Azelaic Acid 15 5, 20% Suppliers & Bulk Manufacturers

Available Forms: Cream / Gel

Available Strengths: 15 5, 20%

Reference Brands: Azelex (USA), Finacea (EU)

Category: Derma Drugs

Azelaic acid 20% cream and 15% gel, topical dermatology products for acne and papulopustular rosacea. For importers, distributors, dermatology wholesalers, pharmacy chains and hospital buyers.

Product Description:

Azelaic acid is a naturally occurring dicarboxylic acid, found in grains such as wheat and barley. On the skin it is antibacterial against Cutibacterium acnes, normalises shedding of follicle-lining cells so pores clog less, and dampens inflammation. It also inhibits tyrosinase, the enzyme behind melanin formation. This page covers 15% and 20% topical forms. The 20% cream is the classic acne presentation; the 15% gel has a light aqueous base suited to sensitive, reddened rosacea skin.

The 20% cream is used for mild to moderate inflammatory acne and the 15% gel for papulopustular rosacea, and in some markets the gel is also approved for acne. Patients apply a thin layer, usually twice daily, to clean, dry skin. Transient burning, stinging or itching is common at first. Contact with eyes and mouth should be avoided. Labels mention rare hypopigmentation, mainly in darker skin, and occasional worsening of asthma.

Sourcing notes. Cream and gel are different formulations, each registered with its own dossier in CTD or ACTD format. At 15% and 20% azelaic acid is prescription-only in many markets, while low-strength skincare products are often handled as cosmetics, so confirm which route applies. Expect aluminium or laminate tubes. Gels can separate in heat, so ask for Zone IVb stability data and keep storage at controlled room temperature. Each batch certificate of analysis should cover assay, pH, viscosity and microbial limits, alongside a GMP certificate and a CoPP. Give strength, form, tube size and labelling language when enquiring.