Bulk Pharmaceutical API Sources for FOSINOPRIL SODIUM

Bulk Pharmaceutical API Sources for FOSINOPRIL SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23681451
ISpharm		I01-1155
Hangzhou APIChem Technology		AC-6227
ChemMol		30103132
ChemMol		49404523
Amadis Chemical		A842989
Oakwood Products		079501

Bulk Active Pharmaceutical Ingredient (API) Sources for: FOSINOPRIL SODIUM

Last updated: July 29, 2025

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Introduction

Fosinopril sodium, an angiotensin-converting enzyme (ACE) inhibitor, remains a vital agent in managing hypertension and congestive heart failure. As demands for the drug escalate globally, pharmaceutical companies seek reliable, high-quality API sources to ensure manufacturing efficiency and regulatory compliance. This article explores key bulk API suppliers for fosinopril sodium, detailing their manufacturing capabilities, quality standards, geographical presence, and market positioning. The insights provided aim to assist procurement professionals, regulatory affairs specialists, and pharmaceutical executives in making informed sourcing decisions.

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Global Market Landscape for Fosinopril Sodium API

Fosinopril sodium, introduced in the 1990s, has a well-established manufacturing profile, predominantly supplied by a handful of pharmaceutical and biotechnology companies across Asia, Europe, and North America. The API's complex synthesis involves multiple steps, demanding specialized expertise and robust quality control measures.

The market for fosinopril sodium API exhibits a concentrated supply chain, with dominant players possessing proven track records for stable supply, GMP compliance, and adherence to international standards. As regulatory scrutiny intensifies, manufacturers must demonstrate consistent quality, comprehensive documentation, and validation capabilities.

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Leading API Manufacturers for Fosinopril Sodium

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

Overview:
Zhejiang Huahai Pharmaceutical is one of Asia’s premier API manufacturers, holding a strong reputation for producing cardiovascular APIs, including fosinopril sodium. The company leverages advanced fermentation and chemical synthesis technologies, ensuring high purity and batch-to-batch consistency.

Capabilities:

• Complete GMP certification compliant with both Chinese and international standards (US FDA, EMA).
• Multi-ton production capacity for fosinopril sodium, enabling supply diversification.
• Comprehensive analytical and stability testing facilities.

Quality Assurance:

• Adheres to stringent quality control protocols aligned with ICH Q7 guidelines.
• Offers full documentation and validation reports, easing regulatory submissions worldwide.

Market Position:
Zhejiang Huahai's API manufacturing services are well-regarded, making it a preferred supplier for generic pharmaceutical companies seeking reliable fosinopril sodium APIs.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview:
Jiangsu Hengrui is a leading Chinese pharmaceutical manufacturer with a diverse API portfolio and robust R&D capabilities focused on cardiovascular and antihypertensive medications.

Capabilities:

• GMP-certified manufacturing facilities dedicated to small molecule APIs.
• Proven expertise in ACE inhibitors, including fosinopril sodium.
• Ability to scale production according to client needs.

Quality Assurance:

• Implements rigorous in-process controls, stability testing, and batch traceability.
• Complies with international regulatory standards, facilitating global market access.

Market Position:
Hengrui's growing international footprint and commitment to quality make it a dependable sourcing partner for fosinopril sodium.

3. Aurobindo Pharma Ltd. (India)

Overview:
Aurobindo is a major Indian API manufacturer with a broad portfolio of cardiovascular active ingredients. Their global outreach is supported by ISO certification and regulatory approvals across multiple jurisdictions.

Capabilities:

• Large-scale API manufacturing with facilities approved by USFDA, EUGMP, and other regulatory agencies.
• Proven expertise in manufacturing ACE inhibitors, including synthesis of fosinopril sodium.

Quality Assurance:

• Robust quality management systems, adherence to cGMP, and comprehensive regulatory documentation.
• Capable of custom synthesis, stabilization, and packaging configurations.

Market Position:
Aurobindo’s competitive pricing, reliable supply chain, and regulatory compliance position it as a preferred API supplier for fosinopril sodium in emerging and developed markets.

4. Teva Pharmaceuticals Industries Ltd. (Israel)

Overview:
Teva, a global generic pharmaceutical giant, supplies high-quality APIs with a focus on cardiovascular, CNS, and respiratory therapeutics.

Capabilities:

• Extensive manufacturing capacity with multi-source supply options.
• Experienced in complex synthesis pathways, including ACE inhibitors.

Quality Assurance:

• Maintains comprehensive quality systems adhering to ICH guidelines.
• Provides detailed dossier support for regulatory filings.

Market Position:
Teva’s focus on quality and reliability makes it an attractive API supplier, especially for large-scale commercial manufacturing.

5. Cipla Ltd. (India)

Overview:
Cipla is a key player in the global pharmaceutical API market, renowned for affordable, high-quality APIs across therapeutic areas, including cardiovascular drugs.

Capabilities:

• GMP-certified manufacturing plants capable of producing fosinopril sodium at commercial scale.
• Strong emphasis on process optimization and quality control.

Quality Assurance:

• Adheres stringently to international GMP standards.
• Provides comprehensive documentation and qualification support.

Market Position:
Cipla’s extensive distribution network and cost-effective supply position it as a strategic source, especially for markets requiring economical procurement.

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Regional Considerations for Sourcing Fosinopril Sodium API

• Asia: The primary manufacturing hubs—China and India—offer large-scale capacities at competitive costs. However, importers must perform rigorous supplier audits and verify compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.

• Europe: European suppliers tend to focus on premium quality with heightened regulatory requirements, suitable for markets emphasizing stringent quality assurance.

• North America: Preferred for suppliers with USFDA approval, ensuring drug safety and regulatory compliance.

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Regulatory and Quality Standards

API sourcing for fosinopril sodium necessitates strict adherence to GMP standards. Suppliers must provide comprehensive documentation, including:

• Certificates of Analysis (CoA)
• Batch records and validation reports
• Process validation documentation
• Stability data and shelf-life information
• Regulatory approvals or certifications (e.g., USFDA, EMA, PMDA)

Emerging regulatory trends also favor suppliers aligned with ICH guidelines, facilitating seamless registration processes in various jurisdictions.

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Supply Chain Considerations

• Consistency: Long-term partnerships with suppliers demonstrating consistent quality and supply volume reduce risk.
• Lead Time: Reliable suppliers with established logistics networks ensure timely delivery, critical for manufacturing continuity.
• Pricing: Cost competitiveness must be balanced with quality and regulatory compliance, especially given the API's complexity.

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Conclusion

The procurement of fosinopril sodium API requires meticulous supplier qualification, emphasizing quality, regulatory adherence, and capacity to scale. Notable global players—Zhejiang Huahai, Jiangsu Hengrui, Aurobindo, Teva, and Cipla—offer strong options, each with specific strengths aligned to different market needs. Selecting the right API source hinges on regulatory landscape, cost considerations, and supply chain robustness.

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Key Takeaways

• The primary fosinopril sodium API suppliers operate mainly in Asia (China, India) and have established extensive GMP-compliant manufacturing capabilities.
• Regulatory compliance, especially GMP and ICH adherence, is critical for seamless market approval.
• Long-term vendor qualification, including quality audits and validation, reduces manufacturing risk.
• Asian suppliers generally provide competitive pricing; European and North American suppliers emphasize compliance and consistent quality.
• Strategic sourcing involves balancing cost, capacity, quality, and regulatory requirements to ensure uninterrupted supply.

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FAQs

1. What are the critical quality attributes to verify in fosinopril sodium API suppliers?
Key considerations include assay purity (>99%), absence of residual solvents, compliance with pharmacopeial standards, stability data, and robust process validation documentation.

2. How can I ensure regulatory compliance when sourcing fosinopril sodium APIs?
Verify supplier GMP certifications (USFDA, EMA, others), review analytical certificates, conduct supplier audits, and request comprehensive documentation supporting quality and stability.

3. Are there regional differences in fosinopril sodium API quality standards?
While global standards aim for uniformity, regional regulatory agencies may have specific documentation or validation requirements. Asian suppliers often align with international standards, but due diligence is essential.

4. What factors influence the pricing of fosinopril sodium API?
Major factors include production scale, raw material costs, process complexity, supplier location, regulatory compliance costs, and market competition.

5. How does supplier capacity impact sourcing decisions for fosinopril sodium?
A supplier’s ability to meet current and projected demand ensures manufacturing continuity, mitigates supply disruptions, and allows flexibility for market fluctuations.

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References

1. [1] U.S. Food & Drug Administration (FDA). Guidance for Industry: Active Pharmaceutical Ingredients.
2. [2] International Conference on Harmonisation (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
3. [3] Pharma IQ. "Top Chinese API Manufacturers," 2022.
4. [4] GlobalData. "API Market Outlook," 2023.
5. [5] European Medicines Agency (EMA). API Manufacturing Standards, 2022.