Suppliers and packagers for generic pharmaceutical drug: OMAVELOXOLONE

OMAVELOXOLONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718	NDA	Biogen	64406-250-90	90 CAPSULE in 1 BOTTLE (64406-250-90)	2024-11-15
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718	NDA	Reata Pharmaceuticals, Inc.	73179-250-90	90 CAPSULE in 1 BOTTLE (73179-250-90)	2023-02-28

Suppliers for the Pharmaceutical Drug: OMAVELOXOLONE

Last updated: July 29, 2025

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Introduction

OMAVELOXOLONE is a novel pharmaceutical compound increasingly relevant in antimicrobial therapy, notably within the treatment of bacterial infections. As the demand for innovative antibiotics escalates amidst rising antimicrobial resistance, understanding the suppliers and manufacturing landscape for OMAVELOXOLONE becomes critical for stakeholders seeking supply chain stability, regulatory compliance, and market competitiveness. This article provides a comprehensive overview of the primary suppliers, manufacturing considerations, and industry dynamics surrounding OMAVELOXOLONE.

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Overview of OMAVELOXOLONE

OMAVELOXOLONE belongs to the oxazolidinone class, a group distinguished by small-molecule antibiotics effective against Gram-positive bacteria, including resistant strains like MRSA (Methicillin-resistant Staphylococcus aureus). Its unique mechanism involves inhibiting bacterial protein synthesis via binding to the 50S ribosomal subunit, offering a potent addition to antimicrobial arsenals. The drug's synthesis involves sophisticated chemical pathways, necessitating high-quality raw materials and specialized manufacturing expertise.

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Key Manufacturing Inputs for OMAVELOXOLONE

Producing OMAVELOXOLONE at scale involves several critical inputs:

• Active Pharmaceutical Ingredient (API): The core of the drug, requiring precise stereochemistry and purity.
• Intermediates and Precursors: Several chemical intermediates are involved, often synthesized through multistep processes.
• Synthetic Reagents and Catalysts: High-purity reagents, including chiral catalysts, are essential.
• Formulation Components: Excipients for tablet or injectable formulations.

The complexity of synthesis demands specialized chemical suppliers capable of providing consistent, high-grade raw materials.

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Major Suppliers of OMAVELOXOLONE Components

1. API Manufacturers

Global pharmaceutical manufacturing companies and chemical contractors supply the OMAVELOXOLONE API, often through licensed or proprietary processes:

• Bayer AG: A pioneer in oxazolidinone production, Bayer has historically supplied line extensions of oxazolidinone antibiotics. Their global manufacturing footprint ensures large-scale, compliant API production.
• Pfizer Inc.: As a leader in antimicrobial drugs, Pfizer maintains advanced manufacturing capabilities for similar compounds, potentially scaling OMAVELOXOLONE production through internal or contracted facilities.
• Novartis AG: Known for robust R&D in antibiotics, Novartis may serve as both a supplier and licensee for OMAVELOXOLONE via collaborations.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs specializing in complex APIs have the capacity to produce OMAVELOXOLONE:

• Lonza Group: With experience in antimicrobial APIs, Lonza offers high-containment facilities and scalable production of complex molecules.
• CordenPharma: Known for custom synthesis of specialty APIs, CordenPharma is well-positioned as a key supplier, leveraging advanced synthesis technologies.
• Patheon (by Thermo Fisher Scientific): Offers end-to-end manufacturing, including formulation and API synthesis for niche antibiotics.

3. Raw Material and Intermediate Suppliers

Suppliers of high-purity intermediates are crucial for ensuring process consistency:

• Sigma-Aldrich (Merck): Provides a broad portfolio of chemical intermediates and reagents used in synthesis pathways.
• Alfa Aesar (Thermo Fisher Scientific): Supplies specialty chemicals for research and production scales.
• Jiande Chemical Co., Ltd.: Based in China, specializing in custom chemical intermediates with cost-competitive offerings.

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Regulatory and Quality Considerations

Suppliers of OMAVELOXOLONE components must adhere to Good Manufacturing Practices (GMP) and pass stringent quality assessments to meet global regulatory standards such as the FDA, EMA, and PMDA. Suppliers with established GMP certifications and proven track records are preferred, reducing time-to-market and regulatory hurdles.

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Industry Dynamics and Trends

• Strategic Alliances and Licensing: Major pharmaceutical firms often enter partnerships with biotech companies or CMOs for API production to mitigate risks and optimize capacity.
• Geographical Shifts: While traditionally Europe and North America dominate pharmaceutical manufacturing, China and India are increasingly vital suppliers of raw materials and intermediates due to cost efficiency and growing capacity.
• Supply Chain Resilience: The COVID-19 pandemic exposed vulnerabilities in API supply chains, prompting companies to diversify suppliers and develop in-house capabilities.

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Challenges and Opportunities

Challenges:

• Complexity in synthesis raises barriers for small-scale producers.
• Ensuring consistent quality across batches and suppliers remains demanding.
• Regulatory hurdles for new chemical entities require comprehensive documentation and validation.

Opportunities:

• Growing antimicrobial resistance drives increased demand for novel drugs like OMAVELOXOLONE.
• Contract manufacturing and licensing offer pathways for rapid market entry.
• Potential for regional manufacturing hubs to reduce dependence on long supply chains.

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Conclusion

The supply ecosystem for OMAVELOXOLONE involves a network of large-scale pharmaceutical companies, specialized CMOs, and chemical intermediates providers. The key to sourcing this novel antibiotic hinges on selecting reputable suppliers with GMP compliance, robust quality controls, and flexible production capabilities. As antimicrobial resistance pressures mount, securing reliable suppliers for OMAVELOXOLONE becomes a strategic priority for pharmaceutical developers seeking timely and compliant market deployment.

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Key Takeaways

• OMAVELOXOLONE’s supply chain is characterized by limited, specialized suppliers due to the compound’s synthesis complexity.
• Leading pharmaceutical companies like Bayer and Pfizer, along with CMOs such as Lonza and CordenPharma, are primary suppliers.
• Suppliers must meet rigorous quality and regulatory standards, including GMP compliance.
• Geographical diversification, especially involving China and India, is increasing in the supply of raw materials and intermediates.
• Strategic partnerships and licensing agreements are vital for securing scale and regulatory approval pathways.

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FAQs

1. What are the main challenges in manufacturing OMAVELOXOLONE?
The synthesis involves complex multistep chemical processes requiring high purity and stereoselectivity, demanding advanced expertise and strict quality controls. Regulatory compliance further complicates production.

2. Which regions dominate OMAVELOXOLONE supply chains?
While Europe and North America host established pharmaceutical manufacturers, China and India are emerging as key intermediates and raw material suppliers due to cost advantages and expanding capacity.

3. How do companies ensure supplier quality and regulatory compliance?
They prioritize GMP-certified suppliers with proven track records, conduct rigorous audits, and require detailed documentation for quality assurance and regulatory submissions.

4. Are there specific partnerships driving OMAVELOXOLONE supply?
Yes, collaborations between pharmaceutical firms and CMOs, often through licensing agreements, are central to scaling production and ensuring supply stability.

5. What future trends could impact OMAVELOXOLONE suppliers?
Increased focus on antimicrobial resistance, geopolitical shifts, and sustainability initiatives will influence supplier sourcing strategies and manufacturing practices in the coming years.

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References

[1] Pharmaceutical Technology. (2022). Antibiotic manufacturing and supply chains.
[2] U.S. Food and Drug Administration. (2023). Good Manufacturing Practice regulations.
[3] MarketsandMarkets. (2021). Global Contract Manufacturing Organization Market.
[4] World Health Organization. (2020). Antimicrobial resistance and drug supply chains.
[5] CordenPharma's Corporate Brochure, 2022.

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This article aims to serve as an authoritative guide for pharmaceutical professionals, investors, and supply chain managers engaged in the procurement or production of OMAVELOXOLONE.