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Ambroxol Hydrochloride is a widely used mucolytic agent, prominently employed in the treatment of respiratory diseases associated with excessive or thick mucus. Known for its role in facilitating mucus clearance and enhancing respiratory function, Ambroxol Hydrochloride remains a staple in the pharmaceutical market, especially in formulations such as syrups, tablets, capsules, and inhalants.
BluepillExpress, as a leading third-party pharmaceutical manufacturing company, offers end-to-end production solutions for Ambroxol Hydrochloride under stringent regulatory guidelines and international quality certifications. With a robust infrastructure, global reach, and dedication to compliance, BluepillExpress is your trusted partner for producing Ambroxol Hydrochloride formulations for domestic and international markets.
About BluepillExpress
BluepillExpress is an established third-party manufacturer with a global reputation for manufacturing and exporting pharmaceutical products. Our operations are fully compliant with:
- WHO-GMP Standards
- ISO Certifications
- FSSAI Registration (for applicable formulations)
- USFDA and EU-GMP aligned practices
- Stringent QA/QC systems
With exports to regions such as the USA, Europe, Latin America, Africa, Southeast Asia, and the Middle East, we support brands with scalable, reliable, and cost-effective manufacturing services tailored to their needs.
Product Overview: Ambroxol Hydrochloride
Molecular Formula: C13H18Br2N2O
Molecular Weight: 414.1 g/mol
Therapeutic Category: Mucolytic, Expectorant
Pharmacological Class: Respiratory Tract Agent
Ambroxol Hydrochloride is a metabolite of bromhexine and exhibits pronounced secretolytic and secretomotor activity. It breaks down mucus structure, making it easier to expel, and is used either as a standalone active or in combination with other ingredients such as salbutamol, guaifenesin, and levosalbutamol.
Available Formulations
BluepillExpress supports third-party manufacturing of Ambroxol Hydrochloride in the following dosage forms:
- Ambroxol Hydrochloride Tablets (30 mg / 60 mg)
- Ambroxol Hydrochloride Syrup (15 mg/5 ml or customized strength)
- Ambroxol Hydrochloride with Salbutamol and Guaifenesin Syrup
- Ambroxol Hydrochloride Oral Drops
- Ambroxol Hydrochloride Inhalation Solution (for nebulization)
- Effervescent Tablets (customizable)
We offer both branded and generic options, customizable to your market requirements.
Manufacturing Capabilities at BluepillExpress
State-of-the-Art Facilities
Our GMP-certified manufacturing plants are equipped with advanced equipment for high-precision production, including:
- Automatic capsule and tablet presses
- High-speed syrup filling lines
- Efficient granulation and blending systems
- Dedicated quality control labs
- Dehumidified and temperature-controlled storage zones
Each batch is manufactured under strict environmental and safety conditions, ensuring consistency, stability, and efficacy.
Batch Size Flexibility
We accommodate small, medium, and large-scale production to suit startups, regional distributors, or global importers. Our flexibility allows clients to scale operations seamlessly without the burden of infrastructure investment.
Quality Assurance & Regulatory Compliance
BluepillExpress maintains rigorous quality checks at every stage of production. Our QA/QC protocols include:
- Raw Material Testing (API and excipients)
- In-Process Quality Control (IPQC)
- Finished Product Testing (assay, dissolution, pH, stability)
- Microbial and Heavy Metal Testing
- Stability Studies (Real-time and Accelerated)
Documentation support includes:
- Certificate of Analysis (CoA)
- Batch Manufacturing Records (BMR)
- Product Master Formula Record (MFR)
- MSDS & Technical Dossiers
- Regulatory Support for Export (as per importing country norms)
Packaging and Private Labelling Services
At BluepillExpress, we understand the importance of effective branding and secure packaging. We offer comprehensive packaging solutions including:
- Blister Packing (Alu-Alu / Blister)
- Bottle Packing (Amber/White PET or Glass Bottles)
- Custom Label Design & Print Support
- Multilingual Packaging for Export
- Tamper-Evident Seals and Security Stickers
Our packaging adheres to both domestic and international standards, with customization available based on regional regulations and client preferences.
Why Choose BluepillExpress for Ambroxol Hydrochloride Manufacturing?
1. Global Compliance
We ensure that our manufacturing protocols align with WHO, USFDA, and EU standards. Clients can be assured of compliance with major global pharmacopeias including BP, USP, IP, and Ph. Eur.
2. High Purity Raw Materials
We source Active Pharmaceutical Ingredients (APIs) from certified suppliers with verified quality and traceability, ensuring consistent performance and therapeutic efficacy.
3. Competitive Pricing
With an optimized production workflow, BluepillExpress offers some of the most competitive rates in the industry without compromising quality.
4. Fast Turnaround Time
From product development to packaging, our streamlined operations deliver your order on time—every time.
5. Complete Customization
From strength, formulation type, flavor (for syrups), to branding and documentation—every aspect can be customized to your market strategy.
Research & Development Support
BluepillExpress not only manufactures but also offers formulation development for custom Ambroxol Hydrochloride combinations. Our R&D team can assist with:
- Stability Optimization
- Bioavailability Enhancement
- Taste Masking Techniques
- New Combination Formulations (e.g., Ambroxol + Levosalbutamol + Montelukast)
- Sustained Release & Novel Drug Delivery Forms
Whether it’s to differentiate your product in a competitive market or to meet evolving clinical needs, our technical team is equipped to develop high-performing, regulatory-compliant solutions.
Export-Ready Formulations
BluepillExpress is a trusted supplier to over 30 countries worldwide. We provide export-ready Ambroxol Hydrochloride formulations, complete with:
- Shipping Documents (COA, COO, Invoice, Packing List)
- CTD Dossier Preparation
- WHO GMP & ISO Certificates
- Stability Data for Tropical Zones
- Custom Packing Based on Country Regulations
We also help our clients with registration and product launch support in their respective countries.
Contract Manufacturing Process at BluepillExpress
Step 1: Product Finalization
Client chooses the Ambroxol Hydrochloride formulation and dosage.
Step 2: Quotation and Terms
We provide a detailed proposal including pricing, timelines, and packaging options.
Step 3: Documentation & Agreement
Execution of third-party manufacturing agreement, NDA, and sharing of required licenses.
Step 4: Production & Quality Testing
Raw material procurement, manufacturing, and quality control procedures are initiated.
Step 5: Packaging & Dispatch
Final products are packed, labelled, and shipped as per client requirements.
Step 6: Ongoing Support
Post-dispatch documentation, regulatory support, and product performance feedback.
Client Support & Services
BluepillExpress provides dedicated client managers for every manufacturing project. Our team ensures seamless communication, real-time updates, and prompt resolution of queries. Additional services include:
- Sample Development
- Market-Specific Compliance Consulting
- Shelf-life Stability Reports
- Marketing Material Development (on request)
Conclusion
Ambroxol Hydrochloride remains a critical respiratory care product with consistent demand across global markets. Partnering with BluepillExpress for its third-party manufacturing ensures high-quality formulations, seamless scalability, and world-class compliance standards. Whether you’re a startup brand or a global distributor, our infrastructure, expertise, and customer-first approach make us the ideal contract manufacturing partner.
