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Guaifenesin
API

To guarantee the highest purity and therapeutic efficacy, we adhere to strict global standards

HUMAN API

Guaifenesin

Guaifenesin is an essential Active Pharmaceutical Ingredient (API) belonging to the Expectorant class. It is the standard compound used to relieve chest congestion and facilitate the removal of mucus from the airways, making it a crucial component in cough, cold, and flu formulations. We supply Guaifenesin in high-purity grades to ensure efficacy and stability across all pharmaceutical preparations.

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:
Expectorant.
Mechanism of Action:
Increases the volume and reduces the viscosity of respiratory tract secretions (mucus), thereby facilitating the expulsion of phlegm and promoting a more productive cough.
Clinical Application:
Relief of cough and cold symptoms associated with chest congestion and thick mucus in adults and children.
Competitive Advantage:
Well-established efficacy as a single agent or in fixed-dose combination products with cough suppressants and decongestants.
Liquid Formulations

Cough syrups, and immediate- and extended-release solutions.

Excellent water solubility and compatibility with sweetening and flavoring systems necessary to mask the inherent bitter taste.

Tablets and Capsules

Immediate-release tablets and liquid-filled capsules.

Supplied in grades with standardized specifications (e.g., flowability and density) to facilitate compression and high-speed filling processes.

Sustained-Release

Tablets or granules designed for extended release.

Ideal for formulations requiring a dual or sustained release of the active ingredient over a 12-hour period.

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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