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Azelastine Hydrochloride bulk supplier for pharma manufacturers

Azelastine Hydrochloride Suppliers & Bulk Manufacturers

Available Forms: Nasal Spray

Available Strengths: 0.1 %, 0.15 %

Reference Brands: Astelin (USA), Astepro (USA)

Category: Allergy Medication

Azelastine Hydrochloride is available in Nasal Spray and strengths such as 0.1 %, 0.15 %. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Azelastine Hydrochloride is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Azelastine Hydrochloride can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Azelastine hydrochloride is a selective H1 receptor antagonist used to treat symptoms of allergic conditions. It is commonly administered as a nasal spray for the management of seasonal and perennial allergic rhinitis and as ophthalmic drops for allergic conjunctivitis. Azelastine provides rapid relief from symptoms such as sneezing, nasal congestion, rhinorrhea, nasal itching, and itchy or watery eyes, with onset of action occurring within minutes for ocular use and within an hour for nasal administration. Effects can last up to 12 hours, allowing convenient twice-daily dosing.

The nasal spray is indicated for use in children five years of age and older for seasonal and perennial allergic rhinitis, and in certain countries, for vasomotor rhinitis in individuals 12 years and older. Azelastine eye drops are indicated for the treatment of seasonal and perennial allergic conjunctivitis, providing localized relief for ocular allergy symptoms. Its dual formulations make azelastine a versatile antihistamine option for both nasal and ocular allergic conditions, delivering effective symptom control with minimal systemic side effects.

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Frequently Asked Questions


Azelastine hydrochloride is used to relieve symptoms of allergic rhinitis, including nasal congestion, sneezing, and runny or itchy nose, as well as ocular allergies causing itchy or watery eyes.


Azelastine hydrochloride is a chemically synthesized antihistamine formulated as nasal spray solutions or ophthalmic drops.


Trade names include Astelin, Astepro, Optivar, and Allergodil.


Azelastine hydrochloride is manufactured and marketed by several pharmaceutical companies worldwide, including Azelis Pharma, Allergan, and Meda Pharmaceuticals.


The generic name is azelastine hydrochloride.


Brand names include Astelin, Astepro, Optivar, and Allergodil.


Azelastine hydrochloride is produced in FDA-, EMA-, and MHRA-approved facilities, adhering to international quality standards for antihistamine medications.

Yes, Azelastine Hydrochloride is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Azelastine Hydrochloride is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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