Azelastine Spray 120 Metered Dose 137 MCG
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Azelastine Spray 120 Metered Dose 137 MCG

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Description

PRODUCT DESCRIPTION:

 

Azelastine Nasal Spray is a fast-acting, non-sedating intranasal antihistamine indicated for the relief of allergic and non-allergic rhinitis symptoms.

Each spray delivers 137 MCG of Azelastine Hydrochloride, providing effective control of sneezing, nasal congestion, itchy nose, and runny nose with rapid onset and sustained relief.

Designed with precision metering technology, this formulation ensures 120 metered doses per unit, offering convenient once or twice-daily use for long-term or seasonal allergy management.

Formulation & Presentation:

  • Dosage Form: Nasal Spray
  • Presentation: Sterile, Multi-use Metered Dose Spray (customizable as per market demand)
  • Available Strengths: 137 MCG per actuation – 120 Metered Doses
  • Route of Administration: Intranasal (spray into each nostrils), as per clinical indication and severity (As per physician’s discretion or decision)

Therapeutic Indications:

  • Seasonal allergic rhinitis (hay fever)
  • Perennial allergic rhinitis
  • Non-allergic (vasomotor) rhinitis
  • Symptom control in chronic rhinitis

Side Effects:

  • COMMON:
    • Bitter taste
    • Headache
    • Nasal burning or irritation
    • Drowsiness (mild and uncommon)
  • SERIOUS (RARE):
    • Epistaxis (nosebleeds)
    • Hypersensitivity reactions
    • Somnolence or fatigue (dose-related)
  • PRECAUTIONS:
    • Avoid use in children below recommended age unless prescribed
    • Use with caution in activities requiring full alertness (e.g., driving)
    • Do not exceed recommended dosage
    • Discontinue if signs of allergic reaction appear

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TECHNICAL INFORMATION

Product Specifications:

  • HSN Code: To be assigned per international classification standards & import jurisdiction
  • Weight: Approx. 40g per Carton (With Packaging)
  • Dimensions: (15x1x8 CMS)
  • Shelf Life (Subject To Country Specific Guidelines): 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications. Cold chain not mandatory.
  • Storage: Non-Pressurized metered-dose inhaler (pMDI). May not require cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. The inhaler should be used strictly as per label guidelines.

Regulatory Status & Supply Information:

  • Regulatory Status: WHO-GMP Complaint Manufacturing. Further certifications available on request
  • Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
  • Stability: Compliant
  • MOQ: Negotiable. Based on market & registration status
  • Export Options: Available for private label, institutional supply, or branded export

Who Should Source This Product?

  • ENT & Allergy Clinics looking for fast-acting non-steroidal nasal antihistamines
  • Hospital Pharmacies managing allergic rhinitis and chronic nasal conditions
  • Retail Chains & OTC Distributors focused on seasonal allergy portfolios
  • Global Importers sourcing dossier-ready antihistamine sprays for regulated and semi-regulated markets

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation support for effective registration
  • Trusted consortium network, simplifying India’s complex pharma supply chain
  • Multiple approved manufacturers for best fit in import country
  • Network of audited, compliant manufacturers across India
  • Customizable & Flexible branding, packaging & formulation flexibility
  • End-to-end logistics support flexibility & support
  • Deep expertise in exporting specialty injectables & all products

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