Levocetrizine

Allergic conditions such as rhinitis, urticaria, and seasonal allergies affect millions globally and can significantly impair the quality of life. The demand for effective, fast-acting, and well-tolerated antihistamines has driven the popularity of Levocetirizine, a third-generation non-sedating antihistamine that offers potent symptom relief with minimal drowsiness.

BluepillExpress, a WHO-GMP certified pharmaceutical manufacturer, offers scalable and high-quality third-party manufacturing of Levocetirizine in various dosage forms for global clients. With years of expertise in antihistamine production, we support private-label brands, government tenders, OTC marketers, and international distributors by offering compliance-ready, cost-effective formulations with full regulatory support.

What is Levocetirizine?

Levocetirizine dihydrochloride is the R-enantiomer of cetirizine, classified as a third-generation non-sedating antihistamine. It acts as a selective antagonist of peripheral H1-receptors, thereby inhibiting histamine-mediated allergic responses.

Due to its high receptor affinity and low blood-brain barrier penetration, Levocetirizine provides effective allergy relief with minimal CNS effects. It is widely prescribed for chronic and seasonal allergic rhinitis, chronic idiopathic urticaria, and other histamine-mediated conditions.

Therapeutic Class

• Non-sedating Antihistamine
• H1 Receptor Antagonist
• Anti-Allergic

Key Benefits of Levocetirizine

1. Potent and Rapid Symptom Relief

Levocetirizine starts working within 30–60 minutes, providing fast relief from sneezing, nasal congestion, itching, hives, and watery eyes.

2. Minimal Sedation

Unlike first-generation antihistamines, Levocetirizine has minimal penetration of the blood-brain barrier, resulting in significantly reduced drowsiness or sedation.

3. Once-Daily Dosing

Its long half-life allows for once-daily administration, improving patient compliance, particularly in chronic allergy conditions.

4. Suitable for All Ages

Available in tablet, syrup, and dispersible forms, Levocetirizine is suitable for pediatric, adult, and geriatric use.

5. Well-Tolerated and Safe

Levocetirizine is generally well tolerated, with a favorable safety profile even with long-term use. It is often used in maintenance therapy for chronic urticaria.

Indications

Levocetirizine is indicated for the symptomatic treatment of:

• Seasonal allergic rhinitis (hay fever)
• Perennial allergic rhinitis
• Chronic idiopathic urticaria
• Skin allergies and hives
• Allergic conjunctivitis (adjunctive use)
• Atopic dermatitis (as supportive therapy)

Its role is to reduce the intensity and frequency of allergic episodes by blocking histamine’s effects in target tissues.

Available Dosage Forms and Strengths

BluepillExpress manufactures Levocetirizine in the following formulations and strengths, customized per regional market requirements and pharmacopoeial standards:

Tablets

• Levocetirizine 5 mg (standard adult dose)
• Levocetirizine 10 mg (for high-resistance cases or special instructions)

Syrup / Oral Solution

• Levocetirizine 2.5 mg/5 ml (commonly used in pediatric cases)
• Available in 30 ml, 60 ml, 100 ml bottles
• Flavored and sugar-free options available

Dispersible Tablets / Orodispersible Tablets (ODT)

• 5 mg flavored dispersible tablets for pediatric and geriatric populations
• Rapidly dissolves in the mouth; ideal for patients with swallowing difficulties

Combination Products (on request)

• Levocetirizine + Montelukast
• Levocetirizine + Phenylephrine
• Levocetirizine + Paracetamol (cold and allergy relief combinations)

All formulations are manufactured using validated processes, ensuring uniform potency, stability, and safety.

Dosage and Administration

Adults and Children Over 12 Years:

• 5 mg once daily (tablet or syrup)

Children Aged 6–12 Years:

• 2.5–5 mg once daily (tablet or syrup, depending on weight)

Children Aged 2–6 Years:

• 1.25–2.5 mg once daily (syrup form preferred)

Important Notes:

• Dose should be adjusted in renal impairment
• Not recommended for children below 2 years unless prescribed by a physician
• Should be taken at the same time daily, preferably in the evening

Pharmacokinetics

• Absorption: Rapid and complete oral absorption
• Bioavailability: Approximately 100%
• Onset of Action: Within 1 hour
• Peak Plasma Time: ~54 minutes
• Half-life: 7 to 10 hours
• Metabolism: Minimal hepatic metabolism
• Excretion: Primarily via urine (unchanged)

These pharmacokinetics support once-daily dosing and long-lasting symptom control.

Manufacturing Capabilities

BluepillExpress offers state-of-the-art facilities and high production capacity for Levocetirizine formulations:

Infrastructure Highlights:

• High-speed tablet compression and coating lines
• Syrup filling and capping lines with laminar airflow zones
• Powder blending and granulation units for dispersibles
• Automated blister packing and HDPE bottle filling
• WHO-GMP compliant production environment with full QA/QC oversight

We offer white-label manufacturing, custom formulations, and private brand support across global markets.

Packaging and Labeling

Our packaging options are designed to meet global compliance, patient convenience, and market preferences.

Tablets:

• Alu-Alu blister packs
• PVC blister or HDPE bottles for bulk supply
• 10×10, 10x1x10, or customized unit dose packs

Syrup:

• Amber PET or glass bottles (30, 60, 100 ml)
• Dosing spoons/caps included
• Child-resistant closures (CRC) available

Dispersibles:

• Blister strips with flavor masking
• Clearly labeled for pediatric or adult use

We support custom branding, multilingual printing, and country-specific packaging.

Quality Control and Regulatory Compliance

We follow rigorous quality assurance and control systems at all manufacturing stages.

Certifications:

• WHO-GMP
• ISO 22000:2018
• FSSAI (for syrup)
• Indian FDA Export License
• EU and ROW registration support available

Tests and Standards:

• Assay and content uniformity
• Dissolution, disintegration, and friability
• Microbial limit tests
• Stability studies (Zone II and IVB)
• Heavy metal and impurity profiling

Each batch is released with Certificate of Analysis (CoA) and complete manufacturing documentation.

Regulatory and Documentation Support

BluepillExpress offers full regulatory assistance to help partners register Levocetirizine in local and export markets.

Documentation Includes:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• Product Dossier in CTD or ACTD formats
• Stability Data (Real-Time & Accelerated)
• MSDS and Manufacturing License

We help partners comply with regulatory frameworks in Asia, Africa, CIS, Latin America, and the Middle East.

Export and Logistics

We provide complete logistics support for small to bulk international shipments:

• Incoterms: EXW, FOB, CIF, DDP
• Air and sea freight coordination
• Custom packaging for temperature-sensitive items
• QR-code tracking and serialization
• Export documentation assistance

Shipments are handled by certified logistics partners with global reach and regulatory experience.

MOQ and Lead Times

Formulation	Minimum Order Quantity	Lead Time
Levocetirizine 5 mg Tablets	100,000 tablets	20–25 working days
Levocetirizine Syrup	25,000 bottles	25–30 working days
Dispersibles / ODT	50,000 units	25–30 working days
Combination Products	50,000 units	25–35 working days
Sample Batches	20–50 units	7–10 working days

Market Demand and Opportunity

Levocetirizine is in high demand due to:

• High prevalence of allergic rhinitis and urticaria
• Shift from sedating to non-sedating antihistamines
• Inclusion in essential medicine lists and OTC catalogs
• Use in seasonal, chronic, and pediatric allergic conditions
• Steady demand in public health programs and private markets

It is widely accepted across Asia, Africa, Latin America, and CIS regions, with potential for expansion in travel kits and e-commerce health brands.

Ideal Partners

We work with:

• Pharmaceutical companies offering anti-allergic portfolios
• OTC and private-label marketers
• Hospital supply contractors and NGOs
• Government tender bidders
• Telehealth and e-pharmacy platforms
• Exporters serving high-volume generics markets

Whether your focus is domestic branding or international expansion, BluepillExpress provides the reliable foundation for your Levocetirizine brand.

Why Choose BluepillExpress?

• WHO-GMP certified and globally trusted
• Competitive pricing for high-volume manufacturing
• Customized formulation and packaging flexibility
• End-to-end regulatory and technical support
• Track record of serving 30+ countries
• Transparent communication and on-time delivery

We bring innovation, integrity, and scalability to every partnership.

Conclusion

Levocetirizine continues to be a front-line treatment for allergic conditions worldwide. Its potency, safety, and tolerability make it a preferred choice among physicians and patients alike. Whether for OTC sales, prescription supply, or government programs, Levocetirizine offers consistent demand and broad market acceptance.

BluepillExpress is your ideal third-party manufacturer for Levocetirizine, offering world-class facilities, certified quality, and customized support to help you meet the growing needs of allergy sufferers around the world.