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Azelastine Hydrochloride bulk supplier for pharma manufacturers

Azelastine Hydrochloride 0.1 %, 0.15 % 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 a Allergy Medication product available as Nasal Spray in strengths 0.1 %, 0.15 %. It corresponds to the reference brands Astelin (USA), Astepro (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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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.

Azelastine Hydrochloride — third party manufacturing & bulk supply

Azelastine Hydrochloride 0.1 %, 0.15 % is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Azelastine Hydrochloride listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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