Suppliers and packagers for FOSINOPRIL SODIUM

FOSINOPRIL SODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	091163	ANDA	Aurobindo Pharma Limited	65862-471-30	30 TABLET in 1 BOTTLE (65862-471-30)	2011-03-30
Aurobindo Pharma Ltd	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	091163	ANDA	Aurobindo Pharma Limited	65862-471-90	90 TABLET in 1 BOTTLE (65862-471-90)	2011-03-30
Aurobindo Pharma Ltd	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	091163	ANDA	Aurobindo Pharma Limited	65862-471-99	1000 TABLET in 1 BOTTLE (65862-471-99)	2011-03-30
Aurobindo Pharma Ltd	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	091163	ANDA	Aurobindo Pharma Limited	65862-472-30	30 TABLET in 1 BOTTLE (65862-472-30)	2011-03-30

Suppliers for the Pharmaceutical Drug: Fosinopril Sodium

Last updated: July 29, 2025

Introduction

Fosinopril sodium is an angiotensin-converting enzyme (ACE) inhibitor used primarily in the management of hypertension and heart failure. Since its approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), fosinopril sodium has become an essential therapeutic agent worldwide. Its manufacturing involves complex chemical synthesis and stringent quality standards, limiting the number of reliable suppliers capable of producing pharmaceutical-grade active pharmaceutical ingredients (APIs). This article provides a comprehensive overview of key suppliers for fosinopril sodium, examining their manufacturing capabilities, regulatory standing, and market influence, assisting stakeholders in procurement, supply chain management, and competitive analysis.

Manufacturing Landscape and Market Players

1. Original Equipment Manufacturers (OEMs)

The initial development and commercial manufacturing of fosinopril sodium were undertaken by pharmaceutical companies such as Chugai Pharmaceutical Co., Ltd., which first developed the drug in the 1980s. While some OEMs still supply APIs to authorized generics or subsequent manufacturers, the dominant market comprises several specialized API manufacturers that operate under Good Manufacturing Practice (GMP) standards.

2. Leading API Suppliers for Fosinopril Sodium

a. Zhejiang Xianju Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Xianju Pharmaceutical is one of the prominent Chinese API manufacturers with a track record of producing ACE inhibitors, including fosinopril sodium, under GMP certification. The company leverages significant capacity, competitive pricing, and compliance with international standards, making it a preferred supplier across Asia and emerging markets.

Capabilities: They manufacture pharmaceutical-grade fosinopril sodium with high purity (>99%) and supply both bulk APIs and intermediates. The company adheres to strict quality controls, and their facilities meet ISO and WHO GMP standards.

Regulatory Status: While primarily serving Asian markets, their API is often sourced by international pharmaceutical firms through third-party distributors, especially for export markets requiring WHO-GMP certification.

b. Hunan Sinuo Biopharmaceutical Co., Ltd. (China)

Overview: Hunan Sinuo Biopharmaceutical specializes in ACE inhibitors, including fosinopril sodium, with a focus on high-quality manufacturing for both domestic and export markets.

Capabilities: Equipped with advanced synthesis and purification processes, Hunan Sinuo ensures compliance with global regulatory standards, offering APIs that meet pharmacopoeial requirements.

Regulatory Status: Their APIs are recognized in multiple regions, including the US (via authorized distributors), Europe, and Asia, thanks to their adherence to GMP and rigorous quality assurance protocols.

c. Global API Suppliers with Direct Supply Capabilities

• Jubilant Life Sciences (India): Jubilant manufactures a broad portfolio of active pharmaceutical ingredients, including ACE inhibitors. Although fosinopril sodium is not their flagship, they have the technical capacity to produce custom orders and are perceived as reliable suppliers within global chains.

• Cipla Limited (India): Known for a broad spectrum of generics, Cipla has the capacity to produce fosinopril sodium, especially for markets in Asia, Africa, and Latin America.

d. European and North American Chem suppliers

Due to strict regulatory requirements, only a few European and North American firms produce fosinopril sodium, primarily for research purposes, advanced formulations, or highly regulated markets. Firms like Toronto-based Alderley Chemical occasionally offer custom synthesis of ACE inhibitors but not always in volume suitable for large-scale procurement.

3. Contract Manufacturing Organizations (CMOs)

Several CMOs in Asia and Eastern Europe have established capacities for fosinopril sodium synthesis, providing custom manufacturing services. Their growing prominence stems from increasing demand for affordable APIs and the globalization of supply chains.

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Regulatory and Quality Considerations

Suppliers must comply with international GMP standards to ensure API safety and efficacy. Regulatory agencies such as the FDA, EMA, and WHO require rigorous documentation, validation records, and batch testing. Suppliers with approved inspections and certifications tend to be favored in procurement negotiations, especially for markets with stringent regulatory oversight.

Market Dynamics and Supply Chain Factors

The sourcing of fosinopril sodium is influenced by factors such as geopolitical stability, manufacturing capacity, regulatory compliance, and pricing. Chinese manufacturers dominate the supply of fosinopril sodium due to cost competitiveness and manufacturing scale, but supply chain risks exist amidst global trade tensions and quality concerns. European and North American suppliers may offer higher assurances of quality but at higher costs and potentially lower capacity.

Key Challenges and Opportunities

• Supply Reliability: Ensuring continuous supply amid geopolitical shifts and raw material shortages.

• Regulatory Approval: Verifying suppliers' regulatory credentials aligns with intended markets—for example, obtaining FDA or EMA approval.

• Cost Management: Balancing quality compliance against procurement expenses, especially for bulk sourcing.

• Quality Assurance: Prioritizing suppliers with proven quality systems, batch consistency, and robust in-process controls.

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Conclusion

The market for fosinopril sodium API is primarily characterized by Chinese manufacturers such as Zhejiang Xianju Pharmaceutical and Hunan Sinuo Biopharmaceutical, providing scale, cost advantages, and GMP-compliant products suitable for global markets. European and North American suppliers are fewer, focusing on high-regulatory-standard manufacturing for niche or highly regulated markets. Stakeholders should consider supplier track record, regulatory approvals, and supply chain stability when selecting fosinopril sodium suppliers. Strategic partnerships with reliable API manufacturers facilitate supply chain resilience and compliance, supporting uninterrupted product availability.

Key Takeaways

• The primary global suppliers of fosinopril sodium are Chinese API manufacturers with GMP certification, notably Zhejiang Xianju Pharmaceutical and Hunan Sinuo Biopharmaceutical.

• European and North American providers are limited, often serving research or niche markets due to regulatory and manufacturing capacity constraints.

• Regulatory compliance, especially GMP standards and approval status, dictates supplier selection, especially for use in highly regulated markets.

• Market dynamics are shifting towards Asia for cost-effective API sourcing, but supply chain risks necessitate diversification and quality assurance.

• Strategic sourcing, validated through regulatory credentials and supply stability, is critical to securing reliable supply of fosinopril sodium.

FAQs

1. What are the primary sources of fosinopril sodium APIs globally?
Chinese manufacturers dominate the market, notably Zhejiang Xianju Pharmaceutical and Hunan Sinuo Biopharmaceutical, due to their large-scale GMP-compliant production capabilities.

2. How can buyers ensure API quality and regulatory compliance?
Buyers should verify supplier GMP certifications, review inspection reports, and seek documentation such as COAs and regulatory approvals (FDA, EMA, WHO) to confirm quality standards.

3. Are there any risks associated with sourcing fosinopril sodium from China?
Potential risks include supply chain disruptions, quality variability, and regulatory compliance differences. Partnering with established, certified suppliers mitigates these risks.

4. Can fosinopril sodium APIs be sourced from European or North American suppliers?
Yes, but limited supply and higher costs often restrict these options to high-regulatory-standard markets, usually for research or specialized formulations.

5. Is there potential for new suppliers to enter the market?
Emerging API manufacturers, especially in Asia and Eastern Europe, may enter the market with GMP-compliant facilities to meet growing global demand, contingent on regulatory approvals and capacity investments.

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Sources:

[1] FDA Drug Approvals and Monographs.
[2] European Medicines Agency (EMA) Data.
[3] Global API Market Reports, IQVIA, 2022.
[4] Pharmaceutical APIs China Market Report, 2022.
[5] WHO Prequalified APIs Database.