Fexofenadine Hydrochloride (CAS No. 83799-24-0) – Non-Sedating Antihistaminic API
GMP API Supplier for Allergy Formulations
Fexofenadine is a selective H1-antagonist and an antihistamine medication used in the treatment of allergy symptoms, including seasonal allergic rhinitis and chronic urticaria. As a second-generation antihistaminic medication, it offers targeted H1 receptor blockade with minimal central nervous system penetration—ideal for formulating non-drowsy antihistamine tablets and suspensions.
It is also the active pharmaceutical ingredient (API) in branded products like Allegra.
How Is Fexofenadine Used in Pharmaceutical Manufacturing?
Fexofenadine is an antihistamine medicine that relieves the symptoms of allergies, commonly formulated into:
- Oral solid dosage forms (one tablet [180 mg] daily)
- Pediatric suspensions
- Non-sedating antihistamine syrups
- Generic versions of Allegra®
It is widely used by OTC drug manufacturers, formulators, and R&D labs targeting seasonal allergic rhinitis and chronic idiopathic urticaria.
Why Do B2B Buyers Choose Pharmint for Fexofenadine Supply?
Pharmint delivers GMP-compliant Fexofenadine Hydrochloride in bulk, with advantages tailored to international procurement:
- COA/MSDS included for every batch
- Scalable supply from kilos to metric tons
- Regulatory-ready documentation: DMF support, HS Code: 29333990
- Export-compliant with end-use declaration requirements
What Are the Technical & Quality Specifications?
| Parameter | Specification |
| CAS Number | 83799-24-0 |
| Molecular Formula | C32H39NO4·HCl |
| Appearance | White to off-white crystalline |
| Purity (HPLC) | ≥ 99% |
| Half-life | ~14 hours |
| Metabolism | Minimal, largely excreted unchanged |
How Is This Antihistamine Packaged and Shipped for Bulk Orders?
- Standard Packaging: HDPE drums or fiberboard with foil liners
- Storage: Cool, dry, light-protected areas
- Shipping: Export-ready with full documentation, REACH pre-registration
- Use Restriction: For research or industrial formulation only, not for human use
What Makes Fexofenadine Ideal for OTC and Generic Products?
Because Fexofenadine is an antihistamine that is taken to help treat allergy symptoms without causing drowsiness, it is ideal for:
- Daytime allergy medications
- Fast-acting formulations
- Pediatric-safe compounds (per region-specific guidance)
- Markets requiring minimal CNS side effects
Fexofenadine Hydrochloride FAQs
Can Fexofenadine Hydrochloride be used in effervescent or fast-dissolving tablet formulations?
Fexofenadine Hydrochloride supports modified-release forms due to its stability and solubility profile, making it compatible with effervescent and fast-dissolving delivery systems for improved patient compliance.
What particle size distribution is typically required for tablet-grade Fexofenadine API?
Tablet-grade Fexofenadine often requires D90 ≤ 150 μm for uniform blending and compressibility, ensuring consistent dosing and content uniformity in solid dosage forms.
Is Fexofenadine Hydrochloride stable under high humidity or temperature conditions?
Fexofenadine exhibits hygroscopic sensitivity; optimal storage is in sealed, moisture-resistant containers under 25°C to maintain stability during transport and storage.
Can Fexofenadine be co-formulated with decongestants or corticosteroids?
Yes, Fexofenadine is often co-formulated with pseudoephedrine or intranasal corticosteroids in fixed-dose combinations for synergistic allergy symptom control in multi-symptom OTC products.
Does Fexofenadine require any specific granulation technique during tableting?
Due to its poor flow properties, Fexofenadine may benefit from wet granulation or direct compression with excipients enhancing flowability and compactability for scalable manufacturing.
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