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Suppliers and packagers for generic pharmaceutical drug: AZELAIC ACID
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AZELAIC ACID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071 | NDA | LEO Pharma Inc. | 50222-303-50 | 1 CAN in 1 CARTON (50222-303-50) / 50 g in 1 CAN | 2018-10-01 |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071 | NDA | LEO Pharma Inc. | 50222-303-91 | 1 CAN in 1 CARTON (50222-303-91) / 15 g in 1 CAN | 2018-10-01 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Azelaic Acid
Introduction
Azelaic acid, a dicarboxylic acid with notable applications in dermatology, is primarily used for treating acne vulgaris, rosacea, and hyperpigmentation. Due to its growing demand in both prescription and over-the-counter formulations, identifying reliable suppliers is critical for pharmaceutical companies, formulators, and distributors. The global supply chain for azelaic acid encompasses a diverse array of chemical manufacturers, bulk chemical traders, and specialty chemical producers, each offering different grades, purities, and compliance standards tailored for pharmaceutical use.
Global Supply Chain Overview of Azelaic Acid
Azelaic acid is predominantly manufactured through chemical synthesis, primarily via the oxidation of oleic acid or the pyrolysis of glutaric acid derivatives. This process requires advanced chemical engineering and strict quality controls, particularly for pharmaceutical-grade material. Consequently, supplier selection hinges on factors such as purity levels (generally ≥99%), regulatory compliance, capacity, and geographic proximity.
Major regions supplying azelaic acid include Asia (notably China and India), Europe, and North America. Asian manufacturers, especially Chinese chemical producers, dominate the market due to competitive pricing and large production capacities. European and North American suppliers tend to focus on high-quality API (Active Pharmaceutical Ingredient) grade azelaic acid, often adhering to stringent cGMP standards.
Key Suppliers for Azelaic Acid
1. Fagron (Belgium)
Overview:
Fagron is a leading supplier in the pharmaceutical compounding sector, providing high-quality raw materials, including azelaic acid. They are known for their strict quality standards and supply chain reliability.
Strengths:
- cGMP certified
- Pharmaceutical-grade APIs
- Global distribution network
Applications:
Fagron supplies azelaic acid for both compounding and commercial pharmaceutical manufacturing, emphasizing quality and compliance.
2. Merck KGaA (Germany)
Overview:
Merck produces a range of specialty chemicals, including azelaic acid, often as part of their solvent and chemical portfolios. Their azelaic acid conforms to pharmaceutical standards suitable for topical formulations.
Strengths:
- ISO-certified manufacturing
- High-purity azelaic acid
- Extensive R&D capabilities
Applications:
Pharmaceutical formulations, cosmetic applications, research purposes.
3. Parchem Fine & Specialty Chemicals (USA)
Overview:
Parchem supplies a broad spectrum of chemical raw materials, including azelaic acid, available in different grades. They are recognized for global logistics and compliance with regulatory requirements.
Strengths:
- Multiple grades available, including pharmaceutical
- Regulatory documentation provided
- Competitive pricing
Applications:
Pharmaceutical manufacturing, cosmetics, and research.
4. Anhui Haimao Chemical Co., Ltd. (China)
Overview:
This Chinese manufacturer specializes in the synthesis and export of azelaic acid, offering bulk quantities at competitive prices. They manufacture pharmaceutical and cosmetic grades and hold ISO certifications.
Strengths:
- Cost-effective solutions
- Large production capacity
- ISO 9001 certification
Regulatory Considerations:
Quality assurances vary; comprehensive import due diligence and certification verification are recommended.
5. Shanghai Sunny Care Chemical Co., Ltd. (China)
Overview:
Shanghai Sunny Care is a prominent chemical producer and supplier of azelaic acid, focusing on high-purity grades suitable for pharmaceutical applications.
Strengths:
- High purity (≥99%)
- Consistent supply chain
- Dedicated R&D team
Regulatory Notes:
Potential for CMC documentation to satisfy regulatory requirements in multiple jurisdictions.
6. Sigma-Aldrich (Merck) (Germany/USA)
Overview:
A major distributor of chemicals, Sigma-Aldrich supplies pharmaceutical-grade azelaic acid globally, offering standard analytical purity levels.
Strengths:
- Quality assurance processes
- Widely recognized standards
- Ease of procurement
Applications:
Research, formulation development, and small-scale manufacturing.
Emerging and Niche Suppliers
With increasing demand, several emerging suppliers are entering the market, focusing on sustainable synthesis, improved purity, and reduced manufacturing costs.
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BASF and Croda International are researching biodegradable carrier systems and derivatives of azelaic acid for specialty formulations, but do not currently supply the raw API at scale.
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Smaller regional suppliers, especially in India and Southeast Asia, are expanding their production capacities, often offering competitively priced products for regional markets.
Regulatory and Quality Standards
Suppliers conforming to pharmacopeial standards, including USP, EP, and BP, are essential for API manufacturing. Regulatory compliance involves documentation such as DMFs (Drug Master Files), Certificates of Analysis (CoA), and cGMP adherence, especially for suppliers targeting global markets like the US, EU, and Japan.
Considerations for Supplier Selection
- Quality & Purity: Ensure pharmaceutical-grade specifications, with stringent QC protocols.
- Regulatory Compliance: Suppliers must provide comprehensive documentation and certifications.
- Capacity & Reliability: Large, established manufacturers minimize supply chain disruptions.
- Cost & Lead Time: Competitive pricing balanced with prompt delivery.
- Sustainability: Suppliers engaging in environmentally responsible synthesis methods are increasingly preferred.
Future Trends in Azelaic Acid Supply
The global pharmaceutical industry's shift toward sustainable sourcing and green chemistry practices is expected to influence azelaic acid suppliers. Innovations in biosynthesis or plant-based production methods could reshape supply paradigms, although current market reliance remains primarily on petrochemical routes.
Furthermore, the increasing application of azelaic acid in cosmeceuticals and medical devices is likely to drive demand for higher purity levels, demanding more robust quality assurances from suppliers.
Key Takeaways
- Diverse Supplier Base: The azelaic acid market comprises established European and North American manufacturers alongside cost-competitive Asian producers.
- Quality Priority: For pharmaceutical use, suppliers must meet rigorous quality and regulatory standards with certifications such as cGMP and pharmacopeial compliance.
- Supply Chain Management: Large-scale manufacturers with global distribution capabilities reduce risk and ensure consistent raw material availability.
- Cost Considerations: While Asian suppliers offer competitive pricing, due diligence on quality and regulatory compliance is crucial.
- Market Dynamics: Growing demand in dermatological and cosmetic markets will shape supplier investments, emphasizing sustainability and innovative production.
FAQs
1. What are the primary regions manufacturing pharmaceutical-grade azelaic acid?
European countries like Germany and Belgium, North America (USA), and Asia (China and India) dominate production, with China leading in bulk quantities due to cost advantages.
2. How can I verify the quality of azelaic acid supplied by a manufacturer?
Request Certificates of Analysis, DMFs, and perform independent testing for purity and impurity profiles, ensuring compliance with pharmacopeial standards like USP or EP.
3. Is azelaic acid supply affected by geopolitical factors?
Yes. Trade tensions, tariffs, and export restrictions may influence supply chains, especially for Chinese and Indian suppliers. Diversifying supplier bases mitigates risks.
4. Are there sustainable production methods for azelaic acid?
Currently, most azelaic acid is synthesized via petrochemical processes. Research into bio-based synthesis methods is ongoing, promising more sustainable options in future markets.
5. What should a pharmaceutical company consider when choosing an azelaic acid supplier?
Prioritize quality certifications, regulatory compliance, capacity, delivery reliability, and cost-effectiveness, while also assessing supplier reputation and sustainability initiatives.
References
[1] "Azelaic Acid," European Pharmacopoeia, European Directorate for the Quality of Medicines & HealthCare, 2021.
[2] "Global Azelaic Acid Market," MarketsandMarkets, 2022.
[3] "Chemical Suppliers and Manufacturers," Alibaba, 2023.
[4] "Active Pharmaceutical Ingredients (API) Sourcing," U.S. Food & Drug Administration (FDA), 2022.
[5] "Sustainable Chemistry Initiatives," Green Chemistry & Commerce Council, 2023.
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