Respiratory & Allergy

Ambroxol Hydrochloride + Guaiphenesin + Terbutaline SulphateThird Party Manufacturing in India

Looking to get Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
Combination product — see individual components
Drug Class
Mucolytic + Expectorant + Bronchodilator combination
Molecular Formula
Combination product
Molecular Weight
Combination product
Grade Standards
IP, BP
Therapeutic Category
Respiratory & Allergy
MOQ
10,000 bottles per batch per pack size
Dosage Forms
Oral Liquid

Mechanism of Action

Ambroxol Hydrochloride, Guaiphenesin, and Terbutaline Sulphate is a rationally designed triple fixed-dose combination that targets obstructive respiratory diseases through three complementary mechanisms covering mucus modification, mucociliary clearance enhancement, and bronchodilation.

Ambroxol Hydrochloride acts as a mucolytic and secretolytic agent by several complementary mechanisms. It stimulates the production of pulmonary surfactant in type II alveolar pneumocytes, which reduces the adhesion of mucus to bronchial walls. Ambroxol also increases serous bronchial secretion, decreasing mucus viscosity and making secretions more easily transportable. It stimulates ciliary beating frequency in the respiratory epithelium, enhancing mucociliary clearance. Additionally, ambroxol exhibits local anaesthetic, anti-inflammatory, and antioxidant properties by reducing cytokine release from inflammatory cells and scavenging free radicals in the airways.

Guaiphenesin works as an expectorant by reflex stimulation of bronchial secretory glands through gastric vagal pathways. It increases the volume and reduces the viscosity of respiratory tract fluid, making coughs more productive and less frequent.

Terbutaline Sulphate is a selective beta-2 adrenergic receptor agonist that relaxes bronchial smooth muscle by activating adenylate cyclase and increasing intracellular cyclic AMP levels. This leads to bronchodilation within minutes of administration, providing rapid relief from airway obstruction.

Together, this combination thins and mobilises mucus, dilates the airways, and restores physiological clearance mechanisms.

Therapeutic Uses & Indications

Therapeutic Uses

Ambroxol + Guaiphenesin + Terbutaline combination is prescribed for the symptomatic treatment of:

  • Acute and Chronic Bronchitis: Provides comprehensive relief from cough, chest congestion, and airway obstruction associated with both acute episodes and chronic bronchitic conditions.
  • Bronchial Asthma: Terbutaline provides rapid bronchodilation during asthmatic episodes while ambroxol helps clear the thick mucus plugs that often accompany asthma exacerbations.
  • Chronic Obstructive Pulmonary Disease: Manages productive cough and airflow limitation in COPD patients, with guaiphenesin facilitating mucus clearance and terbutaline improving expiratory flow rates.
  • Bronchiectasis: Helps mobilise and clear the copious mucopurulent secretions characteristic of bronchiectasis, reducing the frequency of infective exacerbations.
  • Upper Respiratory Tract Infections with Productive Cough: Provides symptom relief for severe cough with thick, tenacious sputum associated with tracheobronchitis and other respiratory infections.
  • Pneumonia: Used as supportive therapy alongside antibiotics to facilitate clearance of infected secretions and improve airway patency.

Why Manufacturers Choose This Combination

This triple combination is one of the most widely prescribed respiratory formulations in the Indian pharmaceutical market, favoured by general practitioners and chest physicians for its comprehensive single-product approach to managing productive cough with bronchospasm. The oral liquid formulation is particularly well suited for paediatric, geriatric, and debilitated patients who have difficulty swallowing tablets. Indian WHO-GMP certified manufacturers with expertise in liquid orals production find this combination to be a consistent high-volume product across both domestic PCD franchise networks and export markets in Africa, Southeast Asia, and the Middle East. The well-established supply chain for all three APIs and the proven efficacy profile make this one of the most consistently demanded cough and cold formulations in third party manufacturing in India.

Dosage Forms We Manufacture

Oral Liquid
15mg + 50mg + 1.25mg per 5ml

Frequently Asked Questions

What is the minimum order quantity for Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate?
Minimum order quantity for Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate is 10,000 bottles per batch per pack size. Please contact us for bulk pricing and custom quantities.
What dosage forms of Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate can you manufacture?
We manufacture Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate as: Oral Liquid (15mg + 50mg + 1.25mg per 5ml).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate for export?
Yes. We provide export-ready Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate?
We manufacture Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate to IP, BP pharmacopoeial standards.
Third Party Manufacturing

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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

HDPE bottle (60ml, 100ml, 200ml) with tamper-evident seal and measuring cup. Mono carton with patient information leaflet. Packaging customized to client brand guidelines.

Start Manufacturing Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Ambroxol Hydrochloride + Guaiphenesin + Terbutaline Sulphate across all dosage forms. PCD franchise and export orders welcome.

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