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Description
PRODUCT DESCRIPTION:
This fixed-dose combination of Formoterol Fumarate, a long-acting β2-agonist (LABA), and Budesonide, a potent inhaled corticosteroid (ICS), is designed for maintenance treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD).
The Dry Powder Inhaler (DPI) format offers breath-actuated delivery, ideal for patients who require portable, propellant-free inhalation support.
Available in 30-capsule packs with three dosage strengths, this formulation provides a tailored approach to managing varying severities of airway obstruction.
Formulation & Presentation:
- Dosage Form: Dry Powder Inhaler Capsules (for use with a compatible inhalation device)
- Presentation: Blister packs of 30 capsules each (customizable as per market demand)
- Available Strengths: Available in 3 Strengths
- 100 MCG Formoterol + 50 MCG Budesonide
- 250 MCG Formoterol + 50 MCG Budesonide
- 500 MCG Formoterol + 50 MCG Budesonide
- Route of Administration: Inhalation (via Dry Powder Inhaler), as per clinical indication and severity (As per physician’s discretion or decision)
Therapeutic Indications:
- Maintenance treatment of persistent asthma where use of an ICS and LABA is appropriate
- Long-term management of moderate to severe COPD, including chronic bronchitis and emphysema
- Reduces exacerbation frequency and improves lung function over time
Side Effects:
- COMMON:
- Hoarseness
- Throat irritation
- Cough
- Oral thrush (candidiasis)
- SERIOUS (RARE):
- Paradoxical bronchospasm
- Hypokalemia
- Adrenal suppression (with prolonged use)
- Pneumonia (in patients with COPD)
- PRECAUTIONS:
- Not to be used for the immediate relief of acute bronchospasm
- Rinse mouth after use to prevent oral fungal infections
- Monitor potassium levels with long-term use
- Use with caution in patients with cardiovascular disease, epilepsy, or thyroid dysfunction
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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: Non-Pressurized metered-dose inhaler (pMDI). May not require cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. The capsules 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?
- Pulmonologists and Respiratory Clinics managing chronic airway diseases
- Hospitals & Pharmacies offering step-wise asthma/COPD care
- Institutional Buyers & Tender Authorities sourcing evidence-based combination inhalation therapies
- Global Importers & Distributors seeking dossier-ready DPI capsules for asthma and COPD markets
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for effective registration in target markets
- Trusted consortium network simplifying India’s pharma supply chain
- Multiple approved manufacturers for best regional fit
- Audited, compliant manufacturing network across India
- Customizable branding, packaging, and formulation flexibility
- End-to-end logistics coordination and support
- Specialized expertise in exporting specialty injectables and DPI products
Contact Details:
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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