artwork samples are developed and submitted for client approval. Custom modifications are made as needed.

Step 4: Production and Testing
Commercial manufacturing begins in GMP-controlled environments. In-process checks and post-production testing ensure accuracy.

Step 5: Packing and Dispatch
Products are packed according to approved specifications and dispatched with full regulatory documentation and batch reports.

Target Clients and Markets

Levetiracetam is in strong demand across:

• Neurology and psychiatric healthcare segments
• Hospitals and specialty clinics
• Public health programs for epilepsy
• Retail pharmacy chains and distributors
• Government tenders and institutional buyers
• International aid agencies and NGOs

It is suitable for markets requiring high-quality, affordable, and safe antiepileptic medications, especially in resource-constrained regions.

Market Insights

The global epilepsy treatment market is projected to surpass USD 10 billion, with Levetiracetam playing a key role due to:

• Its efficacy in drug-resistant epilepsy
• Suitability in elderly and pediatric patients
• Growing demand for combination therapies
• Fewer monitoring requirements compared to older AEDs
• Increasing access through public health programs

By choosing BluepillExpress, you secure a reliable manufacturing partner capable of delivering competitive pricing, global-scale production, and export-ready documentation.

Conclusion

Levetiracetam continues to transform the landscape of epilepsy treatment with its broad-spectrum activity, minimal side effects, and flexible dosing. Its widespread adoption and consistent clinical performance make it a high-value product for pharmaceutical companies and healthcare providers.

At BluepillExpress, we are committed to supporting your success with high-quality Levetiracetam products manufactured to global standards. Our third-party manufacturing services are tailored to your business model, whether you are building a retail brand, supplying tenders, or entering new export markets.