MUCOLYTIC(for Respiratory Health)

Respiratory health is essential for overall well-being, and any compromise in airway function due to infections, pollution, or chronic conditions can significantly affect quality of life. Mucolytic agents, designed to break down and thin mucus in the lungs and airways, are widely used to relieve respiratory symptoms in both acute and chronic respiratory diseases.

At BluepillExpress, we specialize in the third-party manufacturing of high-quality MUCOLYTIC formulations intended to support healthy respiratory function. Our mucolytic products are formulated with clinically proven ingredients like Ambroxol, Bromhexine, Acetylcysteine, and Guaifenesin, available in various delivery forms such as tablets, syrups, dispersible powders, and effervescent tablets.

As a WHO-GMP and ISO 22000:2018 certified manufacturer, we provide complete support from concept to market—ensuring compliance, quality, and customizable formulations suited for both domestic and export markets.

What is a Mucolytic?

Mucolytics are agents that reduce the viscosity of mucus, making it easier to cough up and clear from the respiratory tract. By liquefying and breaking down the structure of mucus, these medications facilitate better airway clearance, relieve chest congestion, and improve breathing efficiency.

Mucolytics are commonly prescribed in the treatment of:

• Acute bronchitis
• Chronic obstructive pulmonary disease (COPD)
• Asthma with mucus plugging
• Cystic fibrosis
• Sinusitis
• Pneumonia
• Post-infectious cough

They are used in both pediatric and adult populations and are frequently included in combination therapies for cold and flu management.

Growing Global Demand for Respiratory Health Products

The global respiratory care drug market is projected to surpass USD 45 billion by 2030. Mucolytics represent a significant segment within this market due to increasing respiratory disorders triggered by pollution, smoking, infections, and allergens.

Market drivers include:

• Increased prevalence of chronic respiratory diseases (e.g., asthma, COPD)
• High pollution levels in urban areas
• Growing demand for pediatric respiratory formulations
• Increasing global awareness of lung health post-COVID-19
• Government and institutional procurement of respiratory medicines

With the rising burden of respiratory illnesses across all age groups, the demand for effective, affordable, and safe mucolytic products is at an all-time high.

Why Partner with BluepillExpress for Mucolytic Manufacturing?

BluepillExpress delivers reliable, science-backed mucolytic formulations for brands, hospitals, government tenders, and distributors globally. With over a decade of experience in contract manufacturing, we ensure your product is manufactured to the highest quality standards and ready for domestic or international launch.

Our Capabilities Include:

• WHO-GMP and FSSAI-certified manufacturing facility
• ISO 22000:2018 and HACCP-compliant quality management systems
• FDA registration for export-ready products
• Wide range of mucolytic APIs and delivery forms
• Pediatric-friendly syrup and powder formulations
• End-to-end private labeling and custom branding support
• Multilingual packaging, regulatory, and documentation assistance

Our products are manufactured under strict hygiene, safety, and pharmaceutical protocols, ensuring batch-to-batch consistency and customer satisfaction.

Mucolytic Product Formats We Offer

1. Mucolytic Syrup

• Suitable for children and adults
• Formulations include Ambroxol, Bromhexine, Guaifenesin, Acetylcysteine
• Pleasant flavors like orange, honey-lemon, and strawberry
• Alcohol-free and sugar-free options available

2. Mucolytic Tablets

• Ambroxol, Acetylcysteine, or combinations
• Extended-release or immediate-release options
• Scored tablets for adjustable dosing
• Used for chronic respiratory diseases in adults

3. Mucolytic Dispersible Tablets / Powders

• Fast-dissolving formulations for children and elderly
• Packaged in sachets or tablets for easy reconstitution
• Effective in both acute and chronic cases

4. Effervescent Mucolytic Tablets

• Formulated with Acetylcysteine (600 mg or 200 mg)
• Dissolves in water for improved absorption and patient compliance
• Suitable for adults with COPD and chronic bronchitis

5. Combination Formulations

• Ambroxol + Guaifenesin + Terbutaline
• Acetylcysteine + Salbutamol
• With antihistamines or bronchodilators for enhanced symptom relief
• Available in syrup and tablet formats

Commonly Used Mucolytic Ingredients

Our mucolytic products are formulated using the highest quality active pharmaceutical ingredients (APIs), sourced from audited suppliers with DMF support:

• Ambroxol Hydrochloride – Stimulates surfactant production and mucus clearance
• Bromhexine Hydrochloride – Reduces sputum viscosity and promotes expectoration
• Acetylcysteine (NAC) – Antioxidant and mucolytic; breaks disulfide bonds in mucus
• Guaifenesin – Expectorant that increases respiratory tract fluid
• Carbocisteine – Reduces mucus adhesion and promotes mucociliary clearance
• Terbutaline Sulfate – Bronchodilator often combined with mucolytics
• Menthol and Camphor (optional) – For added soothing effect in syrups

Sample Product Composition – Mucolytic Syrup (Per 5 ml)

Ingredient	Amount
Ambroxol Hydrochloride	15 mg
Guaifenesin	50 mg
Terbutaline Sulfate	1.25 mg
Menthol	1 mg
Sorbitol Solution	1.5 g
Sodium Benzoate (Preservative)	0.1% w/v
Flavoring and Color	q.s.
Purified Water	q.s. to 5 ml

This formulation can be modified to suit adult or pediatric needs, with sugar-free and alcohol-free versions available.

Quality Control and Testing

Each batch of mucolytic formulation is subjected to rigorous testing to ensure efficacy, safety, and regulatory compliance.

In-Process and Final Product Testing:

• Active ingredient assay using HPLC/UV-spectrometry
• Microbial limit testing (E. coli, Salmonella, Total Plate Count)
• Heavy metal analysis (Lead, Cadmium, Mercury, Arsenic)
• pH and viscosity measurement (syrups)
• Tablet disintegration and dissolution studies
• Flavor, color, and organoleptic analysis
• Stability testing (real-time and accelerated conditions)

We provide batch-wise Certificate of Analysis (CoA) along with MSDS, Stability Reports, and Shelf-Life Validation data.

Packaging Solutions

We offer full packaging solutions that align with your target market, branding, and distribution channels:

Primary Packaging:

• Syrups: 60 ml, 100 ml, 150 ml, and 200 ml amber or PET bottles
• Tablets: Blister packs (Alu-Alu, Alu-PVC)
• Powders/Sachets: 1g–5g sachets with printed foil
• Effervescent Tablets: Tubes with moisture-proof desiccants

Secondary Packaging:

• Custom-designed mono cartons
• Export-grade shipper cartons
• Label printing with dosage and regulatory information
• Multilingual artwork for overseas markets
• Holograms, QR codes, and tamper-evident seals

We offer full support for packaging design, printing coordination, and regulatory content creation.

Export Documentation and Regulatory Compliance

BluepillExpress exports to over 30 countries and provides complete regulatory support for product registration and shipping.

Documentation Support Includes:

• Certificate of Analysis (CoA)
• Certificate of Origin (COO)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Manufacturing License Copy
• Product Dossier (on request)
• MSDS
• Nutritional Labeling / Regulatory Insert
• Invoice, Packing List, and Bill of Lading

We support EXW, FOB, CIF, and DDP shipments via air and sea freight.

Minimum Order Quantities (MOQ) and Lead Time

Product Type	MOQ	Lead Time
Syrup	3,000 bottles	20–25 working days
Tablets (Blisters)	10,000 strips	20–25 working days
Sachets / Dispersible Powder	20,000 sachets	25–30 working days
Effervescent Tablets (Tubes)	5,000 tubes	30 working days

Prototype samples and packaging mockups are typically delivered within 7–10 business days.

Ideal Clients and Business Opportunities

Our MUCOLYTIC third-party manufacturing services are ideal for:

• Pharmaceutical and OTC healthcare brands
• Pediatric and respiratory product lines
• Government tender suppliers
• Hospital and institutional procurement chains
• Online pharmacy and e-commerce sellers
• Global importers and white-label partners
• Chain pharmacies and health retailers

Whether you’re launching a single formulation or building an entire respiratory care portfolio, BluepillExpress provides scalable, cost-effective manufacturing support.

How to Get Started

1. Share your formulation preference or market requirement
2. Receive a detailed proposal with pricing and sample composition
3. Approve product prototype and packaging concept
4. Confirm regulatory details for target country (if exporting)
5. Begin production, labeling, and documentation
6. Receive finished, market-ready products at your warehouse or port

Our team provides continuous guidance throughout your product lifecycle, from development to reordering and scale-up.

Conclusion

As respiratory health becomes a central focus in both preventive and therapeutic care, MUCOLYTIC formulations offer immense market potential and clinical relevance. With increasing cases of pollution-related bronchitis, chronic respiratory conditions, and post-viral congestion, the demand for safe and effective mucolytic products continues to grow.

BluepillExpress offers third-party manufacturing services you can trust—built on quality, compliance, innovation, and efficiency. We empower your brand to meet consumer and clinical needs with reliable mucolytic products backed by proven science and global manufacturing expertise.