WHO-GMP certified API production with complete DMF support.
Availability: In Stock | CAS: 611-75-6 | Grade: Medicinal
Bromhexine HCL API (Bromhexine Hydrochloride) is a pharmaceutical-grade mucolytic agent used as an active pharmaceutical ingredient in respiratory formulations.
Surya Life Sciences Ltd. is a trusted Bromhexine HCL API manufacturer and exporter, supplying high-quality APIs to regulated and semi-regulated pharmaceutical markets worldwide.
Our manufacturing operations are supported by four WHO-GMP–approved manufacturing units, backed by ISO-certified quality systems. Manufacturing operations follow defined quality systems and statutory requirements to support consistent API quality and batch reproducibility.
Bromhexine HCL API Key Specifications
| Attribute | Specification |
|---|
| Chemical Name | Bromhexine Hydrochloride |
| CAS | 611-75-6 |
| Category | Mucolytic/Expectorant |
| Therapeutic Use | Respiratory disorders requiring mucus clearance |
| Standards | IP / BP / EP |
| Molecular Formula | C14H20Br2N2 |
| Molecular Weight | 412.14 g/mol |
| Appearance | White or almost white crystalline powder |
| Solubility | Freely soluble in water and alcohol |
| Purity | 99% min |
| Shelf Life | 3 years |
| Available Grades | Pharmaceutical Grade |
Why Choose Surya Life Sciences as Your Bromhexine HCL API Manufacturer?
As a Bromhexine HCL API manufacturer and exporter, Surya Life Sciences focuses on dependable API quality, structured documentation, and global supply systems aligned with pharmaceutical needs.
Below is a snapshot of our typical quality performance parameters:
Regulatory-Ready Documentation & DMF Support
We support Bromhexine Hydrochloride API programs with structured documentation suitable for development, registration, and commercial supply, including:
- Drug Master File (DMF) support
- IP/BP / EP compliance documentation (where applicable)
- Batch-specific Certificates of Analysis and quality records
Reliable Stock Availability & Supply Continuity
Our manufacturing planning and inventory systems are designed to ensure uninterrupted API availability:
- Stock-based and bulk supply options
- Typical dispatch timelines of one week, subject to availability
- Scalable supply capacity aligned with commercial demand
Easy Ordering & Reasonable Pricing
To support different stages of pharmaceutical development, our ordering process provides:
- Commercial-scale supply starting from defined MOQs
- Transparent pricing based on batch size and volume
- Clearly defined delivery timelines at the order stage
Certified Quality & Compliance
Our API manufacturing operations align with recognised international standards:
- WHO-GMP–approved facilities
- ISO 9001:2000
- ISO 14001:2004
- OHSAS 18001:1999
Bulk Supply and Customization
As a Bromhexine HCL API manufacturer, we supply bulk quantities for domestic and export markets, ensuring reliable delivery timelines and consistent product quality. Our current supply capability supports up to 10,000 kilograms per day, ensuring continuity for large-scale pharmaceutical programs.
Customization Options:
- Batch sizes can be aligned with order volumes and production schedules
- Packaging configurations can be customized on request to meet regulatory and logistics requirements
Bromhexine HCL API Exporter from India for Global Pharmaceutical Supply
Surya Life Sciences is a reliable Bromhexine HCL API exporter from India, supplying pharmaceutical companies across Asia, Africa, Europe, and Latin America.
We support global supply with:
- Regulatory-compliant documentation (DMF, CoA, MSDS)
- Consistent batch quality and traceability
- Efficient international logistics and timely delivery
- Scalable bulk supply for commercial requirements
- Experienced pharmaceutical API exporter for regulated and semi-regulated markets
Clinical Uses & Industry Applications of Bromhexine Hydrochloride API
Bromhexine HCL API (Bromhexine Hydrochloride) is indicated for pharmaceutical applications involving respiratory conditions where mucus clearance is required, including:
This makes it a widely used respiratory API ingredient in pharmaceutical formulations.
Acute and chronic bronchitis
Chronic obstructive pulmonary disease (COPD)
Respiratory conditions associated with excessive or thick mucus
Key industry applications of Bromhexine Hydrochloride API include:
Finished Dosage Form Manufacturing
Used by pharmaceutical manufacturers for the production of oral solid and liquid dosage forms such as tablets and syrups intended for respiratory therapies.
Generic Drug Development Programs
Integrated into formulation pipelines requiring consistent API quality, pharmacopeial compliance, and reproducible batch performance.
Contract Manufacturing & Private Label Supply
Supplied to CDMOs and third-party manufacturers supporting branded and private-label respiratory pharmaceutical products.
Formulation R&D and Process Optimisation
Utilised during formulation development, particle size control, and stability evaluation, where predictable API behaviour is required.
Regulated Export & International Supply Chains
As a Bromhexine HCL API exporter, we support export-oriented pharmaceutical manufacturing programs with consistent quality, documentation, and regulatory compliance.
Storage, Packaging & Handling Information
Proper storage of Bromhexine HCL API is essential to maintain product stability and quality.
Storage
Store in a cool, dry place away from direct sunlight.
Packaging
Packed in 25 kg fiber drums with double inner polyethylene liners to protect against moisture and contamination.
Handling
Handle in accordance with GMP guidelines and MSDS recommendations. Use appropriate Personal Protective Equipment (PPE) during handling and avoid unnecessary exposure.
Request Batch Details, Pricing, and Availability
Connect with our experts for pricing, availability, technical documentation, regulatory assistance, tailored supply options, and more.
FAQs
Is Bromhexine HCL API pharmacopeia compliant?
Bromhexine HCL API is manufactured to meet IP and BP standards, with defined specifications for identity, purity, and quality.
Are DMFs applicable for Bromhexine HCL API export to regulated and semi-regulated markets?
Yes. Surya Life Sciences supports Drug Master Files (DMFs) and associated regulatory documentation for both regulated and semi-regulated pharmaceutical markets, subject to regional requirements.
What is the typical delivery time for bulk API orders?
Bulk Bromhexine HCL API orders are typically dispatched within one week of order confirmation, subject to batch availability and quality release.
What is the minimum order quantity (MOQ) for Bromhexine Hydrochloride API?
The minimum order quantity for Bromhexine Hydrochloride API is 25 kilograms. MOQ details can be reconfirmed with our commercial team.
Do you export Bromhexine HCL API globally?
Yes, we are a Bromhexine HCL API exporter, supplying to multiple international markets with complete regulatory and quality documentation.