Loratadine + Guaifenesin + Ambroxol Syrup

This triple-action combination falls under the Syrups category within the Cough & Cold, Respiratory, and Anti-Histamines therapeutic segments. It provides a comprehensive approach to respiratory tract infections and allergic rhinitis where thick, tenacious mucus is a primary symptom.

Loratadine (5mg/5ml) provides 24-hour non-sedating histamine blockade. Guaifenesin (50mg/5ml) hydrates the respiratory tract, while Ambroxol Hydrochloride (30mg/5ml) physically breaks down mucopolysaccharide fibers in sputum.

Saar Biotech manufactures this highly demanded formulation at our modern manufacturing facility in Baddi, supplying third-party and contract manufacturing partners across the nation with commercial-ready 60ml and 100ml presentations.

At Saar Biotech, we manufacture this complex triple-API syrup using a precision-controlled aqueous compounding process that ensures absolute solubility and stability of all three active components.

• API Solubility Maintenance: Loratadine has specific solubility requirements compared to the highly water-soluble Guaifenesin and Ambroxol. Our R&D team utilizes validated co-solvent systems and pH optimization to prevent crystallization or precipitation across the 24-month shelf life.
• Taste Masking Technology: Ambroxol and Guaifenesin possess inherent bitter profiles. We incorporate specialized pediatric-friendly flavouring systems (such as mixed fruit or strawberry) to ensure excellent patient compliance without compromising API stability.
• Precision Measuring: Every bottle is supplied with a calibrated measuring cap, rigorously tested to ensure accurate dosing volumes—critical for pediatric administration.
• Regulatory-Ready Artwork: Our coordination team ensures all carton artwork includes correct drug concentration disclosures and Schedule M-compliant warnings before production authorization.

This combination syrup is manufactured by Saar Biotech for the following clinically recognised indications:

• Allergic Bronchitis: Relief from productive cough where histamine-driven inflammation is the root cause.
• Productive Cough: Enhancing sputum clearance in acute and chronic respiratory tract infections.
• Asthma Adjunct: Assisting in mucus clearance in asthmatic patients without causing the drying effects of first-generation antihistamines.
• Allergic Rhinitis with Cough: Comprehensive symptom control for post-nasal drip induced coughing.

Schedule G/H Compliance — Requires use strictly as directed by a registered medical practitioner.

Clinical Mechanism of Action

Loratadine is a potent, long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. By blocking histamine at H1 receptors in the respiratory tract, it prevents bronchoconstriction, reduces mucosal edema, and suppresses the allergic cough reflex without crossing the blood-brain barrier.

Guaifenesin acts centrally to reduce the adhesiveness and surface tension of respiratory fluids, allowing for increased ciliary action and promoting the removal of thickened mucus from the bronchi.

Ambroxol Hydrochloride is a specific mucokinetic and secretolytic agent that depolymerizes mucopolysaccharides directly within the mucus, reducing its viscosity and stimulating the release of pulmonary surfactant.

Manufacturing Integrity

• Assay Verification: During production, all three active ingredients are independently quantified via HPLC to ensure they meet the 95–105% label claim parameters established by the Indian Pharmacopoeia.
• Microbial Limit Testing: The syrup base undergoes strict Preservative Efficacy Testing (PET) and routine MLT to confirm the complete absence of specified pathogens throughout the product’s lifespan.

Saar Biotech offers comprehensive Third-Party Manufacturing and Contract Manufacturing services for Loratadine + Guaifenesin + Ambroxol Syrup from our WHO-GMP certified oral liquids block in Himachal Pradesh.

• Facility: Automated oral liquid manufacturing block equipped with variable-speed compounding vessels, inline homogenization, and high-speed rotary filling/capping lines.
• Packaging Options: 60ml and 100ml amber PET or Glass bottles; custom measuring caps; premium mono-cartons with advanced finishes (UV spot, drip-off).
• MOQ: Starting at 5,000 bottles per SKU for emerging brands.
• Turnaround Time: 30–45 working days for new formulations/artwork; 20–25 days for repeat batches.
• Quality Documentation: Full GLP-signed Certificate of Analysis (COA) provided with every commercial dispatch.

Every commercial batch is rigorously quarantined and tested against the following analytical release protocol:

• HPLC Assay (Triple API): Individual quantification of Loratadine, Guaifenesin, and Ambroxol against IP reference standards.
• pH & Specific Gravity: Verification of the finished syrup within the specified stability range.
• Viscosity Testing: Ensuring consistent pourability and dosing accuracy.
• Microbial Limit Testing (MLT): Ensuring total aerobic counts are strictly within IP limits for oral liquid preparations.
• Fill Volume Verification: Gravimetric weight checks to ensure every bottle contains the declared net volume.

For B2B manufacturing enquiries, contract pricing, or to request a complete product dossier for Loratadine + Guaifenesin + Ambroxol Syrup, please use the enquiry form below.