Description
Acebrophylline (SR), Montelukast & Fexofenadine Tablets (200 mg / 10 mg / 120 mg)
Healthy Inc is a specialized global supplier and exporter of advanced pulmonology, ENT, and targeted internal medicine therapeutics. We provide ultra-high-purity, kinetically balanced Acebrophylline (SR), Montelukast & Fexofenadine FDC Tablets, manufactured in WHO–GMP certified, high-precision specialized respiratory facilities. This “Mucoregulatory Bronchodilator, Leukotriene Receptor Antagonist (LTRA) & Antihistamine FDC” is a premium strategic export to pulmonology hospitals, allergy centers, and government health ministries, serving as the globally preferred intervention for Chronic Obstructive Pulmonary Disease (COPD) and Allergic Rhinitis associated with Asthma.
Product Overview
This formulation operates as a “Triple-Front Respiratory Defense.” It targets the three physical barriers to breathing: airway constriction, excessive mucus production, and allergic inflammation.
Mechanism 1 (Airway Stability – Acebrophylline SR): Acebrophylline acts as a bronchodilator by inhibiting Phosphodiesterase (PDE). It physically relaxes the bronchial smooth muscles while stimulating Surfactant production to thin out thick mucus, making it easier to clear the lungs. The Sustained-Release (SR) matrix ensures this effect lasts for 24 hours.
Mechanism 2 (Inflammation Shield – Montelukast): Montelukast blocks the action of Leukotrienes, the chemical messengers that cause swelling in the lungs and tightening of the muscles around the airways. This prevents “delayed-phase” asthma attacks and exercise-induced bronchoconstriction.
Mechanism 3 (The Allergic Interceptor – Fexofenadine): As a second-generation H1-antihistamine, Fexofenadine blocks Histamine receptors. It provides rapid relief from sneezing, runny nose, and itchy eyes without the drowsiness associated with older antihistamines.
Product Composition & Strength
We supply this product as a Sustained-Release, Film-Coated Tablet, engineered to provide a steady-state therapeutic concentration over a full 24-hour cycle.
| Active Ingredient | Strength | Primary Clinical Function |
| Acebrophylline (SR) USP/BP | 200 mg | The Broncho-Mucolytic: Relaxes airways and thins mucus for 24-hour breathing comfort. |
| Montelukast (as Sodium) USP/BP | 10 mg | The LTRA: Prevents chronic inflammation and asthma triggers in the lungs. |
| Fexofenadine HCl USP/BP | 120 mg | The Antihistamine: Provides non-sedating relief from upper respiratory allergic symptoms. |
Technical & Logistics Specifications
HS Code: 3004.90.99 (Other medicaments acting on the Respiratory System – Combinations)
CAS Numbers: 96989-76-3 (Acebrophylline) / 151767-02-1 (Montelukast) / 83799-24-0 (Fexofenadine)
Dosage Form: Sustained-Release (SR) Film-Coated Tablet
Packaging: Alu-Alu Blisters. Protects the API from environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.
Manufacturing Authority & Compliance
SR Matrix Integrity: Our manufacturing process focuses on a Hydrophilic Matrix System that releases Acebrophylline at a controlled rate, preventing the “Theophylline-like” spikes in heart rate and ensuring 24-hour efficacy.
API Purity Excellence: We utilize high-purity Montelukast Sodium that is strictly monitored for Sulfoxide and Cis-Isomer impurities, ensuring the highest level of safety for chronic respiratory therapy.
Primary Indications
Pulmonology: Treatment of Chronic Obstructive Pulmonary Disease (COPD) with an allergic component.
ENT / Allergy: Management of Perennial or Seasonal Allergic Rhinitis associated with Bronchial Asthma.
Internal Medicine: Prevention of exercise-induced bronchoconstriction and relief of chronic productive cough.
Dosage & Administration
Standard Adult Dosing: 1 tablet once daily, preferably in the evening.
Administration: Best taken after food. Tablets must be swallowed whole; do not crush or chew as this destroys the sustained-release mechanism.
Safety Warning: Cardiac Awareness. Use with caution in patients with pre-existing heart conditions or cardiac arrhythmias. Neuropsychiatric Alert: Monitor for changes in mood or behavior in patients taking Montelukast. Strictly contraindicated in patients with severe hepatic or renal impairment.
Global Export & Contract Manufacturing
Healthy Inc is a premier Respiratory Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-precision Respiratory FDCs. Whether you are an Allergy Specialist Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.
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