Suppliers and packagers for zemdri

zemdri

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303	NDA	Cipla USA Inc.	69097-820-96	10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37)	2018-07-16
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303	NDA	Achaogen, Inc.	71045-010-02	10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01)	2018-07-16
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303	NDA	Cipla Therapeutics Inc.	80735-820-96	10 VIAL in 1 CARTON (80735-820-96) / 10 mL in 1 VIAL (80735-820-37)	2018-07-16

Suppliers for the Pharmaceutical Drug: ZEMDRI (Zemdri, plazomicin)

Last updated: August 5, 2025

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Introduction

ZEMDRI (generic name: plazomicin) is an aminoglycoside antibiotic developed by Achaogen, intended for the treatment of complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia (HABP). As a novel aminoglycoside, ZEMDRI addresses rising antimicrobial resistance issues, particularly against multidrug-resistant Enterobacteriaceae. Understanding its supply chain landscape, including primary and secondary suppliers, is essential for stakeholders involved in procurement, manufacturing, and distribution.

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Manufacturers and Primary Suppliers of ZEMDRI

1. Achaogen: The Original Developer and Distributor

Achaogen initially held manufacturing rights for ZEMDRI. Their facilities were responsible for the production, quality control, and distribution of the drug before the company's financial difficulties led to bankruptcy in early 2020. Despite Achaogen's bankruptcy, the drug’s intellectual property rights, including patents, may still influence supply options.

2. Third-Party Contract Manufacturers

Following Achaogen's insolvency, production of ZEMDRI has shifted to third-party contract manufacturing organizations (CMOs). These CMOs are engaged to produce the active pharmaceutical ingredient (API) and finished drug product, ensuring compliance with Good Manufacturing Practice (GMP) standards. However, specific details on these CMOs are typically proprietary, often undisclosed to the public.

3. Availability from Licensing Agreements

In the period following Achaogen's bankruptcy, sublicensees or licensing partners may hold rights to manufacture or distribute ZEMDRI in certain regions. As of 2023, there are limited public records indicating active licensing arrangements involving ZEMDRI, complicating direct supply chain tracing.

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Supply Chain Challenges and Implications

1. Patent and Intellectual Property Constraints

Despite patents expiring in many jurisdictions, manufacturing rights remain protected in key markets, requiring license agreements. These protections can limit the number of suppliers, constraining supply chains, especially during high demand or drug shortages.

2. Manufacturing Capacity and CMO Scarcity

Producing advanced antibiotics like ZEMDRI involves complex fermentation and purification processes. The limited number of qualified CMOs capable of producing high-quality APIs for such drugs reduces supply flexibility. Regulatory hurdles further limit the rapid scaling of production, especially since antibiotic manufacturing is stringently monitored due to biosafety concerns.

3. Distribution and Market Access

Health authorities and hospitals procure ZEMDRI mainly through licensed distributors or directly from manufacturers/licensed partners. Limited options can lead to supply bottlenecks, especially given the critical need for antibiotics effective against resistant strains.

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Regional and Regulatory Considerations

• United States: The FDA approved ZEMDRI in 2018; production has been primarily managed by Achaogen prior to bankruptcy. Post-bankruptcy, distribution relies on licensing partners or authorized distributors.

• Europe and Asia: Regulatory approval and distribution are limited or pending, with local licensing agreements determining supply sources.

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Alternative and Future Suppliers

As of 2023, efforts are underway by pharmaceutical companies and biotech firms to develop generic or biosimilar versions of ZEMDRI or similar aminoglycosides. These initiatives could diversify supply sources but are still in early development stages, limiting their immediate impact.

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Strategic Implications for Stakeholders

• Hospitals and procurement agencies should consider potential supply disruptions due to sole-source manufacturing and explore stockpiling strategies or alternative therapies.
• Manufacturers and license holders must demonstrate robust capacity and compliance to avoid supply shortages.
• Regulatory bodies need to monitor supply chain resilience, given the critical importance of ZEMDRI in combating resistant infections.

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Conclusion

The supply landscape for ZEMDRI remains concentrated, predominantly reliant on the licensing arrangements stemming from Achaogen’s patent rights. The limited number of high-capacity CMOs and the complexities of antibiotic manufacturing constrain supply chain flexibility. As the landscape evolves, stakeholders must monitor licensing developments, manufacturing scalability, and regulatory approvals to ensure uninterrupted access.

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Key Takeaways

• Supply Dependence: Currently, ZEMDRI supply hinges on a limited number of licensors and contract manufacturers, posing risks of shortages.
• Manufacturing Complexity: The complex production process and regulatory scrutiny restrict rapid scaling and diversification of supply sources.
• Post-Achaogen Landscape: Achaogen's bankruptcy affects distribution channels; future licensing and manufacturing agreements will shape supply stability.
• Market Dynamics: The rising demand for effective antibiotics against resistant pathogens underscores the need to expand manufacturing capacity.
• Proactive Strategies: Stakeholders should consider inventory management, alternative therapies, and tracking licensing developments to mitigate supply risks.

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FAQs

1. Who are the current manufacturers of ZEMDRI?
Post-Achaogen bankruptcy, ZEMDRI is produced through third-party contract manufacturing organizations under licensing agreements. Specific manufacturer identities are proprietary and not publicly disclosed.

2. Are there alternative suppliers for ZEMDRI globally?
Currently, no significant alternative suppliers exist. Licensing and manufacturing limitations restrict supply, emphasizing the need for strategic procurement planning.

3. What challenges exist in scaling up ZEMDRI production?
The complex fermentation, purification processes, and regulatory requirements for antibiotic manufacturing limit rapid scale-up, especially given the specialized nature of aminoglycoside production.

4. How might future supply chains evolve for ZEMDRI?
Emerging licensing agreements, biosimilar development, and manufacturing capacity expansion could diversify supply sources, reducing reliance on a single producer.

5. What are the risks of supply shortages for ZEMDRI?
Dependence on limited licensed manufacturers and production challenges pose risks of shortages, potentially impacting treatment options for resistant infections.

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References

1. FDA approval announcement for ZEMDRI (2018): FDA
2. Achaogen bankruptcy filings: SEC Filings, 2020.
3. Industry reports on antibiotic manufacturing: IQVIA, 2022.
4. Patent information: European Patent Office, Patent Database.
5. Regulatory updates: EMA and FDA registries, 2023.

(Note: For proprietary or sensitive details about specific manufacturing partners, consult industry-specific intelligence reports or direct company disclosures where available.)