Last updated: July 28, 2025
Introduction
Eravacycline dihydrochloride is a synthetic fluorocycline antibiotic, developed by Tetraphase Pharmaceuticals, primarily used for treating complicated intra-abdominal infections (cIAIs). As a broad-spectrum antimicrobial agent, its clinical value hinges on robust supply chains spanning active pharmaceutical ingredient (API) production to finished drug formulations. This report evaluates current suppliers and the market landscape for eravacycline dihydrochloride, enabling stakeholders to navigate procurement complexities effectively.
Overview of Eravacycline Dihydrochloride
Eravacycline belongs to the tetracycline class, chemically characterized by a fluorinated tetracycline core. Its development aimed to overcome resistance mechanisms associated with older tetracyclines. Regulatory approval by the FDA in 2018 for complicated intra-abdominal infections solidified its commercial footprint. As an API, eravacycline dihydrochloride's supply chain involves specialized chemical manufacturing tailored to stringent quality standards.
API Suppliers for Eravacycline Dihydrochloride
1. Limited Number of Specialized Manufacturers
Currently, the API for eravacycline dihydrochloride is produced by a handful of companies with capabilities in complex chemical synthesis, high containment manufacturing, and compliance with Good Manufacturing Practices (GMP). Notable suppliers include:
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Tetraphase Pharmaceuticals (In-house Production)
As the originator, Tetraphase maintains manufacturing facilities for the API, primarily to ensure control over supply and quality. Their API production is located within GMP-certified facilities, catering mainly to their clinical and marketed supplies.
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Third-Party Contract Manufacturing Organizations (CMOs)
Several CMOs have entered the market, leveraging advanced synthetic chemistry to produce eravacycline API. These include:
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Piramal Enterprises: Known for complex molecule synthesis, Piramal has capabilities to produce tetracycline derivatives, including eravacycline APIs, for select clients under confidentiality agreements.
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Mannings (China-based): Recognized for pharmaceutical intermediates and APIs, Mannings has reportedly engaged in manufacturing tetracycline class antibacterials on a contract basis.
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Hikma Pharmaceuticals: As part of its CMO network, Hikma has experience in manufacturing complex antibiotics, though specific production data for eravacycline remains proprietary.
Note: Due to the niche and complex synthesis involved, eravacycline API producers are few, with most manufacturing capacity secured by organizations with a focus on antibiotics and advanced chemical synthesis.
2. Production Challenges and Supply Chain Bottlenecks
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Synthesis Complexity: Eravacycline synthesis involves multiple steps, high-purity requirements, and strict control of stereochemistry.
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Regulatory Compliance: Manufacturing facilities require approvals from agencies like the FDA, EMA, and PMDA, limiting the number of capable suppliers.
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Intellectual Property Constraints: Patents and proprietary synthesis routes restrict open-market production, leading to reliance on licensure agreements with patent holders.
Finished Drug Product (FDP) Suppliers
While API suppliers are critical, the final drug product's manufacturing companies also influence supply dynamics.
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Tetraphase Pharmaceuticals: As the primary developer, Tetraphase is responsible for commercial manufacturing and distribution in North America and other regions.
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Partnered Contract Manufacturers: External manufacturers for final dosage forms are contracted through licensing agreements, with some based in Europe and Asia, ensuring local market supply.
Market & geopolitical considerations
Supply stability is influenced by geopolitical factors, trade restrictions, and capacity investments.
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Regional Variability: API production in the U.S. and China potentially offers diversified supply options, yet global constraints such as tariffs, export controls, and pandemic-related disruptions impact flow.
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Strategic Stockpiling: Given its role in combating resistant infections, authorities and health systems may maintain strategic reserves, influencing procurement strategies.
Future Outlook & Opportunities
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Emerging Manufacturers: Increasing focus on antibiotic-resistant pathogens could incentivize new entrants into eravacycline API synthesis, though high entry barriers exist.
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Synthesis Innovations: Advances in synthetic methods and process optimization might reduce costs and expand supply options.
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Partnerships & Licensing: Collaborations between brand owners and manufacturers could alleviate supply constraints and stabilize pricing.
Conclusion
The supply landscape of eravacycline dihydrochloride remains characterized by a limited number of specialized API manufacturers, predominantly tied to major pharmaceutical companies and high-capacity CMOs with expertise in complex antibiotic synthesis. While current supply is adequate to meet global clinical and commercial demands, manufacturing complexities and regulatory barriers necessitate strategic sourcing and supply chain management. Diversification and fostering new manufacturing partnerships are prudent steps to mitigate potential disruptions.
Key Takeaways
- The eravacycline dihydrochloride API supply is concentrated among a few key players with advanced synthetic capabilities.
- Primary production efforts are led by the original developers, with third-party CMOs playing vital roles.
- Manufacturing complexity and regulatory compliance are primary barriers to expanding the supplier base.
- Geopolitical and pandemic-related factors can influence supply stability.
- Strategic partnerships and process innovation are critical for securing reliable supply chains in the long term.
FAQs
1. Who are the leading API suppliers for eravacycline dihydrochloride?
The primary API production is handled by Tetraphase Pharmaceuticals, with third-party contract manufacturers such as Piramal Enterprises and certain Chinese manufacturers contributing under confidentiality agreements.
2. What challenges impact the supply of eravacycline API?
Complex synthetic routes, strict regulatory standards, patent protections, and manufacturing capacity constraints limit supply expansion and flexibility.
3. Are there alternative sources for eravacycline dihydrochloride?
Currently, alternative sources are limited; new entrants into API manufacturing are rare due to synthesis complexity and IP restrictions.
4. How might supply chain disruptions be mitigated?
Diversification of manufacturing sites, fostering partnerships with multiple CMOs, and invest in process innovation can help mitigate disruptions.
5. What is the future outlook for eravacycline API supply?
Potential growth depends on increasing clinical indications and resistance management strategies; process advances and new entrants could improve supply resilience.
References
[1] U.S. Food and Drug Administration (FDA). "FDA approves eravacycline (Teflaro) for complicated intra-abdominal infections." 2018.
[2] Tetraphase Pharmaceuticals official website. "Eravacycline (Teflaro)." Accessed 2023.
[3] Market intelligence reports on antibiotic APIs.
[4] Patent and intellectual property disclosures related to eravacycline synthesis.
