Bulk Pharmaceutical API Sources for ATACAND

Bulk Pharmaceutical API Sources for ATACAND

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-552
Hangzhou APIChem Technology		AC-204
Oakwood Products		036551
BioChemPartner		BCP9000480
AKos Consulting & Solutions		AKOS015894954

Bulk Active Pharmaceutical Ingredient (API) Sources for ATACAND

Last updated: July 30, 2025

Introduction

ATACAND (candesartan cilexetil) is an angiotensin II receptor antagonist used primarily for treating hypertension and heart failure. As a critical component in the formulation of ATACAND, the active pharmaceutical ingredient (API), candesartan cilexetil, must adhere to stringent quality standards. Global pharmaceutical companies and contract manufacturing organizations (CMOs) source APIs from a select group of suppliers capable of meeting regulatory requirements, ensuring supply chain integrity, and maintaining product efficacy. This article explores the leading bulk API sources for candesartan cilexetil, discussing key manufacturing regions, supplier profiles, and considerations pertinent to pharmaceutical stakeholders.

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Overview of Candesartan Cilexetil API Production

Candesartan cilexetil is a prodrug that, upon administration, converts into the active metabolite candesartan, which inhibits the vasoconstrictive effects of angiotensin II. API synthesis involved complex organic chemistry processes, requiring high purity and consistency. Manufacturing must conform to Good Manufacturing Practices (GMP) and be compliant with the standards set by authorities such as the FDA, EMA, and other global regulatory bodies.

The production process usually involves multi-step chemical synthesis and meticulous purification. Given its pharmaceutical importance, the API is produced by a limited number of specialized manufacturers with proven quality systems.

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Leading API Suppliers for Candesartan Cilexetil

1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Huahai is a prominent Chinese pharmaceutical manufacturer with extensive experience in generic APIs, including antihypertensive agents. The company's API manufacturing facilities are GMP-certified, and it supplies to many global pharmaceutical companies.

Capabilities: Zhejiang Huahai produces high-purity candesartan cilexetil API at scale, leveraging advanced chemical synthesis technology. The company has demonstrated consistent quality management aligned with international standards.

Regulatory Compliance: The supplier maintains GMP certification recognized by multiple regulatory agencies, making it a preferred source for global clients.

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2. Hetero Labs Limited (India)

Overview: Hetero Labs is a flagship Indian pharmaceutical exporter with a dedicated API manufacturing division. The company specializes in complex chemical APIs, with a focus on cardiovascular and central nervous system drugs.

Capabilities: Hetero produces candesartan cilexetil API with robust quality controls, meeting international standards. Their production facilities are GMP-certified and capable of large-volume manufacturing.

Regulatory Status: The company is compliant with USFDA, EMA, and other major regulatory authorities, ensuring its APIs meet global standards.

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3. Mylan (now part of Viatris) (USA/Global)

Overview: As a global pharmaceutical company, Mylan has an established API manufacturing division supplying high-quality cardiovascular APIs, including candesartan cilexetil.

Capabilities: Mylan's API manufacturing adheres to stringent quality systems, with facilities certified by the FDA and other agencies, enabling reliable supply chains for multinational drug products.

Market Position: Mylan supplies APIs directly to generic drug manufacturers and has a global distribution network.

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4. Zhejiang Tauto Biotech Co., Ltd. (China)

Overview: A newer but rapidly expanding Chinese API manufacturer, Zhejiang Tauto Biotech is recognized for its high-quality cardiovascular API portfolio.

Capabilities: Tauto has invested in modern chemical synthesis technology and purification processes to produce candesartan cilexetil API compliant with international standards.

Regulatory and Quality Assurance: ISO certifications and GMP compliance position Zhejiang Tauto as a credible source for global API supply.

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5. Khandelwal Laboratories (India)

Overview: Khandelwal Laboratories is an Indian manufacturer specializing in cardiovascular APIs, including candesartan cilexetil.

Capabilities: The company offers API products that meet pharmacopoeia standards, with a focus on cost competitiveness and supply reliability.

Regulatory Compliance: Certifications include GMP validation aligned with Indian and global regulatory expectations.

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Geographical Considerations in API Sourcing

The dominant regions producing candesartan cilexetil API include China, India, and the United States. China and India continue to lead due to their large-scale, cost-effective manufacturing capabilities and significant investment in chemical synthesis technology. US-based manufacturers, like Mylan, emphasize regulatory compliance and supply chain security.

Quality control remains paramount; suppliers gaining approval or certification from regulatory agencies such as the FDA or EMA can better assure quality, reduce regulatory risks, and facilitate easier approval processes for finished drug products.

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Import and Regulatory Dynamics

Global API sourcing involves navigating international trade regulations, tariffs, and import-export restrictions. Recent trends indicate increased scrutiny on Chinese and Indian API suppliers, emphasizing the need for transparent quality documentation and regulatory filings (e.g., Certificates of Analysis, Batch Records).

Regulatory agencies also require comprehensive screening for contaminants and residual solvents, necessitating suppliers with robust analytical testing capabilities.

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Supply Chain Risks and Mitigation

While China and India dominate manufacturing, supply chain disruptions—such as geopolitical tensions, pandemics, or regulatory shifts—pose risks. Diversification of sources and establishing dual or multiple suppliers can mitigate these risks. Qualified vendors with proven GMP compliance, validated production processes, and reliable logistical frameworks should be prioritized.

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Conclusion

Reliable bulk API sources for candesartan cilexetil are limited to reputable manufacturers primarily based in China, India, and select Western countries. Critical factors influencing sourcing decisions include regulatory compliance, manufacturing capacity, quality assurance, and geopolitical stability. Pharmaceutical companies must prioritize suppliers with rigorous quality systems, GMP certification, and transparent documentation to ensure consistent drug efficacy and safety.

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Key Takeaways

• Major Suppliers: Zhejiang Huahai (China), Hetero Labs (India), Mylan (USA/Global), Zhejiang Tauto (China), and Khandelwal Laboratories (India) are key APIs providers for candesartan cilexetil.
• Quality and Compliance: GMP certification and regulatory approvals from FDA/EMA are essential for supplier selection.
• Geographical Advantage: Chinese and Indian manufacturers dominate due to scale and cost advantages; Western suppliers emphasize regulatory rigor.
• Supply Chain Management: Diversify sourcing to mitigate geopolitical and logistical risks.
• Regulatory Due Diligence: Ensure thorough documentation, testing, and certification to meet international drug standards.

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FAQs

1. What are the primary regions supplying candesartan cilexetil API globally?
China and India lead the market in API manufacturing, with additional supplies from US-based companies such as Mylan. These regions offer a combination of large-scale production, cost efficiency, and global supply chain capabilities.

2. How do regulatory standards impact API sourcing for ATACAND?
Regulatory standards demand high-quality APIs produced under GMP conditions, accompanied by comprehensive documentation, analytical data, and compliance certificates. Suppliers meeting FDA and EMA standards reduce regulatory risks in drug approval processes.

3. What factors should companies consider when choosing an API supplier for ATACAND?
Companies should evaluate GMP certification, regulatory approval, capacity, quality control measures, documentation transparency, responsiveness to audits, and supply reliability.

4. Are there concerns about the sustainability of sourcing APIs from China and India?
Yes. While cost-effective, potential issues include geopolitical risks, trade restrictions, and quality variability. Diversification, supplier audits, and stringent quality agreements can mitigate these concerns.

5. How can pharmaceutical companies ensure the quality of candesartan cilexetil API?
Implement rigorous supplier qualification programs, require detailed Certificates of Analysis, perform independent testing, and conduct periodic audits to verify adherence to quality standards and regulatory compliance.

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Sources

[1] Pharmaceutical Technology. "Global supply chain dynamics for antihypertensive APIs." 2022.
[2] U.S. Food and Drug Administration (FDA). "GMP Guidelines for Active Pharmaceutical Ingredients." 2021.
[3] European Medicines Agency (EMA). "Guidelines on the Requirements for Active Substance Manufacturing." 2021.
[4] Global Data. "API manufacturing landscape for cardiovascular drugs." 2022.
[5] Industry Reports. "The Impact of Regional Manufacturing on API Supply Stability." 2022.