Bulk Pharmaceutical API Sources for AZELASTINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for AZELASTINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246645
NovoSeek		54360
ISpharm		I06-0528
MolPort		MolPort-003-666-641

Bulk Active Pharmaceutical Ingredient (API) Sources for: AZELASTINE HYDROCHLORIDE

Last updated: July 27, 2025

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Introduction

Azelastine Hydrochloride, a potent antihistamine used primarily in allergy treatments, is gaining increased market demand. As global healthcare providers and pharmaceutical companies seek reliable supply chains, identifying reputable API sources becomes vital. This article provides an in-depth analysis of key suppliers, manufacturing regions, quality standards, and procurement considerations relevant to Azelastine Hydrochloride.

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Overview of Azelastine Hydrochloride

Azelastine Hydrochloride, chemically known as 4-(8-ChloronAPHTh-1-yl)-4-hydroxy-4-phenylbut-2-en-1-one hydrochloride, exhibits antihistaminic activity through selective H1 receptor antagonism. Approved by the FDA, the drug’s applications in nasal sprays and ophthalmic solutions necessitate high-quality APIs for effective production.

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Global API Manufacturing Landscape

The API production landscape for Azelastine Hydrochloride comprises a mix of domestic (notably India, China, and the European Union) and multinational pharmaceutical firms. These manufacturers adhere to strict quality standards, such as Good Manufacturing Practices (GMP), to meet international regulatory requirements.

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Key API Suppliers and Manufacturers

1. Indian API Manufacturers

India remains a dominant hub for generic APIs due to cost competitiveness and robust regulatory frameworks. Leading Indian API manufacturers for Azelastine Hydrochloride include:

• Laurus Labs: Recognized for their complete API portfolio, they maintain GMP-certified facilities approved by the FDA and EMA. Their Azelastine Hydrochloride API conforms to pharmacopoeial standards, with a reputation for consistent quality and competitive pricing.

• Aarti Drugs: Known for high-volume production, delivering APIs with strict compliance to Indian pharmacopeia and international standards. Their manufacturing processes incorporate advanced purification techniques to ensure API purity.

• Hetero Labs: Hetero offers a reliable supply of Azelastine API, supported by their extensive R&D capabilities and regulatory expertise in global markets.

2. Chinese API Manufacturers

China’s API industry supplies a significant portion of the global Azelastine Hydrochloride market, driven by large manufacturing capacities and competitive pricing:

• Hangzhou Focus Pharmacabeuticals: Certified by Chinese FDA (CFDA), offering APIs that meet international quality standards. They emphasize rigorous quality control and process optimization.

• Shenzhen MicroNano Electronics: A producer with GMP certification, specializing in antihistamines and CNS-related APIs. Their Azelastine Hydrochloride API undergoes comprehensive testing to meet pharmacopoeial specifications.

3. European and US-Based API Providers

While lesser in volume, European and North American suppliers provide high-quality APIs often preferred for regulatory submissions:

• Novartis: An integrated pharmaceutical conglomerate with internal manufacturing for their branded Azelastine formulations, ensuring proprietary quality controls.

• PM Ingredients: Based in Europe, specialized in high-purity APIs, adhering to stringent European Pharmacopoeia standards. They target niche markets requiring advanced quality assurances.

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Quality Standards and Regulatory Compliance

API suppliers are required to produce Azelastine Hydrochloride in accordance with industry standards:

• GMP Certification: Essential for ensuring batch-to-batch consistency and safety.
• Pharmacopoeial Specifications: Compliance with USP, EP, or IP standards guarantees purity, potency, and quality.
• Regulatory Approvals: Suppliers with approvals from agencies like the FDA, EMA, CFDA, or TPD (Therapeutic Products Directorate) underscore reliable compliance.

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Procurement Considerations

When sourcing Azelastine Hydrochloride API, pharmaceutical developers should evaluate:

• Supplier Credibility: Confirm GMP certification, past regulatory audits, and quality track records.
• Pricing and Supply Capacity: Balance cost-effectiveness with volume requirements; large producers often offer economies of scale.
• Lead Times: Assess manufacturing timelines and logistics to prevent supply chain disruptions.
• Technical Support: Engage with suppliers offering comprehensive QC data, stability reports, and technical assistance.
• Intellectual Property: Verify freedom to operate and the absence of patent conflicts, especially in markets with strict patent protections.

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Emerging Trends and Future Outlook

The global API market is witnessing shifts towards more sustainable manufacturing practices, including green chemistry initiatives and digital quality controls. Additionally, increasing regulatory scrutiny encourages suppliers to enhance transparency through traceability and documentation, ensuring compliance with evolving standards.

Furthermore, the rise of Asia-based API manufacturers continues to reshape the supply landscape, with China and India expanding capacities to serve both domestic and international markets. There's also a discernible trend towards regional sourcing for better logistics management and reduced supply chain risks.

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Conclusion

Securing a reliable source of Azelastine Hydrochloride API requires careful evaluation of manufacturer certifications, quality compliance, and supply chain resilience. Leading suppliers include Indian giants like Laurus Labs and Aarti Drugs, Chinese manufacturers such as Hangzhou Focus Pharmacabeuticals, and high-regulatory-standard providers in Europe and North America. As demand grows, establishing partnerships with suppliers adhering to GMP and pharmacopoeial standards becomes essential for consistent product quality and regulatory compliance.

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Key Takeaways

• Indian and Chinese API manufacturers dominate Azelastine Hydrochloride supply, offering cost-effective options with GMP certification.
• European and US-based suppliers generally cater to markets requiring the highest standards and regulatory assurances.
• Rigorous quality standards, including GMP compliance and pharmacopoeial adherence, are non-negotiable for safe and effective API sourcing.
• Supply chain resilience, technical support, and regulatory approval status should guide procurement decisions.
• Emerging trends focus on sustainable manufacturing, traceability, and regional supply chain optimization.

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Frequently Asked Questions (FAQs)

1. What are the primary regions for Azelastine Hydrochloride API manufacturing?

India, China, Europe, and North America are key regions. Indian and Chinese manufacturers lead global supply due to cost advantages, while European and US suppliers often serve compliance-sensitive markets.

2. How do I verify the quality of an Azelastine Hydrochloride API supplier?

Check for GMP certification, regulatory approvals (FDA, EMA, etc.), third-party audits, and detailed QC documentation confirming purity, potency, and compliance with pharmacopoeial standards.

3. Are there any established pharmaceutical suppliers of Azelastine Hydrochloride API with proven reliability?

Yes. Laurus Labs, Aarti Drugs, and Hetero Labs in India, Hangzhou Focus Pharmacabeuticals in China, and select European firms are recognized for consistent quality and regulatory compliance.

4. What factors should influence pricing decisions for Azelastine Hydrochloride API?

Supply capacity, batch size, certification status, and geographic location primarily influence cost. Larger, GMP-certified facilities tend to offer more competitive pricing due to economies of scale.

5. What are upcoming industry trends affecting API sourcing for Azelastine Hydrochloride?

Increased focus on green manufacturing, supply chain transparency, regional sourcing strategies, and advanced digital quality controls are shaping future sourcing practices.

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References

1. U.S. Pharmacopeia. USP Monographs: Azelastine Hydrochloride.
2. European Pharmacopoeia. EP Standards for Azelastine.
3. FDA Database. Drug Master Files (DMFs) for Azelastine API suppliers.
4. Industry Reports. Global API Market Trends 2022-2027.
5. Manufacturer Websites and Certification Documents.

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Note: This analysis provides a comprehensive overview of Azelastine Hydrochloride API sources, aimed at supporting pharmaceutical procurement and strategic planning. For specific supplier contact details and tailored sourcing strategies, consultation with industry experts is recommended.