Suppliers and packagers for azelex

azelex

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428	NDA	Almirall, LLC	16110-869-30	1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE	2018-09-24
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428	NDA	Almirall, LLC	16110-869-50	1 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBE	2018-09-24

Azelex Drug Supply Chain Analysis

Last updated: February 19, 2026

This report details the key suppliers and manufacturing landscape for Azelex (generically known as topical azelaic acid), a prescription medication used to treat acne vulgaris and rosacea. The analysis focuses on active pharmaceutical ingredient (API) manufacturers, finished dosage form (FDF) producers, and critical raw material providers.

Who Manufactures Azelex API?

The active pharmaceutical ingredient for Azelex is azelaic acid. Several global chemical and pharmaceutical manufacturers produce azelaic acid to pharmaceutical-grade specifications. Key players include:

• ChemSpec, Ltd.: A North American distributor and manufacturer, ChemSpec offers azelaic acid as part of its cosmetic and pharmaceutical ingredient portfolio. Their supply chain originates from audited, cGMP-compliant facilities.
• Dishman Carbogen Amcis Ltd.: This contract development and manufacturing organization (CDMO) is known for API synthesis, including azelaic acid, serving global pharmaceutical markets. They operate multiple manufacturing sites adhering to international regulatory standards.
• Spec-Chem Industry Co., Ltd.: A Chinese manufacturer of cosmetic and pharmaceutical raw materials, Spec-Chem lists azelaic acid in its product catalog, catering to both domestic and international clients. Their production facilities are typically subject to Chinese Good Manufacturing Practice (GMP) regulations.
• Vitech Intermediates Pvt. Ltd.: An Indian-based API and intermediate manufacturer, Vitech produces azelaic acid. Their manufacturing processes are designed to comply with ICH guidelines and regulatory requirements of various health authorities.

The choice of API supplier by finished drug manufacturers is influenced by factors including cost, quality, regulatory compliance (e.g., Drug Master Files - DMFs), production capacity, and supply chain reliability.

Where is Azelex Finished Dosage Form (FDF) Manufactured?

Azelex is primarily manufactured as a topical cream. The FDF production involves the formulation of azelaic acid with excipients and packaging. The primary brand holder for Azelex has historically been Valeant Pharmaceuticals International, now known as Bausch Health Companies Inc. Bausch Health, like other large pharmaceutical companies, utilizes a combination of in-house manufacturing and contract manufacturing organizations (CMOs) for its product lines.

Specific FDF manufacturing locations are proprietary. However, pharmaceutical manufacturing for major markets typically occurs in facilities compliant with the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other relevant health authority regulations. This includes plants located in:

• United States: Bausch Health operates manufacturing facilities within the US.
• Europe: Production can occur in European Union member states with robust pharmaceutical manufacturing infrastructure.
• Canada: Bausch Health has a significant presence in Canada, including manufacturing operations.

Contract manufacturers for topical formulations often possess specialized capabilities for creams, gels, and ointments, ensuring precise API dispersion, stability, and product texture.

What Are the Critical Raw Materials for Azelex Formulations?

Beyond the azelaic acid API, the formulation of Azelex cream requires several key excipients to achieve the desired therapeutic and physical properties. These include:

• Emulsifiers: To create and stabilize the oil-in-water emulsion characteristic of creams. Examples include cetearyl alcohol, ceteareth-20, and glyceryl stearate.
• Emollients and Humectants: To provide moisturizing and skin-conditioning benefits. Common ingredients are glycerin, isopropyl myristate, and dimethicone.
• Thickeners/Viscosity Modifiers: To achieve the desired cream consistency. Ingredients like carbomer and xanthan gum are often used.
• Preservatives: To prevent microbial contamination and extend shelf life. Phenoxyethanol and parabens are typical examples.
• pH Adjusters: To maintain the optimal pH for skin compatibility and API stability, such as sodium hydroxide or citric acid.
• Water: Purified or deionized water is the primary vehicle for topical formulations.

Major suppliers of these pharmaceutical excipients include global chemical companies and specialized ingredient distributors. Examples of prominent excipient suppliers include:

• BASF SE: A leading global supplier of specialty chemicals, including a wide range of cosmetic and pharmaceutical excipients.
• Dow Inc.: Offers silicones, emulsifiers, and other ingredients for personal care and pharmaceutical applications.
• Croda International Plc: Specializes in high-performance ingredients for health care and personal care, including emulsifiers and emollients.
• Evonik Industries AG: A specialty chemicals company with a portfolio of pharmaceutical excipients.

The selection and sourcing of excipients are critical for ensuring the safety, efficacy, and stability of the final Azelex product. Manufacturers must adhere to strict quality control measures and often require excipient suppliers to provide certificates of analysis and meet pharmacopeial standards (e.g., USP, EP).

What is the Regulatory Landscape for Azelaic Acid Production?

The production of both azelaic acid API and finished Azelex products is subject to stringent regulatory oversight by health authorities worldwide. Key regulatory requirements include:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to cGMP guidelines established by regulatory bodies such as the FDA (21 CFR Parts 210 and 211), EMA, and others. GMP ensures that products are consistently produced and controlled according to quality standards.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and controls for the API. Finished drug product manufacturers can then reference these DMFs in their own marketing authorization applications.
• Quality Agreements: Pharmaceutical companies enter into quality agreements with their API and excipient suppliers. These legally binding documents define the responsibilities of each party regarding quality control, testing, change management, and regulatory compliance.
• Impurity Profiling and Control: Regulatory agencies require thorough characterization and control of impurities in both APIs and finished drug products. This includes genotoxic impurities, residual solvents, and degradation products.
• Stability Testing: Comprehensive stability studies are required to determine the shelf life of the drug product under various storage conditions. This data supports the expiration dating.
• Facility Inspections: Regulatory agencies conduct periodic inspections of manufacturing facilities to ensure ongoing compliance with GMP regulations.

For azelaic acid, which is also used in over-the-counter (OTC) cosmetic products, a distinction exists in regulatory requirements. Pharmaceutical-grade azelaic acid for prescription products must meet higher purity and manufacturing standards compared to cosmetic-grade ingredients.

Key Takeaways

• Azelaic acid API is sourced from multiple global manufacturers, with ChemSpec, Dishman Carbogen Amcis, Spec-Chem Industry, and Vitech Intermediates being identified producers.
• Azelex FDF manufacturing is primarily associated with Bausch Health Companies Inc., utilizing a mix of in-house and contract manufacturing facilities that comply with international pharmaceutical standards.
• Critical excipients for Azelex cream formulations include emulsifiers, emollients, humectants, thickeners, preservatives, pH adjusters, and purified water, supplied by global chemical companies like BASF, Dow, Croda, and Evonik.
• The entire supply chain, from API to FDF, is governed by rigorous regulatory frameworks, including GMP, DMF filings, and quality agreements, overseen by agencies like the FDA and EMA.

Frequently Asked Questions

What is the primary function of azelaic acid in pharmaceutical formulations like Azelex?

Azelaic acid acts as an active pharmaceutical ingredient with antibacterial and anti-inflammatory properties, making it effective in treating acne vulgaris and rosacea.

How does the regulatory status of pharmaceutical-grade azelaic acid differ from cosmetic-grade azelaic acid?

Pharmaceutical-grade azelaic acid must meet significantly higher purity standards, undergo more rigorous manufacturing controls under cGMP, and be supported by comprehensive regulatory filings (e.g., DMFs) for use in prescription drugs, whereas cosmetic-grade azelaic acid has less stringent requirements.

What are the typical storage conditions recommended for Azelex cream?

Specific storage conditions are product-dependent and detailed on the product packaging and prescribing information. Generally, topical formulations are stored at room temperature, protected from excessive heat and light.

How are the quality and consistency of excipients ensured by pharmaceutical manufacturers?

Manufacturers ensure excipient quality through rigorous supplier qualification programs, requiring certificates of analysis for each batch, conducting incoming raw material testing, and establishing quality agreements with suppliers that define specific quality attributes and control procedures.

What are the potential challenges in the supply chain for azelaic acid API?

Potential challenges include geopolitical instability affecting production or shipping, raw material sourcing for azelaic acid synthesis, and fluctuating global demand impacting pricing and availability.

What is a Drug Master File (DMF) and its importance in the Azelex supply chain?

A Drug Master File (DMF) is a submission to a regulatory agency (like the FDA) that provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. For Azelex, a DMF for the azelaic acid API allows the finished drug product manufacturer to reference this information in their own drug application without directly disclosing proprietary API manufacturing details.

What is the typical manufacturing process for a topical cream formulation?

A typical process involves creating an oil phase and a water phase, heating them separately, then combining them under controlled agitation to form an emulsion. The API and other active ingredients are dispersed or dissolved within these phases or added during cooling. The final product is then homogenized, cooled, and filled into its final packaging.

Who is responsible for ensuring the stability of Azelex once it is formulated?

The finished drug product manufacturer (e.g., Bausch Health) is responsible for conducting and documenting comprehensive stability studies to determine the product's shelf life and recommended storage conditions.

What are the key quality control tests performed on azelaic acid API?

Key tests typically include identification, assay (purity), related substances (impurities), residual solvents, heavy metals, microbial limits, and physical characteristics such as particle size.

How do pharmaceutical companies manage intellectual property related to drug formulations?

Intellectual property is managed through patents, which can cover the active ingredient itself, specific formulations, manufacturing processes, methods of use, and even polymorphs of the API. Companies also rely on trade secrets for proprietary formulation details and manufacturing know-how not covered by patents.

What is the role of contract manufacturing organizations (CMOs) in the Azelex supply chain?

CMOs can be involved in either API synthesis or finished dosage form manufacturing. They provide specialized facilities, expertise, and capacity, allowing pharmaceutical companies to outsource production, manage costs, and scale operations efficiently.

What are the main regulatory requirements for API suppliers to the US market?

API suppliers must comply with US FDA's Current Good Manufacturing Practices (cGMP), submit a Drug Master File (DMF) if applicable, and be subject to FDA inspections. They must also meet pharmacopeial standards (e.g., USP) for their API.

How is the safety of excipients in Azelex cream assessed?

The safety of excipients is assessed through toxicological data, regulatory reviews by agencies like the FDA and EMA, and adherence to pharmacopeial monographs that specify purity limits and testing requirements for pharmaceutical use.

What is the typical concentration of azelaic acid in prescription Azelex formulations?

Prescription formulations of Azelex typically contain 15% azelaic acid.

What is the primary target market for Azelex?

The primary target market is patients with acne vulgaris and rosacea, who are prescribed Azelex by dermatologists or other healthcare professionals.

How does supply chain transparency benefit pharmaceutical companies like those manufacturing Azelex?

Supply chain transparency allows companies to better understand and manage risks, ensure compliance with regulations, verify product quality and authenticity, and optimize logistics and costs throughout the entire manufacturing and distribution process.

What is the difference between a generic and a branded drug in the context of Azelex?

Azelex is the branded name under which Valeant Pharmaceuticals (now Bausch Health) markets topical azelaic acid. Generic versions are chemically equivalent and therapeutically interchangeable but are marketed under the generic name "azelaic acid cream" by other manufacturers after the brand's patent exclusivity expires.

What are the considerations for sourcing pharmaceutical-grade water?

Pharmaceutical-grade water, such as Purified Water (PW) or Water For Injection (WFI), must be produced and monitored according to strict pharmacopeial standards (e.g., USP, EP) to ensure it is free from microbial contamination, pyrogens, and other impurities that could compromise drug product quality and safety.

How are packaging materials for Azelex cream regulated?

Packaging materials must meet stringent quality and safety standards to prevent interaction with the drug product, protect it from environmental factors, and ensure user safety. Regulations cover material composition, extractables and leachables, and functional performance, often referencing pharmacopeial requirements (e.g., USP <661>).

What are the key factors influencing the price of azelaic acid API?

Factors include the cost of raw materials for synthesis, complexity of the manufacturing process, regulatory compliance costs, economies of scale in production, market demand, and the competitive landscape among API manufacturers.

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Citations

[1] ChemSpec, Ltd. (n.d.). Azelaic Acid. Retrieved from https://www.chemspecltd.com/ (Note: Specific product pages and detailed supplier information often require direct login or inquiry).

[2] Dishman Carbogen Amcis Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from https://www.dishman-carbogen-amcis.com/

[3] Spec-Chem Industry Co., Ltd. (n.d.). Azelaic Acid. Retrieved from https://www.spec-chem.com/

[4] Vitech Intermediates Pvt. Ltd. (n.d.). Product List. Retrieved from https://www.vitech.co.in/

[5] Bausch Health Companies Inc. (n.d.). Our Products. Retrieved from https://www.bauschhealth.com/ (Note: Specific manufacturing site details are generally proprietary).

[6] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. Electronic Code of Federal Regulations. Retrieved from https://www.ecfr.gov/

[7] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/

[8] U.S. Food and Drug Administration. (n.d.). Guidance for Industry - Drug Master Files: A Guidance for Industry. Retrieved from https://www.fda.gov/

[9] BASF SE. (n.d.). Personal Care & Hygiene. Retrieved from https://www.basf.com/

[10] Dow Inc. (n.d.). Consumer Solutions. Retrieved from https://www.dow.com/

[11] Croda International Plc. (n.d.). Smart Ingredients for Health Care. Retrieved from https://www.croda.com/

[12] Evonik Industries AG. (n.d.). Health & Care. Retrieved from https://www.evonik.com/