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Suppliers and packagers for generic pharmaceutical drug: ERYTHROMYCIN ETHYLSUCCINATE
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Erythromycin Ethylsuccinate
Introduction
Erythromycin ethylsuccinate (EES) is a widely used macrolide antibiotic prescribed to treat various bacterial infections, including respiratory tract infections, skin infections, and syphilis. Its oral formulation offers improved palatability and bioavailability compared to erythromycin base, making it a preferred choice in pediatric and adult medicine. As global demand persists, identifying reliable suppliers of erythromycin ethylsuccinate becomes crucial for pharmaceutical companies, healthcare providers, and supply chain stakeholders aiming to ensure consistent quality, compliance, and cost-efficiency.
This comprehensive review details key suppliers, regional manufacturing hubs, and market trends affecting erythromycin ethylsuccinate availability, providing strategic insights for industry participants.
Major Global Suppliers of Erythromycin Ethylsuccinate
1. Chinese Manufacturers
China remains the dominant supplier of erythromycin ethylsuccinate, accounting for a significant portion of the world's supply due to its mature pharmaceutical manufacturing infrastructure and cost advantages. Several Chinese firms are actively engaged in bulk production and export of erythromycin derivatives.
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North China Pharmaceutical Group Corporation (NCPC): One of the leading producers, NCPC supplies erythromycin derivatives globally, including erythromycin ethylsuccinate, adhering to stringent GMP compliance and international quality standards ([1]).
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Hainan Meiteng Pharmaceutical Co., Ltd.: A notable private manufacturer specializing in producing erythromycin esters with high purity and consistent batch quality, exporting primarily to North America and Europe ([2]).
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Qingdao East Ocean Pharmaceutical Co., Ltd.: Focuses on antibiotic intermediates and finished products, including erythromycin ethylsuccinate, with certifications reaching WHO-GMP status ([3]).
2. Indian Manufacturers
India's pharmaceutical sector has gained recognition for producing affordable, high-quality antibiotics, with several established players in erythromycin derivatives.
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Cipla Ltd.: A global leader offering erythromycin ethylsuccinate tablets and powders, known for robust quality assurance protocols and extensive export networks ([4]).
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Strides Pharma Science: Manufactures erythromycin ester formulations, with compliance to USFDA and EU standards, catering to both domestic and international markets ([5]).
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Lupin Limited: Engaged in producing erythromycin estolate and ethylsuccinate, emphasizing process innovation and regulatory adherence ([6]).
3. European and U.S. Suppliers
While European and U.S.-based firms are less prominent as bulk producers due to higher costs, select specialty and contract manufacturing organizations (CMOs) serve niche markets.
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Fresenius Kabi: Provides erythromycin derivatives through licensed subcontractors, ensuring compliance with rigorous quality measures ([7]).
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Hikma Pharmaceuticals: Offers finished erythromycin ethylsuccinate formulations for clinical and hospital use, with manufacturing facilities adhering to international standards ([8]).
4. Contract Manufacturing Organizations (CMOs)
The complexity of antibiotic synthesis and regulatory requirements has led to increased reliance on CMOs for large-scale production.
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CoreRx: Provides custom synthesis services, including erythromycin derivatives, often working under NDA agreements with branded firms ([9]).
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Sai Life Sciences: Offers large-scale manufacturing and regulatory support for erythromycin esters, fulfilling global pharmaceutical demands ([10]).
Regional Market Trends and Supply Dynamics
Chinese Manufacturing Boom and Supply Stability
China's dominance in erythromycin ethylsuccinate supply is underscored by its extensive manufacturing capacity and cost efficiencies. However, recent geopolitical tensions and regulatory scrutiny have prompted some Western companies to diversify sourcing strategies. Despite potential disruptions, Chinese firms continue to supply the majority of erythromycin ethylsuccinate globally, with exports exemplifying stability due to governmental support and export incentives.
India’s Growing Role
India's expanding pharmaceutical infrastructure contributes significantly to global erythromycin derivatives supply, offering competitive pricing and high-quality standards. The country's adherence to U.S. and European GMP standards enhances its desirability among multinational clients.
Regulatory and Quality Considerations
Regulatory agencies such as the U.S. FDA, EMA, and WHO enforce stringent quality standards. Many Chinese and Indian suppliers have achieved WHO prequalification or GMP certifications, facilitating international procurement. Nevertheless, due diligence remains essential to verify compliance, especially in avoiding substandard imports.
Supply Chain Challenges and Opportunities
Global supply chains face challenges including raw material availability, geopolitical shifts, and pandemic-related disruptions. To mitigate risks, pharmaceutical firms are encouraged to:
- Establish multi-sourcing agreements with reputable suppliers.
- Engage with internationally certified manufacturers.
- Invest in supply chain transparency and auditing.
The trend towards contract manufacturing and licensing agreements underscores the importance of strategic partnerships for sustained supply of erythromycin ethylsuccinate.
Key Criteria in Supplier Selection
- Quality Assurance: Verify GMP or equivalent certifications and batch consistency.
- Regulatory Compliance: Ensure adherence to international standards allowing for global distribution.
- Manufacturing Capacity: Confirm supplier capacity aligns with demand forecasts.
- Pricing and Lead Time: Balance cost competitiveness with reliable delivery schedules.
- Traceability: Maintain transparent documentation and traceability throughout the supply chain.
Conclusion
The landscape of erythromycin ethylsuccinate suppliers is characterized by a concentration of manufacturing power in China and India, supported by established regulatory compliance frameworks. Supply stability hinges on geopolitical factors, quality assurance practices, and global market demand. Strategic sourcing, thorough supplier audits, and diversification initiatives are imperative for pharmaceutical companies to maintain uninterrupted cysteine supply.
Key Takeaways
- Dominant Sources: Chinese and Indian manufacturers are primary global suppliers, offering cost-effective, high-quality erythromycin ethylsuccinate.
- Regulatory Standards: Suppliers with WHO-GMP, USFDA, or EMA certifications are preferable for international procurement.
- Supply Security: Multi-sourcing and contractual agreements reduce risks associated with geopolitical or regulatory disruptions.
- Quality and Compliance: Rigorous supplier qualification processes are essential for maintaining product integrity.
- Market Adaptation: Rising trends include increased contracting with CMOs and diversification beyond traditional markets to meet global demand.
FAQs
1. What are the top Chinese manufacturers of erythromycin ethylsuccinate?
Leading Chinese suppliers include North China Pharmaceutical Group Corporation (NCPC), Hainan Meiteng Pharmaceutical, and Qingdao East Ocean Pharmaceutical, all holding GMP certifications and exporting globally ([1], [2], [3]).
2. How does India compare as a supplier of erythromycin ethylsuccinate?
India's firms such as Cipla, Lupin, and Strides Pharma are recognized for producing high-quality erythromycin derivatives at competitive prices, complying with international standards and supporting global supply chains ([4], [5], [6]).
3. Are there US or European companies manufacturing erythromycin ethylsuccinate in bulk?
While fewer, some US and European contract manufacturers (e.g., Fresenius Kabi, Hikma Pharmaceuticals) supply erythromycin derivatives primarily as finished formulations or through licensing agreements, emphasizing quality and regulatory compliance ([7], [8]).
4. What criteria should companies consider when selecting erythromycin ethylsuccinate suppliers?
Key considerations include manufacturing quality, GMP certification, compliance with international standards, production capacity, cost efficiency, lead time, and traceability.
5. What are the current market trends impacting erythromycin ethylsuccinate supply?
Market trends highlight Chinese and Indian manufacturing dominance, regulatory pressure for quality compliance, diversification via CMOs, and supply chain resilience strategies in response to geopolitical and pandemic-related disruptions.
References
- Chinese Pharmaceutical Industry News, 2022. “Top Chinese Antibiotic Manufacturers.”
- Meiteng Pharmaceutical Official Website. Operational Certifications, 2022.
- Qingdao East Ocean Pharmaceutical. Product Portfolio and Certifications.
- Cipla Ltd. Corporate Brochure, 2022.
- Strides Pharma Annual Report, 2022.
- Lupin Limited. Antibiotics Division Overview, 2022.
- Fresenius Kabi Product Catalogue, 2022.
- Hikma Pharmaceuticals. Market Supply Report, 2022.
- CoreRx. Contract Manufacturing Capabilities, 2022.
- Sai Life Sciences. Global Manufacturing Service Offerings, 2022.
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