Bromhexine Hydrochloride

In the competitive and fast-evolving pharmaceutical sector, the demand for effective respiratory medications continues to rise. Among the most widely used mucolytic agents is Bromhexine Hydrochloride, known for its efficacy in thinning and loosening mucus in the airways. At BluepillExpress, we specialize in third-party manufacturing services that provide high-quality, compliant, and cost-effective Bromhexine Hydrochloride formulations to pharmaceutical brands, wholesalers, and healthcare distributors worldwide.

With our state-of-the-art manufacturing facilities, internationally certified production standards, and expert R&D teams, BluepillExpress is positioned as a trusted partner for companies seeking to outsource the production of Bromhexine Hydrochloride while ensuring quality, compliance, and timely delivery.

Product Overview: Bromhexine Hydrochloride

Bromhexine Hydrochloride is a synthetic derivative of vasicine, an alkaloid found in the Indian plant Adhatoda vasica. It is primarily used as a mucolytic (expectorant) to treat respiratory disorders associated with excessive or thick mucus, such as:

• Chronic bronchitis
• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Sinusitis
• Emphysema
• Pneumonia

By breaking down mucopolysaccharide fibers in mucus and enhancing mucociliary clearance, Bromhexine Hydrochloride makes it easier for patients to breathe and expel phlegm.

Why Choose BluepillExpress for Bromhexine Hydrochloride Manufacturing?

At BluepillExpress, we take pride in being a trusted third-party pharmaceutical manufacturer delivering excellence in formulation, compliance, and customer satisfaction. Here’s why companies prefer us:

1. Regulatory Compliance & Certifications

• WHO-GMP Certified Facilities
• ISO 9001:2015 Certified Operations
• FSSAI & HACCP Compliance (where applicable)
• Regulatory support for dossiers, labeling, and packaging
• Export-Ready: Products conform to IP, BP, USP standards as per client requirements

2. Flexible Manufacturing Capabilities

• Custom dosage forms: Tablets, syrups, oral drops, dispersible tablets
• Multiple strengths: Bromhexine HCl 4 mg, 8 mg, 16 mg, and combinations with other actives (e.g., Salbutamol, Guaiphenesin)
• Scalable production: From pilot batches to large-scale commercial quantities
• Custom formulation and packaging as per client specifications

3. State-of-the-Art Infrastructure

• Dedicated cleanrooms for respiratory APIs and formulations
• Precision blending, granulation, and coating systems
• Automated blistering and bottle-filling lines
• Analytical labs with HPLC, UV, IR, and microbial testing capabilities
• Cold chain and climate-controlled storage facilities

Manufacturing Process of Bromhexine Hydrochloride

Our manufacturing process is carefully designed to ensure product purity, stability, and efficacy while meeting stringent quality benchmarks.

1. Sourcing of Raw Materials

Only pharmacopeia-grade raw materials (APIs and excipients) are sourced from approved and audited suppliers. Each batch undergoes rigorous identity, purity, and contamination testing before being cleared for production.

2. Granulation & Blending

For tablet and dispersible tablet formulations:

• Wet or dry granulation techniques are used based on formulation requirements.
• Excipients such as microcrystalline cellulose, lactose, and starch are blended with Bromhexine HCl for uniform distribution.

For syrup formulations:

• Solubilizing agents and stabilizers are added to ensure clarity and consistency of the final solution.

3. Compression or Filling

• Tablets are compressed using high-speed rotary machines under strict pressure and weight control protocols.
• Syrups are filled into sterile bottles using automated lines to minimize contamination risks.

4. Coating & Packaging

• Optional tablet coating for masking taste and increasing shelf life.
• Primary and secondary packaging tailored to client brand requirements: blister packs, HDPE bottles, glass bottles, sachets, etc.

5. Quality Control & Quality Assurance

• In-process checks at each manufacturing stage
• Stability studies to validate shelf life
• Batch-wise documentation and traceability
• Finished product testing for:
  • Assay (potency)
  • Dissolution
  • Microbial limits
  • Uniformity of content
  • Heavy metal & impurity profile

Dosage Forms Offered

BluepillExpress offers Bromhexine Hydrochloride in the following dosage forms and strengths to accommodate different patient needs and markets:

1. Tablets

• Bromhexine HCl 8 mg
• Bromhexine HCl 16 mg
• Combination with Salbutamol and/or Guaiphenesin

2. Syrups

• Bromhexine HCl 4 mg/5ml or 8 mg/5ml syrup
• Pediatric and adult formulations
• Sugar-free options available

3. Oral Drops

• For pediatric use
• Measured dropper bottles for accurate dosing

4. Dispersible Tablets

• Easy-to-dissolve options for pediatric and geriatric patients
• Flavored variants to enhance patient compliance

Packaging Capabilities

We provide extensive packaging customization options based on client branding and market preferences:

• Tablets: Blister packs (Alu-Alu, PVC), strip packs, bottle packs
• Syrups: Amber glass or PET bottles (60ml, 100ml, 200ml) with tamper-proof caps
• Labels: Multilingual labeling for global markets
• Secondary Packaging: Printed mono cartons, leaflets/inserts as per regulatory needs
• Export Packaging: Custom cartons, pallets, shrink wrapping with moisture-control layers

Global Reach and Export Readiness

BluepillExpress serves clients across Asia, Africa, South America, CIS countries, and the Middle East. We have experience in supporting product registration and supply chains in over 25 countries.

Export Support Includes:

• CTD/ACTD Dossiers
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate
• Certificate of Origin
• Stability data as per ICH guidelines
• Freight and shipping documentation for smooth customs clearance

Third-Party Manufacturing Process at BluepillExpress

We offer a seamless and transparent contract manufacturing process, ensuring that our partners are informed and involved at every stage.

Step-by-Step Process:

1. Initial Inquiry: You share your product requirement (form, strength, pack type).
2. Quotation & MOA: We provide a detailed quote with timelines, followed by a Memorandum of Agreement (MOA).
3. Product Development: If custom formulation is required, our R&D team develops prototypes.
4. Artwork Finalization: We design/accept your product label and packaging content.
5. Manufacturing & QA: We manufacture and test the product batch as per agreed timelines.
6. Dispatch & Documentation: Product is packed and shipped with complete documentation support.

Why Bromhexine Hydrochloride Is in Demand

With increasing air pollution, rising incidence of bronchial infections, and lifestyle-related respiratory complications, Bromhexine Hydrochloride remains a highly prescribed drug globally. Its compatibility in fixed-dose combinations makes it a core product in many cough, cold, and respiratory care lines.

Partnering with BluepillExpress gives you the edge in delivering this essential medicine efficiently, reliably, and cost-effectively to your markets.

Customization & Private Labeling

We understand the unique branding and marketing strategies of every client. Hence, we offer complete private labeling solutions:

• Product name and brand printing
• Custom formulation flavors
• Tailored carton designs
• Dedicated batch manufacturing for exclusivity

Conclusion

At BluepillExpress, we combine pharmaceutical expertise, regulatory compliance, and client-centric flexibility to deliver high-quality Bromhexine Hydrochloride formulations for domestic and international markets. Whether you’re looking to launch a new respiratory brand or expand your product range through trusted third-party partnerships, BluepillExpress ensures efficiency, transparency, and excellence at every stage.

Partner with us for the third-party manufacturing of Bromhexine Hydrochloride and experience the synergy of scientific precision and global reach.