Why Is Bromhexine Hydrochloride (CAS 611-75-6) a Key API in Respiratory and Expectorant Therapies?

In the pharmaceutical industry, active pharmaceutical ingredients (APIs) with proven efficacy and safety profiles form the foundation of effective treatments. Bromhexine Hydrochloride (CAS 611-75-6) is a widely recognized expectorant used in the management of acute and chronic respiratory conditions. As a subsidiary of Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd., Run'an Pharmaceutical manufactures this API in a state-of-the-art facility that complies with international GMP standards. This article provides an overview of the product's specifications, applications, and the manufacturing excellence that ensures its quality and reliability for global pharmaceutical markets.

The Role of Bromhexine Hydrochloride in Respiratory Care

Respiratory conditions such as acute and chronic bronchitis, asthma, bronchiectasis, and emphysema often involve the production of thick, tenacious sputum that is difficult to expel. Bromhexine Hydrochloride is a mucolytic agent that helps break down the structure of mucus, reducing its viscosity and making it easier for patients to cough up phlegm. This action is particularly important for individuals with compromised respiratory function or those who produce white, sticky sputum that can obstruct small bronchi.

The API is commonly used in combination with other respiratory medications or as a standalone treatment for conditions where mucus clearance is a key therapeutic goal. Its safety and efficacy profiles are well-established, making it a staple in respiratory medicine. Run'an Pharmaceutical produces Bromhexine Hydrochloride in accordance with strict quality standards, ensuring that pharmaceutical manufacturers receive a reliable, high-purity API for their formulations.

Product Specifications

The following table summarizes the key specifications for Bromhexine Hydrochloride (CAS 611-75-6) manufactured by Run'an Pharmaceutical.

These specifications confirm the product's identity, purity, and compliance with regulatory requirements, providing pharmaceutical manufacturers with the assurance needed for formulation and registration.

Manufacturing Excellence: Run'an Pharmaceutical's Commitment to Quality

The production of high-quality APIs requires advanced facilities, rigorous quality control, and compliance with international standards. Run'an Pharmaceutical operates a 25,000-square-meter manufacturing base in Huai'an, Jiangsu, with a total investment of 160 million yuan. The facility includes a general API production workshop, an anti-tumor API production workshop, a fermentation workshop, and a comprehensive R&D center. The entire production process is controlled by a DCS (Distributed Control System), achieving automation that meets domestic advanced standards.

The company's quality management system is designed to meet GMP requirements of regulatory authorities including the FDA, Japan, South Korea, and other countries. Multiple product registrations have been approved, reflecting the company's commitment to quality and regulatory compliance. Run'an Pharmaceutical has also completed all normative acceptance procedures, including safety, environmental protection, and fire safety inspections, demonstrating its dedication to operational excellence and sustainability.

Applications and Clinical Use

Bromhexine Hydrochloride is widely used in respiratory medicine. Its primary therapeutic applications include:

• Acute and chronic bronchitis – Helps clear excessive mucus in patients with inflamed bronchial passages.

• Asthma – Assists in managing mucus production in asthmatic patients, particularly during exacerbations.

• Bronchiectasis – Aids in the clearance of accumulated mucus in patients with permanently dilated bronchi.

• Emphysema – Supports mucus clearance in patients with damaged alveoli and compromised respiratory function.

• Post-operative and critical care – Used in patients with difficulty clearing secretions, especially those with extensive small bronchial obstruction by sputum.

The API is available in various dosage forms, including tablets, syrups, and injectable solutions, making it adaptable to different clinical settings and patient populations.

Frequently Asked Questions

Q: What is the mechanism of action of bromhexine hydrochloride?

A: Bromhexine hydrochloride works as a mucolytic agent by breaking down the structure of mucus, reducing its viscosity and making it easier to expel. It stimulates the production of less viscous mucus and enhances the activity of the cilia in the respiratory tract.

Q: Is Bromhexine Hydrochloride suitable for pediatric use?

A: Bromhexine is used in pediatric respiratory conditions, but dosage should be adjusted according to the child's age and weight. Please consult the prescribing information for specific guidelines.

Q: What quality certifications does Run'an Pharmaceutical hold?

A: Run'an Pharmaceutical's facilities meet GMP requirements for the FDA, Japan, South Korea, and other countries. The company has successfully registered multiple products with international regulatory authorities.

Q: What is the typical packaging for this API?

A: Packaging can be customized according to customer requirements. Please contact the sales team for specific packaging options.

Q: Does Run'an Pharmaceutical supply this API for export?

A: Yes, the company exports products to Japan, South Korea, Spain, and other countries and regions. International inquiries are welcome.

Q: What is the shelf life of Bromhexine Hydrochloride?

A: The shelf life is determined by stability studies and is typically stated on the certificate of analysis and product packaging. Please contact the sales team for specific batch information.

Conclusion

Bromhexine Hydrochloride (CAS 611-75-6) is a well-established API with a proven role in respiratory therapy, particularly in conditions requiring effective mucus clearance. Run'an Pharmaceutical produces this API in a modern, GMP-compliant facility with DCS automation and a comprehensive quality management system. With exports to Japan, South Korea, Spain, and other markets, the company has demonstrated its ability to meet international quality standards and regulatory requirements. For inquiries, technical specifications, or to discuss your API sourcing needs, the Run'an Pharmaceutical team is available to provide detailed product information and professional support.