Formoterol Fumarate + Budesonide Inhaler Inhaler (120 Metered Doses)
Categories:, SKU: 00001-52
Formoterol Fumarate + Budesonide Inhaler Inhaler (120 Metered Doses)

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Description

PRODUCT DESCRIPTION:

 

This combination inhaler unites Formoterol Fumarate, a rapid- and long-acting β2-agonist (LABA), with Budesonide, a highly effective inhaled corticosteroid (ICS), to provide dual-action management in patients with persistent asthma and moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Designed for both maintenance and symptom control, this pressurized metered-dose inhaler (pMDI) delivers 120 metered doses and is offered in three clinically validated strengths to match varying severity levels.

Formulation & Presentation:

  • Dosage Form: Inhaler Device
  • Presentation: Sterile, Multi-use Metered Dose Inhaler (customizable as per market demand)
  • Available Strengths: 3 Strengths with 120 Metered Doses
    • 6 MCG Formoterol + 100 MCG Budesonide
    • 6 MCG Formoterol + 200 MCG Budesonide
    • 6 MCG Formoterol + 400 MCG Budesonide
  • Route of Administration: Inhalation via pressurized metered-dose inhaler (pMDI), as per clinical indication and severity (As per physician’s discretion or decision)

Therapeutic Indications:

  • Maintenance treatment of asthma in patients not adequately controlled with inhaled corticosteroids alone
  • Long-term management of COPD, including chronic bronchitis and emphysema
  • May be used as reliever and controller in a single inhaler (SMART approach), as guided by healthcare professionals

Side Effects:

  • COMMON:
    • Oral candidiasis (thrush)
    • Hoarseness or throat irritation
    • Headache
    • Mild tremors
  • SERIOUS (RARE):
    • Paradoxical bronchospasm
    • Adrenal suppression with prolonged use
    • Hypokalemia
    • Increased risk of pneumonia (especially in COPD)
  • PRECAUTIONS:
    • Not intended for the immediate relief of acute bronchospasm
    • Rinse mouth after each use to reduce risk of fungal infection
    • Use with caution in patients with cardiovascular disease, diabetes, or seizure disorders
    • Monitor potassium levels in long-term use or when combined with diuretics

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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: 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications. Cold chain not mandatory.
  • Storage: Pressurized metered-dose inhaler (pMDI). May not require cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. The inhaler is highly pressurized and should be used strictly as per label guidelines.

Regulatory Status & Supply Information:

  • Regulatory Status: WHO-GMP Compliant 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?

  • Pharmaceutical Distributors focused on respiratory and pulmonary care
  • Hospitals & Tertiary Clinics treating asthma and COPD at varying severity levels
  • Government Health Agencies & Tender Authorities requiring high-volume, essential respiratory products
  • International Buyers & Importers looking for dossier-ready ICS+LABA combinations for both regulated and semi-regulated markets

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation 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 branding, packaging & formulation flexibility
  • End-to-end logistics support & coordination
  • Deep expertise in exporting specialty injectables & inhalation therapies

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