Formoterol Fumarate & Budesonide Metered-Dose Inhaler (MDI)

Healthy Inc is a specialized global supplier and exporter of advanced respiratory, pulmonary, and critical care therapeutics. We provide ultra-high-purity, kinetically stable Formoterol and Budesonide Inhalers, manufactured in WHO–GMP certified, high-precision aerosol manufacturing facilities. This “LABA + ICS Combination” is a massive-volume strategic export to respiratory clinics, retail pharmacies, and international B2B distributors, serving as the globally preferred intervention for the long-term management of Asthma and Chronic Obstructive Pulmonary Disease (COPD).

Product Overview

This formulation operates as a “Dual-Path Bronchodilator and Anti-Inflammatory.” It physically restores airway patency while chemically preventing future flare-ups.

  • Mechanism 1 (Rapid & Long-Acting Bronchodilation – Formoterol): A Selective Beta-2 Agonist that physically relaxes the Bronchial Smooth Muscles. This chemically triggers rapid airway opening (within 1–3 minutes) and physically maintains that dilation for up to 12 hours.

  • Mechanism 2 (Inhaled Corticosteroid Action – Budesonide): A potent glucocorticoid that physically enters lung cells to inhibit Inflammatory Cytokines. This chemically reduces swelling, mucus production, and airway hyper-responsiveness.

  • Mechanism 3 (The SMART Strategy): Because of Formoterol’s rapid onset, this combination is often used for both Maintenance and Reliever Therapy, physically simplifying the patient’s treatment regimen.


Product Composition & Strengths

We supply this product in standardized Metered-Dose Inhaler (MDI) formats, optimized for deep lung deposition.

Active IngredientsStrengths (per act.)Primary Clinical Function
Formoterol Fumarate IP/BP6 mcg / 12 mcgThe Muscle Relaxant: Keeps airways open.
Budesonide IP/BP100 / 200 / 400 mcgThe Anti-Inflammatory: Heals the lungs.
PropellantHFA-134a (CFC-Free)The Carrier: Ensures ozone-friendly delivery.

Technical & Logistics Specifications

  • HS Code: 3004.90.99 (Medicaments acting on the respiratory system / Others)

  • CAS Number: 43229-80-7 (Formoterol) / 51333-22-3 (Budesonide)

  • Dosage Form: Metered-Dose Inhaler (MDI)

  • Packaging: 120 / 200 Metered Actuations in an aluminum canister with a precision actuator and dust cap. Our specialized packaging ensures 24-month stability in Zone IVb tropical climates.


Manufacturing Authority & Compliance

  • Micronization Precision: To reach the deep alveoli, drug particles must physically be between 1 to 5 microns. Our manufacturing process utilizes Advanced Air-Jet Milling to ensure every puff delivers the exact therapeutic dose.

  • CFC-Free HFA Filling: We utilize Hydrofluoroalkane (HFA) Propellants, ensuring the product is physically safer for the patient’s lungs and chemically compliant with international environmental standards (Montreal Protocol).

  • Dose Consistency: We utilize Automated Valve Crimping and Pressure Testing, physically ensuring that the first puff is as potent as the last—a critical factor for chronic disease management.

Primary Indications

  • Pulmonology: Long-term maintenance treatment of Persistent Asthma.

  • COPD: Management of chronic bronchitis and emphysema to reduce exacerbations.

  • Rescue Therapy: Rapid relief of acute bronchospasm and wheezing.

Usage Instructions

  • Preparation: Physically shake the inhaler well for 5 seconds before each use.

  • Administration: Exhale fully, place the mouthpiece in the mouth, and physically press the canister once while inhaling deeply and slowly.

  • Breath-Hold: It is physically critical to hold the breath for 10 seconds to allow the medicine to settle in the lungs.

  • Hygiene: Physically rinse the mouth with water and spit after use to prevent “Oral Thrush” (fungal infection) caused by the corticosteroid.

Safety Warning: For Inhalation Use Only. Oral Thrush Note: Always rinse mouth after use to prevent localized yeast infection. Cardiac Note: Formoterol may physically cause a temporary increase in heart rate or tremors in sensitive patients. Contraindication: Do not use as the primary treatment for Status Asthmaticus or in patients with known hypersensitivity to Budesonide or Formoterol.


Global Export & Contract Manufacturing

Healthy Inc is a premier Respiratory and Pulmonology Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-volume MDIs. Whether you are a National Respiratory Program in the CIS or a B2B Pharma Marketplace partner in Africa or SE Asia, we ensure secure, WHO-GMP compliant delivery.

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