✅ Rupatadine Fumarate – Dual-Action Antihistamine for Allergy & Inflammation Control (API)

High-Purity Active Pharmaceutical Ingredient (API) for Antiallergic and Anti-Inflammatory Formulations

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🌿 Product Overview

Rupatadine Fumarate is a new-generation, non-sedating antihistamine featuring dual action as a histamine H1 receptor antagonist and platelet-activating factor (PAF) inhibitor. It is widely recognized in the pharmaceutical industry for managing allergic rhinitis, urticaria, and chronic allergic conditions, offering fast relief and a strong safety profile.

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🔍 Basic Information

 

 

 

 

 

 

 

 

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🧪 Specification ​

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💧 Physicochemical Properties

• ✔️ Appearance: White to off-white crystalline powder

• ✔️ Solubility: Soluble in methanol and ethanol; slightly soluble in water

• ✔️ Storage: Keep in a cool, dry, and dark place

• ✔️ Shelf Life: 2 years under recommended conditions

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🎯 Key Benefits

✅ Non-sedative formula – suitable for day-time use
✅ Dual-action: antihistaminic & anti-inflammatory
✅ Long-lasting relief with once-daily dosing
✅ Safe for both adults and children
✅ Ideal for mono-preparations or combo drugs
✅ Low interaction profile for broader compatibility

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🌐 Applications

Rupatadine Fumarate is a versatile API suitable for a wide range of pharmaceutical and health supplement products:

💊 Pharmaceutical Tablets & Film-Coated Tablets

• Indication: Chronic urticaria, allergic rhinitis, seasonal pollen allergies

• Dosage: Adults and children over 12: 10 mg once daily

• Features: Non-drowsy, fast-acting, 24-hour effectiveness

• Formulation: Often combined with excipients such as lactose, magnesium stearate, and microcrystalline cellulose

🧴 Oral Solutions & Syrups (Pediatrics & Seniors)

• Indication: Pediatric rhinitis, skin allergies, dust mite allergy

• Dosage: 2.5–5 mg/day for children (ages 2–11)

• Formulation Tips: Flavored liquids for better compliance in children; sugar-free options available

🧬 Combination Formulas

• Applications: Combined with montelukast or corticosteroids for enhanced anti-inflammatory action

• Dosage: Customizable per indication and co-formulation strategy

• Market Position: Popular in adult and pediatric combo packs

🩺 Nutraceuticals / Functional Health Products

• Positioning: Anti-allergy nutraceuticals for immune support

• Dosage: 5–10 mg/day equivalent in functional tablets or chewables

• Target Users: Mild allergy sufferers, seasonal support seekers

🔄Rupatadine Fumarate Production Flowchart

Raw Material Preparation→ Selection and preparation of key intermediates under GMP guidelines

Chemical Synthesis of Rupatadine Base→ Stepwise chemical reaction forming the tricyclic piperidine derivative core

Salt Formation with Fumaric Acid→ Formation of stable fumarate salt to improve bioavailability and shelf-life

Purification & Crystallization→ Filtration, drying, and recrystallization to remove residual impurities

QC Testing & Release→ HPLC (assay, impurities), moisture, heavy metals, residual solvents testing

Final Packaging→ Packed in pharmaceutical-grade containers in cleanroom environment

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💼 Why Use This Product in Business?

🔹 Market Demand: The global allergy therapeutics market continues to expand rapidly due to lifestyle and environmental changes. Rupatadine offers a solution with broad applications and proven efficacy.

🔹 Product Versatility: Suitable for OTC and prescription products, pediatric formulas, and combined therapies – increasing your product range flexibility.

🔹 Customer Preference: Non-sedating, once-a-day dosing and minimal side effects meet modern patient needs and improve compliance.

🔹 High ROI: With long shelf-life, cost-effective sourcing, and global regulatory acceptability, Rupatadine Fumarate supports cost-efficient development of high-margin products.

🔹 Regulatory Advantage: High-purity, GMP-compliant grade makes it easier to register products in multiple markets.

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🏆 Why Choose Chibio Biotech?

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📩 Request Quotation or Free Sample Now!

Looking for premium Rupatadine Fumarate to boost your anti-allergy pharmaceutical or functional supplement line? Chibio Biotech is your trusted global partner for advanced natural APIs!

📧 Email: sales@chibiotech.com
📞 Phone: +86 (0)532 66983270
🌐 Website: www.chibiotech.com

✅ Empower your allergy solutions with Chibio – Natural Science. Global Quality.