Levocetrizine + Montelukast

Levocetirizine + Montelukast is a widely prescribed fixed-dose combination used in the management of allergic rhinitis, chronic urticaria, and asthma-related symptoms. Combining the histamine-blocking effect of Levocetirizine with the leukotriene receptor antagonism of Montelukast, this formulation provides synergistic relief from allergic inflammation, nasal congestion, sneezing, wheezing, and skin-related allergy symptoms.

At BluepillExpress, we offer end-to-end third-party manufacturing services for Levocetirizine + Montelukast in various dosage forms and strengths. Our WHO-GMP certified facilities, advanced formulation capabilities, and global regulatory support make us a trusted partner for pharmaceutical companies worldwide looking to outsource quality-centric and export-ready products.

Therapeutic Applications

The Levocetirizine + Montelukast combination is indicated for the following conditions:

• Seasonal and perennial allergic rhinitis
• Chronic idiopathic urticaria (hives)
• Bronchial asthma (as adjunct therapy)
• Allergic conjunctivitis
• Exercise-induced bronchospasm
• Pollinosis and dust/pet dander-related allergies

This dual-action therapy is well-tolerated, safe for long-term use, and suitable for both adults and children when prescribed appropriately.

Mechanism of Action

This combination provides a dual-mechanism approach for superior allergy control:

1. Levocetirizine:
A third-generation non-sedating antihistamine, Levocetirizine is the active enantiomer of cetirizine. It selectively blocks H1 receptors, preventing histamine-induced symptoms such as sneezing, itching, rhinorrhea, and watery eyes.

• Rapid onset of action
• Long-lasting symptom relief
• Low risk of drowsiness or cognitive impairment

2. Montelukast:
Montelukast is a leukotriene receptor antagonist (LTRA) that binds to cysteinyl leukotriene (CysLT1) receptors, inhibiting the action of leukotrienes which cause bronchoconstriction, airway inflammation, and mucus production.

• Reduces bronchial inflammation
• Improves airflow and respiratory comfort
• Prevents asthma-related symptoms

Together, they provide comprehensive relief from both upper and lower respiratory tract allergies.

Available Dosage Forms by BluepillExpress

BluepillExpress offers Levocetirizine + Montelukast in various dosage strengths and formats to meet clinical and market-specific requirements.

1. Oral Tablets

• Levocetirizine 5 mg + Montelukast 10 mg (for adults)
• Levocetirizine 2.5 mg + Montelukast 4 mg / 5 mg (for pediatric use)

2. Chewable Tablets

• Especially formulated for children
• Available in flavored variants (strawberry, orange, etc.)

3. Oral Dispersible Tablets (ODT)

• Fast-dissolving for ease of administration without water
• Ideal for elderly or patients with swallowing difficulties

4. Syrup / Suspension (Custom development available)

• Sugar-free or preservative-free variants
• Pediatric use from 2 years and above

Packaging Options:

• Blister packs (Alu-Alu / PVC-Alu)
• Bottles with calibrated droppers or measuring caps
• Strip packs for hospital or clinic use
• Bulk packaging for institutional tenders

All formulations comply with IP, BP, USP, or EP standards, as per client and country-specific requirements.

Manufacturing Infrastructure at BluepillExpress

BluepillExpress operates modern, scalable, and compliant production facilities that enable large-scale, efficient manufacturing of fixed-dose combinations.

Key Capabilities Include:

• WHO-GMP, ISO 9001:2015 certified manufacturing facilities
• High-speed compression and coating machines
• Controlled environment production zones
• Automated packing and labeling systems
• In-house quality testing and stability labs
• ERP systems for real-time process monitoring and traceability

With a focus on quality, compliance, and innovation, we ensure reliable manufacturing outcomes that exceed expectations.

Quality Assurance and Quality Control

Every batch of Levocetirizine + Montelukast undergoes stringent quality control protocols to ensure safety, consistency, and therapeutic efficacy.

Our QC/QA measures include:

• Identity and assay tests for both APIs
• Dissolution and disintegration testing
• Microbial and endotoxin testing
• Uniformity of dosage units
• Stability testing (real-time and accelerated)
• Impurity profiling and preservative content checks

Our QA systems are aligned with GMP, ICH, and pharmacopeial standards, ensuring full traceability and documentation support.

Private Label and Customization Services

We offer customized formulation and branding solutions for Levocetirizine + Montelukast products tailored to your specific brand requirements.

Customization Options:

• Strength variation (for pediatric or geriatric use)
• Flavored and sugar-free options
• Packaging artwork, logo, and labeling
• Country-specific language inserts
• Custom blister sizes or bottle formats

Our design and marketing teams collaborate with clients to create compliant, attractive, and market-ready private-label products.

Regulatory Documentation and Dossier Support

BluepillExpress provides complete regulatory support for product registration and market access in both regulated and semi-regulated regions.

Documentation Includes:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Product Development Report
• Stability Reports (Zone III/IV compliant)
• Drug Master File (DMF) – where applicable
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Dossiers in CTD / eCTD / ACTD formats

We assist clients with health authority submissions, regulatory audits, and dossier updates for seamless registration and market entry.

Export Capability and Global Reach

BluepillExpress is a leading exporter of combination therapies like Levocetirizine + Montelukast across various continents. We have an established global footprint in:

• Africa – Nigeria, Kenya, Ghana, Ethiopia, South Africa
• Middle East – UAE, Iraq, Yemen, Oman, Jordan
• Asia – Vietnam, Cambodia, Myanmar, Philippines, Nepal
• Latin America – Bolivia, Peru, Dominican Republic, Guatemala
• CIS Countries – Uzbekistan, Kyrgyzstan, Georgia, Armenia

We support both branded exports and tender supplies, offering documentation like COAs, MSDS, Free Sale Certificates, and custom packaging for different markets.

R&D and Technical Innovation

Our in-house R&D division plays a vital role in developing optimized, patient-friendly, and cost-effective formulations of Levocetirizine + Montelukast.

R&D Capabilities:

• Pediatric and geriatric formulations
• Bioavailability-enhanced versions
• ODTs and fast-release tablets
• Fixed-dose customization with additional APIs (e.g., paracetamol)
• Support for bioequivalence studies through CROs
• Comparative dissolution and pharmacokinetic studies

We support technology transfer, pilot batch production, and scale-up services for clients with proprietary concepts or licensing goals.

Shelf Life and Storage Guidelines

• Standard shelf life: 24 to 36 months
• Storage instructions: Store below 30°C in a dry, light-protected place
• All packaging is tested for moisture resistance, stability, and tamper evidence

We ensure full ICH compliance for products intended for high humidity and temperature regions (Zones III & IV).

Ethical and Environmental Responsibility

At BluepillExpress, we are committed to sustainable and responsible manufacturing practices:

• Zero-discharge effluent treatment plants
• Solvent recovery and minimal environmental waste
• Ethical sourcing of APIs and excipients
• Non-animal tested ingredients upon request
• Employee health, safety, and GMP training programs

We uphold the highest standards of quality, ethics, and environmental care in every aspect of our operations.

Why Choose BluepillExpress for Levocetirizine + Montelukast Manufacturing?

• WHO-GMP & ISO-certified facilities
• Flexible MOQs and competitive pricing
• Custom branding and formulation options
• Complete regulatory and technical dossier support
• Global export logistics and documentation
• Experienced R&D and product development teams
• Reliable lead times and batch consistency

Whether you’re launching a new allergy brand, participating in tenders, or expanding into new geographies, BluepillExpress provides the expertise, capacity, and service excellence you need.

Conclusion

The Levocetirizine + Montelukast combination continues to be a mainstay in the treatment of respiratory and allergic conditions due to its dual action, excellent tolerability, and broad patient acceptance. As global allergy prevalence rises, the demand for high-quality, effective, and affordable combination therapies grows stronger.

BluepillExpress delivers premium third-party manufacturing for Levocetirizine + Montelukast, combining pharmaceutical excellence, global compliance, and tailored branding solutions for your business success.