Azelaic Acid

BluepillExpress is a leading third-party pharmaceutical manufacturer, committed to delivering superior quality formulations in line with global regulatory standards. Among our diverse product portfolio, Azelaic Acid stands out as a highly sought-after dermatological ingredient, widely used in topical treatments for acne, rosacea, and hyperpigmentation. Our third-party manufacturing services for Azelaic Acid are built on precision, innovation, and consistency, ensuring that our partners receive world-class formulations backed by science and supported by state-of-the-art infrastructure.

What is Azelaic Acid?

Azelaic Acid is a naturally occurring dicarboxylic acid found in wheat, barley, and rye. It is recognized for its antibacterial, anti-inflammatory, and keratolytic properties, making it highly effective in the treatment of various skin conditions. Typically used in concentrations ranging from 10% to 20% in creams, gels, and foams, Azelaic Acid works by:

• Killing acne-causing bacteria (Cutibacterium acnes)
• Reducing inflammation and redness
• Normalizing keratinization and unclogging pores
• Inhibiting melanin synthesis to reduce hyperpigmentation

Azelaic Acid is commonly included in formulations for the treatment of:

• Mild to moderate acne vulgaris
• Rosacea
• Post-inflammatory hyperpigmentation (PIH)
• Melasma
• Folliculitis

BluepillExpress: Your Trusted Partner in Azelaic Acid Manufacturing

At BluepillExpress, we serve as a comprehensive contract manufacturer and third-party partner for dermatology brands, cosmeceutical companies, and pharmaceutical marketers looking to outsource the production of high-quality Azelaic Acid formulations.

Our Strengths in Azelaic Acid Manufacturing Include:

1. Advanced Formulation Capabilities

We offer tailored formulation development for Azelaic Acid-based products, including:

• Creams (10% or 20%)
• Gels (oil-free and alcohol-free options)
• Foam preparations
• Combination formulations with other actives like Clindamycin, Niacinamide, or Salicylic Acid

Our R&D team ensures stability, bioavailability, and optimal skin compatibility across all product types.

2. cGMP-Compliant Manufacturing Facilities

Our WHO-GMP and ISO-certified facilities are equipped with cutting-edge machinery and automation systems that enable bulk manufacturing of topical formulations. Cleanroom environments, stringent quality checks, and standardized operating protocols ensure consistent batch quality.

3. End-to-End Services

From sourcing high-purity Azelaic Acid to final packaging and labeling, BluepillExpress offers a complete suite of services including:

• Raw material procurement
• Formulation development
• Analytical testing and stability studies
• Pilot and commercial batch production
• Private labeling and customized packaging

4. Regulatory Support and Documentation

We assist our clients in navigating regulatory requirements, both domestic and international. Our documentation support includes:

• Certificate of Analysis (CoA)
• Product dossiers
• MSDS (Material Safety Data Sheets)
• Stability data
• Regulatory filings (as per client’s target market)

5. Customization and Brand Support

Our services are designed to match your brand’s vision and market positioning. We offer:

• Flexible MOQ (Minimum Order Quantity) for startups and scaling brands
• Product design consultations
• Branding and packaging support
• Logistics and shipping assistance

Types of Azelaic Acid Products Manufactured at BluepillExpress

1. Azelaic Acid 20% Cream

A prescription-grade topical treatment for inflammatory acne and rosacea. It reduces comedones, papules, and pustules effectively without over-drying the skin. Also aids in reducing pigmentation marks caused by acne.

2. Azelaic Acid 15% Gel

Ideal for rosacea-prone skin. This gel-based formulation is non-comedogenic, lightweight, and ideal for oily or combination skin types. It helps reduce redness, swelling, and bumps associated with rosacea.

3. Azelaic Acid 10% Cream

A milder, over-the-counter formulation suitable for long-term use and maintenance. It can be positioned as a skincare product for sensitive skin, helping treat dullness, pigmentation, and uneven texture.

4. Azelaic Acid + Niacinamide Gel

A synergistic formulation combining Azelaic Acid’s anti-inflammatory action with Niacinamide’s barrier-repair and brightening properties. Suitable for acne, rosacea, and post-acne pigmentation.

5. Azelaic Acid Foam

An innovative foam formulation that ensures easy spreadability and deeper skin penetration. Foam is particularly useful for treating larger areas like the chest or back.

Quality Assurance and Testing

At BluepillExpress, quality is embedded at every stage of the manufacturing process. We conduct comprehensive in-house and third-party testing of all raw materials and finished formulations. Key quality assurance steps include:

• Raw Material Testing: Purity, potency, and microbiological analysis
• In-Process Quality Checks: pH levels, viscosity, color, consistency
• Stability Testing: Accelerated and real-time studies as per ICH guidelines
• Finished Product Testing: Microbial load, active ingredient content, packaging integrity

We ensure all products are free from parabens, sulfates, and other harmful additives unless specified otherwise.

Global Compliance and Export Capabilities

BluepillExpress is a globally trusted manufacturing partner, with an established export footprint across Asia, Africa, Latin America, CIS countries, and parts of Europe. Our export services for Azelaic Acid formulations include:

• Product registration support
• Dossier preparation
• International shipping and documentation
• Custom clearance assistance
• Adherence to region-specific regulatory norms (e.g., EU, USFDA, CDSCO, etc.)

We understand the critical importance of compliance in global markets and ensure that all manufactured products meet the standards of the target country.

Why Choose BluepillExpress for Azelaic Acid Manufacturing?

• Trusted Expertise: Years of experience in dermatology and topical product manufacturing
• Quality & Precision: Consistently high-quality formulations adhering to GMP protocols
• Scalability: Capability to handle small, medium, and large batch sizes
• Confidentiality: Strict protection of intellectual property and proprietary formulations
• Affordability: Competitive pricing with uncompromised product quality
• Timely Delivery: Reliable lead times and efficient logistics systems

Packaging and Labeling

We offer customized packaging options to align with your brand’s identity and regulatory needs. Options include:

• Tubes (laminated/aluminum)
• Airless pumps
• Jars
• Sachets (for sample distributions)
• Outer cartons with multilingual printing

Tamper-evident seals, batch coding, and expiry labeling are included to ensure product authenticity and traceability.

Sustainability Commitment

BluepillExpress is committed to environmentally responsible manufacturing. We use eco-friendly packaging materials whenever possible and maintain strict waste management protocols to reduce our environmental footprint.

Client-Centric Process Flow

Here’s a simplified overview of our third-party manufacturing process:

1. Initial Consultation: Understanding your brand needs, product requirements, and regulatory expectations.
2. Quotation & Agreement: Transparent pricing and mutual agreement.
3. Formulation Development: Prototype samples created and shared for feedback.
4. Trial & Testing: Clinical efficacy and compatibility testing, if required.
5. Approval & Production: Commercial batch manufacturing begins post-approval.
6. Quality Check & Packaging: Final product undergoes strict quality control and customized packaging.
7. Dispatch & Delivery: Products are shipped according to schedule, with full logistical support.

Conclusion

BluepillExpress is proud to be a reliable and efficient third-party manufacturing partner for Azelaic Acid formulations. Whether you’re a startup skincare brand or an established pharmaceutical company, we have the experience, infrastructure, and dedication to bring your products to market with quality, compliance, and care.

By choosing BluepillExpress, you gain more than a manufacturer—you gain a partner committed to your growth, reputation, and customer satisfaction. Let us help you formulate and deliver powerful, science-backed skincare solutions that meet the highest international standards.