Azelastine Suppliers & Bulk Manufacturers

Available Forms: Nasal Spray and Eye Drops

Available Strengths: Eye drops: 0.05%, Spray: 137 mcg/spray

Reference Brands: Astelin®, Optivar®(US); Allergodil®, Allergodil® Eye Drops (EU)

Category: Allergy Medication

Azelastine 137 mcg/spray nasal spray and 0.05% eye drops, a topical antihistamine for allergic rhinitis and conjunctivitis. For importers, pharmacy distributors and hospital buyers.

Product Description:

Azelastine hydrochloride is a second-generation antihistamine of the phthalazinone class. It blocks histamine H1 receptors and also dampens the release of other allergy mediators from mast cells. Applied locally, it acts within minutes. This page covers two different products. The nasal spray delivers 137 micrograms per spray from a 0.1% solution in a metered pump. The eye drops are a 0.05% sterile solution in a dropper bottle.

The nasal spray is used for seasonal and perennial allergic rhinitis, and in some markets for non-allergic vasomotor rhinitis. Adults usually take one or two sprays in each nostril twice daily. A bitter taste is common, and some people feel drowsy. The eye drops are used for seasonal and perennial allergic conjunctivitis, typically one drop in each eye twice daily. Many eye drops contain benzalkonium chloride, so soft contact lenses should be removed before use. Combination nasal sprays with a corticosteroid are a separate product. Status ranges from prescription to pharmacy sale by market.

Sourcing notes. Treat the spray and the drops as two products with separate dossiers in CTD or ACTD format. For the spray, ask for delivered-dose uniformity, spray pattern and droplet size data on the pump, and stability in the final device. For the eye drops, ask for sterility testing, preservative efficacy and the in-use period after opening. Ask for a batch CoA, the GMP certificate and a CoPP. Store at room temperature, not frozen. State the form, fill volume, number of sprays and country in your enquiry.