Levocetirizine Dihydrochloride Syrup

Levocetirizine Syrup belongs to the Syrups category within the Anti-Histamines and Pediatric Care therapeutic segments. It is the active R-enantiomer of cetirizine, providing twice the H1 receptor affinity with significantly reduced sedation.

For pharmaceutical marketing companies, this is a high-prescription allergy product with consistent demand across seasonal and perennial allergy conditions. Saar Biotech manufactures it from our manufacturing facility in Baddi.

At Saar Biotech, we manufacture Levocetirizine Syrup using a controlled oral syrup manufacturing process that ensures dose uniformity, palatability, and packaging reliability.

• R-Enantiomer Purity: Levocetirizine requires careful manufacturing to maintain enantiomeric purity.
• Taste Masking: The syrup base effectively masks Levocetirizine’s mild bitterness.
• pH and Stability Management: The active remains chemically stable for 24 months.
• 30ml and 60ml Pack Coverage: Suitable for paediatric and adult allergy management.

This syrup is manufactured and supplied by Saar Biotech for the following established clinical indications:

• Seasonal Allergic Rhinitis: Relief from pollen-induced allergy symptoms
• Perennial Allergic Rhinitis: Year-round allergy relief from dust mites and environmental allergens
• Chronic Idiopathic Urticaria: Reduction of itching and hives
• Allergic Skin Conditions: Relief from allergic dermatitis and pruritus

Levocetirizine is the active R-enantiomer of cetirizine. It competitively and reversibly blocks histamine H1 receptors, preventing histamine-induced vasodilation, capillary permeability, and sensory nerve stimulation.

Manufacturing Integrity

• Enantiomeric Purity: Careful manufacturing maintains the R-enantiomer’s purity.
• pH Stability: The syrup base is pH-buffered to maintain active stability.

• Rapid Onset: Peak plasma concentration within 1 hour.
• Low Sedation: Reduced CNS penetration compared to cetirizine.
• Year-Round Demand: Perennial allergy conditions ensure consistent prescription volume.
• 30ml and 60ml Pack Logic: Suitable for short and extended treatment courses.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Levocetirizine Syrup from our dedicated oral liquid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Oral liquid manufacturing area with controlled processing, automated bottle filling, capping, labelling, and carton packing lines.
• Capacity: Scalable from brand-entry launches to large commercial batches.
• Quality Lab: In-house GLP-certified lab with HPLC assay, pH, viscosity, MLT, and fill volume checks.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 30ml and 60ml PET or dark amber bottles; sticker label, metallic label, measuring cup, printed cap.
• MOQ: Starting at 5,000–10,000 units per SKU.

1. Warehouse Conditions: Store below 30°C in a cool, dry environment. Protect from direct sunlight.
2. Light Protection: Amber bottles and outer cartons protect from photo-degradation.
3. Measuring Cup Use: A calibrated measuring cap ensures accurate dosing.

Every commercial batch is quarantined until it passes a comprehensive analytical release protocol:

• HPLC Assay: Quantification of Levocetirizine Dihydrochloride 2.5mg per 5ml.
• pH Testing: Verification of pH within stability-appropriate specification range.
• Microbial Limit Testing (MLT): IP-compliant microbiological testing.
• Certificate of Analysis (COA): Issued with every B2B batch.

• Low Sedation: Minimal sedation compared to cetirizine; avoid alcohol and CNS depressants.
• Renal Precautions: Dose adjustment required in patients with renal impairment.
• Contraindications: Known hypersensitivity to any component; severe renal impairment.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Levocetirizine Syrup, please use the B2B enquiry form below.