Fexofenadine Hydrochloride Suspension

Fexofenadine Hydrochloride Suspension belongs to the Suspensions category within the Anti-Histamines and Pediatric Care therapeutic segments. It is a third-generation antihistamine that provides effective allergy relief without the sedative effects associated with first-generation agents. The liquid suspension form enables accurate weight-based dosing for pediatric patients aged 6 months to 11 years.

Fexofenadine’s pharmacological advantage lies in its inability to cross the blood-brain barrier in significant amounts, unlike first-generation antihistamines (chlorpheniramine) or even second-generation agents (cetirizine). This non-sedating profile makes it the preferred choice for school-going children, working adults, and patients who need to maintain daytime alertness. Saar Biotech manufactures this suspension from our manufacturing facility in Baddi with validated two-API suspension quality control.

At Saar Biotech, we manufacture Fexofenadine Suspension using a controlled suspension manufacturing process that ensures dose uniformity, palatability, and packaging reliability for the competitive antihistamine segment.

• Non-Sedating Clinical Positioning: Fexofenadine’s third-generation, non-sedating profile is a key differentiator for B2B brands. Our formulation maintains the drug’s pharmacokinetic integrity, ensuring patients get effective allergy relief without daytime drowsiness — a crucial clinical advantage for pediatric and working adult populations.

• Taste Masking Excellence: Fexofenadine possesses a bitter note that requires expert taste-masking for pediatric compliance. We develop vanilla and raspberry-flavoured suspension bases that effectively mask bitterness while delivering a clean, pleasant taste experience that children accept readily.

• Suspension Uniformity: Fexofenadine must be uniformly distributed to ensure consistent dosing. Our high-shear mixing and validated fill procedures ensure every 5ml dose delivers the full 30mg label claim from first spoonful to last.

• 60ml Pack Premium Execution: From dark amber bottles to drip-off embossed cartons and company-logo printed caps — our packaging options help antihistamine brands stand out at pharmacy level.

Fexofenadine Suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:

• Seasonal Allergic Rhinitis: Provides effective relief from sneezing, rhinorrhea, itchy/watery eyes, and itchy nose/throat associated with seasonal allergies
• Chronic Idiopathic Urticaria: Reduces itching and the number/duration of hives in pediatric patients
• Perennial Allergic Rhinitis: Year-round allergy relief from dust mites, pet dander, and environmental allergens
• Pediatric Allergy Management: Weight-based dosing for children aged 6 months to 11 years

Schedule H — Requires valid medical prescription. Not for use in children under 6 months.

Clinical Mechanism of Action

Fexofenadine Hydrochloride is a selective, peripheral H1-receptor antagonist. It competitively blocks histamine from binding to H1 receptors on respiratory smooth muscle and capillary endothelial cells, preventing histamine-induced vasodilation, capillary permeability, and sensory nerve stimulation that causes sneezing, rhinorrhea, and pruritus. Unlike first-generation antihistamines, Fexofenadine has minimal CNS penetration due to its zwitterionic structure and P-glycoprotein efflux mechanism, resulting in non-sedating action.

Manufacturing Integrity

• Suspension Uniformity: Fexofenadine must be uniformly suspended to ensure consistent dosing. Our suspending agent system and validated mixing process guarantee homogeneous API distribution throughout the 60ml bottle.
• pH and Stability Management: The suspension vehicle is pH-buffered to maintain Fexofenadine’s chemical stability for 24 months under tropical storage conditions, preventing degradation of the active.
• Taste Masking: Vanilla and raspberry flavour systems are engineered to mask Fexofenadine’s bitterness without compromising the clean, pleasant taste profile that drives pediatric compliance.

• Rapid Onset: Fexofenadine reaches peak plasma concentration within 1–3 hours, providing fast, visible symptom relief that builds prescription loyalty and brand trust.
• Non-Sedating Profile: The ability to market a “non-drowsy” antihistamine is a significant commercial advantage for B2B partners, particularly for pediatric and daytime-use allergy brands.
• Year-Round Demand: Allergic rhinitis is a perennial condition in India, driven by dust mites, pollen, and environmental allergens throughout the year, maintaining consistent prescription frequency.
• 60ml Pack Logic: The 60ml format provides approximately a 15-day supply for pediatric patients at standard dosing (5ml twice daily), reducing prescription refill friction.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Fexofenadine 30mg/5ml Suspension from our dedicated oral suspension manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Oral suspension manufacturing area with controlled processing, automated bottle filling, capping, labelling, and carton packing lines suited for 60ml presentations.
• Capacity: Scalable from brand-entry launches to large commercial batches; 160×60ml distributor dispatch configurations available.
• Quality Lab: In-house GLP-certified lab with validated HPLC assay for Fexofenadine, plus pH, viscosity, suspension uniformity, MLT, and fill volume checks.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 60ml PET or dark amber bottles; sticker label, metallic label, drip-off carton, brand embossed carton, measuring cup, printed cap, with-carton or without-carton supply.
• MOQ: Starting at 5,000–10,000 units per SKU.

1. Warehouse Conditions: Store below 30°C in a cool, dry environment. Do not freeze — sub-zero temperatures can disrupt the suspension matrix.
2. Shake Well Before Every Dose: Critical for uniform Fexofenadine distribution, ensuring every 5ml dose contains the full 30mg.
3. Measuring Cup Use: A calibrated measuring cup ensures accurate 5ml dosing, particularly important for pediatric weight-based administration.
4. Light Protection: Dark amber bottles and outer cartons protect the suspension from light-induced degradation.

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

• HPLC Assay: Quantification of Fexofenadine Hydrochloride 30mg per 5ml against IP specifications — the primary release test for this formulation.
• Suspension Uniformity & Re-Dispersibility: Sediment behaviour and post-shaking uniformity are evaluated to ensure dose-to-dose consistency.
• pH & Viscosity Testing: The suspension’s pH and flow characteristics are monitored to maintain stability and accurate pourability.
• Microbial Limit Testing (MLT): IP-compliant microbiological testing confirming absence of specified pathogens.
• Certificate of Analysis (COA): Issued with every B2B batch.

• Non-Sedating: Fexofenadine does not cause significant drowsiness, making it suitable for daytime use in children and working adults.
• Renal Precautions: Dose adjustment required in patients with severe renal impairment (creatinine clearance < 10 ml/min).
• Food Interaction: Should not be taken with fruit juices (grapefruit, orange, apple) as they reduce absorption.
• Contraindications: Known hypersensitivity to any component. Safety in children under 6 months not established.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Fexofenadine HCl 30mg Suspension, please use the B2B enquiry form below.