Terbutaline Sulphate, Ambroxol, Guaiphenesin and Menthol

At BluepillExpress, we take pride in offering world-class third-party manufacturing services for high-quality pharmaceutical formulations. One of our most in-demand combination products is the Terbutaline Sulphate, Ambroxol, Guaiphenesin, and Menthol syrup—a well-established formulation for managing productive cough and respiratory tract disorders. Our commitment to excellence, compliance with international standards, and robust infrastructure make us a trusted partner for brands seeking reliable, GMP-compliant manufacturing.

This comprehensive cough syrup is designed to deliver symptomatic relief from bronchospasm, mucus congestion, and inflammation in both upper and lower respiratory tract conditions. BluepillExpress ensures that each component is processed, blended, and bottled with utmost precision and pharmaceutical-grade quality.

Composition Overview

Terbutaline Sulphate: A beta-2 adrenergic receptor agonist that acts as a bronchodilator by relaxing airway muscles and widening the bronchial tubes.

Ambroxol Hydrochloride: A mucolytic agent that breaks down phlegm and reduces its viscosity, making it easier to expel from the lungs.

Guaiphenesin: An expectorant that promotes the removal of mucus from the respiratory tract by increasing the volume and reducing the viscosity of bronchial secretions.

Menthol: A naturally derived cooling agent that provides a soothing effect on the throat and reduces irritation associated with coughing.

Pharmacological Action and Clinical Relevance

Each of the four ingredients serves a unique therapeutic purpose:

• Terbutaline Sulphate initiates bronchodilation and alleviates symptoms of wheezing, tightness, and shortness of breath in bronchial asthma and chronic obstructive pulmonary disease (COPD).
• Ambroxol aids in thinning and liquifying mucus, facilitating better breathing and improving airway clearance.
• Guaiphenesin works synergistically to ease productive coughing and helps clear chest congestion.
• Menthol offers symptomatic relief by reducing throat irritation, acting as an analgesic and decongestant.

This multi-action formulation is effective in treating conditions such as bronchitis, asthma, tracheobronchitis, pharyngitis, and other inflammatory conditions of the respiratory tract.

Manufacturing Excellence at BluepillExpress

At BluepillExpress, we uphold stringent manufacturing protocols that align with WHO-GMP, ISO, and DCGI standards. Our facilities are equipped with fully automated processing units, high-capacity bottling lines, in-house R&D labs, and comprehensive quality assurance (QA) and quality control (QC) systems.

Key Manufacturing Features:

• Batch Uniformity: Controlled blending and mixing processes ensure dosage uniformity and product consistency across all batches.
• Precision Bottling: Our liquid filling lines offer precise dosing, tamper-evident sealing, and cleanroom packaging protocols.
• Stability Testing: All batches undergo rigorous stability testing to confirm shelf-life, potency, and microbial safety under different storage conditions.
• Labeling and Branding: We offer full customization of labels, packaging materials, and branding elements as per client specifications and regulatory mandates.

Dosage and Packaging Customization

We offer flexible dosage and packaging options to suit the needs of various markets:

• Dosage Form: Oral Syrup
• Common Strengths:
  • Terbutaline Sulphate 1.25 mg
  • Ambroxol Hydrochloride 15 mg
  • Guaiphenesin 50 mg
  • Menthol 1 mg
• Standard Bottle Sizes: 60 mL, 100 mL, 150 mL, and 200 mL
• Packaging Types: PET/Amber bottles with child-resistant caps, tamper-evident seals, and customized cartons
• Labeling Languages: Available in English, Spanish, Arabic, French, Hindi, and others as per export market needs

Quality Control and Compliance

Our commitment to product safety and therapeutic efficacy is reinforced by a multi-tier quality assurance system.

Core Quality Checks:

• Raw Material Testing: Each API and excipient is tested for purity, potency, and microbial content.
• In-Process Monitoring: pH, viscosity, uniformity, and fill volume are monitored in real time.
• Finished Product Analysis: Conducted for assay, sterility, uniformity, dissolution, and organoleptic characteristics.
• Documentation & Traceability: Every product batch is accompanied by Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), and full traceability reports.

All documentation complies with national and international regulatory bodies including US FDA, MHRA (UK), TGA (Australia), ANVISA (Brazil), and GCC authorities.

Regulatory Support and Documentation

BluepillExpress provides complete regulatory support to clients, enabling seamless entry into domestic and global markets. Our dossier preparation team ensures the availability of the following:

• Product Dossier (CTD Format)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Stability Data
• Manufacturing License Copy
• Product Labels & Artwork
• Method of Analysis (MOA)

We assist clients with registration and approval processes in multiple jurisdictions, simplifying compliance and product launch timelines.

Why Choose BluepillExpress for Contract Manufacturing?

Our unmatched capability and client-centric approach make us a reliable manufacturing partner for companies across India, Africa, Southeast Asia, Latin America, and the Middle East.

Key Differentiators:

• Regulatory-Ready Facilities: WHO-GMP and ISO certified units with export-compliant documentation
• Fast Turnaround Time: Quick batch cycles and reliable logistics support ensure timely delivery
• Low Minimum Order Quantities (MOQs): Ideal for startups and mid-size pharmaceutical companies
• Private Label Services: Complete confidentiality and white-labeling for your brand
• Transparent Communication: Dedicated account managers for real-time updates and query resolution
• Affordable Pricing: Competitive cost structures without compromising quality

Research & Development Focus

Our in-house R&D division continually works on enhancing formulation stability, taste masking (especially for pediatric syrups), and bioavailability. We also explore:

• Sugar-Free Options: Formulations tailored for diabetic and health-conscious consumers
• Herbal Integration: Addition of natural expectorants or immune-boosting ingredients for niche markets
• Extended Shelf-Life Formulations: Using preservatives and stabilizers to maximize product viability

BluepillExpress invites clients to collaborate in co-development projects and customized formulation research.

Logistics and Global Export Capabilities

BluepillExpress partners with leading freight forwarders and cold chain logistics providers to ensure safe and timely delivery. We export to over 40 countries with fully compliant shipping procedures.

• Air and Sea Freight Solutions
• Temperature-Controlled Shipping
• Customs Documentation
• Door-to-Door Delivery Available

We offer country-specific labeling, packaging, and documentation to align with destination country regulations.

Client Collaboration Process

We follow a collaborative and transparent process to onboard clients for third-party manufacturing:

1. Product Requirement Discussion
2. Quote and MOQs Finalization
3. Agreement and Non-Disclosure Assurance
4. Sample Development and Approval
5. Artwork Design and Confirmation
6. Production and QC Clearance
7. Dispatch and Documentation Handover

We assign a dedicated project manager to streamline communication and ensure timely execution from concept to completion.

Industries We Serve

BluepillExpress partners with:

• Pharmaceutical Marketing Companies
• Hospital Chains and Clinics
• Government Procurement Agencies
• Online Pharmacies
• Retail and OTC Distributors
• NGOs and Relief Organizations

Our customizable offerings are ideal for launching new brands or expanding existing portfolios.

Conclusion

BluepillExpress stands as a premier third-party manufacturer of Terbutaline Sulphate, Ambroxol, Guaiphenesin, and Menthol syrup. Our synergy of modern technology, scientific expertise, and regulatory excellence enables partners to offer superior-quality cough relief solutions with confidence.

Whether you’re a growing pharmaceutical company or a multinational brand looking to outsource manufacturing, BluepillExpress provides a reliable, scalable, and fully compliant solution to your formulation needs.