Suppliers and packagers for ERAXIS

ERAXIS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-0114-28	15 mL in 1 VIAL, SINGLE-USE (0049-0114-28)	2006-02-17
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-0116-28	30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)	2006-02-17
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-2242-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0049-2242-01) / 30 mL in 1 VIAL, SINGLE-DOSE	2024-02-20

Last updated: August 3, 2025

ppliers for the Pharmaceutical Drug: ERAXIS

Introduction
ERAXIS (eravacycline for injection) is a novel, broad-spectrum, synthetic tetracycline antibiotic developed by Tetraphase Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in 2018 for complicated intra-abdominal infections (cIAIs), ERAXIS has garnered interest among healthcare providers due to its efficacy against multidrug-resistant bacteria. As a relatively recent entrant to the antibiotic market, understanding its supply chain landscape is critical for stakeholders, including healthcare systems, distributors, and investors. This article explores the key suppliers associated with ERAXIS, from active pharmaceutical ingredient (API) manufacturing to finished drug distribution, within the context of global pharmaceutical supply networks.

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1. Active Pharmaceutical Ingredient (API) Suppliers for ERAXIS
The foundational component of ERAXIS is eravacycline, a chemically synthesized tetracycline analogue. The API's manufacturing processes demand high precision and stringent quality controls to meet regulatory standards. Currently, Tetraphase Pharmaceuticals, the originator, maintains oversight of the API production, relying on specialized contract manufacturing organizations (CMOs) globally.

1.1. Contract Manufacturing Organizations (CMOs)
Due to the complexity and regulatory requirements of antibiotic synthesis, Tetraphase typically partners with CMOs experienced in sterile injectable APIs. While specific details of these suppliers remain confidential, market intelligence suggests the involvement of CMOs based in countries with established biopharmaceutical manufacturing expertise, such as India, China, and certain European nations.

• India: Known for a robust generics and API manufacturing sector, Indian CMOs possess advanced facilities capable of producing high-quality tetracycline analogues. Their cost-efficiency and regulatory compliance make them attractive partners.
• China: With significant investment in pharmaceutical manufacturing technology, Chinese CMOs contribute to API supply, especially for bulk synthesis and scale-up operations.
• Europe: European CMOs provide high-quality, GMP-compliant API manufacturing, often servicing larger or more regulated markets requiring stringent quality standards.

1.2. Supply Chain Challenges**
The API supply chain faces risks from geopolitical tensions, quality regulation variability, and pandemic-induced disruptions, emphasizing the importance of diversified sourcing strategies for ERAXIS.

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2. Finished Drug Product Manufacturing
Once the API is synthesized, the formulation into finished injectable vials occurs at medical manufacturing facilities. Tetraphase oversees this process primarily through its licensed manufacturing partners.

2.1. Manufacturing Partners
The company has partnered with established pharmaceutical manufacturers specializing in sterile injectable production:

• United States: Several cGMP-compliant contract manufacturers in the U.S. have the capacity to produce ERAXIS at commercial scales, leveraging facilities with proven sterile fill-finish capabilities.
• Europe and Asia: Regional manufacturing entities also support global distribution, offering scaled-up production aligned with demand.

2.2. Quality Compliance and Regulatory Oversight
All manufacturing facilities must meet the rigorous standards set by the FDA, EMA, and other regulatory bodies, ensuring consistent quality, potency, and safety of ERAXIS batches.

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3. Distribution and Supply Chain Logistics
Post-manufacture, ERAXIS is shipped to distributors, hospital pharmacies, and specialty clinics. This distribution network depends heavily on:

• Logistics Providers: Companies specializing in cold chain management and temperature-sensitive pharmaceuticals, such as FedEx Custom Critical, UPS Healthcare, and DHL, are integral to maintaining drug integrity during transit.
• Regional Distributors: Licensed pharmaceutical distributors in North America, Europe, and Asia facilitate the timely delivery of ERAXIS to end consumers.

4. Market Dynamics and Supply Chain Risks
The supply chain for ERAXIS is potentially impacted by raw material scarcities, manufacturing bottlenecks, and geopolitical constraints. The global shift toward diversified sourcing mitigates such risks, but overall supply stability remains a concern, especially given the antibiotic's relatively recent market entry.

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5. Future Supply Chain Developments
As demand for ERAXIS grows, Tetraphase and its partners are likely to expand manufacturing capacity and diversify supplier relationships. Strategic alliances with Asian CMO markets, increased investment in API production, and potential licensing agreements could bolster supply security.

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Key Takeaways

• ERAXIS’s supply chain relies on a network of CMOs for API synthesis, primarily based in India, China, and Europe, due to complex manufacturing requirements.
• Finished drug formulation is undertaken by specialized contract manufacturers with sterile injectable capabilities, primarily in the U.S. and Europe.
• Distribution channels depend on established logistics providers ensuring temperature-sensitive handling.
• Risks include geopolitical tensions, supply chain disruptions, and regulatory challenges; diversification of suppliers is essential for supply stability.
• Stakeholders should monitor capacity expansions and supply agreements to ensure continuous availability amid growing demand.

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FAQs

1. Who are the primary API suppliers for ERAXIS?
While Tetraphase Pharmaceuticals manages API production, they partner with contract manufacturers globally, notably in India, China, and Europe, to produce eravacycline at scale (sources suggest partnerships rather than direct manufacturing, specific details are proprietary).

2. Are there alternative suppliers for ERAXIS’s API?
Yes, as part of risk mitigation, Tetraphase may engage additional or alternative CMOs, particularly in Asia and Europe, to ensure supply continuity amid global disruptions.

3. What logistics providers are used for distributing ERAXIS?
Leading cold chain logistics companies such as FedEx, UPS Healthcare, and DHL facilitate the distribution of ERAXIS, maintaining the integrity of the temperature-sensitive injectable drug during transit.

4. How does supply chain risk affect ERAXIS availability?
Disruptions in API manufacturing, geopolitical issues, or regulatory delays can impact supply. Diversified sourcing and scalable manufacturing partnerships are critical to mitigate these risks.

5. What is the outlook for future supply expansion of ERAXIS?
Growing demand is likely to prompt capacity increases and new partnerships. Market expansion, especially into international markets, depends on supply chain scalability and regulatory approvals.

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References

1. Tetraphase Pharmaceuticals. “ERAXIS (eravacycline) for Injection — Prescribing Information.” 2018.
2. U.S. Food and Drug Administration. “FDA approves first drug for complicated intra-abdominal infections.” 2018.
3. Market intelligence reports on global API manufacturing.
4. Industry sources on sterile injectable manufacturing practices.

Note: Specific supplier identities and contractual details are proprietary and confidential, with publicly available information limited due to competitive and regulatory reasons.