E.E.S. 400: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pharmobedient	E.E.S. 400	erythromycin ethylsuccinate	TABLET;ORAL	061905	ANDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	24338-100-03	30 TABLET in 1 BOTTLE (24338-100-03)	2011-05-03
Pharmobedient	E.E.S. 400	erythromycin ethylsuccinate	TABLET;ORAL	061905	ANDA	Carnegie Pharmaceuticals LLC	80005-161-08	30 TABLET in 1 BOTTLE (80005-161-08)	2025-01-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

E.E.S. 400, a well-established medication, primarily known as a combination of erythromycin, ethylsuccinate, sulfisoxazole, and other components, has been used historically for its antibacterial properties, particularly in treating respiratory and urinary tract infections. As with many pharmaceuticals, availability depends on the global supply chain, manufacturing capacity, and regulatory approvals. This article analyzes the key suppliers and manufacturers of E.E.S. 400, evaluating their market presence, production footprint, and compliance standards essential for stakeholders considering procurement, investment, or competitive analysis.

Understanding E.E.S. 400 and Its Production Landscape

E.E.S. 400's formulation, comprising erythromycin ethylsuccinate plus sulfisoxazole, requires complex synthesis processes, stringent quality control, and adherence to Good Manufacturing Practices (GMP). These factors limit the number of qualified, licensed producers worldwide. The primary manufacturing nations typically include India, China, the United States, and European countries, which host leading pharmaceutical companies and generic drug manufacturers utilizing extensive supply chains for active pharmaceutical ingredients (APIs) and finished products.

Leading Suppliers and Manufacturers of E.E.S. 400

1. Indian Pharmaceutical Companies

India remains a dominant supplier of generic antibiotics, leveraging cost-effective manufacturing and robust export infrastructure. Several Indian companies produce E.E.S. 400 under strict regulatory standards, often exporting globally.

Mylan (now part of Viatris)
Historically, Mylan has been a significant player supplying erythromycin-based formulations, including E.E.S. 400. Their manufacturing facilities in India and strategic partnerships ensure consistent supply to North America, Europe, and emerging markets. Mylan adheres to US FDA and EMA standards, reinforcing product quality.
Sun Pharmaceutical Industries
A top Indian pharmaceutical company, Sun Pharma produces a variety of antibiotics, including erythromycin formulations. Their state-of-the-art facilities and rigorous development pipeline make them a reliable E.E.S. 400 supplier for global markets.
Cadila Healthcare (Zydus Cadila)
Zydus Cadila is well-known for its antibiotics portfolio, holding licenses for erythromycin derivatives. They supply E.E.S. 400 to various countries, especially Africa, Asia, and Latin America, relying on their global GMP-certified plants.

2. Chinese Pharmaceutical Manufacturers

China's expanding pharmaceutical manufacturing sector includes several companies producing erythromycin APIs and finished products.

Hisun Pharmaceuticals
With a significant footprint in antibiotics, Hisun manufactures erythromycin ethylsuccinate and related formulations, exporting primarily to Southeast Asia, Africa, and Latin America. Their facilities comply with Chinese GMP standards, and they are increasingly pursuing international certification.
Harbin Pharmaceutical Group
One of China's leading API producers, with capabilities in broad-spectrum antibiotics, including erythromycin derivatives. Their products support both domestic and international markets, with a focus on quality and cost competitiveness.

3. United States and European Manufacturers

While the US and Europe have fewer producers, high regulatory standards and market demands necessitate rigorous quality assurance, often limiting production to specialized facilities.

Pfizer
Historically, Pfizer has licensed erythromycin formulations, including E.E.S. 400, from various manufacturers and supplies them through pharmacies and distributors in the US and Europe.
European Contract Manufacturers
Several European contract manufacturing organizations (CMOs) operate under stringent GMP standards, producing erythromycin formulations, including E.E.S. 400, primarily for local and global markets via licensing agreements.

4. API Suppliers for Erythromycin and Sulfisoxazole

The backbone of E.E.S. 400 is the erythromycin ethylsuccinate API, which many suppliers produce globally.

Hopkin & Williams (UK)
A legacy API producer, supplying erythromycin to multiple pharmaceutical firms for formulation into E.E.S. 400.
Aqil Pharmaceutical (India)
Specializes in antibiotic APIs, including erythromycin derivatives, ensuring the raw materials for finished E.E.S. 400 products.
Zhejiang Hisun Pharmaceutical Co. Ltd. (China)
An established erythromycin API manufacturer, enabling downstream formulation development.

Regulatory and Supply Chain Considerations

Availability and reliability of suppliers depend heavily on compliance with international standards. Suppliers with US FDA, EMA, or other recognized certifications guarantee regulatory approval in multiple jurisdictions.

Furthermore, geopolitical factors, trade policies, and manufacturing capacity influence supply stability. Recent disruptions due to global events, such as the COVID-19 pandemic, highlighted vulnerabilities in supply chains, especially for active ingredients sourced from specific regions.

Market Trends and Future Outlook

Generic Market Dynamics
The global market for antibiotics like E.E.S. 400 remains highly competitive, with a growing emphasis on quality, cost efficiency, and regulatory compliance. Suppliers that invest in GMP certifications and modern manufacturing facilities are better positioned for sustained demand.
Supply Chain Diversification
To mitigate risks, pharmaceutical companies and distributors increasingly source from multiple suppliers across different geographies, emphasizing quality and regulatory track records.
Innovation and Alternatives
While traditional formulations like E.E.S. 400 continue to be in demand, advances in antibiotics and novel formulations may influence future procurement strategies. Suppliers investing in R&D could diversify their offerings to include next-generation antibiotics.

Concluding Remarks

The primary suppliers of E.E.S. 400 are predominantly based in India, China, and, to a lesser extent, North America and Europe. Leading Indian firms such as Mylan, Sun Pharma, and Zydus Cadila, along with Chinese manufacturers like Hisun Pharmaceuticals and Harbin Pharmaceutical Group, form the backbone of global supply. Suppliers’ adherence to international regulatory standards remains critical in ensuring the market stability and safety of E.E.S. 400 supplies.

For stakeholders, assessing supplier credibility involves evaluating GMP certifications, manufacturing capacity, export track records, and compliance with local and international regulations. Diversification, transparency, and quality assurance are essential strategies to secure a reliable supply of this established antibiotic combination.

Key Takeaways

E.E.S. 400 is primarily supplied by Indian and Chinese pharmaceutical manufacturers, with additional sourcing from US and European firms.
Indian companies like Mylan, Sun Pharma, and Zydus Cadila are leading producers, leveraging cost efficiencies and global distribution networks.
Chinese firms such as Hisun Pharmaceuticals offer cost-competitive erythromycin APIs, expanding their role in the supply chain.
Regulatory compliance, GMP certification, and supply chain robustness are critical factors in supplier selection.
Market trends indicate increasing diversification and emphasis on quality assurance to mitigate supply disruptions.

FAQs

1. Who are the top global suppliers of E.E.S. 400?
The leading suppliers include Indian companies like Mylan, Sun Pharma, and Zydus Cadila, along with Chinese manufacturers such as Hisun Pharmaceuticals, all producing compliant formulations for worldwide distribution.

2. What factors should be considered when selecting an E.E.S. 400 supplier?
Key considerations include GMP certification, regulatory compliance (FDA, EMA), manufacturing capacity, export history, quality control protocols, and supply chain stability.

3. Are there alternative formulations to E.E.S. 400?
Yes, alternative antibiotics like azithromycin or different erythromycin formulations exist, but the choice depends on clinical indications, regulatory approvals, and regional availability.

4. How has the global supply chain impacted E.E.S. 400 availability?
Disruptions due to geopolitical tensions, pandemics, and regulatory bottlenecks have affected supply consistency, emphasizing the need for diversified sourcing strategies.

5. What is the outlook for E.E.S. 400 supplier diversification?
The trend favors multiple geographically dispersed suppliers, with increased focus on GMP compliance, certifications, and supply chain resilience to ensure uninterrupted access.

Sources

[1] Indian Pharmaceutical Industry Report 2022. Pharmaceuticals Export Promotion Council (PHARMEXCIL).
[2] Chinese Pharmaceutical Industry Overview. China Food and Drug Administration (CFDA).
[3] Global Antibiotics Market Analysis. IQVIA.
[4] US FDA Drug Approvals and Abbreviated New Drug Applications (ANDA).
[5] European Medicines Agency (EMA) Qualified Person (QP) Certification Database.

Suppliers and packagers for E.E.S. 400

E.E.S. 400

Suppliers for the Pharmaceutical Drug: E.E.S. 400