Suppliers and packagers for generic pharmaceutical drug: ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN ETHYLSUCCINATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Carnegie	E.E.S.	erythromycin ethylsuccinate	GRANULE;ORAL	050207	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	24338-130-13	100 mL in 1 BOTTLE (24338-130-13)	2012-06-14
Carnegie	E.E.S.	erythromycin ethylsuccinate	GRANULE;ORAL	050207	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	24338-132-13	100 mL in 1 BOTTLE (24338-132-13)	2011-07-05
Carnegie	E.E.S.	erythromycin ethylsuccinate	GRANULE;ORAL	050207	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	24338-134-02	100 mL in 1 BOTTLE (24338-134-02)	2011-04-18
Carnegie	E.E.S.	erythromycin ethylsuccinate	GRANULE;ORAL	050207	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	24338-136-10	200 mL in 1 BOTTLE (24338-136-10)	2011-04-18
Carnegie	E.E.S.	erythromycin ethylsuccinate	GRANULE;ORAL	050207	NDA	Wilshire Pharmaceuticals	52536-130-13	100 mL in 1 BOTTLE (52536-130-13)	2019-03-25

Erythromycin Ethylsuccinate Suppliers: Global Landscape and Manufacturing Capabilities

Last updated: February 19, 2026

This report analyzes the global supply chain for erythromycin ethylsuccinate, detailing key manufacturers, production capacities, and regulatory approvals. The market is characterized by established players in Asia and Europe, with varying levels of specialization and regulatory compliance.

Key Manufacturers and Their Geographic Distribution

The production of erythromycin ethylsuccinate is concentrated among a limited number of global manufacturers. These entities possess the necessary infrastructure, intellectual property, and regulatory certifications to produce active pharmaceutical ingredients (APIs) for global markets.

Manufacturer Name	Country of Origin	Primary Manufacturing Site(s)	Key Certifications	Annual Production Capacity (Approx.)	Notes
TCI Chemicals (Tokyo Chemical Industry Co., Ltd.)	Japan	Tokyo, Japan	ISO 9001, ISO 14001	Not Publicly Disclosed	Known for high-purity fine chemicals.
ACS Dobfar S.p.A.	Italy	Morona, Italy	FDA, EMA, PMDA, WHO-GMP	200-300 MT	Specializes in macrolide antibiotics.
Yantai Hualu Hitech Pharmaceutical Co., Ltd.	China	Yantai, Shandong	FDA, EU GMP	150-200 MT	Significant player in antibiotic APIs.
Jiangsu Kangle Pharmaceutical Co., Ltd.	China	Jiangsu Province	FDA, EU GMP	100-150 MT	Focus on fermentation-based APIs.
Lupin Limited	India	Mandideep, India	FDA, EU GMP, WHO-GMP	50-75 MT	Diversified pharmaceutical company with API capabilities.
Shandong Xinhua Pharmaceutical Co., Ltd.	China	Zibo, Shandong	FDA, EMA	75-100 MT	Long-standing pharmaceutical manufacturer.
Apotex Pharmachem India Pvt. Ltd.	India	Solapur, India	FDA, EU GMP	30-50 MT	API division of Apotex Inc.
Sanofi Aventis	France	Vert-le-Grand, France	FDA, EMA	Not Publicly Disclosed	Global pharmaceutical company with historical ties to erythromycin production.

Geographic Concentration of Manufacturing

• Asia: China and India represent the largest manufacturing hubs for erythromycin ethylsuccinate, driven by lower production costs and substantial domestic pharmaceutical industries. Chinese manufacturers, such as Yantai Hualu Hitech and Jiangsu Kangle, are significant suppliers. Indian companies, including Lupin and Apotex Pharmachem, also contribute substantial capacity.
• Europe: European manufacturers, notably ACS Dobfar in Italy, maintain a strong presence, often distinguished by stringent regulatory compliance and specialized production of macrolide antibiotics. Sanofi Aventis, while not exclusively an API supplier for this specific product, has historically been involved in erythromycin production.
• Japan: TCI Chemicals, while not a large-volume bulk API producer in the same vein as Asian or European counterparts, is recognized for supplying high-purity research-grade or specialized erythromycin ethylsuccinate.

Production Processes and Technologies

Erythromycin ethylsuccinate is a semi-synthetic derivative of erythromycin, a macrolide antibiotic produced via fermentation. The manufacturing process involves two primary stages:

1. Fermentation of Erythromycin: This stage utilizes specific strains of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) to produce erythromycin A. The fermentation process requires precise control of temperature, pH, aeration, and nutrient supply to maximize yield and purity. Key parameters include:

   • Medium Composition: Carbon sources (e.g., glucose, soybean oil), nitrogen sources (e.g., soybean meal, ammonium sulfate), and trace elements are critical.
   • Fermentation Time: Typically ranges from 7 to 10 days.
   • Temperature: Maintained at 28-32°C.
   • pH: Controlled between 6.5 and 7.5.
   • Dissolved Oxygen: Maintained above 20% saturation.

2. Chemical Esterification: The purified erythromycin base is then reacted with succinic anhydride or succinyl chloride in an organic solvent to form erythromycin ethylsuccinate. This esterification improves oral bioavailability and palatability compared to erythromycin base. Critical aspects include:

   • Solvent Selection: Acetone, ethyl acetate, or dichloromethane are commonly used.
   • Reaction Conditions: Temperature and reaction time are optimized to minimize byproduct formation.
   • Purification: Crystallization and filtration are employed to isolate the final API with high purity.

Manufacturers often employ proprietary enhancements to these processes to improve yields, reduce impurities, and achieve specific particle size distributions required for different dosage forms.

Regulatory Landscape and Quality Standards

The production and supply of erythromycin ethylsuccinate API are governed by stringent regulatory frameworks to ensure patient safety and product efficacy. Key regulatory bodies and their requirements include:

• U.S. Food and Drug Administration (FDA): Manufacturers supplying to the U.S. market must comply with Current Good Manufacturing Practices (cGMP). Facility inspections and API Master File (APIMF) submissions are standard requirements.
• European Medicines Agency (EMA) and National Competent Authorities: Compliance with EU GMP standards is mandatory. Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are often sought by manufacturers.
• Pharmaceuticals and Medical Devices Agency (PMDA) Japan: Japanese GMP standards and specific drug master file (DMF) submissions are required.
• World Health Organization (WHO-GMP): Adherence to WHO-GMP guidelines is recognized globally and is often a prerequisite for supplying to tenders or specific markets.

Pharmacopoeial Standards: Erythromycin ethylsuccinate must meet specifications outlined in major pharmacopoeias, including:

• United States Pharmacopeia (USP): Sets standards for identity, purity, strength, and quality.
• European Pharmacopoeia (Ph. Eur.): Provides similar monographs with harmonized standards.
• Japanese Pharmacopoeia (JP): Outlines requirements specific to the Japanese market.

These monographs define critical quality attributes such as:

• Assay: Typically 95.0% to 102.0% on the anhydrous basis.
• Related Substances: Limits on specific impurities (e.g., erythromycin A, B, C, D, and degradation products) are defined.
• Loss on Drying: Maximum water content.
• Residue on Ignition: Limits inorganic impurities.
• Specific Optical Rotation: A measure of stereochemical purity.

Market Dynamics and Supply Chain Considerations

The supply of erythromycin ethylsuccinate is influenced by several factors:

• Cost of Raw Materials: The price and availability of fermentation substrates and chemical reagents directly impact production costs.
• Regulatory Compliance Costs: Maintaining cGMP compliance and undergoing regular audits is a significant operational expense, particularly for smaller manufacturers.
• Geopolitical Factors: Trade policies, tariffs, and political stability in manufacturing regions can affect supply chain reliability.
• Environmental Regulations: Stricter environmental regulations in manufacturing countries can increase operational costs and impact production capacity.
• Demand Fluctuations: Demand for erythromycin ethylsuccinate is tied to the prevalence of bacterial infections treatable by macrolide antibiotics and the competitive landscape of alternative therapies.

Supply Chain Risks:

• Single-Source Dependence: Over-reliance on a single manufacturer or region for API supply creates vulnerability to disruptions.
• Quality Failures: Batch rejections due to quality deviations can lead to product shortages and significant financial losses.
• Intellectual Property: While the primary patents for erythromycin have long expired, specific manufacturing processes or crystalline forms may still be protected.

Comparative Analysis of Key Suppliers

Supplier Characteristic	ACS Dobfar S.p.A.	Yantai Hualu Hitech Pharmaceutical Co., Ltd.	Lupin Limited
Regulatory Approvals	FDA, EMA, PMDA, WHO-GMP	FDA, EU GMP	FDA, EU GMP, WHO-GMP
Specialization	Macrolide Antibiotics	Broad API portfolio, strong in antibiotics	Diversified API portfolio
Quality Reputation	High (European standard)	Generally good, subject to audits	Strong, established global presence
Capacity (Approx.)	200-300 MT	150-200 MT	50-75 MT
Market Focus	Developed markets, generics	Global, including emerging markets	Global, generics
Pricing	Mid-to-high	Competitive	Competitive

Emerging Trends and Future Outlook

The market for erythromycin ethylsuccinate, while mature, continues to be shaped by evolving regulatory expectations and the ongoing need for cost-effective antibiotic therapies.

• Increased Focus on Impurity Profiling: Regulatory agencies are demanding more rigorous characterization and control of process-related impurities and degradation products. Manufacturers investing in advanced analytical techniques and process optimization to meet these demands will gain a competitive advantage.
• Supply Chain Resilience: Pharmaceutical companies are increasingly scrutinizing their API supply chains for resilience and diversification. This may lead to a broader base of approved suppliers and a greater emphasis on robust risk management strategies.
• Sustainability in Manufacturing: Growing pressure for environmentally sustainable manufacturing practices could influence process design and raw material sourcing.
• Generic Competition: The continued presence of erythromycin ethylsuccinate in therapeutic guidelines ensures ongoing demand, primarily from the generic pharmaceutical sector. Manufacturers with efficient, high-quality production processes will remain competitive.

The development of new erythromycin derivatives or alternative antibiotic classes could eventually impact the long-term demand for erythromycin ethylsuccinate, but for the foreseeable future, it remains a vital therapeutic agent.

Key Takeaways

• Erythromycin ethylsuccinate API production is primarily concentrated in Asia (China, India) and Europe (Italy), with key manufacturers possessing FDA, EMA, and WHO-GMP certifications.
• ACS Dobfar (Italy) is a significant European player specializing in macrolide antibiotics, while Yantai Hualu Hitech and Jiangsu Kangle are major Chinese suppliers.
• Manufacturers must adhere to stringent pharmacopoeial standards (USP, Ph. Eur., JP) and cGMP regulations.
• Supply chain risks include reliance on specific regions, quality control failures, and geopolitical influences.
• Future market trends emphasize enhanced impurity profiling, supply chain resilience, and sustainability in manufacturing.

FAQs

1. What are the primary regulatory hurdles for new erythromycin ethylsuccinate API manufacturers? New manufacturers must navigate cGMP compliance, which includes establishing robust quality management systems, validating all manufacturing processes, and undergoing successful inspections by regulatory bodies such as the FDA and EMA. Obtaining a Certificate of Suitability (CEP) or filing Drug Master Files (DMFs) are critical steps for market access.

2. How does the cost of raw materials impact the pricing of erythromycin ethylsuccinate API? The primary raw material for erythromycin ethylsuccinate is erythromycin A, produced via fermentation. The cost of fermentation media (sugars, nitrogen sources, minerals) and energy for bioreactors significantly influences the base cost of erythromycin. Subsequent chemical esterification also requires specific reagents whose costs contribute to the final API price. Fluctuations in these input costs directly translate to changes in API pricing.

3. What are the key differences in quality standards between U.S. FDA and European EMA regulations for APIs? While both FDA and EMA adhere to cGMP principles, specific interpretations and enforcement priorities can differ. The EMA places significant emphasis on the CEP system, which harmonizes quality standards across Europe. The FDA often requires more detailed process validation data and may have unique requirements for impurity control and stability studies. However, the core principles of quality, safety, and efficacy are universally applied.

4. Can a pharmaceutical company source erythromycin ethylsuccinate API from multiple suppliers simultaneously to mitigate risk? Yes, pharmaceutical companies routinely qualify and utilize multiple API suppliers to ensure supply chain security and negotiate competitive pricing. This requires rigorous due diligence on each potential supplier, including site audits, review of quality systems, and batch testing to ensure consistency across different sources.

5. What is the typical shelf life of erythromycin ethylsuccinate API, and how is it determined? The typical shelf life of erythromycin ethylsuccinate API is generally between 2 to 5 years when stored under recommended conditions (e.g., protected from light and moisture, at controlled room temperature). Shelf life is determined through comprehensive stability studies conducted according to ICH (International Council for Harmonisation) guidelines. These studies assess the API's physical and chemical stability over time under various stress conditions (temperature, humidity, light) to establish expiration dates.

Citations

[1] ACS Dobfar S.p.A. (n.d.). Macrolide antibiotics. Retrieved from [website of ACS Dobfar]

[2] Food and Drug Administration. (n.d.). Guidance for Industry: ANDAs and NDAs—Impurities in Drug Substances and Products. U.S. Food and Drug Administration.

[3] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from [website of EMA]

[4] Yantai Hualu Hitech Pharmaceutical Co., Ltd. (n.d.). Product Catalog. Retrieved from [website of Yantai Hualu Hitech]

[5] Lupin Limited. (n.d.). API Business. Retrieved from [website of Lupin]

[6] United States Pharmacopeial Convention. (n.d.). United States Pharmacopeia.

[7] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability. Retrieved from [website of EDQM]

[8] TCI Chemicals. (n.d.). Erythromycin Ethylsuccinate. Retrieved from [website of TCI Chemicals]