Bulk Pharmaceutical API Sources for eravacycline dihydrochloride

Bulk Pharmaceutical API Sources for eravacycline dihydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-16980A
AbaChemScene		CS-7480
MuseChem		I013150
AA BLOCKS		AA01EOPN
MolPort		MolPort-046-417-174
BLD Pharm		BD00852721

Bulk Active Pharmaceutical Ingredient (API) Sources for: ERAVACYCLINE DIHYDROCHLORIDE

Last updated: August 6, 2025

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Introduction

Eravacycline dihydrochloride, a synthetic tetracycline derivative, has garnered significant attention as a broad-spectrum antibiotic active against multi-drug resistant bacteria, including carbapenem-resistant Enterobacteriaceae (CRE). Its innovative mechanism targeting the bacterial ribosome and its enhanced stability against tetracycline-specific resistance mechanisms have positioned it as a promising pharmaceutical asset. Securing reliable sources for bulk eravacycline dihydrochloride API is critical for pharmaceutical companies, contract manufacturing organizations (CMOs), and investors aiming to meet escalating clinical demand.

This article explores the landscape of API suppliers for eravacycline dihydrochloride, analyzing key market players, manufacturing capabilities, sourcing considerations, and strategic trends shaping supply chain resilience.

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Market Overview of Eravacycline Dihydrochloride API Suppliers

1. Overview of the API Manufacturing Landscape

Given eravacycline’s recent approval status, the global API manufacturing community for this compound remains limited, predominantly concentrated among a few specialized biotech and pharmaceutical CDMOs with proprietary synthesis routes. The complex chemical synthesis, involving multiple stereoselective steps and advanced purification, necessitates high technical expertise, limiting mass production to experienced facilities.

2. Major API Suppliers

a. Tetraphase Pharmaceuticals (now involved in licensing and licensing partners)

Tetraphase Pharmaceuticals developed eravacycline, with initial manufacturing collaborations established with CDMOs capable of high-containment synthesis of complex tetracyclines. Currently, the company may serve as a primary source for early procurement, either directly or via licensed manufacturing partners.

b. Contract Manufacturing Organizations (CMOs)

While detailed supplier identities are often confidential, several global organizations specialize in tetracycline and similar broad-spectrum antibiotics. These include:

• Hetero Labs: Based in India, Hetero possesses extensive capacity for tetracycline derivatives and has shown capacity for complex API synthesis, including newer agents.
• Shandong Lukang Pharmaceutical (Lukang Pharma): Chinese pharmaceutical companies, such as Lukang, have expanded their antibiotic API portfolios, often producing tetracycline class APIs, possibly extending to eravacycline with licensing agreements.
• Granules India and Aurobindo Pharma: Known for generic tetracyclines, these firms may develop or already produce eravacycline APIs under licensing arrangements.

c. Proprietary Synthesis and Licensing Partners

Many pharmaceutical companies rely on strategic licensing agreements that include API manufacturing rights. These partners are often located in regions with established large-scale chemical synthesis capabilities, such as India, China, or specialized European facilities.

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Sourcing Considerations for Eravacycline API

3. Quality and Regulatory Compliance

Sourcing from qualified API manufacturers requires rigorous validation of cGMP compliance, stability profiles, impurity profile control, and adherence to international pharmacopoeia standards (USP, EP, JP). Suppliers should have documented stability data for the API, including moisture sensitivity and storage conditions.

4. Capacity and Supply Chain Security

Limited global manufacturers raise risks of supply shortages. Companies should evaluate supplier capacity, lead times, and contingency plans. Multiple sourcing strategies or strategic partnerships can mitigate risks associated with manufacturing disruptions, geopolitical factors, and regulatory hurdles.

5. Cost and Pricing Dynamics

Given the niche status, eravacycline API typically commands premium pricing due to synthesis complexity and limited competition. Bulk purchasing agreements or long-term supply contracts can improve pricing stability.

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Emerging Market Trends and Strategic Insights

6. Licensing and Strategic Alliances

Partnerships between innovator firms and regional manufacturers are becoming increasingly common to accelerate production capacity and meet global demand pressures. Licensing agreements often include technology transfer provisions to facilitate local manufacturing.

7. Technological Innovations in Synthesis

Advances in stereoselective synthesis, green chemistry, and process optimization are reducing costs and increasing throughput, enabling scalability. The adoption of continuous flow synthesis and other modern manufacturing techniques is expected to improve API supply resilience.

8. Regulatory Pathways and Global Market Access

Manufacturers with established registration in key markets (US, EU, China) possess advantage in API distribution. Companies should prioritize sourcing from suppliers with validated APIs compatible with regional regulatory requirements.

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Challenges and Opportunities

• Limited supplier diversity creates potential bottlenecks, underlining the importance of strategic supplier development.
• Intellectual property considerations may restrict access to certain synthetic methodologies, impacting new entrants.
• Expanding manufacturing capacity and technological investments are crucial to satisfy anticipated demand, especially in the face of rising antibiotic resistance.

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Conclusion

The supply chain for eravacycline dihydrochloride API remains niche, predominantly served by specialized CDMOs and regional pharmaceutical manufacturers with the requisite expertise in complex tetracycline synthesis. Ensuring supply security involves assessing manufacturer capabilities, regulatory compliance, capacity, and strategic licensing partnerships. As demand for advanced antibiotics grows globally, investments in manufacturing capacity and technology will be critical for a resilient and sustainable API sourcing strategy.

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Key Takeaways

• Eravacycline API sourcing is concentrated among a limited number of specialized manufacturers, primarily in India and China.
• High synthesis complexity demands rigorous quality standards and qualified suppliers with strong regulatory track records.
• Strategic licensing, technological advancements, and capacity expansion are pivotal to securing a reliable API supply.
• Diversifying supplier relationships and establishing long-term agreements minimize supply disruption risks.
• Companies should monitor technological trends and regulatory developments to optimize sourcing strategies.

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FAQs

1. Who are the main global manufacturers for eravacycline dihydrochloride API?
Major manufacturing capabilities are attributed to specialized CMOs and regional pharmaceutical firms in India and China, with the original synthesis developed by Tetraphase Pharmaceuticals and licensing partners.

2. What challenges do companies face in sourcing eravacycline API?
Limited supplier diversity, complex synthesis requiring high technical expertise, quality assurance, and regulatory compliance are primary challenges impacting supply chain stability.

3. How does licensing influence API sourcing for eravacycline?
Licensing agreements with technology transfer provisions enable regional manufacturers to produce the API, expanding supply options while maintaining quality standards through validated processes.

4. What technological advancements can enhance API production?
Innovations such as continuous flow synthesis, stereoselective catalysis, and greener chemical routes improve scalability, reduce costs, and enhance environmental sustainability.

5. Are there regional supply chain differences impacting API sourcing?
Yes, regional regulatory standards, manufacturing capacity, and geopolitical factors influence sourcing strategies, often making Asia-Pacific region a dominant hub for complex antibiotic APIs.

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References

[1] FDA Drug Approval Archive. Eravacycline (Xerava) Summary. 2018.
[2] GlobalData. Antibiotic API Market Analysis. 2022.
[3] Pharmaceutical Technology. Advances in Tetracycline Synthesis. 2021.
[4] Chemical & Engineering News. API Manufacturing in China and India. 2020.
[5] World Health Organization. Antimicrobial Resistance and Supply Risks. 2022.