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Clotrimazole
Micronized

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

HUMAN API

Clotrimazole Micronized

Clotrimazole is a key Active Pharmaceutical Ingredient (API) belonging to the Broad-Spectrum Imidazole Antifungals class. It is primarily used to treat cutaneous and mucosal infections caused by fungi and yeasts. We supply Clotrimazole in its Micronized form, which is essential for achieving an increased surface area. This enhances its solubility (in formulation bases) and maximizes local bioavailability for optimal therapeutic efficacy.

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:
Topical Antifungal.
Mechanism of Action:
Inhibits the biosynthesis of ergosterol in the fungal cell membrane, leading to increased membrane permeability and eventual fungal cell death.
Clinical Application:
Treatment of Athlete's foot (Tinea pedis), Ringworm (Tinea corporis), Cutaneous Candidiasis, and vaginal yeast infections.
Competitive Advantage of Micronized Form:
The reduced particle size ensures better penetration into the stratum corneum (outer skin layer), significantly boosting the clinical effectiveness of the topical product.
Dermal Preparations

Creams, ointments, topical solutions, and dusting powders.

Micronization ensures uniform and homogeneous distribution in semi-solid formulations and minimizes insoluble particles.

Vaginal Suppositories/Tablets

Vaginal tablets or inserts.

Improved flow characteristics and compatibility with solid bases aid in molding and compression processes.

Oral Topical Formulations

Troches (lozenges) or pastilles for oral candidiasis.

High purity meets the necessary requirements for mucosal applications.

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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