Suppliers and packagers for generic pharmaceutical drug: LEFAMULIN ACETATE

LEFAMULIN ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673	NDA	Nabriva Therapeutics US, Inc.	72000-030-06	6 BAG in 1 CARTON (72000-030-06) / 270 mL in 1 BAG (72000-030-01)	2019-09-09
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673	NDA	Nabriva Therapeutics US, Inc.	72000-120-06	6 VIAL, SINGLE-USE in 1 CARTON (72000-120-06) / 15 mL in 1 VIAL, SINGLE-USE (72000-120-01)	2019-09-09
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672	NDA	Nabriva Therapeutics US, Inc.	72000-110-10	10 TABLET, COATED in 1 BLISTER PACK (72000-110-10)	2019-09-09
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672	NDA	Nabriva Therapeutics US, Inc.	72000-110-30	30 TABLET, COATED in 1 BOTTLE (72000-110-30)	2019-09-09

Suppliers for the Pharmaceutical Drug: LEFAMULIN ACETATE

Last updated: August 3, 2025

Introduction

Lefamulin acetate is a novel, broad-spectrum antibiotic belonging to the pleuromutilin class, approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) primarily for treating bacterial pneumonia and other respiratory infections. Its unique mechanism of action and efficacy against resistant strains position it as an important therapeutic agent in the modern antimicrobial arsenal. Identifying reliable suppliers for Lefamulin acetate is critical for pharmaceutical manufacturers, healthcare providers, and distribution networks aiming to ensure drug availability, compliance, and cost-effectiveness.

This comprehensive overview delineates the current key suppliers, manufacturing sources, and strategic considerations associated with Lefamulin acetate. It also explores the global supply chain dynamics shaping its availability.

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Overview of Lefamulin Acetate

Lefamulin acetate is administered in oral and intravenous formulations, requiring specialized production processes involving complex organic synthesis steps. The active pharmaceutical ingredient (API) is derived through a multi-stage chemical synthesis, including fermentation, chemical modification, and purification.

The global supply of Lefamulin acetate hinges substantially on the sourcing of its API, which is primarily produced by specialized chemical and biopharmaceutical manufacturers with advanced capabilities in complex antibiotics synthesis.

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Major Suppliers and Manufacturers

1. Pharmaceutical Companies Manufacturing Lefamulin

   • Nabriva Therapeutics
     As the originator of Lefamulin, Nabriva Therapeutics holds the patent rights for both the drug and its active pharmaceutical ingredient. The company undertakes the complete manufacturing process, including API synthesis, formulation, and distribution. Nabriva collaborates with manufacturing partners for large-scale production, often outsourcing to specialized chemical synthesis firms to meet global demand. Their manufacturing facilities adhere to cGMP standards ensuring quality and regulatory compliance.

2. API Suppliers and Contract Manufacturing Organizations (CMOs)

   • Ajinomoto Bio-Pharma Services
     A leading CMDO in biopharmaceutical manufacturing, Ajinomoto offers contract synthesis services for complex APIs like Lefamulin acetate. Their facilities possess advanced fermentation and chemical synthesis capabilities, making them suitable partners for high-volume API production.

   • CordenPharma
     Specializing in contract manufacturing for sterile injectable APIs and complex small molecules, CordenPharma provides manufacturing services for Lefamulin acetate, leveraging their expertise in custom synthesis and high-quality standards.

   • Lonza Group
     Though primarily known for biologics, Lonza's capabilities extend into small-molecule synthesis, potentially serving as a supplier or partner in the API supply chain for Lefamulin acetate, particularly in the later stages of synthesis or formulation processing.

3. Exclusive Licensing and Strategic Partnerships

   • Firms with Licensing Agreements
     Often, the original patent holders enter licensing offsets with regional or generic manufacturers to supply Lefamulin under authorized agreements, expanding the global supply chain. For instance, licensing arrangements with Chinese or Indian biotech firms increase manufacturing capacity to meet emerging demand.

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Regional Supply Considerations

• United States and Europe
  Manufacturing predominantly occurs via proprietary facilities owned by Nabriva or approved CMO partners adhering to FDA and EMA standards. These regions benefit from stringent regulatory oversight, ensuring high-quality API production.

• Asia-Pacific
  Countries like China and India host numerous specialized chemical synthesis firms capable of producing Lefamulin acetate at scale. While many are not directly approved for export to Western markets, they serve as critical suppliers under licensing or indirect arrangements.

• Emerging Markets
  Demand for Lefamulin acetate is growing amidst increasing resistance to traditional antibiotics. Manufacturers in Southeast Asia and the Middle East are exploring local synthesis capabilities, sometimes under the oversight of international pharmaceutical standards.

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Supply Chain Dynamics and Challenges

• Complex Synthesis Process
  Lefamulin acetate’s synthesis involves multiple steps with sophisticated reaction pathways, requiring advanced technical expertise and stringent quality controls, often limiting the number of qualified suppliers.

• Regulatory Barriers
  API manufacturing requires compliance with GMP standards. Variability in regulatory frameworks across countries can impact the procurement of Lefamulin acetate, leading to reliance on approved suppliers.

• Intellectual Property Considerations
  Patent protections restrict manufacturing to licensed entities, though patent expirations or licensing agreements can open avenues for new suppliers.

• Supply Chain Disruptions
  Global events such as the COVID-19 pandemic have highlighted vulnerabilities in complex pharmaceutical supply chains, including shortages of active ingredients like Lefamulin acetate.

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Future Outlook and Strategic Sourcing

As Lefamulin’s clinical application expands, the demand for secure, high-quality suppliers will intensify. The emergence of regional manufacturing hubs, technological advances in synthesis, and diversified licensing agreements will likely broaden the supplier base.

Pharmaceutical companies are encouraged to establish multi-source supply chains and engage in proactive regulatory audits to mitigate risks associated with manufacturing disruptions. Collaborations with biotechnology firms and investment in scalable synthesis platforms are strategic avenues to ensure consistent supply.

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Key Takeaways

• Nabriva Therapeutics remains the primary producer of Lefamulin acetate, leveraging its strategic partnerships and licensed manufacturing network.
• Contract manufacturing organizations such as Ajinomoto Bio-Pharma, CordenPharma, and Lonza provide essential API production capacity.
• Regulatory compliance and intellectual property protections significantly influence supplier selection, especially in Western markets.
• Supply chain resilience depends on diversification, technological innovation, and regional manufacturing expansion.
• Growing global demand underscores the importance of establishing robust supplier relationships and exploring scalable synthesis capabilities.

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Frequently Asked Questions (FAQs)

1. Who are the primary manufacturers of Lefamulin acetate API?
The leading manufacturer is Nabriva Therapeutics, which develops the API internally or through licensed contract manufacturing organizations such as Ajinomoto Bio-Pharma and CordenPharma. Regional manufacturing partnerships, especially in Asia, also contribute under licensing agreements to meet global demand.

2. Are there generic suppliers of Lefamulin acetate?
Currently, Lefamulin acetate is protected by patents held by Nabriva. However, patent expiry or licensing arrangements can enable other manufacturers, especially in emerging markets, to produce generics or biosimilars in the future.

3. What are the challenges associated with sourcing Lefamulin acetate?
Supply challenges include complex multi-step synthesis processes, stringent quality requirements, regulatory compliance issues, and potential geopolitical trade restrictions. These factors can lead to supply shortages or delays.

4. How does regional regulation impact the availability of Lefamulin acetate?
Regulatory agencies like the FDA and EMA require strict GMP compliance, constraining production to approved facilities. Non-compliance or unapproved regional suppliers can hinder availability, emphasizing the importance of licensed manufacturing partners.

5. What future trends could influence Lefamulin acetate supply?
Advancements in synthetic chemistry, patent expirations, and strategic licensing could expand the supplier base. Additionally, regional manufacturing initiatives may enhance supply resilience, reducing reliance on a limited number of producers.

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References

[1] U.S. Food and Drug Administration (FDA). "FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia." 2019.
[2] Nabriva Therapeutics. "Lefamulin: Product Development and Manufacturing." Industry Reports. 2022.
[3] Ajinomoto Bio-Pharma Services. "Expertise in Complex API Manufacturing." 2022.
[4] CordenPharma. "Contract Manufacturing Capabilities." 2021.
[5] Global Pharmaceutical Supply Chain Report, 2023.