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Miconazole
Micronized

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

HUMAN API

Miconazole Micronized

Miconazole is a core Active Pharmaceutical Ingredient (API) belonging to the Broad-Spectrum Imidazole Antifungals class, closely related to Clotrimazole. It is highly effective for treating a wide range of cutaneous and mucosal infections caused by fungi and yeasts. We supply Miconazole (typically as the Nitrate salt) in its Micronized form, which is crucial for achieving optimal solubility and deeper penetration into skin layers, thereby maximizing clinical 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 enzymes necessary for ergosterol synthesis in the fungal cell membrane, leading to increased cell permeability, leakage of essential components, and eventual cell death.
Clinical Application:
Treatment of Candidiasis, Athlete's foot (Tinea pedis), Ringworm (Tinea corporis), and vulvovaginal fungal infections..
Competitive Advantage of Micronized Form:
The micronized particle size ensures superior, homogeneous distribution in pharmaceutical bases and boosts local bioavailability for faster and sustained action.
Dermal & Mucosal Preparations

Creams, ointments, powders, topical solutions, and oral gels.

Micronization ensures the highest degree of homogeneity in semi-solid products and minimizes the gritty texture of undissolved material.

Vaginal Suppositories/Tablets

Vaginal inserts or suppositories.

Enhanced powder flow and cohesiveness for efficient compression and molding processes.

Oral Topical Formulations

Oral gels for the treatment of oral thrush (Oral Candidiasis).

High quality meets the necessary requirements for effective mucosal absorption.

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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