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Bromhexine
API

Bromhexine Hydrochloride grades are available to suit both liquid and solid formulations

HUMAN API

Bromhexine

Bromhexine Hydrochloride is a key Active Pharmaceutical Ingredient (API) belonging to the Mucolytic Agents class. It works by breaking down thick mucus fibers, reducing the viscosity of phlegm and facilitating its expectoration. Bromhexine is a vital component in cough and bronchitis formulations where thick, troublesome sputum is present. We supply this product in high-purity grades, suitable for both adult and pediatric formulations.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Therapeutic Class:
Mucolytic Agent.
Mechanism of Action:
Depolymerizes acid mucopolysaccharides in respiratory secretions, which reduces mucus viscosity and stimulates ciliary action to improve breathing.
Clinical Application:
Treatment of respiratory disorders associated with viscous mucus, such as acute and chronic bronchitis, and bronchial asthma.
Competitive Advantage:
An effective and reliable API for enhancing Mucociliary Clearance, thereby alleviating chest congestion.
Liquid Formulations

Cough syrups, inhalation solutions, and drops.

The good solubility of the Hydrochloride salt ensures the preparation of clear, stable aqueous solutions, suitable for sweetening.

Tablets and Capsules

Immediate- and sustained-release tablets.

API powder offers good Flow and Compressibility characteristics for standard compression processes.

Injectables

Intravenous or intramuscular injections (in select markets).

Availability of high-purity grades that meet the sterility requirements for sterile preparations.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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