Bulk Pharmaceutical API Sources for AZILSARTAN MEDOXOMIL

Bulk Pharmaceutical API Sources for AZILSARTAN MEDOXOMIL

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS007930700
Acesobio		cc-351
AK Scientific, Inc. (AKSCI)		X6106
Chembase.cn		130440
Ark Pharm, Inc.		AK-68150
MedChemexpress MCE		HY-14736

Bulk Active Pharmaceutical Ingredient (API) Sources for: AZILSARTAN MEDOXOMIL

Last updated: August 9, 2025

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Introduction

Azilsartan Medoxomil is a next-generation angiotensin receptor blocker (ARB) primarily prescribed for hypertension management. As a vital component in pharmaceutical formulations, high-quality bulk API sourcing is central to ensuring drug efficacy, safety, and manufacturing continuity. This comprehensive analysis examines key suppliers, geographical hubs, regulatory considerations, and strategic sourcing decisions relevant to Azilsartan Medoxomil.

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Overview of Azilsartan Medoxomil API

Azilsartan Medoxomil, a prodrug, converts into its active form, Azilsartan, in vivo, antagonizing the angiotensin II receptor type 1. Its molecular formula is C_25H_24N_6O_5, with stringent purity standards (generally 99% or higher). The API's synthesis involves complex multi-step processes requiring specialized chemical expertise, access to high-grade starting materials, and rigorous quality controls.

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Global API Manufacturing Landscape

1. Major API Producing Regions

• India: The dominant global API manufacturer, India accounts for over 50% of the world's generic APIs, including complex molecules like Azilsartan Medoxomil. Notable India-based API producers leverage advanced chemical synthesis capabilities, cost advantages, and a well-established regulatory environment.

• China: Rapidly expanding API manufacturing sector with significant capacity for complex pharmaceuticals. Chinese firms often focus on large-volume supplies and competitive pricing but may face rigorous quality audits internationally.

• Europe and the USA: These regions host numerous high-quality, often CD-based, API manufacturers, predominantly serving markets with strict regulatory oversight (EMA, FDA). While manufacturing costs are higher, these suppliers emphasize compliance, traceability, and GMP adherence.

2. Leading API Suppliers

Several contract manufacturing organizations (CMOs) and pharmaceutical ingredient companies excel in producing Azilsartan Medoxomil API, driven by their technical expertise, compliance record, and capacity. Key industry players include:

• Sun Pharmaceutical Industries Ltd (India): Known for scalable manufacturing of ARBs, including Azilsartan Medoxomil, with global regulatory approvals.

• Hetero Labs Ltd (India): Experienced in synthesizing complex APIs, with extensive R&D capabilities and GMP-certified plants.

• Macleods Pharmaceuticals (India): Offers reliable API production, emphasizing quality and cost-efficiency.

• Zhejiang Huahai Pharmaceutical (China): Possesses advanced fermentation and chemical synthesis capabilities, leveraging large-scale production.

• Venus Pharma (India): Focuses on high-potency APIs with stringent quality control frameworks.

3. Contract Manufacturing and Exporters

International sourcing often involves engaging with CMOs or API brokers specializing in complex ARBs. These entities serve as intermediaries or direct suppliers, enabling flexibility in procurement volumes and regulatory compliance.

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Criteria for API Supplier Selection

For procurement, several critical factors impact sourcing decisions:

• Regulatory Compliance: Suppliers must have a current Good Manufacturing Practice (GMP) certification recognized by relevant authorities (FDA, EMA, MHRA). Maintaining regulatory stability is essential to avoid supply disruptions.

• Quality Certification: Certificates of Analysis (CoA), Particle Size Distribution, Residue Limits (Heavy Metals, Solvents), and stability data ensure product robustness.

• Manufacturing Capacity and Lead Time: Ensuring the supplier can meet projected demand, especially amid global supply chain constraints.

• Cost Effectiveness: Competitive pricing without compromising quality remains a pivotal factor.

• Supply Chain Security: Diversified sourcing reduces reliance on a single supplier, minimizing risk.

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Regulatory and Quality Considerations

API manufacturers supplying Azilsartan Medoxomil must reliably adhere to GMP standards and align with international regulatory expectations. Many suppliers possess approvals or can achieve certifications recognized by multiple agencies, facilitating global distribution.

Importantly, compliance with pharmacopoeia monographs, such as the USP, EP, or JP, demonstrates adherence to rigorous purity and quality metrics. Suppliers often provide extensive documentation, including stability studies, impurity profiles, and manufacturing CMC data, enabling downstream regulatory approval.

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Emerging Trends and Strategic Procurement

• Local vs. Global Sourcing: Increasing emphasis on local manufacturing to reduce lead times and logistical complexities, balanced against cost considerations.

• Supply Chain Resilience: Manufacturers are expanding supplier portfolios, adopting dual sourcing, or qualifying new suppliers to mitigate risk from geopolitical or pandemic-related disruptions.

• Sustainability and Traceability: Growing demand for environmentally responsible manufacturing practices, along with comprehensive supply chain transparency.

• Technological Advances: Innovations like continuous manufacturing and development of more efficient synthetic routes are shaping future API supply landscapes.

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Conclusion

Azilsartan Medoxomil's API sourcing landscape is characterized by a diverse array of global suppliers, notably in India and China, offering cost-effective, high-quality manufacturing capacity. Regulatory compliance and supply chain resilience are paramount.

Manufacturers and purchasers must prioritize GMP adherence, transparency, and regulatory alignment when selecting suppliers. Building strategic partnerships with reputable CMOs or established API producers ensures supply stability, compliance, and product integrity.

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Key Takeaways

• India remains the dominant source of Azilsartan Medoxomil API, driven by cost efficiency and manufacturing expertise.

• Chinese manufacturers offer competitive pricing but require rigorous supplier qualification and regulatory oversight.

• Suppliers with current GMP certification, comprehensive documentation, and proven regulatory approvals are preferable.

• Diversification of supply sources mitigates risks associated with geopolitical, environmental, and logistical disruptions.

• Strategic procurement should balance cost, quality, regulatory compliance, and supply chain resilience.

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FAQs

1. What are the primary challenges in sourcing Azilsartan Medoxomil API?
Challenges include ensuring regulatory compliance, maintaining high purity standards, managing supply chain risks, and verifying supplier traceability — especially amid geopolitical tensions and global disruptions.

2. How does manufacturing capacity influence procurement decisions?
Adequate manufacturing capacity ensures timely supply, prevents shortages, and accommodates future demand growth. Suppliers with scalable facilities and proven track records are preferred.

3. Are there regulatory differences between sourcing from India and China?
Yes. Indian suppliers often possess ISO and GMP certifications recognized globally, while Chinese counterparts may vary. Due diligence and qualification processes are essential to validate compliance.

4. What role do contract manufacturing organizations play?
CMOs provide flexible, scalable, and compliant manufacturing solutions. They often serve as intermediaries, facilitating procurement, quality assurance, and regulatory filings.

5. How are sustainability considerations integrated into API sourcing strategies?
Manufacturers increasingly evaluate suppliers’ environmental practices, including waste management, energy use, and sustainable raw material sourcing. Certifications and audit reports serve as compliance anchors.

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References

[1] U.S. Pharmacopeia (USP). Monograph on Azilsartan Medoxomil.
[2] European Pharmacopoeia (EP). Standard specifications for Azilsartan Medoxomil.
[3] S. Patel et al., "Emerging Trends in ARB API Manufacturing," Pharmaceutical Manufacturing, 2022.
[4] IQVIA, "Global API Market Analysis," 2021.
[5] Indian Pharmaceutical Alliance, "API Industry Overview," 2022.