Description
Acebrophylline (SR) & Montelukast Tablets (200 mg / 10 mg)
Healthy Inc is a specialized global supplier and exporter of advanced pulmonology, respiratory, and targeted internal medicine therapeutics. We provide ultra-high-purity, kinetically balanced Acebrophylline (SR) & Montelukast FDC Tablets, manufactured in WHO–GMP certified, high-precision specialized respiratory facilities. This “Mucoregulatory Bronchodilator & Leukotriene Receptor Antagonist (LTRA) FDC” is a massive-volume strategic export to pulmonology hospitals, chest clinics, and government health ministries, serving as the globally preferred intervention for Chronic Obstructive Pulmonary Disease (COPD) and persistent Bronchial Asthma.
Product Overview
This formulation operates as a “Comprehensive Airway Stabilizer.” It addresses the two physical barriers to breathing: the mechanical tightening of the airways and the underlying chemical inflammation.
Mechanism 1 (Sustained Bronchodilation – Acebrophylline SR): Acebrophylline relaxes the bronchial smooth muscles by increasing cAMP levels. The Sustained-Release (SR) matrix ensures that the airways remain open consistently over 24 hours, preventing “morning dips” in breathing capacity.
Mechanism 2 (Mucus Clearance): Acebrophylline acts as a mucoregulator by stimulating Surfactant production. This physically thins out thick, “sticky” mucus, making it significantly easier for the patient to cough up and clear the lungs.
Mechanism 3 (Inflammatory Shield – Montelukast): Montelukast blocks Leukotrienes, the potent chemicals released during an allergic or asthmatic reaction that cause airway swelling and constriction. This prevents the “late-phase” asthmatic response and reduces the frequency of acute attacks.
Product Composition & Strength
We supply this product as a Sustained-Release, Film-Coated Tablet, engineered to provide synchronized therapeutic levels with convenient once-daily dosing.
| Active Ingredient | Strength | Primary Clinical Function |
| Acebrophylline (SR) USP/BP | 200 mg | The Airway Opener: Provides 24-hour bronchodilation and thins thick mucus. |
| Montelukast (as Sodium) USP/BP | 10 mg | The Inflammation Blocker: Prevents asthma triggers and reduces lung swelling. |
| Excipients | Hydrophilic Matrix | Controlled-Release System: Engineered to provide a smooth plasma curve, minimizing heart palpitations. |
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)
Dosage Form: Sustained-Release (SR) Film-Coated Tablet
Packaging: Alu-Alu Blisters. Protects the sensitive APIs 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 Validated Diffusion-Controlled Matrix that releases Acebrophylline at a steady rate, ensuring superior cardiovascular safety compared to standard xanthines.
API Purity Excellence: We utilize high-purity Montelukast Sodium strictly monitored for Sulfoxide impurities, ensuring the highest level of safety for long-term chronic respiratory therapy.
Primary Indications
Pulmonology: Long-term management of Chronic Obstructive Pulmonary Disease (COPD).
Respiratory Medicine: Prevention and chronic treatment of Bronchial Asthma in adults.
Chronic Care: Management of chronic bronchitis characterized by excessive, thick mucus production.
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 a history of cardiac arrhythmias or high blood pressure. Neuropsychiatric Alert: Monitor for changes in mood, aggression, or sleep disturbances 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 a National Health Tender Buyer in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.
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