Azelaic Acid Cream 20%
| Product/Composition:- | Azelaic Acid Cream |
|---|---|
| Strength:- | 20% |
| Form:- | Cream |
| Production Capacity:- | 1 Million Cream / Month |
| Packaging:- | 15gm |
| Therapeutic use:- | Skin Care, Dermatology |
| Package Insert/Leaflet:- | Available upon request |
Introduction
Actiza Pharmaceutical is a WHO-GMP certified pharmaceutical exporter supplying Azelaic Acid Cream 20% w/w as a topical finished dosage formulation not API to importers, distributors and dermatology-focused buyers across Africa, Southeast Asia and Latin America.
The product is manufactured in a dedicated non-sterile semisolid block with validated homogenisation and controlled-temperature emulsification, then filled into internally lacquered tubes selected for compatibility with an acidic formulation.
Every batch ships with a complete CTD dossier, also available in ACTD and eCTD format, supported by CoPP, FSC, ICH Zone IVb stability data and full physicochemical characterisation so your regulatory team can move directly to MOH registration rather than chasing supplementary documentation.
Product Overview
| Field | Details |
| Product Name | Azelaic Acid Cream |
| INN / Generic Name | Azelaic Acid |
| Therapeutic Class | Dicarboxylic acid topical dermatological agent |
| Mechanism (brief) | Antimicrobial activity against C. acnes and S. epidermidis, plus normalisation of keratinisation producing an anticomedonal effect |
| Indications | Mild to moderate inflammatory acne vulgaris; rosacea (gel presentation); pigmentation indications where locally approved |
| API Quality | Manufactured using DMF-grade Azelaic Acid |
| Pharmacopoeial Standard | API to USP / Ph. Eur.; finished product to validated in-house specification [CONFIRM a finished-product monograph may not exist for this dosage form] |
| Available Strengths | 20% w/w cream (15% w/w gel and 10% w/w cream [TBC]) |
| Dosage Forms | Topical cream (oil-in-water emulsion); gel [TBC]; foam [TBC] |
| Product Type | Non-sterile topical semisolid |
| Pack Sizes | 15 g, 30 g and 50 g tubes; institutional packs on request |
| Shelf Life | 24 Months [CONFIRM against stability data] |
| In-Use Period | Discard [TBC] months after first opening must be supported by in-use stability |
| Storage | Store below 25°C, protected from light. Do not freeze. |
| Manufacturing Facility | WHO-GMP certified dedicated semisolid (cream and ointment) block |
| Dossier Available | Yes, CTD / ACTD / eCTD format |
| Regulatory Documents | CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data, Microbial Limits, PET |
| Markets Served | Africa, Southeast Asia, LATAM, Middle East, CIS |
Product Variants, Dosage Forms & Strengths
Azelaic Acid Cream 20% w/w (15 g / 30 g / 50 g)
The core presentation and the strength approved internationally for mild to moderate inflammatory acne vulgaris.
Formulated as an oil-in-water emulsion with a controlled globule size distribution, since release behaviour in a semisolid is governed by the microstructure of the vehicle rather than by the assay value alone.
Supplied in internally lacquered aluminium tubes; laminated tubes are available where buyers prefer a softer pack presentation.
Target buyers: dermatology distributors, private pharmacy chains, MOH formulary supply.
Key markets: Nigeria, Kenya, Ghana, Philippines, Vietnam, Colombia, Peru, Iraq, Uzbekistan.
Quality Specification & Testing
Azelaic acid is USP and Ph. Eur. grade drug substance.
The finished cream is released against a validated in-house specification which is entirely normal for topicals.
Regulatory & Dossier Support
Dossier Availability
We provide dossiers in CTD (Common Technical Document), ACTD (ASEAN Common Technical Dossier), and eCTD formats.
Module 3 quality documentation includes emulsification and homogenisation process validation, container-closure compatibility, microbial limits and preservative system justification.
Stability data includes real-time and accelerated testing under ICH Zone IVb (30°C / 75% RH), plus in-use stability supporting the after-opening period and freeze-thaw cycling data for emulsion integrity.
Bioequivalence for a Topical: Why Plasma PK Does Not Apply
Conventional bioequivalence rests on measuring the drug in plasma.
Regulators therefore accept two alternative routes.
We develop toward Q1/Q2 sameness so that the in-vitro route remains open to our partners wherever the authority permits it.
IVRT (in-vitro release testing) and IVPT (in-vitro permeation testing) data packages are available on request for markets applying EMA-style topical equivalence expectations.
Drug Master File (DMF)
Drug Master File reference for the Azelaic Acid API is available for cross-referencing in your registration dossier.
API is sourced from a qualified vendor with full impurity, residual solvent and particle-size characterisation.
CDSCO / Indian DMF reference is accepted by a large number of importing authorities and shortens query cycles.
Manufacturing Compliance
WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis.
Site Master File (SMF) is available for regulatory submissions.
Dedicated non-sterile semisolid block with validated vacuum emulsification, controlled-temperature processing and inline homogenisation batch-to-batch rheological consistency is controlled by process parameters.
Water system qualification and microbial control programme are documented.
Export Packaging & Supply Chain
Primary Packaging
Available in 15 g, 30 g and 50 g tubes. Internally lacquered aluminium tubes are standard for compatibility with an acidic formulation.
Laminated tubes are available where buyers prefer a softer pack presentation for retail.
Institutional packs available on request.
Labelling & Customisation
Private label manufacturing available across all tube sizes.
We handle tube and carton artwork, multi-lingual labelling in English, French, Spanish, Portuguese, Arabic and Russian, and country-specific regulatory text including registration number fields and mandated cautions.
Logistics
Standard export documentation includes Certificate of Analysis, Certificate of Pharmaceutical Product, Free Sale Certificate, Method of Analysis, GMP Certificate, microbial limits report, Packing List, Commercial Invoice and Bill of Lading.
Preservative efficacy data, Q3 characterisation, container compatibility data and batch manufacturing records are available on request.
Why Source Azelaic Acid Cream From Us?
Frequently Asked Questions
Q1. Do you provide a dossier for Azelaic Acid Cream?
Yes. We provide complete dossiers in CTD, ACTD and eCTD formats.
The dossier includes Module 3 quality documentation, emulsification process validation, ICH Zone IVb stability with in-use and freeze-thaw data, microbial limits, preservative efficacy results and full Q3 physicochemical characterisation.
Country-specific customisation and regulatory query support are included.
Q2. How is bioequivalence demonstrated for a topical cream?
Not through plasma measurement. Systemic exposure after topical azelaic acid is negligible.
Regulators accept either a comparative clinical endpoint study in acne vulgaris, or an in-vitro characterisation approach where the product is qualitatively (Q1) and quantitatively (Q2) the same as the reference.
We develop toward Q1/Q2 sameness to keep the faster route available.
Q3. Which specification does your Azelaic Acid Cream comply with?
The API is USP and Ph. Eur. grade. The finished cream is released against a validated in-house specification covering assay, content uniformity, pH, viscosity, globule size distribution, microbial limits per USP <61> and <62>, and preservative efficacy per USP <51>.
Q4. Can you supply Azelaic Acid Cream under our private label?
Yes. We offer private label manufacturing across all tube sizes, and dermatology is among our highest private-label categories.
We handle tube and carton artwork, multi-lingual labelling and country-specific regulatory text.
Q5. What is the MOQ for Azelaic Acid Cream export?
MOQ varies by tube size, tube type and artwork requirement.
Lacquered aluminium and laminated tubes carry different minimums, and printed tubes have their own setup thresholds.
Contact our export team with your target market, required pack sizes and estimated annual volume.
Q6. Which countries do you export Azelaic Acid Cream to?
We export across Africa (Nigeria, Kenya, Ghana, Tanzania), Southeast Asia (Philippines, Vietnam, Cambodia, Indonesia), Latin America (Colombia, Peru, Ecuador) and the Middle East and CIS (Iraq, Jordan, Uzbekistan, Kazakhstan).
Our regulatory team provides country-specific registration support.
Q7. What documents do you provide with each shipment?
Standard export documentation includes Certificate of Analysis, Certificate of Pharmaceutical Product, Free Sale Certificate, Method of Analysis, GMP Certificate, microbial limits report, Packing List, Commercial Invoice and Bill of Lading.
Preservative efficacy data, Q3 characterisation, container compatibility data and BMR are available on request.
Q8. Is azelaic acid registered as a drug or as a cosmetic?
It depends on the market and the concentration. At 20% w/w, it is regulated as a medicinal product in most jurisdictions, requiring full MOH registration with a CTD dossier and CoPP.
Some markets permit cosmetic or quasi-drug classification at lower concentrations, with a shorter pathway but restricted claims.
We confirm the applicable classification for your market before dossier compilation.
Ready to Source Azelaic Acid Cream FDF?
Share your target market, required pack sizes and volume, and our export team will respond with the applicable specification, classification pathway, dossier format, tube options and pricing.
If you are still evaluating, request the dossier summary, Q3 characterisation overview and a sample CoA first no commitment required.